Genome editing is an exciting but still nascent field, and companies in the area face as many obstacles as they do opportunities. Sangamo CEO Sandy Macrae told us how his company is being cautious about the hype and finding ways to be financially viable in an emerging space.

Cutting edge is, for once, a truly apt description when it comes to gene editing both because the field is pushing medicine into areas we might never have dreamed possible, and because these technologies involve literally cutting DNA at a specific point in the genome.

This has, of course, garnered immense excitement Doctors Emmanuelle Charpentier and Jennifer Doudna were named winners of the Nobel Prize for chemistry in recognition of their discovery of CRISPR/Cas9 gene editing technology.

Since that discovery, a flurry of gene-editing focused biopharma companies have launched including Intellia Therapeutics, CRISPR Therapeutics, Caribou Biosciences and Mammoth Biosciences and the first drug therapies based on the technology are now in human testing for diseases like cancer.

California-based Sangamo Therapeutics is one such company that believes in the powerful potential of in vivo genome editing and regulation, together known as genome engineering, and has built up a sizable preclinical pipeline of genome regulation treatments for diseases such as Huntingtons disease and Amyotrophic lateral sclerosis (ALS).

But when I spoke to CEO Sandy Macrae during the JP Morgan Health Care Conference 2021, he stressed that companies cannot be successful in the area unless they are wise about the hype, and understand that focusing purely on in vivo editing is unlikely to be financially viable for some time.

Zinc fingers

Macrae had previously worked at GSK and Takeda before he was recruited by Sangamo.

Maybe in 50 years time well be using gene editing to lower cholesterol, but it wont replace statins in anyone but those with life threatening mutations for a long time

They wanted someone who had lots of experience in drug development, was a molecular biologist, and was stubborn enough to take on CRISPR! he jokes.

Since Macrae joined the company just four years ago, Sangamo has more than tripled its staff and raised $1.6 billion in funding. It has also built its own manufacturing site and launched partnerships with six big pharma companies.

This growth reflects the continued and increasing interest in gene therapy and with stock prices rising for editing companies across the board, Macrae says there has never been a more interesting time to be in genomic medicine.

When I started in 2016 it was still a very academic field without much industrial interest. Then over the next two or three years, gene therapy was accepted as something that companies got involved in, and several biotechs have been bought up by big pharma.

And Macrae notes that we still dont even know the full potential for the field.

At the moment its mostly being applied to ultra-rare diseases. That can be incredibly effective, but it doesnt allow for a sustainable business model. Thats why companies like ours have decided to move into larger unmet medical needs such as transplant, multiple sclerosis, or inflammatory bowel disease.

The companys primary technology is its zinc finger (ZF) platform. ZFPs can be engineered to make zinc finger nucleases, or ZFNs, which are proteins that can be used to edit genomes by knocking select genes in or out to specifically modify DNA sequences.

ZFPs can also be engineered to make ZFP transcription-factors, or ZFP-TFs, which are proteins that can be used to regulate genomes by selectively increasing or decreasing gene expression.

Zinc fingers are the most common control gene in the body, Macrae explains. We can place them near the promoter of a gene and repress or upregulate it.

The exact mechanism depends on the disease in question. For example, the company is working on repressing promoter genes in tauopathies in collaboration with Biogen, but its partnership with Novartis is focused on upregulating genes related to autism, both leveraging the ZFP-TF platform.

The genomic medicine journey

Genome editing and regulation are still in their early stages, though, and Macrae says the fields evolution is likely to come in waves.

First of all it will be used for ultra-rare monogenic disease. Then itll be used for common monogenic disease, then polygenic disease or diseases where theres a genetic component. And ultimately we will be able to add genetic influences to diseases that dont have a genetic cause. Hypertension is one example there are probably 20-30 genes that control your hypertension, and perhaps one day well be able to identify which ones we can turn up or down.

Thats some way off, but it could be a whole new way of treating people.

That said, Macrae notes that the industry needs to be cautious about this hype.

We have to be thoughtful and prudent, because the worst thing that could happen is that gene editing is used in the wrong kind of patient, where theres a risk without a benefit. That would just slow the whole field down.

This is still a new area of medicine, and every company is realising that we dont always know as much about some of these rare diseases as we thought we did. Weve never had treatments for these conditions before, and now that we do we often find that we need to know a lot more about the physiology and the pathology of the disease than we imagined.

Many companies in this area tell wonderful stories about preclinical potential, but once youre in a clinical trial it doesnt matter how clever your science is what matters is whether the patient gets better, and because of that you really need to understand the potential risk.

Gene editing, he says, still has to go through a long journey to truly reach this potential.

That involves collecting as much safety data and uncovering as much about the benefit-risk profile as we can, Macrae says. The benefit-risk for a child thats going to die without treatment is unquestioned. The benefit for lowering your cholesterol, when there are other tools you can use, is more uncertain. We shouldnt go there until we have enough data to be sure that its safe.

Maybe in 50 years time well be using gene editing for things like that but while many patients might benefit from gene editing for lowering cholesterol, its not going to replace statins for anyone but those with life threatening mutations for a long time.

On top of this, there are the well-documented manufacturing challenges that come with such a new field.

I think weve all learnt that we need to spend more time earlier on in developing the industrial processes, Macrae says.

The call I get most often from headhunters is, Do you know anyone that can do manufacturing in cell therapy? The field has grown so rapidly that there are very few people with experience in it. There is also a shortage of manufacturing sites.

This is part of the reason Sangamo has built its own manufacturing site in California and is building a European site in France.

Owning your own fate in manufacturing is really important, says Macrae. The process of gene editing needs lots of care and attention, and were at an early stage of the science where we dont know all the answers. Thats why its so important to have your own people in-house who know how to do it well.

Pragmatic genomics

As such, while Sangamo strongly believes in the potential of in vivo genome editing and regulation, Macrae says that early on the company made a pragmatic decision that it shouldnt depend on the field becoming financially viable anytime soon, and required a near-term strategy that would bring in revenue and benefit patients.

That is why the company is also working on gene therapy and ex vivo gene-edited cell therapy.

If youre working in gene editing, you can also work in gene therapy, because you already know a lot about delivery, vectors, molecular biology etc., Macrae explains. So it seemed like a sensible decision for us to work on that while gene editing is still an evolving field.

The companys gene therapy pipeline now includes treatments for PKU, Fabry disease and hemophilia A (in partnership with Pfizer).

The next easiest area for the company to take on with its existing capabilities was ex vivo gene-edited cell therapy.

In this area, Macrae says he is most excited about the companys CAR-Treg platform, from its acquisition of French company TxCell.

Tregs travel to the site of the inflammation and release mediators to calm it. We can put our localising CAR onto the Treg, which takes it specifically where we want it to go. For example, for multiple sclerosis you can use a CAR that takes the Treg to the myelin sheath.

You dont need to know the cause of the disease, you just need to know where the disease is.

Sangamo still anticipates, though, a time when in vivo genome editing and regulation is just as key to the business as these other two pillars and in fact Macrae anticipates that over time, Sangamo will shift its development focus to genome engineering as the field and science mature.

Gene therapy can ultimately only take you into the liver, he explains. There are 7,000 liver diseases, and only 10-20 of them that are big enough to run large clinical trials. Most of them are rare mutations.

Everyone is going to the liver and doing the same disease, and what was already a small population gets sliced and diced between several companies. We therefore dont see it as a long-term sustainable opportunity.

We have the advantage of also being able to edit cells in vivo, and eventually we will be able to do fundamental once-and-done editing in other tissues. Its just a matter of getting the field there.

About the interviewee

Sandy Macrae has served as Sangamos president and chief executive officer and as a member of the Board of Directors since June 2016. He has twenty years of experience in the pharmaceutical industry most recently serving as the global medical officer of Takeda Pharmaceuticals. From 2001 to 2012, Dr Macrae held roles of increasing responsibility at GlaxoSmithKline, including senior vice president, Emerging Markets Research and Development (R&D).

About the author

George Underwood is pharmaphorums Deep Dive magazine editor. He has been reporting on the pharma and healthcare industries for seven years and has worked at a number of leading publications in the UK.

Visit link:
Gene editing: beyond the hype - - pharmaphorum

Recommendation and review posted by Bethany Smith

Eric Pastor joins Spirovant Sciences as SVP of Technology Development and Operations.

PHILADELPHIA, PA, Jan. 26, 2021 (GLOBE NEWSWIRE) -- Spirovant Sciences, a gene therapy company developing treatments and cures for respiratory diseases including cystic fibrosis, todayannounced the leasing of its new, expanded headquarters and laboratories in the robust gene and cell therapy epicenter of Philadelphias University City in Wexford Science + Technologys uCity Square at 3675 Market Street. The Company also announced the appointments of Eric Pastor as Senior Vice President of Technology Development and Operations and Maria Limberis, PhD, as Vice President of Research.

In 2020, Spirovant advanced our pipeline and generated data that reaffirmed our vision to change the course of cystic fibrosis, said Joan Lau, Ph.D., Chief Executive Officer of Spirovant Sciences. As evidenced by our new team members Eric and Maria, we are focused on hiring leaders in gene therapy who share our values of collaboration, diversity, empowerment, and scientific rigor in our relentless pursuit of developing life-altering medicines for those in need. Additionally, our new, modern laboratories will energize the team in its pursuit to discover and develop advancements in the field.

In his new role, Eric Pastor brings more than 20 years of CMC and technical operations and experience will be responsible for expanding Spirovants technology development and manufacturing capabilities. He was most recently Vice President, CMC Operations, for Vedere Bio. Previously, Pastor served in a number of scientific positions at Sanofi, mostly recently as Head of Gene Therapy Development, as well as at AMRI and Targeted Genetics. He earned a Bachelor of Science degree at the University of Northern British Columbia.

Maria Limberis has more than 15 years of gene therapy research experience and will be responsible for applying Spirovants gene therapy vectors to therapy candidates. Previously, she was Associate Professor in the Department of Medicine and Director, Program of Excellence in Cystic Fibrosis in the Orphan Disease Center at the University of Pennsylvania, leading pre-clinical R&D and translational gene therapy programs in cystic fibrosis and airborne infectious diseases. She earned a PhD in molecular biology from the University of Adelaide.

The Company was assisted in its search for its new headquarters by Joseph Fetterman and Clifford Brechner of Colliers International.

About Spirovant Sciences, Inc.Spirovant is a gene therapy company focused on changing the course of cystic fibrosis and other respiratory diseases. The company's current investigational gene therapy technologies are designed to overcome the historical barriers that have prevented effective genetic treatments for cystic fibrosis. Spirovants lead programs are in development for cystic fibrosis. Spirovant is a wholly owned subsidiary of Sumitovant Biopharma Ltd., which is itself a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Spirovant is located inPhiladelphia, PA.More information is available athttps://www.spirovant.com/.

About Sumitovant BiopharmaLtd.Sumitovant is a global biopharmaceutical company with offices inNew York CityandLondon. Sumitovant is a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sumitovant is the majority shareholder of Myovant and Urovant, and wholly owns Enzyvant, Spirovant andAltavant. Sumitovant'spipeline is comprised of early- through late-stage investigational medicines across a range of disease areas targeting high unmet need. For further information about Sumitovant please visithttps://www.sumitovant.com/.

About Sumitomo Dainippon Pharma Co., Ltd.Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies inJapan, operating globally in major pharmaceutical markets, includingJapan, the U.S.,Chinaand the European Union. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 6,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website athttps://www.ds-pharma.com/.

See more here:
Spirovant Continues Rapid Growth with New Headquarters and Expanded Leadership - GlobeNewswire

Recommendation and review posted by Bethany Smith

INDIANAPOLIS, Jan. 29, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced financial results for the fourth quarter and full year of 2020.

$ in millions, exceptper share data

Fourth Quarter

%

Full Year

%

2020

2019

Change

2020

2019

Change

Revenue

$

7,440.0

$

6,114.0

22%

$

24,539.8

$

22,319.5

10%

Net Income Reported

2,116.8

1,495.7

42%

6,193.7

8,318.4

(26)%

EPS Reported

2.32

1.64

41%

6.79

8.89

(24)%

Net Income Non-GAAP

2,509.0

1,583.3

58%

7,235.9

5,568.2

30%

EPS Non-GAAP

2.75

1.73

59%

7.93

6.04

31%

Certain financial information for 2020 and 2019 is presented on both a reported and a non-GAAP basis. Some numbers in this press release may not add due to rounding. Reported results were prepared in accordance with U.S. generally accepted accounting principles (GAAP), include all revenue and expenses recognized during the periods, and reflect Elanco Animal Health (Elanco) as discontinued operations during the first quarter of 2019. Non-GAAP measures reflect adjustments for the items described in the reconciliation tables later in the release, and assume that the disposition of Elanco occurred at the beginning of 2019 (including the benefit from the reduction in shares of common stock outstanding). The company's 2021 financial guidance is being provided on both a reported and a non-GAAP basis. The non-GAAP measures are presented to provide additional insights into the underlying trends in the company's business.

"Lilly closed a complex year by delivering impressive results in the fourth quarter of 2020. We finished the year with strong momentum in our core business areas, as volume-based revenue growth for our newest medicines and initial sales of our COVID-19 antibody therapy, coupled with our ongoing productivity agenda, drove robust margin expansion and solid earnings growth," said David A. Ricks, Lilly's chairman and CEO. "I am also encouraged by exciting recent data readouts for three of our most important pipeline assets: tirzepatide, LOXO-305 and donanemab. Each of these potential medicines has a chance to significantly improve patient outcomes in areas of high unmet medical need, and, should they go on to receive approvals, reinforce our growth prospects for the decade ahead."

Key Events Over the Last Three Months

COVID-19

Regulatory

Clinical

Business Development/Other Developments

Fourth-Quarter Reported Results

In the fourth quarter of 2020, worldwide revenue was $7.440 billion, an increase of 22 percent compared with the fourth quarter of 2019, driven by a 24 percent increase in volume and a 1 percent increase due to the favorable impact of foreign exchange rates, partially offset by a 4 percent decrease due to lower realized prices. The company recognized worldwide revenue of $871.2 million in the fourth quarter of 2020 for bamlanivimab, its COVID-19 antibody therapy. Excluding bamlanivimab revenue, worldwide revenue grew by 7 percent. Key growth products launched since 2014, consisting of Trulicity, Verzenio, Taltz, Tyvyt, Olumiant, Jardiance, Emgality, Cyramza, Retevmo, Baqsimi and Basaglar contributed nearly 12 percentage points of revenue growth and represented approximately 48 percent of total revenue for the quarter, or 55 percent of total revenue excluding bamlanivimab.

Revenue in the U.S. increased 31 percent, to $4.598 billion, driven by a 36 percent increase in volume, partially offset by a 5 percent decrease due to lower realized prices. The company recognized U.S. revenue of $850.0 million in the fourth quarter of 2020 for bamlanivimab. Excluding bamlanivimab revenue, revenue in the U.S. grew by 7 percent. Increased U.S. volume for key growth products, including Trulicity, Taltz, Verzenio, Emgality, Retevmo, Cyramza, Olumiant, Jardiance and Baqsimi, was partially offset by lower volume for certain other products, including Forteo and Tradjenta. Inventory stocking in the fourth quarter of 2020 was approximately $120 million higher than in the fourth quarter of 2019 due to lower than typical year-end stocking in 2019. The decrease in realized prices in the U.S. in the fourth quarter of 2020 was primarily driven by increased rebates to gain and maintain broad commercial access across the portfolio, partially offset by modest list price increases, largely for diabetes, and, to a lesser extent, by changes to estimates for rebates and discounts, most notably for Taltz. Segment mix was not a major driver of U.S. price performance in the fourth quarter of 2020, as increased utilization in more highly-rebated government segments was offset by lower utilization in the 340B segment, primarily for Trulicity and Humalog.

Revenue outside the U.S. increased 10 percent, to $2.842 billion, driven by a 9 percent increase in volume and a 3 percent increase due to the favorable impact of foreign exchange rates, partially offset by a 2 percent decrease due to lower realized prices. The increase in volume outside the U.S. was driven primarily by increased volume for key growth products, including Tyvyt, Trulicity, Olumiant, Taltz, Verzenio, Jardiance, Cyramza, Basaglar, Emgality and Baqsimi, as well as volume gains for Alimta, partially offset by decreased volume for Cialis, Forteo and Trajenta. In addition, revenue outside the U.S. in the fourth quarter of 2019 benefited from a milestone from Bayer Consumer Care AG resulting from its exclusive development and commercialization license for Vitrakvi. The decrease in realized prices outside the U.S. was driven primarily by the inclusion of Tyvyt in the government reimbursement programs in China.

Gross margin increased 18 percent, to $5.720 billion, in the fourth quarter of 2020 compared with the fourth quarter of 2019. Gross margin as a percent of revenue was 76.9 percent, a decrease of 2.1 percentage points compared with the fourth quarter of 2019. The decrease in gross margin percent was primarily due to unfavorable product mix driven by bamlanivimab sales, higher amortization of intangibles expense related to Retevmo, the unfavorable effect of foreign exchange rates on international inventories sold, and the impact of lower realized prices on revenue, partially offset by greater manufacturing efficiencies.

Total operating expenses in the fourth quarter of 2020, defined as the sum of research and development and marketing, selling, and administrative expenses, increased 3 percent to $3.392 billion compared with the fourth quarter of 2019. Research and development expenses increased 16 percent to $1.838 billion, or 24.7 percent of revenue, driven primarily by approximately $265 million of development expenses for COVID-19 antibody therapies and baricitinib. Excluding these COVID-19 expenses, research and development expenses remained flat. Marketing, selling, and administrative expenses decreased 8 percent to $1.554 billion, primarily due to lower marketing expenses, reflecting reduced promotional activity.

In the fourth quarter of 2020, the company recognized acquired in-process research and development charges of $366.3 million related to the previously-announced business development transactions with Innovent Biologics, Inc., Disarm Therapeutics, Inc., and Fochon Pharmaceuticals, Ltd. There were no acquired in-process research and development charges in the fourth quarter of 2019.

In the fourth quarter of 2020, the company recognized income for asset impairment, restructuring and other special charges of $30.1 million, reflecting adjustments to prior period estimates for asset impairment and severance costs. In the fourth quarter of 2019, the company recognized asset impairment, restructuring and other special charges of $151.7 million. These charges were primarily related to the decision to close and sell a research and development facility located in the United Kingdom, as well as severance costs incurred as a result of actions taken to reduce the company's cost structure.

Operating income in the fourth quarter of 2020 was $1.992 billion, compared to $1.400 billion in the fourth quarter of 2019. The increase in operating income was primarily driven by higher gross margin, lower asset impairment, restructuring and other special charges, and lower marketing expenses, partially offset by higher acquired in-process research and development charges and higher research and development expenses. Operating margin, defined as operating income as a percent of revenue, was 26.8 percent.

