Chambers and The Fruitery will be revealing an exciting new launch at this years Fruit Logistica, as The Fruitery announces its decision to expand its business to include the supply of fresh fruit and branded medley pots for the foodservice, retail and culinary trade sectors, alongside the original white label offering.

Last year Chambers - which enjoys a strong heritage as a grower whose innovative business model enables customers to access soft fruit direct from the grower resulting in a shelf life extension of two days - became the UKs only specialist fruit grower to launch its own prepared fruit facility, The Fruitery. Created in response to thegrowing demand for a healthy snacking option within the buoyant take home and on the go markets, The Fruitery accesses the same premium fresh fruit grown by Chambers (either in the UK or at one of its partner farms located in countries around the world) to create a range of berry medley pots. The extended shelf life, as well as reduced food miles and 100% traceability and provenance, have proved popular within the foodservice and food retailer sectors, where The Fruitery has previously provided a white label product.

The launch of a branded berry medley offering represents another first for The Fruitery, as it will be the first branded prepared berry product to hit the market, providing consumers with a unique fresh berry medley choice in line with current healthy eating guidance. In addition, the move towards the supply of fresh fruit under The Fruitery brand enables the business to service the needs of the discerning culinary trade who, while acknowledging the benefits of The Fruiterys current catering pack and the extended shelf life, are more interested in buying larger volumes of fruit in a fresh rather than prepared format.

Commenting on The Fruiterys new plans, Commercial Director James Miller says, The Chambers business model is based on four key pillars, growing, packing, importing and prepared, all of this is underpinned by an ongoing commitment to innovation and tracking current and future market opportunities. The Fruitery has been well received within the industry and our advantageous reduced supply chain timeline, 2m investment in the high care facility, BRC accreditation and ability to provide a seamless year-round supply of berries direct from the grower resonates favourably with our customers. We are now keen to pursue wider distribution channels for the product including culinary professionals with whom we have already started a seeding programme via the renowned Westminster Kingsway college in London. We believe that The Fruitery can operate successfully as a proprietary brand, alongside the existing white label business, leveraging the successful supply chain model pioneered by Chambers.

Chambers and The Fruitery will be in Hall 8.2 stand A-03 at Fruit Logistica.

For media information:Carla WesselEmail: Carla@foxredmedia.co.ukTel 01227 700 175

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The Fruitery to expand its business to include supply of fresh fruit and branded medley pots for the foodservice - FreshPlaza.com

Recommendation and review posted by Bethany Smith

I get asked many questions about stem cell therapies, but one of the most common over the years has been about the stem cell treatment cost. For instance, a reporter might ask, How much does a stem cell treatment for MS cost? and a patient might ask me, How much is a fair cost for a stem cell therapy for arthritis? Or, patients will voluntarily tell me what they paid or mention it in the comments. We hear various numbers thrown around about costs so I decided to do a poll on this. I even did an early update on the results of this poll, voicing my skepticism that the costs paid were worth it.

But the poll has gotten well over 500 responses now so I thought I would revisit it and what it might mean.

You can see a screenshot of the images. Its fair to say, as much as Internet polls arent considered particularly accurate, that this one largely fits with what is reported out in the field.

(On a side note, I wish there was such a thing as going out into the field for stem cell scientists as Ive always been a bit jealous of scientists who really do go out in the field. What do we do, go out in the wild and catch wild or feral stem cells in the bush?)

Patients self-reported most often paying between $2,500 and $7,500 for their stem cell therapy so if we take the average of those we get that $5,000 figure that is what I hear most often from others. Yes, not necessarily very rigorous, but the result makes good sense. Not far behind though were responses in the $7,500-20,000 range.

About 1 in 10 respondents reported paying $20,000 or more, including some beyond $100,000. Thats a whopping stem cell treatment cost, especially for something most often unproven and unapproved by the FDA.

If we consider these responses, the average cost may be more like $7,500-$10,000.

Notably, about 1/16 respondents indicated their stem cells were free. Im not sure what that means in terms of how that came to be.

Interestingly, most respondents who also went on to answer a 2nd poll in that post about where they got the treatment indicate it was at a stem cell clinic (scroll down in that Oct. 2017 post and youll see the 2nd poll). This 2nd poll has about 200 responses.

So today buying a simple stem cell treatment, most often unproven and non-FDA approved, is often not so different in cost than buying a 10-year old used car, while less often it is similar to buy various new cars including at the high end of stem cell therapy cost, some very expensive new cars. This cost and the risks involved are why I have suggested to patients in the past to be assertive when considering a stem cell treatment, ask questions, dont just accept too good to be true kinds of answers, etc. In short, be at least (or ideally much more) rigorous about unproven stem cell treatments as you are about buying a car.

Related

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Update on stem cell treatment cost for 2018 from ongoing ...

Recommendation and review posted by Bethany Smith

The Indian Psychiatric Society (IPS) the professional body that represents psychiatrists in India, strongly condemned the use of stem cell therapy in psychiatric disorders, particularly autism, until such a time that research evidence substantiated its effectiveness.

IPS, in its position statement on stem cell therapy on January 17, said that till now, there is no scientifically validated and scrutinized research evidence that proves that stem cells are helpful in any psychiatric disorders including autism.

Autism is a complex neurodevelopmental disorder with no known single cause.

The advisory from the IPS comes at a time when stem cell therapy clinics that claim to have developed stem cell therapies to treat complex psychiatric problems such as autism, cerebral palsy (movement disorder), muscular dystrophy (weakness of muscles), mental retardation, spinal cord injury and brain stroke have mushroomed across the country.

These stem cell therapy centres extract stem cells from the bone marrow of each child and then inject it into the childs spinal canal. The whole procedure takes place under general anaesthesia.

These clinics use aggressive marketing techniques and false claims to lure parents of children who are suffering from disease like autism.

The Indian Council of Medical Research (ICMR) has already published guidelines that cover the various diseases that are applicable for stem cell treatment. No psychiatric disorders, including autism, are listed there under this advisory.

Stem cells are special human cells that have the ability to develop into many different cell types, from muscle cells to brain cells. In some cases, they also have the potential to repair damaged tissues, and provide a cure for various diseases. But the clinical evidence at this point is low.

Psychiatric disorders including autism are combined derangements of both neurodevelopmental and neurodegenerative trajectories of brain and are polygenetic in origin. So they actually are symptomatic manifestations of a variety of different pathogenetic processes about which scientific evidence is as yet inconclusive, IPS said.

Originally posted here:
Psychiatric body condemns use of stem cell therapies to treat psychiatric disorders - Moneycontrol.com

Recommendation and review posted by Bethany Smith

Health technology and precision genomics company Color has raised $75 million in a series D funding round led by T. Rowe Funds andViking Global Investors.

TheBurlingame, California-based company counts Apple, Verily, Northshore University HealthSystem,the Teamsters Health and Welfare Fund of Philadelphia and Vicinity, and now Sanford Health among its partners.

Color has raised $150 million in financing to date, according to Color spokesman Ben Kobren. Kobren said the value of the company's contracts has grown significantly in the past year,and the company has expanded its margins. The recently raised funds will help Colorscale its infrastructure.

Color was recently named one of FierceHealthcare's Fierce 15 2020 award winners.

In 2019 alone, Color announced a slew of new partnerships, including withthe Teamsters Health and Welfare Fund of Philadelphia and Vicinityto provide access to Color's clinical-grade genomic services to about 14,000 members of their regional unions.

Color also is teaming up with Ochsner Health System on a first-of-its-kind, fully digital population health pilot program that integrates clinical genomics intostandard care.

The company is expanding its partnerships with healthcare systems looking to integrate genetic testing into the primary care setting. This week, the company announced that it had met its goal of enrolling 10,000 patients into the DNA-10K programa year after launching itwith NorthShore University Health System.

RELATED:Ochsner Health System teaming up with Color to integrate genetic information into preventive care

At the38th J.P.Morgan Healthcare Conference in San Francisco this week, Color also announced that it is working with Sanford Health, the nations largest rural not-for-profit healthcare system,to build on its Imagenetics genomics program. The Imagenetics program, which began in 2014, allows Sanford Health to embed genetic medicine directly into primary care.

Through that partnership, Sanford Healthphysicians willhave further access insights to enhance clinical decision-making. Sanford also will implement Colors digital tools to engage patients, increase adoption and streamline clinical reporting across Sanford Health's locations in North Dakota, South Dakota and Minnesota, the organizations said.