Other income was $477.0 million in the fourth quarter of 2020, compared with other income of $262.9 million in the fourth quarter of 2019. The increase in other income was driven primarily by higher net gains on investment securities.

The effective tax rate was 14.3 percent in the fourth quarter of 2020, as compared with 10.1 percent in the fourth quarter of 2019. The effective tax rates for both periods were impacted by net discrete tax items.

In the fourth quarter of 2020, net income and earnings per share were $2.117 billion and $2.32, respectively, compared with net income of $1.496 billion and earnings per share of $1.64 in the fourth quarter of 2019. The increase in net income and earnings per share in the fourth quarter of 2020 was primarily driven by higher operating income and higher other income, partially offset by higher income tax expense.

Fourth-Quarter Non-GAAP Measures

On a non-GAAP basis, fourth-quarter 2020 gross margin increased 20 percent, to $5.848 billion compared with the fourth quarter of 2019. Gross margin as a percent of revenue was 78.6 percent, a decrease of 1.3 percentage points. The decrease in gross margin percent was primarily due to unfavorable product mix driven by bamlanivimab sales, the unfavorable effect of foreign exchange rates on international inventories sold, and the impact of lower realized prices on revenue, partially offset by greater manufacturing efficiencies.

Operating income on a non-GAAP basis increased $850.5 million, or 53 percent, to $2.456 billion in the fourth quarter of 2020 compared with the fourth quarter of 2019, due primarily to higher gross margin and lower marketing expenses, partially offset by higher research and development expenses. Operating margin was 33.0 percent on a non-GAAP basis.

The effective tax rate on a non-GAAP basis was 14.4 percent in the fourth quarter of 2020, as compared with 12.6 percent in the fourth quarter of 2019. The effective tax rates for both periods were impacted by net discrete tax items.

On a non-GAAP basis, in the fourth quarter of 2020 net income increased 58 percent, to $2.509 billion, while earnings per share increased 59 percent, to $2.75, compared with $1.583 billion and $1.73, respectively, in the fourth quarter of 2019. The increase in net income and earnings per share was driven primarily by higher operating income and higher other income, partially offset by higher income tax expense.

For further detail on non-GAAP measures, see the reconciliation below as well as the "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information" table later in this press release.

Fourth Quarter

2020

2019

% Change

Earnings per share (reported)

$

2.32

$

1.64

41%

Acquired in-process research and development

.35

Amortization of intangible assets

.11

.05

Asset impairment, restructuring and other special charges

(.03)

.14

Gain on sale of China antibiotics business

(.26)

Charge related to repurchase of debt

The rest is here:
Lilly Reports Strong Fourth-Quarter and Full-Year 2020 Financial Results - BioSpace

Recommendation and review posted by Bethany Smith

Scientists have identified a protein that can slow or stop some signs of Parkinsons disease in mice.

The team found that the bone morphogenetic proteins 5 and 7 (BMP5/7) can have these effects in a mouse model of the disease.

This research, which appears in the journal Brain, may be the first step toward developing a new treatment for Parkinsons disease.

This type of brain disorder typically affects people over the age of 60, and the symptoms worsen with time.

Common symptoms include stiffness, difficulty walking, tremors, and trouble with balance and coordination.

The disease can also affect the ability to speak and lead to mood changes, tiredness, and memory loss.

Parkinsons Foundation report that about 1 million people in the United States had the disease in 2020, with about 10 million affected globally.

Despite this prevalence, scientists are still unsure why Parkinsons disease affects some people and not others, and there is currently no cure.

The National Institute on Aging note that some cases of Parkinsons disease seem to be hereditary. In other words, the disease can emerge in different generations of a family but for many people with the disease, there appears to be no family history.

Researchers believe that multiple factors may affect a persons risk, including genetics, exposure to environmental toxins, and age.

Since there is currently no cure for Parkinsons disease, treatments typically focus on alleviating its symptoms.

Existing treatments can help alleviate of Parkinsons disease, such as stiffness. However, they may work less well, or not work, for others, such as tremors or a loss of coordination.

Though researchers are still unsure why some develop the disease and others do not, they understand what occurs in the brain of a person with Parkinsons.

The disease causes the neurons in the part of the brain that controls movement to stop working or die. The brain region, therefore, produces less of the chemical dopamine, which helps a person maintain smooth, purposeful movement, as the National Institute of Neurological Disorders and Stroke observe.

Also, Lewy bodies occur in the brains of some people with Parkinsons disease. These bodies are clumps primarily made up of misfolded forms of the protein alpha-synuclein.

In their recent study paper, the scientists refer to research suggesting that neurotrophic factors molecules that help neurons survive and thrive could, in theory, restore the function of neurons that produce dopamine. However, the clinical benefit of these factors had yet to be proven.

The team focused on bone morphogenetic proteins 5 and 7 (BMP5/7). They had previously shown that BMP5/7 has an important role in dopamine-producing neurons in mice.

In the latest study, the scientists wanted to see whether BMP5/7 could protect the neurons of mice against the damaging effects of misfolded alpha-synuclein proteins.

To do this, they injected one group of mice with a viral vector that caused misfolded alpha-synuclein proteins to form in their brains. They used other mice as a control group. The scientists then injected the mice with the BMP5/7 protein.

The researchers found that the BMP5/7 protein had a significant protective effect against the misfolded alpha-synuclein proteins.

According to senior study author Dr. Claude Brodski, of the Israel-based Ben-Gurion University of the Negevs Department of Physiology and Cell Biology, We found that BMP5/7 treatment can, in a Parkinsons disease mouse model, efficiently prevent movement impairments caused by the accumulation of alpha-synuclein and reverse the loss of dopamine-producing brain cells. He continues:

These findings are very promising, since they suggest that BMP5/7 could slow or stop Parkinsons disease progression. Currently, we are focusing all our efforts on bringing our discovery closer to clinical application.

The universitys technology transfer company, BGN Technologies, is currently looking to bring the development to the market.

Dr. Galit Mazooz-Perlmuter, the companys senior vice president of bio-pharma business development, notes that There is a vast need for new therapies to treat Parkinsons disease, especially in advanced stages of the disease.

Dr. Brodskis findings, although still in their early stages, offer a disease-modified drug target that will address this devastating condition. We are now seeking an industry partner for further development of this patent-pending invention.

See more here:
Protein identified that may help treat Parkinsons disease - Medical News Today

Recommendation and review posted by Bethany Smith

Jan. 26, 2021 12:00 UTC

Timothy J. Douros, J.D., former General Counsel at Bluebird Bio, joins as Chief Legal Officer and Corporate Secretary, brings over 25 years of legal experience in the biotech industry

Tracy M. Porter, M.Ed., SPHR, former Head of Human Resources at Audentes Therapeutics, joins as Chief People Officer, brings nearly 30 years of human resources experience

DALLAS--(BUSINESS WIRE)-- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a patient-centric gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system in both rare and large patient populations, today announced new additions to its leadership team with the appointments of Timothy J. Douros, J.D., as Chief Legal Officer and Corporate Secretary and Tracy M. Porter, M.Ed., SPHR, as Chief People Officer. Mr. Douros will lead all aspects of the companys legal organization. Ms. Porter will oversee all aspects of human resources, including operations, talent acquisition and employee development.

We are thrilled to welcome Tim and Tracy to the Taysha leadership team, said RA Session II, President, Founder and CEO of Taysha. Tim brings significant gene therapy experience from Bluebird Bio where he led a global team, in cross functional collaboration with all corporate functions. His experiences include a wide range of legal and corporate matters which will be invaluable as we continue to advance our programs and evolve as a company. With her vast experience in strategic and operation roles in human resources, Tracy has successfully led and scaled global organizations quickly, most recently at Audentes where she helped grow the base of global gene therapy professionals by more than 50% in less than a year. Tracy will be instrumental in helping us continue to build a successful organization, scale thoughtfully and maintain our culture. Importantly, both Tim and Tracys experiences working in companies at various stages of the biotech life cycle will be essential to our future growth strategy.

Mr. Douros brings over 25 years of legal experience in biotech specializing in intellectual property, strategic licensing and contracting, litigation and dispute resolution, as well as international and healthcare compliance while building and managing high-performing teams. Prior to joining Taysha, he served as Senior Vice President, General Counsel at Bluebird Bio, Inc., where he led a global team of attorneys and staff and was a strategic partner to all internal clients, including business development, research and development, clinical operations and regulatory affairs. Prior to that, he was Vice President, Deputy General Counsel and Chief IP Counsel at Bluebird Bio where he provided counsel and managed all legal services related to the companys European infrastructure build to support product launches as well as provided counsel on all areas of compliance. Mr. Douros also led the corporate intellectual property function and managed all corporate dispute resolution matters. Before joining Bluebird, he spent nearly 13 years at Cubist Pharmaceuticals, Inc., holding positions of increasing responsibility, most recently serving as Vice President, Chief International Counsel & Chief IP Counsel. Mr. Douros received an A.B. in Chemistry from Dartmouth College and a J.D. from Boston College Law School.

I could not be more excited to join such an accomplished and energetic team of gene therapy trailblazers, said Mr. Douros. With its potentially de-risked approach to gene therapy development, Taysha is well-positioned to be a leader in developing potentially disease-modifying gene therapies for patients with monogenic CNS diseases and I look forward to contributing to the companys growth.

Ms. Porter joins Taysha with nearly 30 years as a human resources executive focused in entrepreneurial global business environments and specializing in pharmaceuticals and biotech. She has guided organizations from start-up and early-stage biotech to initial product launches and has provided human resources support through manufacturing expansion, acquisitions, divestitures, strategic business reorganizations and integrations. She most recently served as Vice President, Head of Human Resources at Audentes Therapeutics, where she developed, implemented and sustained its human capital strategy to rapidly scale and support the companys growth. Prior to joining Audentes, she spent time at Medivation Inc., and Bayer Healthcare LLC. Ms. Porter received a B.S. in Human Development and Counseling from the University of North Carolina at Greensboro and an M.Ed. in Global Human Resource Development from the University of Illinois at Urbana-Champaign.

Tayshas community of talented, diverse and passionate people is exceptional and I am honored to be a part of the team, said Ms. Porter. Taysha has a remarkable vision to develop and commercialize innovative therapies to potentially transform patients lives. I look forward to helping build the team and capabilities to realize that vision.

About Taysha Gene Therapies

Taysha Gene Therapies (Nasdaq: TSHA) is on a mission to eradicate monogenic CNS disease. With a singular focus on developing curative medicines, we aim to rapidly translate our treatments from bench to bedside. We have combined our teams proven experience in gene therapy drug development and commercialization with the world-class UT Southwestern Gene Therapy Program to build an extensive, AAV gene therapy pipeline focused on both rare and large-market indications. Together, we leverage our fully integrated platforman engine for potential new cureswith a goal of dramatically improving patients lives. More information is available at http://www.tayshagtx.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210126005462/en/

View post:
Taysha Gene Therapies Continues to Add Significant Gene Therapy Expertise to Leadership Team with the Appointment of Chief Legal Officer and Chief...

Recommendation and review posted by Bethany Smith

Jan. 29, 2021 12:00 UTC

Program to screen for congenital, monogenic hearing loss in children diagnosed with auditory neuropathy

BOSTON--(BUSINESS WIRE)-- Decibel Therapeutics, a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, today announced a partnership with Invitae, a leading medical genetics company, to launch AmplifyTM, a no-charge genetic testing program to screen for the genetic cause of congenital hearing loss in children diagnosed with auditory neuropathy.

We are pleased to collaborate with Invitae to introduce AmplifyTM, which is designed to bring patients one step closer to molecular diagnosis and clinical management of auditory neuropathy, a disorder that affects approximately 10 percent of children who are born with hearing loss, said Jonathon Whitton, Au.D., Ph.D., Vice President of Clinical Research at Decibel. This program seeks to provide much-needed answers to patients and families of patients who experience congenital, monogenic hearing loss. We hope that AmplifyTM will provide those patients with a better understanding of their diagnosis and their treatment options.

Auditory neuropathy is a hearing disorder in which the cochlea, the hearing organ located in the inner ear, receives sound normally, yet the transmission of sound to the brain is interrupted. The most common genetic cause of auditory neuropathy is insufficient production of a protein called otoferlin, which facilitates communication between the inner ear sensory cells and the auditory nerve. When this protein is lacking, the ear cannot communicate with the auditory nerve and the brain, resulting in profound hearing loss. Decibels lead investigational gene therapy program, DB-OTO, is designed to treat congenital, monogenic hearing loss caused by a deficiency in the otoferlin gene.

Amplify Program Eligibility

AmplifyTM is available to individuals who meet the following criteria:

AmplifyTM is a no-charge program that offers genetic testing for those who qualify. Although genetic testing can confirm a potential diagnosis, the absence of a genetic alteration does not preclude a diagnosis of genetic hearing loss. For more information about the program, please visit the Amplify program page.

About DB-OTO

DB-OTO is Decibels investigational gene therapy to restore hearing in children with congenital hearing loss due to a deficiency in the otoferlin gene. The program, developed in collaboration with Regeneron Pharmaceuticals, uses a proprietary, cell-selective promoter to precisely control gene expression in cochlear hair cells. DB-OTO is in preclinical studies, and Decibel expects to initiate clinical testing in 2022.

About Invitae

Invitae Corporation (NYSE: NVTA) is a leading medical genetics company whose mission is to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Invitae's goal is to aggregate the world's genetic tests into a single service with higher quality, faster turnaround time, and lower prices. For more information, visit the company's website.

About Decibel Therapeutics

Decibel Therapeutics is a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, one of the largest areas of unmet need in medicine. Decibel has built a proprietary platform that integrates single-cell genomics and bioinformatic analyses, precision gene therapy technologies and expertise in inner ear biology. Decibel is leveraging its platform to advance gene therapies designed to selectively replace genes for the treatment of congenital, monogenic hearing loss and to regenerate inner ear hair cells for the treatment of acquired hearing and balance disorders. Decibels pipeline, including its lead investigational gene therapy program, DB-OTO, to treat congenital, monogenic hearing loss, is designed to deliver on our vision of a world in which the privileges of hearing and balance are available to all. For more information about Decibel Therapeutics, please visit http://www.decibeltx.com or follow @DecibelTx.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210129005089/en/

See the original post here:
Decibel Therapeutics and Invitae Announce Launch of Amplify Genetic Testing Program - BioSpace

Recommendation and review posted by Bethany Smith

MIAMI, Jan. 25, 2021 (GLOBE NEWSWIRE) -- Ambulero, Inc., a biotechnology company developing cell and gene therapy treatments for patients suffering from vascular disease, today announced that it raised up to $5.5M in funding from Orphinic Scientific (Orphinic). As part of the investment, Ambulero and Orphinic formed a Polish subsidiary (Ambulero Sp. z o.o.) that will lead clinical testing of a novel gene therapy for a serious vascular disease in Europe. The disease is rare in the US but more common in certain parts of Central and Eastern Europe.

Ambulero holds an exclusive license from the University of Miami to develop and commercialize research from the laboratories of Drs. Omaida C. Velazquez and Jun Zhao-Liu. That research demonstrated in relevant animal models that an important cell adhesion molecule (E-selectin) can help promote vascular repair.

Ambulero is delighted to partner with Orphinic as they share our commitment to advance gene therapies for the benefit of patients suffering from vascular diseases, said Robert L. Buchanan, Co-founder and CEO of Ambulero.

We are excited to participate in a global development of Ambuleros breakthrough gene therapy that has a potential to reduce risk of limb ulcers and amputation in patients affected by vascular diseases, said Dr. Artur Plonowski, Partner and CMO at Orphinic.

About Ambulero

Ambulero is a biotechnology company dedicated to advancing a platform of cell and gene therapies to treat serious vascular diseases. The company is a 2019 spin-out of the University of Miami co-founded by Robert L. Buchanan, Randy Berholtz, Omaida C. Velazquez and Jun Zhao-Liu. Ambuleros cell therapy program uses stromal cells engineered to express E-selectin to promote tissue repair. The companys gene therapy program uses established approaches to administer E-selectin directly to injured tissues. Ambulero is financially backed by Ventac Holdings, LLC and is currently sourcing investors for a Series A round. See http://www.ambulero.com

About Orphinic With offices in Palo Alto, CA and Warsaw, Poland, Orphinic is an innovative drug development and investment company focused on mid-market opportunities and orphan drugs in late preclinical research and Phase 1/2. See http://www.orphinic.com

Follow Ambulero, Inc.Twitter: @ambulero1LinkedIn: http://www.linkedin.com/company/ambulero

ContactAmbulero, IncConverge Miami1951 NW 7th Street, STE. 600Miami, FL 33136Dr. Carlton AndersonChief Operation OfficerEmail: canderson@ambulero.com

See the article here:
Ambulero Raises Up To $5.5 Million from Orphinic ScientificMiami Cell and Gene Therapy Company Opens European Subsidiary To Advance Gene Therapy For...

Recommendation and review posted by Bethany Smith

Those most famous of disruptive innovators, the team at ARK, has published its annual Big Ideas report for 2021, highlighting an extraordinarily broad range of themes detailing the latest developments in innovation and offering what it calls some of their most provocative research conclusions for the year.

First out of the box is Deep Learning, which the team believes could be the most important software breakthrough of our time.

Until recently, humans programmed all software. Deep learning, a form of artificial intelligence (AI), uses data to write software, the ARK team writes. By automating the creation of software, deep learning could turbocharge every industry. The ARK teams research shows that deep learning will add USD30 trillion to the global equity market capitalisation during the next 15-20 years.

Up next for causing huge change is the Reinvention of the Data Centre, according to ARK, which observes a revolution occurring in the sector. Cheaper, faster, and more power efficient processors are starting to displace Intelwhich traditionally had captured over 90 per cent of all processor revenue, the firm says. It believes that ARM, RISC-V, and graphics processing units (GPUs) are likely to emerge as the new powerhouse processors. Together they could scale at a 45 per cent annual rate to USD19 billion in revenue by 2030. In the data centre, we believe accelerators, dominated by GPUs, will become the dominant processors for new workloads, growing 21 per cent at an annual rate to USD41 billion by 2030.

The next big theme for ARK is Virtual Worlds, consisting of video games, augmented reality and virtual reality. ARK writes: A virtual world is defined as a computer-simulated environment that can be accessed by anyone at any time.

Society interacts daily with virtual worlds which today are in their infancy. According to our research, revenue from virtual worlds will compound 17 per cent annually from roughly USD180 billion today to USD390 billion by 2025. Today, virtual worlds are independent from each other, but in the future they could become interoperable, culminating in what futurists have deemed 'The Metaverse.

Next up is Digital Wallets, which, ARK says, could represent a USD4.6 trillion opportunity in your pocket, and upend traditional banking.

More overthrowing of the traditional comes in the firms predictions and observations on bitcoin - the firm estimates that if all S&P 500 companies were to allocate 1 per cent of their cash to bitcoin, its price would increase by approximately USD40,000.

ARK believes bitcoins rapid growth has positioned it for an allocation in investment portfolios. We believe bitcoin offers one of the most compelling risk-reward profiles among assets. As our analysis suggests, it could scale from roughly USD500 billion to USD1-5 trillion in network capitalisation during the next five to 10 years.

Electric vehicles are also part of the changing world for ARK which has famously supported Tesla throughout its volatile run. The firm says that electric vehicles are approaching sticker price parity with gas-powered cars.

Robotics and automation come next with ARK commenting that while the robots are coming they will help to create jobs. Autonomous ride hailing comes next with ARKs research suggesting that autonomous ride-hailing platforms will generate more than USD1 trillion in profits per year by 2030. In addition, automakers and fleet owners could enjoy profits of USD250 billion and USD70 billion, respectively. ARKs research on Drone Delivery, another big theme for disruptive innovation according to the firm, finds that drone delivery platforms will generate roughly USD275 billion in delivery revenues, USD50 billion in hardware sales, and USD12 billion in mapping revenue by 2030.

Orbital aerospace comes next with ARKs prediction that the orbital aerospace opportunity including satellite connectivity and hypersonic flight will exceed USD370 billion annually. Back on earth, 3D printing is another potential disruptor, with ARK estimating that 3D printing will revolutionise manufacturing, growing at an annual rate of roughly 60 per cent from USD12 billion last year to USD120 billion in 2025.

Long-Read Sequencing, that could provide a more complete picture of the human genome is also covered in the report, with ARK estimating that long-read revenues will grow 82 per cent at an annual rate, from USD250 million in 2020 to roughly USD5 billion in 2025.

Turning to health care, ARK believes that going forward, Multi-Cancer Screening using liquid biopsies could prevent more cancer deaths that any other medical intervention in history.

According to ARKs research, the convergence of innovative technologies has pushed the cost of multi-cancer screening down by 20-fold from USD30,000 in 2015 to USD1,500 today and it should drop another 80 per cent+ to USD250 in 2025.

As a result, the multi-cancer screening market should scale to USD150 billion in the US. A multi-cancer screening protocol could avert 66,000 cancer deaths per year in the US, saving 1.4 million human life years, the firm says.

Cell and Gene Therapy: Generation 2 is the final outing in the report, with ARK predicting that the second generation of cell and gene therapies could increase the total addressable market for oncology therapeutics by more than 20-fold.

See the original post:
ARK's Big Ideas for 2021 lists the firm's 'most provocative research conclusions for the year' - ETF Express

Recommendation and review posted by Bethany Smith

DEAR MAYO CLINIC: My mom was diagnosed with breast cancer. During her care, she was found to have a BRCA2 mutation. Her doctor suggested that my brothers and I get tested for this mutation, too. I am a 26-year-old woman, and I am not sure what this means for me and my risk of cancer.

ANSWER: Having a loved one with a breast cancer diagnosis can be scary. It also can become confusing when you start to hear about genetic mutations. The good news is that the information can help guide your family regarding screening and future cancer risk.

BRCA2 is a genetic abnormality that can be passed down from a parent to children. It is autosomal dominant, which means there is a 50% chance that each of your mom's biological children could have the mutation. Being positive for the mutation would mean that you or your brothers may be at increased risk of developing certain cancers, compared to the general population.

In addition to breast cancer, these cancers are also known to be associated with BRCA2: ovarian cancer, melanoma, prostate cancer and pancreatic cancer.

To understand your risk, you would want to meet with a genetic counselor who can help you understand the implications of undergoing genetic testing and whether this is something you want to do. Typically, genetic testing is performed using a blood or saliva sample. The counselor would review the results with you and, if you are positive, recommend next steps to learn more about personalized screening and specific risk reduction options.

Generally speaking, it is recommended that women who have a BRCA2 mutation begin monthly breast self-examinations, beginning at 18. Clinical breast examinations are recommended every six months, beginning at 25, or before if there is an earlier breast cancer in the family. Annual breast MRIs should begin at 25. Tomosynthesis mammograms are recommended annually, beginning at 30. They are usually alternated with breast MRIs every six months. Based on risk and family history, some woman may choose to undergo a preventive mastectomy to remove their breast tissue and hopefully decrease their risk of developing breast cancer.

There is no screening test for ovarian cancer. However, women can have transvaginal ultrasounds and a blood test called CA 125 every six to 12 months, beginning at ages 30-35, while their ovaries are still in place.

If desired, women can undergo surgery to remove their ovaries and fallopian tubes once they are done having children. Ideally, this would occur between the ages of 40-45. As this surgery results in women going through menopause, some women may be started on hormone therapy until ages 50-51 to alleviate menopausal symptoms and offset some long-term risks associated with early menopause.

Research has shown that many ovarian cancers begin in the fallopian tubes. With this knowledge, women have recently been having surgery to remove their fallopian tubes and delay surgery to remove their ovaries for a few years though the recommended age for a woman to have her ovaries removed is still 40-45 in a BRCA2 mutation carrier. The benefit of removing just the fallopian tubes is that this allows women to preserve their natural hormonal function longer. The safety of this strategy is being studied, and this type of surgery is being performed as part of clinical trials.

Women who undergo surgery to remove their ovaries before menopause have a 50% reduction in their risk of developing breast cancer. In addition to surgeries, there are medications that can be given to help decrease the risk of developing breast and ovarian cancers. Selective Estrogen Receptor Modulators (SERMS) and Aromatase Inhibitors (AIs) are types of medications that can reduce the risk of developing breast cancer. Oral contraceptives can decrease the risk of developing ovarian cancer by 50%.

Since the BRCA2 mutation can be passed down to offspring, understanding your status and that of a future partner is important, as there is a genetic condition called Fanconi anemia that can occur if both the male and female partners have a BRCA2 mutation.

Thus, for men and women who test positive for BRCA2 and have not yet had biological children, it may be worthwhile to meet with a specialist in reproductive endocrinology and infertility to discuss options.

There are no standard screening guidelines for pancreatic cancer or melanoma. Based on your situation, a consultation with a pancreatic specialist may be worthwhile to discuss whether to pursue MRI or endoscopic ultrasound. Likewise, a referral to a dermatologist can be made to initiate skin cancer screenings.

Understandably, you may be nervous about your risk for cancer, given your mother's diagnosis. However, you are young, and you should not feel rushed to make any decisions regarding genetic testing. If you choose to undergo testing and are found to have a BRCA2 mutation, your health care providers will give you the information that you need so that you can begin to think about what makes sense for your life and your priorities.

Casey Swanson, physician assistant, Gynecologic Surgery, Mayo Clinic, Rochester, Minnesota

More:
Mayo Clinic Q And A: Genetic abnormalities and cancer risk - Greater Milwaukee Today

Recommendation and review posted by Bethany Smith

For most females, the first period usually begins around 2 years after the first signs of puberty start. Signs of puberty can include the development of breasts, the growth of body hair, and changes in body shape.

This information comes from the Office on Womens Health.

Knowing the signs of a first period can help young females and their parents or caregivers feel prepared.

Around 98% of females begin their first period by the time they are 15 years of age, but the average age has decreased over time.

This article will look at some of the signs a female can expect before they begin their period, as well as what it might be like and what to do when it begins.

The best way to tell if a female is about to have their first period is to assess whether or not they have begun puberty.

Some signs of puberty include:

The first period will typically begin a couple of years after the first signs of puberty appear. However, there is no precise way of knowing when it will begin.

Several days before the first period, some females may notice spotting in their underwear or abdominal cramps. Some may also notice more acne appearing. Not everyone will experience this, however.

The first period typically occurs after a female first ovulates. This happens when the ovaries release an egg into the fallopian tube.

When this happens, the womb lining thickens in preparation for the egg to be fertilized. If fertilization does not occur, the lining sheds, as the body no longer needs it. This is where period blood comes from.

In most females, this cycle continues regularly from the age of the first period until menopause, which is when periods end.

According to the Centers for Disease Control and Prevention (CDC), the average age at which females began menstruating in the United States in 20132017 was 1112 years old. However, periods can start earlier or later than this.

Every females period is different. Periods can vary in duration, frequency, and heaviness. Some females have very light periods, while others have heavy periods.

For some, the first period is light, with a small amount of blood. It may begin gradually, starting with some spotting or brown discharge before becoming red.

For others, periods begin suddenly, with bright red blood appearing straight away. In either case, this is normal. Period blood can range in color from brown to dark red. Some people may also pass small blood clots.

Having a period can feel similar to having vaginal discharge, but some females do not feel much at all.

When a period begins, try to find a way to absorb the blood. A female can do this by asking a friend or family member for a pad or tampon.

If it is not possible to use a pad or tampon, try to wrap something absorbent, such as toilet paper or a clean washcloth, around the crotch area of some underwear. This can absorb the blood and prevent leaks.

It can be helpful to prepare a period kit before the first period arrives. This can help with feeling ready. This period kit could consist of:

Most periods last for 37 days. However, first periods can be less predictable, so they may be slightly shorter or longer.

During the first few years after a females first period, periods may be irregular, coming at unpredictable intervals. Over time, however, they typically become more regular.

Most females get a period about every 28 days, though the actual length varies from person to person as well as period to period. The cycle length may vary by as much as a week in any given year.

The following sections will look at some absorption methods in more detail.

Sanitary pads are a popular form of period protection. They line the underwear with absorbent material, which soaks up the blood.

Some benefits of pads include the fact that they:

Some drawbacks of pads include the fact that they:

It is also possible to purchase reusable fabric pads or period panties, which absorb blood in a similar way to a pad. These products are washable, meaning that a female can reuse them. This can be more cost effective than using disposable pads.

Change pads every 48 hours or whenever the current one starts to feel uncomfortable.

Some benefits of tampons include the fact that they:

Some drawbacks of tampons include the fact that they:

It is crucial to change tampons every 48 hours and to use the lowest absorbency possible. Parents and caregivers should ensure that young females who want to use tampons understand how to use them safely to prevent TSS.

Menstrual cups are small silicone cups that females can wear internally. They work by catching blood inside the vagina. When the cup is full, it is important to remove it and rinse it with clean water before reusing it.

Some benefits of menstrual cups include the fact that they:

Some drawbacks include the fact that they:

Although many manufacturers say that there is no risk of TSS with menstrual cups, there has been at least one confirmed case of TSS in a cup user.

It takes time to adjust to having a period, and they can sometimes cause discomfort. However, periods are a normal part of life, and they do not have to limit or change anyones daily activities.

The following tips may help females take care of themselves during their first period.

For pain and cramping, try:

After the first period, it can be difficult to predict when the next period will happen. It also takes some time to adjust to using period products. Occasionally, this may result in leaks.

Try:

It is generally safe to assume that most females who get periods can get pregnant.

The first period usually means that ovulation has occurred. Ovulation means that pregnancy is possible. However, both periods and ovulation can be irregular during the first few years after the first period, making it difficult to predict fertility.

Although it is normal for periods to be somewhat irregular to begin with, it is a good idea to talk with a doctor if they do not settle into a regular rhythm or if they cause symptoms that disrupt daily life.

The frequency and heaviness of periods, and any symptoms that accompany them, can be an important indicator of a females health.

It is a good idea for a person to talk with a doctor if they or a young female in their care experiences:

Emergency medical help is necessary if someone develops any symptoms of TSS, which can include:

A females first period is an important milestone. Waiting for it can be scary, exciting, or both. There is no reliable way to predict when it will arrive, and periods affect females in different ways.

Once a period begins, it can take time to learn how to manage them. Talk with a trusted adult, doctor, or nurse to ask questions and get advice.

Follow this link:
First period: Early signs, how long it lasts, and self-care tips - Medical News Today

Recommendation and review posted by Bethany Smith

- Company licenses exclusive worldwide rights to develop, manufacture and commercialize targeted, highly specific immunosuppressive therapeutic proteins for the potential treatment of neuromyelitis optica spectrum disorder (NMOSD) from Julius-Maximilians-University of Wuerzburg, Germany- Initial step in growth strategy to build-out pipeline of assets - Aeterna Zentaris to develop potential therapeutic treatment option for neuromyelitis optica spectrum disorder (NMOSD), an orphan indication with strong unmet medical need and significant market opportunity

CHARLESTON, S.C., Jan. 28, 2021 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS), through its wholly-owned subsidiary Aeterna Zentaris GmbH, (Aeterna or the Company), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, today announced that it has licensed the exclusive worldwide rights to develop, manufacture and commercialize targeted, highly specific, autoimmunity modifying proteins (AIM Biologicals) for the potential treatment of neuromyelitis optica spectrum disorder (NMOSD) from the Julius-Maximilians-University Wuerzburg (the University).

This demonstrates Aeternas commitment to execute on our stated plans of expanding our pipeline to have multiple assets in research and development. The work that Dr. Valentin Bruttel and Prof. Joerg Wischhusen have conducted at the University represents what we believe to be a compelling opportunity for innovative development in the high-value indication NMOSD, an orphan indication with significant unmet need, commented Dr. Klaus Paulini, Chief Executive Officer of Aeterna.

Prof. Joerg Wischhusen of the University added, Based on pre-clinical data obtained by the University to date, the AIM Biologicals technology has the potential to be a breakthrough in the treatment of autoimmune-related diseases. It is based on a mechanism developed by nature to protect the fetus from the mothers immune system without compromising immune protection against foreign antigens. This has the potential to offer a new treatment for NMOSD patients. We believe that the collaboration with Aeterna will accelerate the further development towards the clinic.

Autoimmunity Modifying (AIM) Biologicals - Targeted Immunosuppressive Therapeutics

During pregnancy, the maternal immune system tolerates paternal antigens from the embryo but is still effective to protect mother and embryo from foreign antigens. Parts of the natural mechanisms responsible for this feto-maternal immune tolerance form the scientific basis for the concept of AIM Biologicals.

AIM Biologicals utilize a novel mechanism which is believed to demonstrate that peptide antigens presented on immunosuppressive MHC class I molecules can selectively and efficiently induce antigen-specific tolerance. Based on this mechanism, the targeted immunosuppressive therapeutics are being designed as optimized soluble molecules with the goal that they may be adapted to selectively induce tolerance to various autoantigens. Pre-clinical studies conducted by the University thus far indicate that tolerance induction appears to be achieved via selective elimination of antigen-specific immune effector cells and via induction of antigen-specific regulatory T cells from nave T cells. AIM Biologicals thus have the potential to become highly specific and effective yet not personalized treatments of NMOSD.

For the treatment of NMOSD, it is believed that the AIM Biologicals will present a specific antigen derived from the water channel protein aquaporin-4 (AQP4) loaded to soluble immunoregulatory HLA-G protein to selectively induce immunological tolerance in the central nervous system.

In collaboration with the University and the University clinic, Aeterna plans to conduct further pre-clinical research to identify and characterize an AIM Biologicals based development candidate for the treatment of NMOSD, including meeting with the regulatory authorities to confirm the further pre-clinical data required as we work towards advancing such candidate into human clinical trials.

About Neuromyelitis Optica Spectrum Disorder (NMOSD)

NMOSD is an antibody mediated inflammatory central nervous system (CNS) disorder that affects about one per million population per year. NMOSD, also known as Devic disease, is a chronic disorder of the brain and spinal cord dominated by inflammation of the optic nerve (optic neuritis) and of the spinal cord (myelitis). Typical symptoms include visual loss, muscle spasms, paraparesis, and incontinence. If left untreated, 50% of individuals with NMOSD will be wheelchair bound and blind, and 30% will have died within five years after the first attack. The water channel protein AQP4 is widely expressed in the brain, spinal cord, and optic nerves. Auto-antibodies directed against the AQP4 channel play an important role in the pathogenesis of NMOSD.

Currently there are only three approved medications available for the treatment of NMOSD with very high annual treatment costs, and the risk of the patient contracting serious infections. Therefore, there is a strong medical need to offer new therapeutic options to the patients.

In the U.S. and Europe there are currently approximately 10,000 to 15,000 patients living with NMOSD. Of these the AQP4 antibody seropositive patients who represent about 80% of the NMOSD population are the targeted patients for a potential therapy based on the AIM Biologicals technology.

Transaction Terms and Conditions

Under the terms of the exclusive patent license agreement entered into with the University, Aeterna obtained worldwide rights to develop, manufacture and commercialize products for the treatment of NMOSD using the AIM Biologicals technology for an up-front cash payment of 100,000 and milestone payments to be paid upon the achievement of certain development and regulatory milestones as well as royalty payments on net sales. Aeterna will be responsible for the formal preclinical and clinical development, regulatory activities, and manufacturing of the licensed products. Aeterna has also engaged the University and University clinic to conduct certain pre-development activities with respect to the AIM Biologicals program to be funded by Aeterna.

The Company intends to continue balancing risks and secure growth opportunities by re-establishing a diversified, yet focused, development pipeline to which Aeterna can best leverage its expertise and experience. Aeterna is focused on opportunistically utilizing its network with universities in Europe and the U.S. The license of the AIM Biologicals program for NMOSD demonstrates Aeternas progress towards achieving its goal to obtain access to innovative development candidates in different indications, with a focus on rare or orphan indications with potential significant commercial opportunity.

About Aeterna Zentaris Inc.

Aeterna Zentaris Inc. is a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests. The Companys lead product, macimorelin, is the first and only U.S. FDA and European Commission approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). Macimorelin is currently marketed in the United States under the tradename Macrilen through a license agreement with Novo Nordisk where Aeterna receives royalties on net sales. According to a commercialization and supply agreement, MegaPharm Ltd. will seek regulatory approval and then commercialize macimorelin in Israel and the Palestinian Authority. Additionally, upon receipt of pricing and reimbursement approvals, Aeterna expects that macimorelin will be marketed in Europe and the United Kingdom through a recently established license agreement with Consilient Health Ltd. and Aeterna will receive royalties on net sales and other potential payments.

Aeterna is also leveraging the clinical success and compelling safety profile of macimorelin to develop it for the diagnosis of childhood-onset growth hormone deficiency (CGHD), an area of significant unmet need.

Aeterna is actively pursuing business development opportunities for the commercialization of macimorelin in Asia and the rest of the world, in addition to other non-strategic assets to monetize their value. For more information, please visit http://www.zentaris.com and connect with the Company on Twitter, LinkedIn and Facebook.