The NIH All of Us Research Program awardedColora $4.6 million grant to act as the initiatives nationwide genetic counseling service. It expanded onColors existing genotyping of patient samples as part of the program.

"In the last 18 months, we saw a huge acceleration with institutions around the world and across every type of player in the health ecosystemwhether its hospitals or health systems, large-scale research programs, payers, care delivery, employerswho want to change the care delivery model for their population by understanding genetics across the population,"Caroline Savello, vice president of commercial for Color,told FierceHealthcare.

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JPM20: Health technology company Color scores $75M funding round to scale its infrastructure - FierceHealthcare

Recommendation and review posted by Bethany Smith

(TNS) Incoming House Speaker Chris Sprowls had little trouble Thursday convincing members of a House health-care panel to approve legislation that would prohibit life-insurance, long-term care insurance and disability-insurance companies from using customers genetic information in changing, denying or canceling policies.

Florida would become the first state to have such a law if Sprowls proposal is ultimately passed by the Legislature and signed by Gov. Ron DeSantis.

Members of the House Health & Human Services Committee passed Sprowls bill (HB 1189) without any debate, and committee Chairman Ray Rodrigues, R-Estero, praised Sprowls for introducing the bill.

I think our privacy is important. And I think its equally important to be a visionary, to look forward and I 'm happy that Florida is going to be the state that leads the way on this issue, Rodrigues said.

Insurance industry lobbyists, who opposed the measure, sat quietly, agreeing to waive their speaking time.

Curt Leonard, regional vice president for state relations for the American Council of Life Insurers, said his association had expressed concerns on the issue for the past two years.

Weve expressed our concerns with Speaker Sprowls and other interested parties on this issue going back to 2018. So theres no point in repeating the same things over and over again, in the interest of the committee's time, Leonard said. That being said, we do share the speaker-designates (Sprowls) concerns about privacy. I think it's a concern for everybody.

The bill will have to clear the Commerce Committee before it would be ready to go to the full House. Sprowls, R-Palm Harbor, is slated to become speaker after the November elections.

In addition to preventing insurers from using the information in making policy decisions, Sprowls bill also would block the companies from requiring or soliciting genetic information from applicants.

Sprowls said insurance companies have for years been able to sell policies without having access to the genetic data.

Insurance carriers have been successful without access to genetic information. They have been able to provide affordable coverage to consumers without genetic information. Insurance is about spreading risk, not guaranteeing the outcomes or rewards to the (carriers). And affordable life, disability, and health insurance should not be available simply to the genetic elite, Sprowls said.

While Sprowls influence looms large in the House, he must convince the Florida Senate to go along. For that, Sprowls said he will look to Sen. Kelli Stargel, R-Lakeland, to spearhead the issue.

Senate President Bill Galvano, though, told The News Service of Florida that he supports a potential compromise on the issue.

Leonard said a compromise would authorize consumers to use their private information any way they want to. And that might include them wanting to share their genetic science or genetic testing information, he said. So we dont like the idea that consumers will be handcuffed in how they use that information.

2020 The Orlando Sentinel (Orlando, Fla.) Distributed by Tribune Content Agency, LLC.

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Florida Genetic Information Bill Advances in House - Government Technology

Recommendation and review posted by Bethany Smith

The following are the top rated Healthcare stocks according to Validea's Small-Cap Growth Investor model based on the published strategy of Motley Fool. This strategy looks for small cap growth stocks with solid fundamentals and strong price performance.

ZYNEX INC. (ZYXI) is a small-cap growth stock in the Medical Equipment & Supplies industry. The rating according to our strategy based on Motley Fool is 83% based on the firms underlying fundamentals and the stocks valuation. A score of 80% or above typically indicates that the strategy has some interest in the stock and a score above 90% typically indicates strong interest.