Forward-Looking Statements

This press release contains forward-looking statements (as defined by applicable securities legislation) made pursuant to the safe-harbor provision of the U.S. Securities Litigation Reform Act of 1995, which reflect our current expectations regarding future events. Forward-looking statements include those relating to the potential to obtain the necessary pre-clinical data and regulatory approvals necessary to advance any product using the AIM Biologicals technology into human clinical trials or to develop the AIM Biologicals to treat NMOSD or any other indication into an approved product, the ability of any product using the AIM Biologicals technology to compete with existing approved products (or any other products in development) for NMOSD, the ability of the Company to obtain approval of macimorelin for CGHD, the Companys ability to secure marketing partners for macimorelin in other key markets, the timing of the commencement of the CGHD Study P02, and may include, but are not limited to statements preceded by, followed by, or that include the words "will," "expects," "believes," "intends," "would," "could," "may," "anticipates", potential and similar terms that relate to future events, performance, or our results. Forward-looking statements involve known and unknown risks and uncertainties, including those discussed in this press release and in our Annual Report on Form 20-F, under the caption "Key Information - Risk Factors" filed with the relevant Canadian securities regulatory authorities in lieu of an annual information form and with the U.S. Securities and Exchange Commission. Known and unknown risks and uncertainties could cause our actual results to differ materially from those in forward-looking statements. Such risks and uncertainties include, among others, our ability to raise capital and obtain financing to continue our currently planned operations, our ability to continue to list our Common Shares on the NASDAQ, our now heavy dependence on the success of Macrilen (macimorelin) and related out-licensing arrangements and the continued availability of funds and resources to successfully commercialize the product, including our heavy reliance on the success of the License Agreement with Novo Nordisk, the global instability due to the global pandemic of COVID-19, and its unknown potential effect on our planned operations, including studies, our ability to enter into out-licensing, development, manufacturing, marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect, our reliance on third parties for the manufacturing and commercialization of Macrilen (macimorelin), potential disputes with third parties, leading to delays in or termination of the manufacturing, development, out-licensing or commercialization of our product candidates, or resulting in significant litigation or arbitration, uncertainties related to the regulatory process, unforeseen global instability, including the instability due to the global pandemic of the novel coronavirus, our ability to efficiently commercialize or out-license Macrilen (macimorelin), our reliance on the success of the pediatric clinical trial in the European Union (E.U.) and U.S. for Macrilen (macimorelin), the degree of market acceptance of Macrilen (macimorelin), our ability to obtain necessary approvals from the relevant regulatory authorities to enable us to use the desired brand names for our product, our ability to successfully negotiate pricing and reimbursement in key markets in the E.U. for Macrilen (macimorelin), the outcome of our pre-clinical and clinical development efforts of in-licensed products (including the AIM Biologicals), any evaluation of potential strategic alternatives to maximize potential future growth and shareholder value may not result in any such alternative being pursued, and even if pursued, may not result in the anticipated benefits, our ability to take advantage of business opportunities in the pharmaceutical industry, our ability to protect our intellectual property, and the potential of liability arising from shareholder lawsuits and general changes in economic conditions. Investors should consult our quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties. Given these uncertainties and risk factors, readers are cautioned not to place undue reliance on these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or applicable law.

Investor Contact:

Jenene ThomasJTC TeamT (US): +1 (833) 475-8247E: aezs@jtcir.com

Original post:
Aeterna Zentaris Expands Orphan Drug Development Pipeline with Targeted Immunosuppressive Therapeutics - GlobeNewswire

Recommendation and review posted by Bethany Smith

The Daily Beast

Erin Scott/GettyWhether its harassing the survivor of a school shooting for the benefit of a cameraman or accusing the Rothschild family of building a satellite-mounted laser that nearly burned down California, Rep. Marjorie Taylor Greene (R-GA) has made it clear that she will do almost anything for attention.But unlike nearly everyone else in the country, the White House isnt interested in giving it to her. Period.The Biden administrations policy regarding the first-term congresswoman from Georgia was made clear on Wednesday when a reporter asked White House press secretary Jen Psaki whether the president had any reaction to recent reports of online behavior that many found appalling, even for an avowed supporter of the QAnon conspiracy cult.Was there any response to the first-term congresswomans online and in-person behavior, which included the harassment of David Hogg, a survivor of the Stoneman Douglas High School shooting she once called #littleHitler? As well as her apparent belief that the shooting itself was a false flag? And a Facebook comment in which she suggested removing House Speaker Nancy Pelosi with a bullet to the head?We dont, Psaki said curtly. And Im not going to speak further about her, I think, in this briefing room.For an administration that has made fighting disinformation and right-wing extremism a top priority following the attack on the U.S. Capitol earlier this month, and a communications team with a demonstrated unwillingness to cede ground to unhelpful narratives, Psakis blunt refusal even to say Greenes name was surprising. But according to those familiar with the administrations thinking, it was also strategicand proof, they said, that the Biden administration has learned the lesson of the early months of Donald Trumps campaign for the White House, when unfettered attention helped raise his profile and stoke the followers who would eventually carry him to the Oval Office.Like Trump, one person familiar with the communications teams thinking said, Greene thrives off both positive and negative attention, and is validated when those in power stoop to fight her. In a media landscape that plays up conflict, such an engagement would actually raise her profileand while a West Wing-style takedown from the briefing room podium would make great television, it would also give Greenes stans one more battle arena in which to root for her.Refusing even to say her name in the White House briefing room makes their disapproval clear, one administration ally said, without dignifying her behavior with the attention of the leader of the free world.It was the perfect balance, the ally told The Daily Beast, who said that Psakis refusal to feed the trolleven one elected to Congresswas clearly rooted in a rare understanding of the modern environment.She simultaneously displayed sincere condemnation while denying that anthropomorphic hemorrhoid the attention she craves, the ally said, perhaps a bit graphically.Psakis refusal to engage may have been frustrating for those expecting a full-throated condemnation of Greenes conspiracism and calls for violence, but experts in the far right told The Daily Beast that the approach is the least-bad option when dealing with extremists desperate for the spotlight.By talking about her, they make her a hero to the folks on the fringeshed become sort of the right-wing AOC, and then gets more attention than she probably should have, said Randy Blazak, an Oregon-based sociology professor and hate crime researcher who specializes in movements that want to overthrow the U.S. government.The Biden administration is treading carefully on this matter, because its easy to blame them, Blazak said, summing up how far-right extremists would view any on-camera condemnation from the White House. One basket of deplorables comment and theyve got a whole new bunch of recruits to bring in. They have to be very careful in how they navigate this because this is no longer a small fringe groupits now a largely mainstream movement that includes people in our own families.House Democrats, meanwhile, are forced by proximity to deal directly with Greene. And few within their ranks feel like ignoring her: In her short time in office, the freshman congresswoman has explained away the Jan. 6 attack with a conspiracy theory, conspicuously shunned a mask in a crowded safe room where several of her colleagues later came down with COVID, immediately moved to impeach President Joe Biden, and was discovered to have endorsed the execution of the Democratic partys leader and to have flirted with the theory that a Jewish-controlled space laser started California wildfires.Greene has responded by calling the reporting on her publicly available social media activity by CNNs KFILEmuch of which has been scrubbed sincea project of the Democrats and the so-called fake news. They are coming after me because Im a threat to their goal of Socialism, said Greene, in a statement given on Thursday. They are coming after me because like President Trump, I will always defend conservative values. They want to take me out because I represent the people. And they absolutely hate it.On Twitter on Thursday morning, Greene posted a 2016 Facebook comment in which she said I have friends of different races, religions, and political preferences and asked why that sentiment was being ignored alongside her endorsement of killing Pelosi.Many Democratic lawmakers feel that Greenes conduct deserves the most forceful reprimand they can mustera vote to expel her from Congress. On Wednesday night, Rep. Jimmy Gomez (D-CA) introduced a resolution calling for just that, and it could come to the floor as soon as Tuesday. Two-thirds of the House would have to vote in favor to secure her removal, however, and few Republicans expect that dozens of their lawmakers will vote to oust Greene, even if many believe shes the second coming of Steve King, the former congressman and notorious racist.GOP Thought Steve King Was as Bad as It Got, Then Came Marjorie Taylor GreeneHouse Democratic leaders arent disavowing the push to remove Greene, but their careful remarks so far suggest they are just as interested, if not more so, in holding House GOP leadership accountable for Greene than Greene herself.Party brass have zeroed in on the House GOP leader, Rep. Kevin McCarthy (R-CA), who has so far done little to signal any repercussions for Greenes conduct. After the CNN story dropped, McCarthy promised to have a conversation with her about the Facebook posts.At a press conference on Thursday, the first question asked of Pelosi was about concern around Greene, but the first words out of her mouth were about McCarthy. What Im concerned about is Republican leadership in the House of Representatives, said the speaker. Mentioning GOP leaderships appointment of Greenewho has posited that the countrys most horrific school shootings, from Sandy Hook to Parkland, Florida, were false flagsto the House Education and Labor Committee, Pelosi asked, What could they be thinking? before quickly adding thinking might be too generous a word.Asked about Pelosis comments Thursday, a McCarthy spokesperson forwarded the comment they provided to Axios two days ago: These comments are deeply disturbing and Leader McCarthy plans to have a conversation with the Congresswoman about them.Later Thursday, Rep. Pramila Jayapal (D-WA), chair of the Congressional Progressive Caucus, said at a press briefing that the group had not talked about taking a position on Greenes ouster. I know there is a lot of rage and even fear from many of our members, frankly across the Democratic caucus, about serving with people like Marjorie Taylor Greene who condoned putting a bullet in the head of Speaker Pelosi, said Jayapal, when asked by The Daily Beast. Were looking at all of the options, working with leadership on how we bring accountability.But Jayapal hastened to add a question: What is Kevin McCarthy doing about this? What are our Republican colleagues doing about this?To one House Democratic aide, those moves solidified what the partys approach should be. As a matter of strategy, when you start talking about expelling, it puts the onus on Dems, the aide told The Daily Beast. And I think the argument that the onus should be on Republicans is persuasive.Democrats are betting that McCarthy wont reprimand Greene in any serious wayand are laying the groundwork to make Republicans pay for it at the ballot box. Already, those who are working to elect more Democrats in 2021 and 2022 as reinforcements for Biden have seized on the lightning-rod lawmaker the president conspicuously ignores as an effective bogeyman for the post-Trump era.In the last week, the Democratic Congressional Campaign Committee, the partys official House campaign arm, has sent out a press release on a near-daily basis in an attempt to make Greene an albatross for McCarthy and every GOP lawmaker running for re-election. Several Democrats are fundraising off Greeneincluding Terry McAuliffe, the former DNC chair running for another term as governor of Virginia, who put Greenes name as the subject line of a recent fundraising email.Democratic strategists see the attempt to make Greene the face of todays GOP as a potent strategy to put vulnerable Republicans in a tight spot. Tying the opposing party to its most extreme members is the playbook Republicans ran last year against House and Senate candidates. But Democrats are confident that independent-minded suburban voters will find Greenes endorsement of political assassinations and a conspiracy theory about cannibalistic pedophile elites more extreme and off-putting than Rep. Alexandria Ocasio-Cortezs (D-NY) endorsement of, for example, the Green New Deal.While the White House isnt going to engage, Democratic strategists around the House map plan to put her front and center, said one Democratic operative of Greene. Every day that Marjorie Taylor Greene dominates, and is the face of Republicans in the House, is another bad day for them.But as long as Greene remains in a position of authority, she will likely remain a hero to those who see her as an ally in the dream of overthrowing liberal democracy.In Georgia, few believe that Greenes constituents will boot hershe convincingly won a June primary after many of her Q-sympathetic and Islamophobic comments were already public knowledgeand there is not, as of yet, any kind of real effort brewing to defeat her. The district is so heavily Republican that a Democratic win is virtually impossible.Blazak pointed to The Turner Diariesan ur-text of white supremacist fantasies about violently toppling the U.S. government, which he called sort of a flowchart model of how to start a civil war in Americaas a guideline for what those who stormed the U.S. Capitol hope to see out of Greene.Part of the plan is to have people who are sympathetic on the inside who can figuratively, or literally, open the door and let the barbarians into the gates, that can provide access to nuclear code so they can bomb Israel, Blazak said. This is how far it goes.The current unwillingness of Republican congressional leadership to take action against Greene has only emboldened the extremists who back herwith potentially catastrophic consequences.I have this naive hope that Biden, being an old-school politician, can talk to the Democratic leadership and talk to the Republican leadership in a way that says, weve got a real crisis here and we have to determine what the country is going to look like, what these political parties are going to look like, and encourage them, maybe behind the scenes, to push this person off, Blazak said. But the fact that she was given a pretty decent committee position on education, of all things, means that work really needs to be done inside the community.Were gonna see the Tea Party on meth, Blazak said.Read more at The Daily Beast.Get our top stories in your inbox every day. Sign up now!Daily Beast Membership: Beast Inside goes deeper on the stories that matter to you. Learn more.

See the article here:
UK variant will cause rise in cases in the U.S., says doctor - Yahoo News

Recommendation and review posted by Bethany Smith

You might sweat in your sleep because you're too hot, but it could also be a symptom of something more serious.

Image Credit: demaerre/iStock/GettyImages

There are certain times you expect to sweat in the middle of a heat wave, during your spin class and maybe even before a gigantic work presentation. But if you've ever woken up in the middle of the night drenched, you may wonder what's happening.

"Sweating itself is completely normal it's a way for your body to regulate its temperature," says Donald Ford, MD, a family medicine specialist at the Cleveland Clinic.

If you wake up sweaty in the middle of the night underneath a heavy blanket or in a too-hot bedroom, it's one thing. That's due to overheating, and when you remove the culprit, your body temp and your nocturnal awakenings should return to normal.

But if you wake up in soaking sheets and your thermostat is set to a cool 65 degrees, there may be other, underlying health issues causing your night sweats, Dr. Ford says.

They're actually surprisingly common up to 41 percent of people in a primary care setting reported having them in the last month, per a November-December 2012 review in the Journal of the American Board of Family Medicine. They were most common in people ages 41 to 55.

Here, five common reasons you might get night sweats, and what to do about them.

1. You're Going Through Menopause

The years leading up to menopause known as perimenopause are prime time for hot flashes: Almost 80 percent of women report experiencing them as they go through this stage of life.

This is due to significant fluctuations in your body's production of the sex hormones estrogen and progesterone, says Stephanie Faubion, MD, medical director of the North American Menopause Society and director of the Mayo Clinic's Center for Women's Health. These fluctuations occur multiple times a day, including at night, when they cause night sweats.

Fix it: If your hot flashes are mild, you can try lifestyle changes such as keeping your thermostat at a low temperature, using lighter bedding and sleeping in lightweight, loose-fitting clothing, Dr. Faubion says.

You should also avoid caffeine and alcohol, especially in the evening, as they can cause spikes in body temperature and trigger sweating.

Regular exercise may also help: A February 2017 study in Menopause found sedentary people who completed a 20-week exercise program reported reductions in hot flashes, including night sweats.

But if these changes don't help, or your symptoms are more severe, talk to your doctor about your options.

If you're within the first 10 years of menopause and you don't have risk factors such as heart disease, diabetes, high cholesterol, high blood pressure or a history of breast cancer, then you can try a course of hormone therapy, Dr. Faubion notes. You can also ask about Brisdelle, an anti-depressant that's also FDA approved to treat hot flashes.

2. It's a Side Effect of Your Meds

Certain medications are known to be associated with night sweats: "They alter neurotransmitters in your brain, causing it to overproduce the hormone serotonin, which in turn throws your body temperature out of whack," Dr. Ford explains.

The biggest offenders are a class of anti-depressants known as selective serotonin reuptake inhibitors (SSRIs), certain blood pressure and diabetes medications and over-the-counter drugs like the heartburn drug omeprazole (Prilosec) or the pain-reliever naproxen (Aleve).

Fix it: Talk to your doctor. You may be able to switch to another type of medication that won't cause the same reaction, Dr. Ford says. You should also avoid caffeine and alcohol, since they can exacerbate the problem.

3. You've Got a Hormone Issue

Hyperthyroidism (where your body produces too much thyroid hormone) can overstimulate your nervous system, which means you not only have trouble falling and staying asleep, but you can wake up in the middle of the night sweating up a storm, says Peter Bidey, DO, an osteopathic family physician and assistant professor in the Department of Family Medicine at the Philadelphia College of Osteopathic Medicine.

If you have undiagnosed diabetes, that can also wreak havoc with your blood sugar levels and cause you to sweat more easily, including at night.

While there are other conditions caused by adrenal tumors such as pheochromocytoma and carcinoid syndrome that can cause night sweats, these diseases are relatively rare, Dr. Bidey says.

Fix it: See your doctor, especially if you have other symptoms of hyperthyroidism such as heart palpitations, mood swings, hyperactivity and weight loss, or of type 2 diabetes, such as increased thirst, hunger and urination. Your physician can run blood tests to diagnose either condition, Dr. Bidey says.

4. It's a Side Effect of Sleep Apnea

Night sweats occur about three times as often in people with untreated sleep apnea a condition where your throat tissue blocks your airway, causing you to stop breathing multiple times throughout the night according to an April 2013 study in BMJ Open.

This is because each episode of apnea causes your body to release the stress hormone cortisol, which activates your nervous system, Dr. Bidey says.

Fix it: Watch for other symptoms of sleep apnea, including snoring, morning headache and feeling super fatigued during the day (to the point where if you sit down, you sometimes nod off). If you have them, see your doctor, who can refer you to a sleep specialist.

Sleep apnea is diagnosed via an overnight sleep study, where you're hooked up to equipment that monitors your breathing patterns and blood oxygen levels while you sleep.

If you do have sleep apnea, you'll need a CPAP, a machine that delivers air pressure through a mask while you sleep.

Life-threatening infections such as tuberculosis, human immunodeficiency virus (HIV), endocarditis (a heart valve infection) and osteomyelitis (a bone infection) are associated with night sweats, most likely because they can trigger a fever, Dr. Ford says.

Fix it: These diseases usually present with other symptoms, such as chills, fever, body aches, fatigue and loss of appetite, Dr. Ford says. If you notice any of these, see your doctor right away.

When to See a Doctor for Night Sweats

If you get night sweats once or twice, there's no need to be concerned, Dr. Bidey reassures, especially if they're relieved by opening a window or applying ice packs or cold compresses to your body.

But if they occur more often than that, or you've got other symptoms like fatigue, high fever, weight loss or body aches, see your doctor. He or she can rule out underlying medical conditions such as an infection, a hormonal condition, or, more rarely, a blood cancer such as leukemia or lymphoma.

Originally posted here:
5 Reasons Why You Sweat in Your Sleep - LIVESTRONG.COM

Recommendation and review posted by Bethany Smith

Morning diarrhea is often due to something you ate or drank the day before.

Image Credit: Patcharanan Worrapatchareeroj/Moment/GettyImages

Wow. This morning has been something else. You woke up with diarrhea. Aside from being sick, it might also have to do with what you ate, an as-yet undetected GI condition or even the monster to-do list you have brewing today.

Here's what's up and what you can do about it.

1. Youre Worried About All the Things Today

Not everyone feels well-rested when they get up and you might be swimming in worries about what's on your plate (e.g. a ton of to-dos, a not-so-pleasant meeting with your boss, a worrisome visit to the doctor, news from a friend).

When you're stressed, your body releases cortisol the fight-or-flight hormone and two things can happen in terms of your gut function: you can get diarrhea or constipation, plus bloating and flatulence, Monica S. Borkar, MD, a gastroenterologist with NorthShore University HealthSystem in Glenview, Ilinois, tells LIVESTRONG.com.

Fix it: Taking care of yourself will help out your gut.

"Getting enough sleep, eating a healthy diet, drinking at least 64 ounces of water daily, avoiding caffeine, alcohol and tobacco and exercising can help your gut-brain axis get back on track," she says.

2. You Overserved Yourself Last Night

Alcohol tends to cause diarrhea, Dr. Borkar says. Imbibing too many IPAs or glasses of vino can cause the runs the next morning because you're drinking more fluid and alcohol might change your gut microbiome in ways that alter your BM habits.

Another possible related factor: Midnight snacking, she says. If you drank alcohol and then followed it up by diving into the chips or slices of pizza to quell the booze-induced munchies, then you can see why your BMs are making themselves known this morning.

Research in the Asian Pacific Journal of Cancer Prevention in 2019 suggests that diarrhea following drinking is associated with an increased risk of developing colorectal tumors, so this isn't a sign you should just brush off if it happens to you regularly.

Fix it: To reduce the risks associated with drinking, the Centers for Disease Control and Prevention recommends those assigned male at birth limit themselves to two drinks per day while those assigned female consume no more than one per day.

3. You Took a Laxative a Couple Days Ago

If you're constipated, OTC laxatives can be tricky they don't produce pooping immediately.

"Most over-the-counter laxatives can take anywhere from 8 to 72 hours to work," Dr. Borkar says.

If you popped one a couple of days ago, now just might be your time to have a BM.

Talk to your doctor before starting any of these medications, Dr. Borkar advises: They can interact with other medications you are taking and have the potential to cause incontinence.

4. Youre Sensitive to Your Nighttime Treat

Did you hit the pint of low-cal ice cream hard last night? Some artificial sweeteners and sugar alcohols in these types of desserts and other foods are associated with GI complaints, like bloating or diarrhea in some people, Dr. Borkar says. Dairy can loosen your stools, too, if you're sensitive to lactose, the sugar found in milk.

Fix it: If you notice that this happens frequently after you eat certain foods, you can try avoiding them to see if that quells your symptoms.

For a more thorough investigation to pinpoint your GI triggers, talk to a registered dietitian or your doctor.

5. Youve Got the 'Stomach Flu'

The "stomach flu" (read: viral gastroenteritis) can seemingly strike out of nowhere. You go to bed fine and you wake up with watery diarrhea (that has no blood), stomach pain, nausea, vomiting, a headache and a fever.

Fix it: Unfortunately, there's no treatment for this bug, notes the Mayo Clinic. And sometimes it's tough to know what got you sick in the first place, because the symptoms can appear several days after you came in contact with the contaminated food (or water).

You can make yourself more comfortable by avoiding mediations like NSAIDs that can cause stomach upset, avoiding food until your stomach starts to feel better and taking small sips of water to avoid dehydration. And let your doctor know if symptoms don't subside in a couple days.

Pregnancy is another contributor to morning diarrhea, Dr. Borkar says.

The American Pregnancy Association notes that this not-so-great symptom can be chalked up to newfound sensitivities to foods that didn't bother you before or hormonal changes that slow digestion.

If you have diarrhea, make sure youre drinking adequate fluids to avoid dehydration, which can be dangerous during pregnancy. And if it's persistent, definitely mention it to your ob-gyn.

See the article here:
6 Causes of Morning Diarrhea and How to Treat It - LIVESTRONG.COM

Recommendation and review posted by Bethany Smith

RALEIGH, N.C., Jan. 28, 2021 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, a specialty pharmaceutical company focusing on treating conditions that are primarily associated with testosterone deficiency, today announced that it has appointed Himanshu H. Shah and Shalin Shah as co-CEOs to drive the next phase of growth as the company looks to a potential launch of KYZATREX in Q4 2021 and further the development of Marius deep clinical pipeline.

Himanshu H. Shah brings over 30 years of experience across global capital markets and will continue his role as chairman of the board in addition to co-CEO. He has advised numerous public and private companies over the past decades to help them unlock substantial shareholder value and execute both innovative and pragmatic business strategies.

I am proud to continue serving Marius and work on developing the best treatment options for men with hypogonadism, a common but not widely discussed disease among patients and prescribers, said Himanshu H. Shah, chairman and co-CEO of Marius Pharmaceuticals. Misconceptions about hypogonadism are having a huge impact on the health of millions of men globally and costing the U.S. healthcare system alone billions of dollars annually. There is a huge opportunity for Marius to address these issues and drastically alter the testosterone therapy landscape.

Shalin Shah will also step into the role of co-CEO from chief financial officer and executive vice president of strategy for Marius. Shalin has been integral in driving overall strategy at Marius for the past four years and will oversee the growth of the team and execution of innovative models as it expands both clinically and commercially to become a leading pharmaceutical company.

I am excited for the opportunity to serve Marius in this new capacity, especially at a time when the world is seeing technology and healthcare intersect more than ever, truly helping patients, said Shalin Shah, co-CEO of Marius Pharmaceuticals. I am confident in Marius mission to better the lives of patients by ensuring adequate levels of testosterone and enhance patient care through disruptive technologies and personalization.

Om Dhingra, Ph.D., led the company from initial development of the lead compound through two successful Phase 3 clinical trials and will move into the role of vice chairman. He will help guide the companys clinical development plan and ensure KYZATREX and its differentiating safety and efficacy data is well known in the medical world.

It has been my great pleasure serving the company as CEO. I am very proud of the data we have generated, which we believe will position KYZATREX as the standard of care for patients suffering from hypogonadism globally, said Dr. Om Dhingra, vice chairman of Marius Pharmaceuticals.

If approved by the FDA, KYZATREX has the potential to become the new standard of care for treating patients with hypogonadism. Testosterone is a crucial hormone that is essential to sexual and reproductive health, but also has important functions in metabolic, inflammatory, cardiovascular and neurological health. In the U.S. there are at least six million symptomatic men suffering from hypogonadism, and over 100 million men globally. The resulting medical costs associated with men with untreated hypogonadism and related comorbidities are more than $25 billion in the U.S. alone. Current treatments on the market are dominated by therapies with unappealing administration methods, including auto-injections, in-office infusions and topical gels and creams that have a high transference risk. KYZATREX is an orally administered treatment that avoids the drawbacks that keep men from continuing treatment on available testosterone therapies.

About KYZATREX KYZATREX if approved, will represent a novel oral testosterone replacement therapy option for adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).

The ReTUNE study was a multi-center, 12-month study across the U.S. that studied the safety and efficacy of KYZATREX in hypogonadal subjects (total testosterone 281 ng/dL). Efficacy was determined by number of subjects in the normal, eugonadal range after 90 days of treatment, including dose titrations, while safety was monitored for a further 9 months while on a steady dose. In addition to testosterone parameters, the study collected Patient Reported Outcomes (PROs), which showed statistically significant results both from baseline and against its comparator. A pivotal six-month Phase 3 study was conducted, in which subjects were monitored using ABPM, now considered the standard BP assessment by the FDA and clinical experts. An improved dose regimen was also used in the pivotal six-month Phase 3 study. The results of the Phase 3 studies will be published in leading medical journals and presented at national conferences in 2021.

The FDA has conditionally accepted KYZATREX as the trade name for this investigational drug. The safety and efficacy have not been fully evaluated by any regulatory authority.

About Marius PharmaceuticalsMarius is a specialty pharmaceutical company focusing on treating conditions that are primarily associated with hypogonadism, commonly referred to as testosterone deficiency. The companys mission is to improve the functional lives of patients and reduce the risks of the downstream effects of endocrine imbalance by ensuring appropriate level of testosterone. For more information, please visit http://www.mariuspharma.com.

Media Contact: Emily Brice919-610-3319ebrice@fwv-us.com

Photos accompanying this announcement are available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/f825d70b-874a-4cef-9160-429f83bbfc66

https://www.globenewswire.com/NewsRoom/AttachmentNg/ba2569ca-0922-4b49-8d68-49424b5e44d4

Himanshu H. Shah

Co-CEO and Chairman of the Board, Marius Pharmaceuticals

Shalin Shah

Co-CEO, Marius Pharmaceuticals

Follow this link:
Marius Pharmaceuticals Announces Co-CEOs Himanshu H. Shah and Shalin Shah to Drive Growth ahead of Anticipated FDA Action of its Lead Asset, KYZATREX...

Recommendation and review posted by Bethany Smith

Testosterone replacement therapy is done to restore the testosterone levels in men. It is referred to ashormone replacementtherapy. Testosterone is a hormone in men that is produced in the testicles and helps to maintain sex drive, bone density, facial and body hair, sperm production, fat distribution, and red blood cells production. Testosterone levels are highest during adolescence and early stages of adulthood. The levels decline gradually as men age at around 30-40 years.

Testosterone in men may decline due to two reasons. First, it may be due to health conditions that have an effect on the testicles eg cancer, infection, and injury. The disease that results from low levels of testosterone is called hypogonadism. This condition prevents testosterone production by affecting the testicles and pituitary glands. Secondly, it may be as a result of natural decline as a man ages i.e. when men reach 30, they may start experiencing testosterone reduction. Low testosterone levels are considered normal but to some men, it may be extremely abnormal levels hence require replacement.

Decline testosterone levels can lead to symptoms such as reduced sexual desire with few erections that happen spontaneously, physical changes such as decreased muscle strength and mass, increased body fat, swollen and tender breasts, hair loss, fatigue, osteoporosis, emotional changes that lead to reduced motivation and self-esteem eg depression, and infertility. These symptoms can be a result of the side effects of the therapy, thyroid problems, diabetes, and obstructive sleep apnea. Hormone replacement therapy is administered to reverse the lowered testosterone levels in men. The therapy can be recommended to various people with the problem. Both healthy and aging men without hypogonadism diagnosis can be prescribed for testosterone replenishment on showing symptoms. Very high levels of testosterone on the other hand can also cause side effects such as the risk of stroke, infertility, enlarged breasts, and enlarged prostate.

There are several ways in which testosterone replacement can be administered. Testosterone can be taken in gels, intramuscular injections, patches, and topical creams. The method used for administration depends on ones lifestyle and the type of medical need. It can also be taken orally while being monitored to prevent it from being too high. Hormone replacement therapy is meant to induce and maintain secondary characteristics and to correct the symptoms and side effects arising due to low testosterone levels. Testosterone therapy can have some effects when used to prevent normal aging. It worsens sleep obstruction a disorder that causes abrupt stop and start of breathing, promotion of prostate cancer growth, stimulated overproduction of red blood cells increasing blood clotting risks, and reduction in sperm production or testicle shrinkage.

Hypogonadism can be diagnosed as primary or secondary hypogonadism. Abnormalities in testicular levels should be diagnosed, treated, and monitored. Hypogonadism causes testis failure hence reduced production of testosterone concentration and affect the normal number of spermatozoa. It can result from either defect that causes a change in the testis or the hypothalamus. Primary hypogonadism is a result of low T levels, raised gonadotropin levels, or impaired spermatogenesis. Causes of primary hypogonadism include trauma, HIV infection, cancer chemotherapy, myotonic dystrophy, testes exposure to radiation, and infectious orchitis. Secondary hypogonadism is due to low T levels, low or unsuitably normal gonadotropin levels, and spermatogenesis impairment. It is caused by severe obesity, androgenic anabolic steroid withdrawal, hypothalamic tumours, pituitary tumour, and surgery and deprivation therapy of androgen with gonadotropin.

Before testosterone therapy is administered, the clinicians discuss the potential risks and the need for monitoring. Urological evaluation is necessary for men with prostate nodule or induration. In older men, testosterone therapy has a life expectancy of up to 10 years and above. The therapy may lead to side effects and risks such as prostate cancer risk and require prostate monitoring. Some of the symptoms that are evident during T administration include.

Acne and oily skin

Reduced sperm production and fertility

Detection of subclinical cancer

Erythrocytosis

Metastatic prostate cancer growth

Male pattern balding

Breast cancer growth

Obstructive sleep apnea

Heart attack and heart disease

Before settling for testosterone therapy, it is important to take a few cations and think about all the aspects of the therapy. First, analyzing ones health history is key.it is advisable to first consider any other reasons that may be causing the symptoms that are similar to those of low testosterone levels. Sex dysfunctions can also be due to psychological or relationship issues. Cardiovascular disease can also be the reason behind erectile dysfunction. Several clinical measurements may be required to fully diagnose low testosterone levels. The tests are done on varied days and detailed interpretation is needed to establish the amounts of available testosterone. It is also necessary to have information on the possible risks and effects of the therapy and the side effects of the different methods used in administering testosterone.

Baseline evaluation before T administration is done helps to identify and exclude those prone to prostate cancer or who have a high risk of developing prostate cancer. Screening and monitoring in the case of cancer risk require patient and doctor agreement and patient awareness. Factors that should be considered during the baseline assessment are age, race, family history, and prostate examination results. Patient administered with T therapy requires frequent monitoring and assessment to establish whether the therapy is working and in case there are any adverse effects, and that they are responding to the treatment regimen. During the first 12 months of T treatment, it is advisable to get urological consultation to identify ant abnormalities.

Testosterone decline can be due to aging or medical conditions. The treatment and restoration of the levels of testosterone are referred to as testosterone replacement therapy. This therapy requires diagnosis, treatment, and constant monitoring. This is because the therapy treatment has different side effects and risks that vary from one patient to another. A qualified specialist team atLiv Naturalhelps by providing solutions to testosterone deficiency and solve any other health problems that result from low testosterone levels such as erectile dysfunction, low libido, and low muscle mass. Low T levels can only be determined by a diagnosis administered by clinicians i.e. testosterone level test.

(Visited 6 times, 6 visits today)

Go here to read the rest:
Male Hormone Replacement Therapy And The Side Effects - Nerd's Magazine

Recommendation and review posted by Bethany Smith

From contraceptives to mesh implants, shampoos to pasta, New York state and federal courts issued decisions in 2020 which further shaped the landscape in the medical and life sciences legal world. To prepare the best product liability and class action defense strategies for pharmaceuticals, medical devices and other FDA regulated products, it is often helpful to step back and review holdings that have affected the industry and may shape the year ahead.

In the New York Medical and Life Sciences: Year in Review 2020, we review, analyze and share potential implications for future life science cases, based on several key judicial holdings in New York in 2020 pertaining to:

In Re: Mirena IUS Levonorgestrel-Related Products Liability Litigation (No. II), 982 F.3d 113 (2d Cir. 2020)

In an appeal from a judgment of the United States District Court for the Southern District of New York granting summary judgment in favor of Bayer dismissing mass tort plaintiffs' products liability Mirena claims after preclusion of the opinions of all of plaintiffs expert witnesses on general causation, the Second Circuit affirmed. Plaintiffs argued that the district court abused its discretion by (1) focusing on plaintiffs' experts' conclusions rather than their methodologies, (2) requiring the experts to back their opinions with published studies that definitively supported their conclusions, and (3) taking a "hard look" at the experts' methodology. The Second Circuit held that plaintiffs may challenge whether the district courts reliability analysis was correct, but plaintiffs had no basis to argue that the district court did not engage in a detailed analysis of their experts' methodologies. An expert need not back his/her opinion with published studies that support his/her conclusion if he/she has utilized reliable scientific methods to reach that conclusion. But here, because the district court found that plaintiffs' experts did not otherwise reliably utilize scientific methods and the conclusions were not supported by other studies, the experts' reports were properly excluded. Not only was it appropriate for the district court to take a hard look at plaintiffs' experts' reports, the court was required to do so to ensure reliability. Plaintiffs also argued that the district court erred in precluding differential-diagnosis evidence, which they argued would have shown general causation. While the Second Circuit declined to adopt a bright-line rule that "a differential diagnosis may never provide a sufficient basis for an opinion as to general causation," they explained that the district judge had broad discretion in determining whether in a given case a differential diagnosis is enough by itself to support such an opinion. And here it was not.

English v Bayer, 468 F. Supp.3d 573 (W.D.N.Y. 2020)

Plaintiffs, three former users of Essure, a Class III medical device contraceptive implant, subject to Pre-Market Approval procedures, and granted PMA by the FDA, asserted causes of action for negligent training of physicians, breach of express warranty and negligent misrepresentation (advertising concerning safety and effectiveness at preventing pregnancy, and qualifications of implanting physicians), negligent risk management (failing to report adverse events to the FDA), and negligent failure to warn. Defendants moved pre-Answer to dismiss under FRCP 12(b)(6) on the basis that plaintiffs claims were entirely preempted by the Medical Device Amendments to the federal Food Drug and Cosmetic Act. The court found plaintiffs did not plausibly allege that the FDA-approved training requirements placed any duty on defendants to do so. To the extent that plaintiffs claimed that defendants did deviate from FDA-approved training requirements by failing to ensure that implanting physicians completed preceptoring requirements, read and understood the Physician Training Manual, and successfully completed simulator training, those claims did not seek to impose obligations beyond those mandated by the FDA, and thus arguably were not expressly preempted. However, they were nonetheless impliedly preempted since plaintiffs did not plead any parallel state law cause of action that supported their negligent training claims, nor did their opposition identify any New York law establishing liability on the part of a non-employer for injuries to third parties arising out of alleged negligent training. With respect to plaintiffs failure to report adverse events to the FDA claims, even if they were characterized as a failure to warn, they were expressly preempted: plaintiffs could not maintain a claim that defendants were required to issue additional warnings beyond what the FDA prescribed and approved. Furthermore, as a standalone claim, failure to report adverse events to the FDA is not a cognizable cause of action under New York law.

Montero v. Teva Pharmaceuticals USA Inc. et al., No. 19 Civ. 9304, 2020 WL 1862593 (S.D.N.Y. April 14, 2020)

Plaintiff alleged that she developed blood-clots, resulting in a pulmonary embolism, as a result of using an oral contraceptive, marketed as a generic drug. The complaint asserted causes of action for negligence, strict liability, breach of warranty, fraud and negligent misrepresentation. On a FRCP 12(c) motion for judgment on the pleadings, the court dismissed the warning and design claims as preempted, citing Supreme Court precedents (PLIVA, Inc. v. Mensing 564 U.S. 604 (2011) and Mut. Pharm. Co. v. Bartlett, 570 U.S. 472 (2013)). Moreover, plaintiff could not proceed on her other claims, including a failure to test theory, a theory premised on the suggestion that such testing would have shown that the oral contraceptive was too dangerous for the market. That argument is inconsistent with Bartlett, which held that the stop-selling rationale that products should be pulled from the market is incompatible with preemption jurisprudence because preemption cases presume that an actor seeking to satisfy both his federal and state law obligations is not required to cease acting altogether in order to avoid liability.