Company Description: Zynex, Inc. operates through the Electrotherapy and Pain Management Products segment. The Company conducts its business through its subsidiaries and the operating subsidiary is Zynex Medical, Inc. (ZMI). Its other subsidiaries include Zynex Monitoring Solutions, Inc. (ZMS) and Zynex Europe, ApS (ZEU). ZMI designs, manufactures and markets medical devices that treat chronic and acute pain, as well as activate and exercise muscles for rehabilitative purposes with electrical stimulation. ZMS is in the process of developing its blood volume monitoring product for non-invasive cardiac monitoring. ZEU intends to focus on sales and marketing its products within the international marketplace, upon receipt of necessary regulatory approvals. It markets and sells Zynex-manufactured products and distributes private labeled products. Its products include NexWave, NeuroMove, InWave, Electrodes and Batteries. ZMI devices are intended for pain management to reduce reliance on drugs and medications.

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LEMAITRE VASCULAR INC (LMAT) is a small-cap growth stock in the Medical Equipment & Supplies industry. The rating according to our strategy based on Motley Fool is 80% based on the firms underlying fundamentals and the stocks valuation. A score of 80% or above typically indicates that the strategy has some interest in the stock and a score above 90% typically indicates strong interest.

Company Description: LeMaitre Vascular, Inc. is a provider of medical devices for the treatment of peripheral vascular disease. The Company develops, manufactures and markets medical devices and implants used primarily in the field of vascular surgery. It is engaged in the design, marketing, sales and technical support of medical devices and implants for the treatment of peripheral vascular disease industry segment. The Company's product lines include valvulotomes, balloon catheters, carotid shunts, biologic vascular patches, radiopaque marking tape, anastomotic clips, remote endarterectomy devices, laparoscopic cholecystectomy devices, prosthetic vascular grafts, biologic vascular grafts and powered phlebectomy devices. Its portfolio of peripheral vascular devices consists of brand name products that are used in arteries and veins outside of the heart, including the Expandable LeMaitre Valvulotome, the Pruitt F3 Carotid Shunt, VascuTape Radiopaque Tape and the XenoSure biologic patch.

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INMODE LTD (INMD) is a small-cap growth stock in the Medical Equipment & Supplies industry. The rating according to our strategy based on Motley Fool is 79% based on the firms underlying fundamentals and the stocks valuation. A score of 80% or above typically indicates that the strategy has some interest in the stock and a score above 90% typically indicates strong interest.

Company Description: Inmode Ltd is an Israel-based company. It designs, develops, manufactures and commercializes energy-based, minimally-invasive surgical aesthetic and medical treatment solutions. The Company's proprietary technologies are used by physicians to remodel subdermal adipose, or fatty, tissue in a variety of procedures including fat reduction with simultaneous skin tightening, face and body contouring and ablative skin rejuvenation treatments. Its products target a wide array of procedures including simultaneous fat killing and skin tightening, permanent hair reduction, skin appearance and texture, among others. The Company's products may be used on a variety of body parts, including the face, neck, abdomen, upper arms, thighs and intimate feminine regions. It owns six product platforms: BodyTite, Optimas, Votiva, Contoura, Triton and EmbraceRF. All are market and sell traditionally to plastic and facial surgeons, aesthetic surgeons and dermatologists, among others.

The following table summarizes whether the stock meets each of this strategy's tests. Not all criteria in the below table receive equal weighting or are independent, but the table provides a brief overview of the strong and weak points of the security in the context of the strategy's criteria.

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BIOLIFE SOLUTIONS INC (BLFS) is a small-cap growth stock in the Medical Equipment & Supplies industry. The rating according to our strategy based on Motley Fool is 76% based on the firms underlying fundamentals and the stocks valuation. A score of 80% or above typically indicates that the strategy has some interest in the stock and a score above 90% typically indicates strong interest.

Company Description: BioLife Solutions, Inc. (BioLife) is engaged in the developing, manufacturing and marketing a portfolio of biopreservation tools and services for cells, tissues and organs, including clinical grade cell and tissue hypothermic storage and cryopreservation freeze media and a related cloud hosted biologistics cold chain management application for shippers. The Company's product offerings include hypothermic storage and cryopreservation freeze media products for cells, tissues, and organs; generic blood stem cell freezing and cell thawing media products; custom product formulation and custom packaging services; cold chain logistics services incorporating precision thermal packaging products and cloud-hosted Web applications, and contract aseptic manufacturing formulation, fill and finish services of liquid media products. Its products include HypoThermosol FRS, CryoStor, BloodStor, Cell Thawing Media, PrepaStor and biologistex cold-chain management service.