Contraceptives Potential implication for future cases: In contraceptive product liability actions, whether the product is regulated as a drug or a device, preemption remains a first line of defense. Even non-traditional theories, such as failure to test, train or report AERs, are vulnerable to dismissal. New York continues to be wary of admitting differential diagnosis expert opinion on issues of general causation.

Balura v Ethicon, No. 3:19-CV-1372, 2020 WL 819293 (N.D.N.Y. Feb. 19, 2020)

In a massive products liability multi-district litigation involving transvaginal surgical mesh used primarily to treat pelvic organ prolapse and stress urinary incontinence, defendants moved to exclude a specific causation expert alleging differential diagnosis, as the opinion was replete with factual errors, which prohibited him from forming a proper foundation for his opinions. The court ruled that the differential diagnosis opinion was suitable in a specific causation analysis. However, the opinion that plaintiffs pelvic injuries were caused by a defective device without specifying any design defect was insufficient under New York law. The court ruled the expert failed to describe or explain how a defect in the mesh caused plaintiffs injuries, as opposed to the mere presence of the mesh itself. Finally, the experts opinions about alleged future complications were speculative and unreliable, as not consistent with Dauberts methodology requirements.

Arruda v. C.R. Bard, No. 6:19-cv-1523, 2020 WL 4569436 (N.D.N.Y. Aug. 6, 2020)

In a product liability matter involving Align, a 510K device, defendant contended that plaintiff could not prevail on a design defect claim unless she also demonstrated a failure to warn. Defendant argued that a medical device that is implanted and requires a prescription is a Comment K unavoidably unsafe product to which strict products liability would not normally apply. Defendant, however, largely relied on cases that involved prescription drugs, not devices. The court noted the Second Circuit would assess the viability of a design defect claim under the legal standard for such claims in New York a utility/risk analysisrather than by applying the unavoidably unsafe products exception. The court thus did not require plaintiff to show a failure to warn in order to maintain a design defect claim. Defendants attempt to have the court adopt a categorical approach to the exception stated in Comment K, finding that any medical device implanted pursuant to a prescription is unavoidably unsafe, was rejected. Among other things, the court denied defendants motion for summary judgment on design defect and failure to warn claims.

Dunham v. Covidien, 19-cv-2855, 2020 WL 5995102 (S.D.N.Y. Oct. 9, 2020) and Krulewich v Covidien, No. 19-cv-2857, 2020 WL 5995103 (S.D.N.Y. Oct. 9, 2020)

In a Covidien mesh action, defendant moved to dismiss claims for common law strict products liability (manufacturing defect, design defect, and failure to warn), negligence, breach of warranty (express and implied), negligent and fraudulent misrepresentation, unconscionable commercial practices under New York General Business Law Sections 349 and 350, unjust enrichment, and punitive damages, which was granted. Dunham v. Covidien. On the same day, the same court dismissed claims for common law strict products liability (manufacturing defect, design defect, and failure to warn), negligence, breach of warranty (express and implied), negligent and fraudulent misrepresentation, unconscionable commercial practices under New York General Business Law Sections 349 and 350, unjust enrichment, punitive damages, and loss of consortium. Krulewich v Covidien. In both cases, plaintiffs proposed alternative design was to use polypropylene instead of polyester. Plaintiffs did not adequately plead that the use of polyester was a substantial factor in causing the injuries. The plaintiffs thus failed to allege adequately a design defect claim. The court also found deficiencies in the plaintiffs failure to warn claims because the allegations did not identify how the warnings given were insufficient to warn physicians and the plaintiffs of the potential dangers of using the mesh. The warnings provided noted the risks of the complications that plaintiff actually experienced, namely, chronic pain, adhesion, and hernia recurrence.

Surgical MeshPotential implication for future cases: Surgical mesh plaintiffs must adequately plead their design defect and warning claims under traditional New York concepts of product liability. New York approaches design defect for a medical device under a risk utility balancing approach, not as an unavoidably unsafe product. Plaintiffs must specify the design defect through expert witness opinion evidence.

Gayle v. Pfizer, Inc., 452 F. Supp.3d 78 (S.D.N.Y. 2020).

24 plaintiffs claimed the cholesterol drug Lipitor caused their type II diabetes. Pfizer moved for judgment on the pleadings under FRCP 12(c) on the basis that if the claims arose after the 2012 Lipitor label change, they were preempted and if the claims arose before April 2016 they were time-barred. The court found the claims preempted, even though plaintiffs theorized 6,000 adverse event reports relating to diabetes from Pfizer to the FDA constituted newly acquired information which would enable the manufacturer to change the label under the FDAs Changes Being Effected (CBE) regulations. In order to qualify as "newly acquired information," the information must demonstrate "reasonable evidence of a causal association with a drug" 21 C.F.R. 201.57. But the fact that a user of a drug has suffered an adverse event, standing alone, does not mean that the drug caused that event. Additionally, while plaintiffs did not allege when their claims accrued, to the extent they accrued before April 2016, they were deemed untimely. Applying New Yorks borrowing statute CPLR 202 (which applies the shorter of the New York or other state statute of limitations) the court found the claims untimely. Plaintiffs could not take advantage of New Yorks discovery rule allowing plaintiffs to bring a claim one year after discovery of the cause of the injuries, because plaintiffs would still be caught in the preemption trap. Plaintiffs did not plead that technical, scientific or medical knowledge and information sufficient to ascertain the cause of their injury had not been discovered. Nor did plaintiffs plead with particularity that Pfizer fraudulently concealed the information, to equitably toll the statute of limitations.

Potential implication for future cases: Adverse event reports are not evidence of causation, and do not enable plaintiffs to do an end-run around preemption.

Vardouniotis v. Pfizer, 2020 NY Slip Op 32233(U) (Sup. Ct., NY County 2020)

In a state court action involving Chantix, a smoking cessation medication manufactured by Pfizer, defendant moved, pursuant to CPLR 3211(a)(7), to dismiss the verified complaint. The court dismissed the negligence, gross negligence, and willful, wanton and malicious conduct claims insofar as those causes of action were based upon failure to warn allegations, as well as the breach of express warranty, fraudulent misrepresentation, fraudulent concealment, reckless and/or negligent misrepresentation and concealment claims, and the plaintiffs request for punitive damages. Plaintiff argued that the label for Chantix did not include warnings for dystonia, muscular spasm, movement disorders and abnormal posture, which are typically due to neurological disease or a side effect of drug therapy. According to the plaintiff, Pfizer knew or should have known of these side effects, citing newspaper articles and scientific journal publications identifying adverse effects, especially those experienced by the plaintiff, not identified in the Chantix label. Although plaintiff cited newspaper articles and journal articles in her memorandum of law, these articles were not annexed to the complaint or her opposition to Pfizers motion to dismiss. The court declined to take Judicial Notice of facts alluded to, as that is reserved for matter[s] of common and general knowledge, well-established and authoritatively settled. Prince, Richardson on Evidence 2-201 (Farrell 11th ed). There was no showing that these websites were of sufficient authenticity and reliability. Plaintiff also alleged negligence, gross negligence and that Pfizer was wanton and malicious in its actions, misrepresentations, and omissions as a result of Pfizers failure to adequately test Chantix and failure to conduct post-marketing surveillance. Pfizers motion seeking dismissal of these claims was denied. Breach of express warranty was dismissed as no express warranties were pled or presented but the plaintiff adequately alleged that Pfizer breached the implied warranties of merchantability and fitness by holding Chantix out as reasonably fit and suitable when it was allegedly unreasonably dangerous. Unjust enrichment was not duplicative of any other claim, given that plaintiff sought disgorgement of Pfizers profits and monetary benefits. It is well-settled that conduct warranting an award of punitive damages need not be intentionally harmful but may consist of actions which constitute willful or wanton negligence or recklessness. Home Ins. Co. v American Home Prods. Corp., 75 NY2d 196, 204 (1990). Here, the complaint failed to allege that Pfizer engaged in any morally culpable conduct and plaintiffs request for punitive damages was denied.

Potential implication for future cases: New York State courts require that plaintiffs plead their complaints with particularity or be subject to early dismissal of claims not supported. AERs are not facts of which courts will take as Judicial Notice.

Crespo v Merck, No. 13-cv-2388, 2020 WL 5369045 (E.D.N.Y. Sep. 8, 2020), reconsideration denied 2020 U.S. Dist. LEXIS 188955 (E.D.N.Y., Oct. 12, 2020), appeal filed (Jan. 7, 2021)

Plaintiffs pro se brought this products liability action in the District of New Jersey. The Judicial Panel on Multidistrict Litigation transferred it to New York for coordinated pretrial proceedings, pursuant to 28 U.S.C. 1407. Plaintiff alleged sexual dysfunction from use of Propecia, was diagnosed with erectile dysfunction in 2003, and was diagnosed with hypogonadism in Florida, in 2009. At some point in 2009, his doctors discussed the possibility that plaintiffs use of Propecia had caused his sexual dysfunction. Merck moved for summary judgment on the basis of time bar, as plaintiffs filed the action on April 2, 2013. Generally, [a] federal court sitting in diversity jurisdiction applies the choice of law rules of the forum state. Forest Park Pictures v. Universal Television Network, Inc., 683 F.3d 424, 433 (2d Cir. 2012). When the JPML transfers a case, however, the transferee court applies the substantive state law, including choice-of-law rules, of the jurisdiction in which the action was filed. Menowitz v. Brown, 991 F.2d 36, 40 (2d Cir. 1993). The court applied New Jerseys choice-of-law rules, not the rules in New York. Here, two states had a potential interest in this action. New Jersey was the state in which plaintiffs filed the action, and the state in which defendants were incorporated, had their principal place of business, and made decisions regarding the labeling and marketing of Propecia. Florida was the state in which plaintiff was prescribed, purchased, and took Propecia. Plaintiff choose to file suit in New Jersey and there were no exceptional circumstance to justify departing from the general rule that New Jerseys statute of limitations applied, which barred plaintiffs claims.

Potential implication for future cases: In MDL cases, choice of law is not necessarily the law of the forum state, or the plaintiffs residence. Plaintiffs choice of forum may dictate choice of law.

Webb v Mentor, 453 F. Supp.3d 550 (N.D.N.Y. 2020)

MemoryGel silicone breast implants are Class III medical devices, approved by the FDA through the PMA process in 2006. Plaintiff sued in product liability (negligence based on failure to warn and manufacturing defect, negligence per se, strict liability in design and manufacturing defect, breach of express and implied warranty) and asserted claims related to the implants safety and effectiveness. Defendants moved to dismiss the complaint, asserting that plaintiffs claims were preempted, pursuant to the Medical Device Amendments of 1976, 21 USC 360c and, alternatively, that plaintiff failed to state any claims upon which relief may be granted, under FRCP 12(b)(6). To succeed in asserting a claim that fits through the narrow gap between express and implied preemption, plaintiff must identify a parallel law upon which she has based her state law claims. Plaintiff alleged that defendants did not comply with the FDAs Quality System Regulations and Current Good Manufacturing Practices (CGMPs). However, plaintiff failed to identify specific regulations or explain how defendants violated the CGMPs. Plaintiffs general allegations could not withstand preemption because she failed to establish the necessary link between defendants federal violations and her alleged causes of action. Plaintiffs failure to warn and design defect claims were preempted because she sought to impose safety related requirements on the device or labeling beyond those imposed by the FDA. Plaintiffs express and implied warranty claims were preempted; plaintiff did not identify specific representations of the manufacture which exceeded the scope of FDA approved labeling statements nor did she show defendants alleged federal violations caused the implants to have a deviated from their purpose, that they failed, or that they were unfit for patients.

Potential implication for future cases: PMA medical devices, including breast implants, continue to enjoy preemption in New York.

Berni v Barilla, 964 F.3d 141 (2d Cir. 2020)

Plaintiffs brought a class action against Barilla for deceptive packaging, alleging that Barilla intentionally sold its pasta in misleading boxes which concealed non-functional slack-fill, asserting claims under New York General Business Law section 349. The Second Circuit held future harm to pasta purchasers is not likely, and as a result, the injunctive relief sought would not provide a remedy for all members of the class. Pasta purchasers who alleged they were deceived were alleging past harm. Such past harm is of the kind that is commonly redressable at law through the award of damages, not injunctive relief. The district court did, in fact, err in certifying a Rule 23(b)(2) class because not all class members stand to benefit from injunctive relief, the kind of relief the settlement primarily provides. The Second Circuit held that past purchasers of a productlike the purchasers of Barilla pasta in this casewere not eligible for class certification under FRCP Rule 23(b)(2).

Sibrian v Cento Fine Foods, Inc., No. 19-CV-0974, 2020 WL 3618953 (E.D.N.Y. July 2, 2020)

Plaintiffs alleged misleading labeling of canned tomato products from Italy labeled Certified San Marzano under New York General Business Law sections 349 and 350. The court dismissed these claims as conclusory and strained, as the reasonable consumer would not have an expectation that a San Marzano tomato must be certified by the Consortium of the San Marzano Tomato Protected Designation of Origin. Plaintiffs did not allege that Cento falsely claimed the product was certified by the Consortium, and Consortium-certified seals did not appear on the product labels. Rather, plaintiffs contended the labeling and packaging created the impression of that certification. While there might be a few consumers who expect a San Marzano tomato to be certified by the Consortium, drawing upon common sense and common experience, the vast majority of reasonable consumers expect no such thing.

Steele v Wegmans, No. 19 Civ. 9227, 2020 WL 3975461 (S.D.N.Y. July 14, 2020)

Plaintiffs claimed deceptive acts or practices in violation of federal, New York, and Pennsylvania statutes and standards, false advertising, common-law negligent misrepresentation, fraud, breach of warranty and unjust enrichment alleging they were deceived into believing Wegmans ice cream was flavored with vanilla beans or extract. Upon a motion to dismiss, the court found the label on the ice cream container did not misrepresent the container's contents and the plaintiffs elaborate gas chromatography-mass spectrometry analysis chemists performed failed to show there was fraudulently little vanilla bean extract in the ice cream. Similarly in a case involving vanilla almond milk the SDNY found the term vanilla by itself does not communicate to a reasonable consumer that the product was made exclusively with vanilla bean and a reasonable consumer would understand vanilla refers to a flavor, not an ingredient. Cosgrove et al. v. Blue Diamond Growers, No. 19-Civ-8993 (S.D.N.Y. December 7, 2020).

Price v LOral, No. 17 Civ. 614, 2020 WL 4937464 (S.D.N.Y. Aug. 24, 2020)

After certification of two classes of New York and California consumer fraud plaintiffs who claimed they were deceived into purchasing Matrix Biolage Advanced line of Keratin shampoos and conditioners because they contained Keratin, defendants LOral and Matrix moved to exclude plaintiffs experts and both sides moved for summary judgment. The motion to exclude plaintiffs marketing expert opinion on consumer perceptions was granted in part and the economic expert opinion on class-wide damages was excluded as unreliable. Except for the breach of contract claim dismissed under New York law, the summary judgment motions were denied.

Devane v. LOral, No. 19 Civ. 4362, 2020 WL 5518484 (S.D.N.Y. Sept. 16, 2020)

Purported class action plaintiffs alleged LOral deceptively marketed and labeled Eversleek Keratin Caring products to make consumers believe the shampoos and conditioners contained Keratin, even though the products were labeled as vegan and Keratin was not on the ingredient list. Upon a motion to dismiss fraud, warranty and consumer fraud statutory claims (Alabama, Florida and New York), the court analyzed the claims under the reasonable consumer standard. The Second Circuit has noted it is not reasonable to assume that a product contains an ingredient when it is not on the ingredient list. As the product label was clear that the shampoos and conditioners cared for Keratin already found in hair and Keratin was not a listed ingredient, the court dismissed the entire case as not plausible.

Class ActionsPotential implication for future cases: Federal courts in New York scrutinize purported class actions involving FDA-regulated products for plausibility and expert support. The reasonable consumer, drawing on common sense and common experience, does not assume a product contains an ingredient not listed on the label.

The developments of 2020 indicate that it is critical to remain informed about changes in the law in order to develop the strongest product liability defense of pharmaceuticals and medical devices. We know it takes an enormous investment to develop innovative pharmaceuticals and medical devices to improve life experiences. Thats why our attorneys, with a national reputation for aggressively defending some of the largest entities in the regulated pharmaceutical, medical device, cosmetics and nutritional supplement industries, leverage their combination of medical and legal credentials to protect your critical life sciences products.

View post:
New York Medical and Life Sciences: Year in Review 2020 - JD Supra

Recommendation and review posted by Bethany Smith

We've all heard of the menopause, when a woman's reproductive function starts to slow down but do men experience something similar? The term 'male menopause' refers to the physical and emotional changes that some men experience as they get older. It's a surprisingly controversial topic and experts are divided on the subject, with many disagreeing on what it is, how is should be defined, and if it even exists.

But while debate rages on about what to call this life stage, if you're a man in your late forties or older and you experience worrying symptoms including erectile dysfunction, a loss of sex drive, depression, or fatigue, it is worth getting checked out.

We spoke to nutritionist and male hormone expert Roberta Stringer, co-founder of testosterone health brand DNA, and Dr Luke Pratsides, lead GP at Numan, about the male menopause symptoms, causes and treatment options:

The male menopause, also known as andropause or colloquially as 'manopause' is a term used to describe a cluster of symptoms associated with an age-related decline in testosterone. Despite the name, male menopause differs substantially from female menopause.

Unlike the hormonal drop that occurs in women during this time, sex hormones tend to decrease more gradually in men. Not every man will experience andropause whereas all women experience menopause and men can still reproduce, while women can no longer become pregnant naturally.

'Male menopause is the gradual reduction of testosterone specifically related to ageing,' says Dr Pratsides. 'It is not strictly a menopause, which specifically refers to the cessation of menstruation in women where ovulation ends and hormone production plummets during a relatively short period of time instead, it happens over many years.'

Unlike the hormonal drop that occurs in women during this time, sex hormones tend to decrease more gradually in men.

Male menopause is not recognised as a medical condition. The term is often used alongside testosterone deficiency syndrome (TDS), which occurs when the testes produce few or no hormones. TDS is characterised by abnormally low testosterone levels (below 300 ng/dL) and has many different causes.

While it's true that many older men experience TDS approximately 40 per cent of men over the age of 45, according to a study published in the journal Frontiers in Endocrinology, and 50 per cent over the age of 80 abnormally low testosterone levels are not an inevitable result of ageing.

'Some men still maintain a normal level of testosterone throughout their lives, experience no symptoms and can father children well into their eighties,' says Dr Pratsides. TDS can affect men of any age, but when it occurs later in life, it's known as late-onset hypogonadism or androgen decline in the ageing male (ADAM).