The following table summarizes whether the stock meets each of this strategy's tests. Not all criteria in the below table receive equal weighting or are independent, but the table provides a brief overview of the strong and weak points of the security in the context of the strategy's criteria.

For a full detailed analysis using NASDAQ's Guru Analysis tool, click here

MEDPACE HOLDINGS INC (MEDP) is a mid-cap growth stock in the Biotechnology & Drugs industry. The rating according to our strategy based on Motley Fool is 76% based on the firms underlying fundamentals and the stocks valuation. A score of 80% or above typically indicates that the strategy has some interest in the stock and a score above 90% typically indicates strong interest.

Company Description: Medpace Holdings, Inc. is a clinical contract research organization. The Company provides clinical research-based drug and medical device development services. The Company partners with pharmaceutical, biotechnology, and medical device companies in the development and execution of clinical trials. The Company's drug development services focus on full service Phase I-IV clinical development services and include development plan design, coordinated central laboratory, project management, regulatory affairs, clinical monitoring, data management and analysis, pharmacovigilance new drug application submissions, and post-marketing clinical support. The Company also provides bio-analytical laboratory services, clinical human pharmacology, imaging services, and electrocardiography reading support for clinical trials. The Company's operations are principally based in North America, Europe, and Asia.

The following table summarizes whether the stock meets each of this strategy's tests. Not all criteria in the below table receive equal weighting or are independent, but the table provides a brief overview of the strong and weak points of the security in the context of the strategy's criteria.

For a full detailed analysis using NASDAQ's Guru Analysis tool, click here

Since its inception, Validea's strategy based on Motley Fool has returned 639.27% vs. 234.94% for the S&P 500. For more details on this strategy, click here

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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Validea's Top Five Healthcare Stocks Based On Motley Fool - 1/19/2020 - Nasdaq

Recommendation and review posted by Bethany Smith

New research has found that the cell and gene therapy clinical environment in the UK has encouraged commercial sponsorship from around the world.

Researchers have found that the UK accounts for over 12 percent of global cell and gene therapy clinical trials. Another finding revealed that these trials have increased by approximately 45 percent in the UK compared to 2018.

According to a report published by Cell and Gene Therapy Catapult (CGT Catapult), international companies are also recognising the appeal of the UK cell and gene therapy environment. The findings show they are sponsoring the majority of UK commercial clinical trials, which account for 77 percent of the total 127 ongoing trials. This is an increase from the 25 percent of commercially sponsored trials in 2013.

The researchers suggest that the National Health Service (NHS) and UK ecosystem are providing the right platforms to allow innovative therapies to progress through to the clinic in ever increasing numbers.

Keith Thompson, CEO of CGT Catapult said: The total number of cell and gene therapy clinical trials in the UK has been increasing consistently by an average of 25 percent year-on-year since 2013. This has been enabled by the development of the UKs fantastic ecosystem to support the development and clinical adoption of cell and gene therapies. The infrastructureand initiatives that have been put in place, with strong backing by the government, including the Advanced Therapy Treatment Centrenetwork, are giving companies the confidence to setup and run their innovative clinical studies here. The result is that we are now seeing therapies moving from academic projects towards becoming commercial products that can be delivered at scale by the NHS.

The report highlights that the main indication for cell and gene therapy clinical trials remains oncology at 39 percent, followed by 13 percent ophthalmology and 12 percent haematology.

Health Minister Baroness Nicola Blackwood said: These extraordinary figures show the UKs life sciences sector is leading the world in getting cutting-edge treatments to NHS patients as quickly as possible.

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UK accounts for 12 percent of global cell and gene therapy clinical trials - European Pharmaceutical Review

Recommendation and review posted by Bethany Smith

A new team at Medical College of Georgia is taking aim at defective gene sequences that cause disease using the revolutionary CRISPR method that allows precise editing of specific sequences to create animal models of those diseases.

Drs. Lin Gan and Joseph Miano sit at a conference table outside their new lab at Augusta University, and in the blink of an eye the discussion goes from how they began using a certain technology in its early days of 2013 to how they are applying the latest iteration that came out only last month.