The symptoms associated with male menopause are attributed to a gradual age-related decease in testosterone levels. 'Testosterone peaks at around the age of 20 in men,' says Stringer. 'Depending on health, diet and lifestyle factors, testosterone levels should remain consistent during men's twenties. They decline steadily from 30 at around one per cent a year.'

While declining T-levels are a given, 'the extent of decline and the age at which this happens varies even more so with today's lifestyle factors,' she says. The effects appear to be accelerating. One US study identified a 'substantial' drop in the general population since the 1980s, with testosterone levels declining by one per cent per year on average.

Stress, smoking, poor sleep, high body mass index, certain medications, lack of exercise and alcohol are all known to sap testosterone levels. Low T has also been linked to conditions like type 2 diabetes, high cholesterol, high blood pressure, metabolic syndrome and obesity, though it's unclear whether it's a cause or effect.

So, why is male menopause controversial? Some experts suggest that a gradual age-related drop in testosterone is not the primary cause of male menopause symptoms. They believe lifestyle and psychological factors play a far more prominent role. For example, feeling stressed because of problems at work could affect your libido and energy levels.

Male menopause is associated with physical, sexual, and psychological symptoms, that tend to emerge slowly and worsen as you grow older. 'Some men notice symptoms from their thirties, others in their sixties, and some particularly the older generation who were brought up at a time where male hormonal health was not discussed may not acknowledge any change at all,' says Stringer.

Common male menopause symptoms include:

If you're experiencing any of the symptoms associated with male menopause or have any concerns, make an appointment with your doctor.

When you visit your GP they will carry out a detailed check-up based on each of your specific symptoms and address them accordingly. They will also make sure to exclude other medical issues with relevant scans or tests as required.

Your doctor will carry out a detailed check-up based on each of your specific symptoms and address them accordingly.

Your doctor might ask about your personal life to determine whether other factors, such as stress or anxiety, play a part. They may also take a sample of your blood to test your testosterone levels. This will likely take place early or mid-morning, since your testosterone levels fluctuate though the day. A level of less than seven indicates low testosterone. Between seven and 14 is borderline, so further tests may be needed.

Some male menopause symptoms can be treated with hormone replacement therapy if your testosterone levels are found to be low. 'Testosterone replacement can be given in gels, patches, or injections,' says Dr Pratsides. 'It should always be guided by a suitably qualified clinician and obtained from a regulated provider.'

Testosterone treatment has various risks and side effects, including acne, worsened prostate cancer, enlarged breasts, disturbed breathing while sleeping (sleep apnea) and high red blood cell counts, which increases your risk of forming a blood clot. Men using testosterone therapy long-term appear to have a higher risk of heart disease.

If your symptoms are attributed to a combination of physical, lifestyle, and psychological factors, your doctor may adopt a more holistic approach. 'Symptoms of low testosterone due to advancing age can be treated individually,' says Dr Pratsides, 'for example, Viagra to help treat erectile dysfunction, or counselling to treat low mood.'

The simplest way to manage symptoms of male menopause is by making healthier lifestyle choices. Eating a well-balanced diet, making time for regular exercise, getting enough enough sleep, reducing your stress levels, and minimising alcohol and tobacco use are all recommended.

Hormone therapy isn't the only way to give your testosterone reserves a boost. Here are four evidence-based ways to increase your testosterone levels naturally:

Optimise your diet with a balance of carbs, healthy fats and protein. And don't forget the micronutrients. 'Nutrient deficiencies are increasingly common and can cause significant issues for maintaining positive testosterone levels,' says Stringer. B vitamins and zinc are particularly potent, improving sperm quality by 74 per cent in one study. 'Increasing your magnesium intake can raise testosterone levels within a month,' she adds.

Keep your favourite tipple for special occasions. 'Alcohol directly inhibits the production of testosterone in your testes,' says Stringer. 'It can also impact sleep as testosterone levels replenish overnight, this in turn can further impact levels.' Getting five hours a night can slash your T-levels by as much as 15 per cent, the University of Chicago Medical Centre found.

Maintain a healthy weight and pay attention to body fat levels, says Stringer. 'Obesity has a direct and negative impact on testosterone levels,' she explains. 'Fat cells metabolise testosterone to oestrogen, lowering testosterone levels. Also, obesity reduces levels of sex hormone binding globulin (SHBG), a protein that carries testosterone in the blood. Less SHBG means less testosterone.'

If you don't have a workout routine, now's the time to start. 'A 2004 study of older men found that regular physical activity increased testosterone and growth hormone (GH) levels as well as have a positive effect on brain function,' says Stringer. 'Resistance training has shown to be particularly beneficial for testosterone levels.'

Last updated: 28-01-2020

This content is created and maintained by a third party, and imported onto this page to help users provide their email addresses. You may be able to find more information about this and similar content at piano.io

See the article here:
Male menopause: symptoms, diagnosis and treatment - Netdoctor

Recommendation and review posted by Bethany Smith

A 15-year-old girl from Satara district of Maharashtra approached a doctor in Pune because she hadnt started her period yet. Tests revealed that the girl has a condition called Androgen insensitivity syndrome (AIS), that affects only four in 100,000 people.

In AIS, androgen, a hormone found in greater quantities in males, is suppressed and the secondary sex characteristics may or may not resemble that of a males.

In the case of the young girl, she was unable to menstruate because she does not have ovaries.

A team of doctors from the hospital is now helping the young girl to continue to live her life in her chosen gender. The condition disallows her from becoming pregnant, though she may still have children through other procedures like surrogacy or adoption if she so chooses.

Dr Manish Machave, gynaecologist and endoscopic surgeon from Ruby Hall Clinic, who diagnosed and treated her said that the girl had her gonads (testes) removed through laparoscopy and also had a breast augmentation surgery. She will receive hormone injections that will help sustain her through the rest of her teenage years and early adulthood.

She had gonads (testes) positioned in the abdomen and another in the inguinal canal and because of the position of gonads, she had a risk of developing a form of cancer called gonadoblastoma. Hence, we first performed laparoscopic gonadectomy and removed testes from both the sides, around three months ago. Once she turns 18-year-old, we will perform laparoscopic vaginoplasty, Machave said.

Dr Anupama Mane, breast surgeon from Ruby Hall Clinic, who performed the girls breast augmentation surgery said, She was brought up as a girl and hence she wanted to remain so. We performed breast augmentation surgery for her. Hormonal injections will be required for things like hair growth to stop. We are assisting her to complete her transition as a female. The medical treatment to give her feminine characteristics will go on for years.

Activists say that AIS is often used as a means to stigmatise intersex people by bringing their bodies under intense scrutiny, and which the medical fraternity then attempts to correct through surgery. Activists argue that intersex persons like the 15-year-old girl are subjected to a misplaced understanding of what bodies of men and women should look like.

However, as gender and sexuality rights activists point out, all bodies are different and neither gender nor sexuality is derived from a persons biological sex. As the case of this teenager shows, gender does not lie in the body but in the mind.

See original here:
Heres how sex and gender are different things - Hindustan Times

Recommendation and review posted by Bethany Smith

RIAN JACKSON

Sachi Tanaka says after having COVID-19 for three weeks, she experienced insomnia in a way that she never had.

At that time, I had gotten myself into a good routine of falling asleep around 10 p.m. and waking up early, said the 24-year-old Texas woman. And then, all of the sudden, it was like I couldnt fall asleep until 6 or 7 in the morning.

Her insomnia was a nagging feeling. She tossed and turned in bed, feeling like she was at the brink of sleep, but would be interrupted by her thoughts.

Tanaka isnt alone. COVID-19 has affected many peoples sleep, whether theyve had the virus or not. Sleep neurologists call it COVID-somnia, a phenomenon where people have trouble sleeping because of the virus. And its effects can last even after the pandemic ends.

Coronavirus upended our lifestyles. Morning commutes were replaced with teleworking, which may mean less physical activity and exposure to sunlight and more screen time, said Dr. George Zureikat, a sleep medicine specialist and director of Mid Michigan Sleep Center in Grand Blanc.

That can ruin sleep by disrupting the circadian rhythm the powerhouse of our sleep-wake cycle.

Stress induced by COVID can also result in insomnia, said Zureikat, who has seen a surge of insomnia cases since the pandemic.

COVID-19 is unlike anything many people have experienced, he said. Insomniacs may lose sleep worrying about unemployment or about contracting the virus. Some people feel trapped during lockdowns and are constantly reading news articles about overcrowded hospitals and rising death numbers.

A recent study by the American Academy of Sleep Medicine found 2.77 million Google searches for insomnia in the first five months of 2020 a 58% increase compared with the same months from the previous three years. Most of those queries happened between midnight and 5 a.m., suggesting people were searching while unable to fall asleep.

Difficulties like trouble falling and staying asleep or waking up too early rose from 36% before the pandemic to 51% during it, Rebecca Robillard, a University of Ottawa professor who leads clinical sleep research at the Royals Institute of Mental Health Research, said in a Medpage Today article.

If your (circadian) rhythms are thrown off, that also throws off your sleep at night time, said Dr. Christopher Morgan, the medical director at Mercy Health Saint Marys Sleep Center in Grand Rapids. Your melatonin may not be producing the right amounts at the right time, which is part of your internal rhythms in your body.

Melatonin is the hormone that your brain produces in response to darkness. It helps time your circadian rhythms and sleep.

Humans are social animals, said Dr. Lila Massoumi, a professor of psychiatry at Michigan State University and chair of the American Psychiatric Association Caucus on Complementary & Integrative Psychiatry.

We draw both strength and calm from our fellow humans. Ripping that social support away by telling us to self-isolate removes that source of strength and calm, she said.

Unsurprisingly, those who contract the virus may also stress about their health.

Morgan said those who struggle with chronic insomnia, or insomnia experienced at least three nights a week for at least a month, may develop bad habits that can be difficult to shake.

You have an acute stressor, which is COVID, and you become an insomniac, he said. And then lets say I still havent gotten a job in six months. Now, Im sitting in bed for 10 hours a day just thinking about how terrible things are in my life, and I have insomnia.

So, now I start watching TV in bed because Im awake during the night time, and I start drinking pop in the middle of the night, and I start laying in bed even longer because I think Im not getting enough sleep. So, all these maladaptive behaviors develop.

Whats worse, according to Mayo Clinic researchers, those whove had chronic insomnia report a lower quality of life than those who sleep well. Chronic insomnia may lead to anxiety or depression, slowed reaction time while driving and increased risk of long-term diseases such as heart disease.

Many professionals treat patients with cognitive behavioral therapy. It works by identifying and replacing thoughts and behaviors that create sleep problems with ones that promote healthy sleep.

Its just a matter of just tweaking certain habits and changing certain things, said Rachel Freedland, a clinical social worker at Bright Spot Therapy, a counseling clinic in Farmington Hills. If there are other mental health needs, for example, if a person already has anxiety or depression, we address those as well.

After assessing a patients sleeping habits with sleep diaries and questionnaires, Freedland, who is certified in cognitive behavioral therapy for insomnia, and her clients design a program that helps them sleep and wake up when they want.

Yoga and mindfulness, a type of meditation where you focus on being aware of what youre feeling and sensing at the moment, can release feel-good hormones that alleviate anxiety and promote healthier sleep, according to Asha Ravindran, a clinical team lead at St. Mary Mercy hospital in Livonia.

If you dont sleep, if youre anxious, youre out of sync with your body, said Ravindran, who owns Stepping Stones Wellness Center in Plymouth and conducts virtual yoga and meditation sessions with her patients.

She advises clients to create a private space where they can journal, practice yoga and meditate. This space can be as simple as the foot of the bed.

The key is to be present in the moment, Ravindran said. From yoga poses to breathing exercises, you can de-stress with strategies that help focus on the present without worrying about the past or future.

Visit link:
Experts treat insomnia, anxiety caused by COVID-19 - City Pulse

Recommendation and review posted by Bethany Smith

In 2020 alone, the FDA approved 6 systemic therapies for novel indications across breast cancer subtypes.1 With the continuously evolving treatment landscape for this disease, staying up-to-date with the latest changes is of paramount importance.

To assist in this endeavor, the virtual 38th Annual Miami Breast Cancer Conference(MBCC), hosted by Physicians Education Resource, LLC (PER) will feature presentations from industry thought leaders on innovations in the arena of breast cancer treatment, including topics about systemic therapy and beyond.

It includes both the new data in surgery and radiation oncology [as well as that] in medical oncology, in both early-stage and metastatic disease, Hope S. Rugo, MD, FASCO, one of the program cochairs, said in an interview with Targeted Therapies in Oncology. We cover all of the clinically pertinent information thats come out of the most recent presentations and publications, and theres the ability to discuss this and ask questions of the presenters.

One of the great advantages of the meeting is its juxtaposition to the San Antonio Breast Cancer Symposium (SABCS). The virtual MBCC follows SABCS by approximately 12 weeks, March 4-7, 2021, giving MBCC faculty the advantage of tailoring the program to the most relevant research updates.

We can update the agenda to reflect the most recent data that were presented at San Antonio and apply this to the clinic, Rugo, a professor of medicine and director of Breast Oncology and Clinical Trials Education at the Helen Diller Family Comprehensive Cancer Center at the University of California, San Francisco, said.

Rugo detailed abstracts from SABCS in which the validity of standard treatment approaches for hormone receptorpositive disease was tested in more precise patient subpopulations, with the goal of identifying those who derive the greatest benefit.

RxPONDER in Pre/Postmenopausal Patients

The randomized, phase 3 RxPONDER trial (NCT01272037) evaluated the efficacy of standard adjuvant endocrine therapy with or without chemotherapy in patients with hormone receptorpositive, HER2-negative early-stage breast cancer who had 1 to 3 positive nodes and a recurrence score of 25 or less by Oncotype DX screening.2

Results of the study demonstrated that postmenopausal women did not derive further benefit from the addition of chemotherapy, but premenopausal women with the same characteristics experienced a significant relative risk reduction in invasive diseasefree survival (iDFS).

Using the recurrence score is fascinating and will result in a lot more analyses, Rugo said. This already will impact our care of patients with node-positive, early-stage hormone receptorpositive, HER2-negative breast cancer.

Despite no significant difference in iDFS noted with or without chemotherapy in the primary analysis (P=.3), a prespecified subgroup analysis revealed that an interaction between chemotherapy use and menopausal status existed (P=.004). The hazard ratio for the comparison of both treatment arms favored the use of chemotherapy in patients who were premenopausal (HR, 0.54; 95% CI, 0.38-0.76; P =.0004) versus those who were postmenopausal (HR, 0.97; 95% CI 0.78-1.22; P =.82). At 5 years, the iDFS rate in the premenopausal group was 94.2% for those who received versus 89.0% in those who did not.

Results of a subanalysis of the randomized phase 3 monarchE trial (NCT03155997) of adjuvant endocrine therapy with or without abemaciclib (Verzenio) in patients with resectable hormone receptorpositive, HER2-negative tumors at high risk suggest that a threshold of 20% or greater Ki-67, which is a marker of cellular proliferation, may be a useful clinicopathological feature of response to the CDK4/6 inhibitor.3

Its not just the clinical features, like stage and grade, but Ki-67 also is emerging as an incredibly important factor, Rugo said of the results, which were also reported at SABCS. I think this is likely to be practice changing in the next year.

Patients with high Ki-67 in the overall patient population and patients in cohort 1those with other high-risk clinicopathological features such as tumor involvement, tumor size, and gradewere assessed for superiority of abemaciclib therapy as determined by iDFS. A statistically significant improvement in the primary end point was seen with the agent in both the overall population (HR, 0.685; 95% CI, 0.462-1.017; P=.0591) and in cohort 1 (HR, 0.643;95% CI, 0.475-0.872; 2-sided P=.0042).

J101 Reveals HER2-Low Populations

The phase 1 J101 trial (NCT02564900) of fam-trastuzumab deruxtecan-nxki (Enhertu) indicated that certain patients with low HER2 expression, defined as those with an immunohistochemistry (IHC) score of 2+/1+ and negativity by in situ hybridization, may derive benefit from treatment with the antibody-drug conjugate. These data, which were also presented at SABCS, may help potentially define a patient population of medical unmet need who would otherwise not be treated with anti-HER2 therapy.4

Were going to see data in the next year about the efficacy of these antibody-drug conjugates in other populations, such as patients who have newly-defined HER2-low disease, Rugo said. [These patients are] not HER2 positive but not 0 by IHC.

Patients in the analysis were assessed using deep learningbased digital analysis to produce a novel HER2 quantitative continuous score (QCS), a method found to be more predictive of response to trastuzumab deruxtecan versus manual assessment by pathologists.

Out of 151 patients, 65 were identified as having HER2-low expression by conventional IHC scoring; the response rate in this group was 42%. When investigators further stratified the patients into QCS-high and QCS-low subgroups, they were able to identify 21 of the 27 responders who were missed by conventional screening methods. To validate these promising results, further studies into the use of QCS are ongoing.

Rugo said several immunotherapy agents could possibly become available for use in the adjuvant/neoadjuvant setting in the near future, mirroring the success seen in advanced tumors.

Namely, results of one investigational arm of the open-label, randomized, phase 2 I-SPY 2platform study that were published in JAMA Oncology in February 2020 showed that the addition of pembrolizumab (Keytruda) to standard neoadjuvant chemotherapy more than doubled pathologic complete response rates in patients with hormone receptorpositive/HER2-negative and triple-negative breast cancer.5 Further exploration of this data set examined surrogate markers of this regimen and were presented at SABCS.6 Larger studies are ongoing.

I think the analyses of immunotherapy in the metastatic setting are already practice changing and in the next year will potentially be practice changing for the neoadjuvant setting as well, Rugo said.

Other agents to watch for are antibody-drug conjugates, such as trastuzumab deruxtecan and sacituzumab govitecanhziy (Trodelvy), as therapy for patients with triple-negative breast cancer. Rugo said data from trials involving these agents are likely to be reported this year and have the potential to change the treatment paradigm for triple-negative disease.

To conclude, Rugo reflected on the advantages of MBCC for those treating patients with breast cancer across clinical settings. You will get that great interaction with the speakers and timely updates of [the latest] data put into perspective.

References:

1. Hematology/oncology (cancer) approvals & safety notifications. FDA. Updated December 18, 2020. Accessed December 21, 2020. https://bit.ly/3avuIwR

2. Kalinsky K, Barlow WE, Meric-Bernstam F, et al. First results from a phase III randomized clinical trial of standard adjuvant endocrine therapy (ET) +/- chemotherapy (CT) in patients (pts) with 1-3 positive nodes, hormone receptor-positive (HR+) and HER2-negative (HER2-) breast cancer (BC) with recurrence score (RS) < 25: SWOG S1007 (RxPonder). Presented at: 2020 San Antonio Breast Cancer Symposium; December 8-12, 2020; virtual. Abstract GS3-0 . https://bit.ly/2WsISGT

3. Harbeck N, Johnston S, Fasching P, et al. High Ki-67 as a biomarker for identifying patients with high risk early breast cancer treated in monarchE. Presented at: 2020 San Antonio Breast Cancer Symposium; December 8-12, 2020; virtual. https://bit.ly/2WsISGT

4. Gustavson M, Hanedar S, Spitzmeuller A, et al. Novel approach to HER2 quantification: digital pathology coupled with AI-based image and data analysis delivers objective and quantitative HER2 expression analysis for enrichment of responders to trastuzumab deruxtecan (T-DXd; DS-8201), specifically in HER2-low patients. Presented at: 2020 San Antonio Breast Cancer Symposium; December 8-12, 2020; virtual. https://bit.ly/2WsISGT

5. Nanda R, Liu MC, Yau C, et al. Effect of pembrolizumab plus neoadjuvant chemotherapy on pathologic complete response in women with early-stage breast cancer: an analysis of the ongoing phase 2 adaptively randomized I-SPY2 trial. JAMA Oncol. 2020;6(5):676-684. doi:10.1001/jamaoncol.2019.6650

6. Magbanua MJM, Wolf D, Renner D, et al. Personalized ctDNA as a predictive biomarker in high-risk early stage breast cancer (EBC) treated with neoadjuvant chemotherapy (NAC) with or without pembrolizumab (P). Presented at: 2020 San Antonio Breast Cancer Symposium; December 8-12, 2020; virtual. https://bit.ly/2WsISGT

Read the original post:
MBCC Offers Review of Burgeoning Advancements in Breast Cancer Management - Targeted Oncology

Recommendation and review posted by Bethany Smith

Choosing to go on a diet isn't a 100% healthy endeavor. After all, if you're cutting yourself off from certain nutritious foods or entire food groups, drastically limiting your calorie intake overall, fasting for prolonged periods of time, or signing up for a fad-like program that promises extreme results in short order, there's a good chance you're actually embarking on a path that your body may not actually respond favorably to. Whether you're trying the Ketogenic diet or intermittent fasting, going low carb or low fat, below are some common side effects of going on a super-strict dieting regimen you should be aware of. And for more healthy weight loss tips, don't miss this list of Sneaky Weight Loss Tricks That Totally Work, According to Experts.

If you're considering intermittent fasting, in which you restrict your food consumption for long stretches on certain days of the week, you'd be wise to consider some of the consequences. "Depending on the length of the fasting period," write the health experts at Harvard Medical School, "people may experience headaches, lethargy, crankiness, and constipation. To decrease some of these unwanted side effects, you may want to switch from alternate-day fasting to periodic fasting or a time-restricted eating plan that allows you to eat every day within a certain time period."

RELATED: Sign up for our newsletter for daily healthy eating advice.

A simple fact: If you eat less food (also known as fuel), your body will have less energy to burn and you'll ultimately feel sluggish. One study, published in the Annals of Internal Medicine, found that cutting carbohydrates from your diet was associated with a greater risk of fatigue. Another study, which focused entirely on the Ketogenic diet and was published in the Journal of the American Dietetic Association, found that "low-carbohydrate diets enhance fatigability and can reduce the desire to exercises in free-living individuals."

Cutting carbs completely from your diet isn't your only path to lower energy levels. Other studies have linked diets that restrict nutrients such as vitamin B12, folate, and iron with fatigue, as well as anemia. For more weight loss tips, make sure you're aware of the 12 Foods That Drive the Most Weight Loss of All, Say Experts.

A now-famous study published in the journal Obesity that analyzed the weight-loss efforts of contestants of NBC's wildly popular series The Biggest Loser, which was conducted by researchers at the National Institutes of Health, found that people who go on an extreme crash diet hobbled their metabolisms so profoundly that they never fully recovered. The chief reason, according to the researchers, was the influence of leptin, the body's hormone that tells you you're satiated, or no longer hungry. Over the course of the crash diet, the contestants' leptin levels essentially flatlined. The researchers also tracked their ghrelin levelsthe hormone that tells you when you're hungryand it had actually risen. In effect, the dieters had reprogrammed their bodies to be fat-storing, low-energy machines.

According to a study published in the journal Dermatology Practical & Conceptual, embarking on a low-calorie diet is associated with hair loss, as the lack of nutrients disrupts your hair follicles to function as intended. "Nutritional deficiency may impact both hair structure and hair growth," write the researchers. "Effects on hair growth include acute telogen effluvium (TE), a well-known effect of sudden weight loss or decreased protein intake, as well as the diffuse alopecia seen in niacin deficiency."

For a study published in The American Journal of Clinical Nutrition, researchers from the University of Kiel in Germany took 32 non-obese males and slashed their calories by an average of 1,300 for a three-week period. On the whole, the subjects emerged from the experience having gained weight while seeing a dramatic decrease in muscle massroughly 5% across the board.

RELATED: 15 Underrated Weight Loss Tips That Actually Work

"A lack of proper nutrition due to a fad diet can actually strain your organs and muscles," says Ashlee Van Buskirk, a nurse, health and wellness coach with a BS in Dietetics and Clinical Nutrition Studies, and the founder of Whole Intent. "For instance, a high-protein diet can actually lead to dehydration, which may place a significant strain on your kidneys as you may be more prone to developing kidney stones."

"Most diets fail most of the time [and] repeated diet failure is a negative predictor for successful long term weight loss," writes Anna Guerdjikova, Ph.D., LISW, CCRC, director of administrative services at the Harold C. Schott Foundation Eating Disorders Program at the University of Cincinnati. "Chronic dieters consistently report guilt and self-blame, irritability, anxiety and depression, difficulty concentrating and fatigue. Their self-esteem is decreased by continuous feelings of failure related to 'messing my diet up again,' leading to feelings of lack of control over one's food choices and further life in general. Dieting can be particularly problematic in adolescents."

RELATED: This Diet Mistake Can Make Your Depression Worse, Science Says

"Fad diets are not always terrible, but people should understand the food groups and should try to ingest foods from all of them to keep vitamin and mineral balance," says Stephen Newhart, Ph.D., owner of Vigor Active. "Grains provide energy, fiber, iron, and help with constipation, dairy provides calcium and iron, fruits and vegetables provide vitamins and minerals and protein supports muscle mass. Always try and eat something from all the food groups to sustain health, just be sure to eliminate the sugars."

If you're older and you're trying intermittent fasting, you could be at risk of losing too much weight. "If you're already marginal as far as body weight goes, I'd be concerned that you'd lose too much weight, which can affect your bones, overall immune system, and energy level," Kathy McManus, RD, director of the Department of Nutrition at Brigham and Women's Hospital, told Harvard Medical School.

According to the International Journal of Eating Disorders, 35% of "normal dieters" may become pathological dieters, and 20 to 25% of those are prone to develop an eating disorder. "The onset of eating disorders has commonly been associated with following restrictive diets, as they become a way for individuals to exercise control, counting calories and fat grams, limiting types and amounts of food, and obsessing about a number on the scale," write the experts at Behavioral Nutrition.

As the Cleveland Clinic notes, many health experts believe that "80 to 95% of dieters gain weight back that they've worked so hard to lose." If that's an experience you're aware of, don't miss these tips for Losing Weight and Keeping it Off for Good.

Originally posted here:
Dangerous Side Effects of Going on a Diet, According to Science | Eat This Not That - Eat This, Not That

Recommendation and review posted by Bethany Smith

One way or another, if you are researching the topic 'how to build muscle', you will come across the question 'what is testosterone' and how different levels of the T hormone can affect the muscle building process. Many will say you need to take supplements if your T levels are low in order to build and maintain muscle mass. But is this true? Is testosterone the key to muscle building?

We asked Marc S. Schneider, M.D., surgeon, medical journal author and co-founder of Dioxyme Craft Nutrition, to answer some of the most frequently asked questions about testosterone. Since T3 is not a medical journal and we understand that people won't reference T3 in their dissertations, we kept the discussion on a level that's informative yet doesn't require extensive knowledge about human anatomy and biology.

IMPORTANT: if you have any concerns about your health including testosterone levels, please consult a medical professional and don't rely on information found on the internet. We made sure that all information presented here is accurate but it doesn't mean it replaces GPs and surgeries. Please be mindful about your health and always seek medical help when in doubt.

As Marc explains, "testosterone is the primary sex hormone found in men and is responsible for androgenic effects (male sexual characteristics) and anabolic effects (growth of tissues). It is responsible for brain and sex organ development in the fetus, the changes that occur in puberty, muscle and bone growth, sex drive and fertility."

Although most people associate high testosterone levels with bullish behaviour, normal testosterone levels are required for a male body to work properly. According to Medical News Today, testosterone "has many important functions, including the development of the bones and muscles, the deepening of the voice, hair growth, and other factors related to appearance [and] the production of sperm"

Low levels of testosterone can have a range of negative health effects, as discussed below.

(Image credit: Getty Images)

"Testosterone levels fall within different ranges throughout an individual's life and from day to day. T levels tend to be the highest from ages 16-18 (300-1200 nanograms per deciliter in men) and then drop as the individual enters their 20s and 30s", Marc explains. "As men get older, their testosterone levels may decline about 1 percent per year after age 30", according to Healthline.

Not only the healthy levels of testosterone levels can vary widely in general but also from day to day and right now, the only way to find out T levels is to do a blood test, administered by a medical professional. Despite the broad range in which it's considered healthy, low levels of testosterone can cause health issues in individuals.

Grass-fed Ultra Whey Protein | Buy it for $45.99 (2-lbs bag) directly from DioxymeThe Dioxyme Grass-fed Ultra Whey Protein is a combination of whey isolate 93 and whey concentrate 80. Each 38-gram serving contains 27 grams of protein, 3 grams of sugar and less than 1 gram of fat. All protein is sourced grass-fed cows and the product itself is paleo-, keto- and eco-friendly too!View Deal

Though physicians generally consider this huge range to be normal, as Marc explains, "lower levels within the normal range may leave the individual feeling tired, cause an increase in body fat, decreased mental attention, affect mood, lead to lack of sexual desire or performance issues, and loss of muscle."

On the other hand, it is incredibly rare for there to be excess testosterone without an individual taking an anabolic steroid. "Excess levels are associated with a host of issues including ED, heart disease, liver disease, blood clots, acne, mood swings and impaired judgement", Marc says.

"Low normal testosterone levels are now commonly seen with increased frequency in young and middle aged men", Marc goes on, "probably the most common causes that we see in our clinic in young men is due to a combination of excess stress, long working hours, lack of physical activity, and the constant use and carrying of cellphones in their pocket."

As explained in a Harvard Medical School articled titled Treating low testosterone levels, possible treatments to low-T levels include skin patch, gels and oral therapy, all being non-invasive type of treatment or pellets and injections, the latter two being on the invasive side.

(Image credit: Getty Images)

According to Marc, "physicians typically recommend adequate levels of Vitamin D, Zinc, sleep, elimination of stress, exercise (particularly weight lifting/resistance training) and losing body fat, to help reverse lower T levels."

"Though these may support normal higher levels of testosterone, we have not seen this approach alone correct lower testosterone levels", he adds.

Of course, eliminating stress factors is usually easier said than done, but the other factors are well within the reach of most individuals. There are vitamin D and zinc supplements available or you can just go for a walk on a sunny day to get some vitamin D and exercising, all in one go. Sleep can be improved by following a sleep schedule and putting your mobile phone away a couple of hours before bedtime.

Dioxyme MPO (Muscle Performance Optimizer) | Buy it for $69.99 directly from DioxymeThe MPO is a stimulant-free pre-workout powder that is said to trials show MPO will increase your muscle power and strength, increase your muscle endurance in training and competition, natural mTOR and growth stimulators increase muscle growth and improve your recovery by decreasing muscle soreness (DOMS) and muscle damage (EIMD). It does require an acquired taste, though.View Deal

As Marc explains, "often men will seek to correct the symptoms of low T on their own by taking over the counter supplements. Tribulus terrestris, Tinospora cordifolia, and icariin are commonly claimed to increase testosterone, however clinical studies in humans do not show benefits. Numerous additional herbal remedies are popular yet human data showing that they increase testosterone is lacking."

"The decision to place someone on hormone replacement (testosterone) or prescribe them a testosterone stimulator such as HCG, is dependent upon a combination of their hormonal levels, their overall health, lifestyle and the symptoms they are feeling", he goes on, "the most effective therapy is often a combination of lifestyle modification along with hormone replacement. Combined with an effective exercise and nutritional plan, not only do the individuals improve their energy and sexuality, they can often drop significant amounts of body fat, gain lean muscle and most importantly, feel youthful and vibrant again."

In short, unless it's medically advised, you shouldn't be worry about increasing your testosterone levels with supplements. Most men can benefit from resistance training regularly and following a healthy diet, not just from a T level perspective, but also for improved health, sleep and mood. Increased testosterone levels are just the icing on the cake.

Today's best Sports Nutrition And Supplements deals

BetterYou DLux1000 Vitamin D3...

Pure Product Australia...

PhD Nutrition Diet Whey...

Wiley's Finest, Wild Alaskan...

MusclePharm Combat Protein...

RSP AvoCollagen - Collagen...

Optimum Nutrition Serious...

Pukka Herbs, Womankind,...

Myprotein Vegan Protein...

Today's best Bars & Weights deals

Bowflex Select Tech Dumbbell...

Bowflex 840 SelectTech...

The rest is here:
What is testosterone: MD explains all commonly asked questions about the T hormone - T3

Recommendation and review posted by Bethany Smith

Pune, January 27, 2021: A 15-year-old girl had a shock of the lifetime when she came to know that shes not a girl. Although born as a girl, her chromosomes are of a boy and not of a girl.

The girl who hails from Satara came for a medical check-up at a doctor in Pune as despite passing the age of 15, she had not attained puberty. When the doctor conducted the medical examination, it was revealed that the girl is not a girl, but a boy.

The doctor after the further investigation came to know that shes having Androgen insensitivity syndrome (AIS). In this, a person is born with the chromosome of a boy having an external appearance of a girl.

Ruby Hall Clinic gynaecologist and endoscopic surgeon Dr Manisha Machave treated the patient. During the investigation, it was found that the girl has partial AIS. Androgen is a hormone found in boys. The breasts in the girl are not developed. Similarly, she does not have a uterus and ovaries. Her vagina too is underdeveloped.

The girl wants to lead a life as a girl. Her parents have supported her decision.

Visit link:
Pune: 15-Year-Old Girl Comes To Know That She's A Boy - Punekar News

Recommendation and review posted by Bethany Smith

SOUTH SAN FRANCISCO, Calif., Jan. 26, 2021 (GLOBE NEWSWIRE) -- Amunix Pharmaceuticals, Inc.. (Amunix), a biopharmaceutical company focused on developing prodrugs to bring the promise of potent immune-activating biotherapeutics to patients with solid tumor cancers, today announced the appointment of Zeeshan Merchant as Chief Financial Officer and Trisha Millican to the Board of Directors.

Mr. Merchant joins Amunix with over 15 years of experience in biotechnology as an investment banker and investor. He joins from Morgan Stanley, where he served as an Executive Director in the healthcare investment banking group, advising biotechnology companies on financings and strategic matters.

Ms. Millican, who will head the audit committee, brings over 20 years of experience in the life science industry, including experience with debt and equity financings, mergers and acquisitions, licensing transactions, co-development and promotional arrangements, and commercial product launches.

We are excited to welcome Zeeshan and Trisha, both leaders in the financial services and healthcare industry, to Amunix, said Angie You, CEO of Amunix. Their expertise and leadership will be invaluable as we continue to grow Amunix and transition into a clinical stage company. We are excited about the potential of our lead development candidate, AMX-818, a protease-activated T cell engager prodrug targeting HER2+ solid tumors, to significantly benefit patients.

ABOUT ZEESHAN MERCHANT

Zeeshan Merchant has over 15 years of experience in biotechnology as an investment banker and investor. Prior to joining Amunix, Mr. Merchant worked as an investment banker at Morgan Stanley, serving as an Executive Director in the firms healthcare investment banking group. In this role, Mr. Merchant advised U.S. and Asia based biotechnology companies on financings and strategic matters, and successfully executed over 50 transactions, including $20 billion in financing and $25 billion in mergers and acquisitions. Prior to Morgan Stanley, Mr. Merchant worked as Senior Analyst at Ayer Capital, a healthcare dedicated investment fund. In this role, Mr. Merchant identified and analyzed biotechnology and healthcare investments globally. Prior to Ayer Capital, Mr. Merchant worked as a private equity Associate at TA Associates, a leading, global growth private equity firm. Mr. Merchant received a B.A. in Economics from the University of Pennsylvania.

ABOUT TRISHA MILLICAN

Trisha Millican has 20 years of leadership experience in the life science industry encompassing debt and equity financings, mergers and acquisitions, licensing transactions, co-development and promotional arrangements, and commercial product launches. She is currently the Chief Financial Officer of Metacrine. Prior to Metacrine, Ms. Millican was the Senior Vice President of Finance at Seragon, a private biotechnology company focused on developing Selective Estrogen Receptor Degraders (SERDs) targeting hormone dependent cancers, which was acquired by Genentech. Prior to Seragon, she served as Vice President of Finance at Aragon, a discovery-stage small molecule company focused on therapeutics for the treatment of hormone-resistant cancers, which was acquired by Johnson and Johnson. Prior to Aragon, Ms. Millican worked in various senior financial management roles at Zogenix, a pharmaceutical company developing and commercializing innovative central nervous system therapies for people living with serious and life- threatening rare central nervous system disorders and medical conditions. Ms. Millican spent five years with the public accounting firm Deloitte LLP. She holds a B.S. in Accountancy from the University of San Diego and is a certified public accountant in the state of California.

About Amunix Pharmaceuticals

Amunix Pharmaceuticals, based in South San Francisco, CA, is focused on developing prodrugs to bring the promise of potent immune-activating biotherapeutics to patients with solid tumor cancers. The company is leveraging its proprietary T cell engager (XPAT) and cytokine (XPAC) platforms to advance a pipeline of novel masked prodrugs that are preferentially activated in the tumor microenvironment. Both platforms utilize Amunixs proprietary masking technology that has been clinically validated to extend drug half-life with limited immunogenicity. Amunix is advancing its lead development candidate, AMX-818, an XPAT T cell engager targeting HER2+ solid tumors, toward the clinic (currently in IND-enabling studies), and has several earlier programs underway. Amunix is also working on their first protease-activated masked cytokine program, IL12-XPAC, which is in discovery.

For additional information about the company, please visit http://www.amunix.com.

Contacts

Company Contact:Jen Herbach Director, Corporate DevelopmentBD@amunix.com

More:
Amunix Announces the Appointment of Healthcare Investment Banking Veteran Zeeshan Merchant as Chief Financial Officer and Trisha Millican to the Board...

Recommendation and review posted by Bethany Smith