Thats how fast they, and their field of genome editing and manipulation, are moving.

Gan and Miano and colleague Xiaochun Long were recently recruited as a team to the Medical College of Georgia at AU, where Gan became the founding director of the Transgenic and Genome Editing Core. He is a Georgia Research Alliance Eminent Scholar in Neuroscience, and Miano is a J. Harold Harrison Distinguished University Chair in Vascular Biology.

The floor of their lab shows they are only a few months into the new stint in Augusta.

Were still living out of boxes, Miano said as he stepped around cardboard boxes.

The two have been together since the early 1990s in Houston and spent the past 20 years working together at the University of Rochester, though they had no idea they were both headed there initially.

Unbeknownst to me, he was being recruited at the same time, Miano said.

Were meant to be together and we didnt even coordinate our move, Gan said jokingly.

The move to Augusta was deliberate. Miano had interviewed at MCG in 1995 and wanted no part of it then and was not interested again after recently giving a talk at the school and receiving some initial offers.

But then I came down for a second visit and I thought, Hmm, this is interesting, Miano said. They have really built it up well. Theres an opportunity here to make a difference.

But the three were a package deal Long and Miano are now married, and Gan would not have come without them.

I also see this as an opportunity, Gan said. I can definitely have more support here for the Core.

He was quite familiar with MCG and in particular the eye researchers there, which is also an interest for him.

There is a very strong eye group here, Gan said, and he has been supplying them with animal models of disease for more than a decade. Creating those animals models, where a gene may be knocked out or silenced, got a lot easier for him with the advent of CRISPR, or clustered regularly interspaced short palindromic repeats.

It is the ability to take a short length of genetic material known as a guide RNA, which will match up with a highly specific target in DNA and in many instances attach an enzyme that then precisely cuts the DNA at that spot, allowing researchers to target very specific sections of that DNA and either silence genes or in some cases begin the replacement of defective sections.

Gan and Miano use CRISPR to create animal models in mice of human disease that other researchers can use to study those diseases. They often involve a small mutation in the genetic material that gives rise to the condition, known as a single nucleotide polymorphism or SNP.

CRISPR is very effective for SNPs, for mutations, Gan said. It is a little quicker.

There are a lot of them, and more are being added all of the time, Miano said.

The latest database of SNPs, that last time I looked was over 600 million, he said.

Miano was at the conference in 2012 when Dr. Jennifer Doudna of the University of California, Berkley made what he called a jaw-dropping revelation that a bacterial defense system against viruses allows for the precise targeting and cutting of DNA. CRISPR soon became a hot new technique that he and Gan adopted the following year.

Though they are primarily working in mice, CRISPR can be used in other animal models and outside the field as well, Miano said.

I think what is exciting, as Lin says, anything with a genome can be edited, he said. The agricultural field is blowing up. There are all kinds of stuff going on in agriculture with editing.

It has already reached the human level. The National Library of Medicines database of clinical trials involving CRISPR-aided therapy or testing lists 20 active studies, although only a handful are in the U.S. and most are in China. Therapies are most likely to focus first on what Miano called the low-hanging fruit, the 7,000 or so diseases that arise from a single gene defect, such as cystic fibrosis.

More complex conditions, such as heart disease, are going to be tough, he said.

There is no silver bullet for those, but CRISPR will be at the center of that work, he said.

For his part, Gan would like to focus on the eye. The tissue there is thinner and more concentrated, so correcting a defect in vision in, for instance, the macular area of the retina at the back of the eye involves manipulating much fewer cells than trying to correct something in the brain or elsewhere.

This is great for manipulation because a lot of our vision comes from the macular region, Gan said. Its a very small region. That is why he believes in terms of therapies, the eye will be one of the first.

See the article here:
Genome editing heralds new era of disease research, therapy - The Augusta Chronicle

Recommendation and review posted by Bethany Smith

GenScript Biotech Global Forum Highlights Advances in Cell and Gene Therapy and Opportunities in China

GenScript Biotech Corp., a leading global biotechnology group and a pioneer in the field of gene synthesis, held its inaugural "Global Forum on Cell & Gene Therapy and the Booming China Market," during the JP Morgan Healthcare Conference week, attracting hundreds of industry leaders, investors and others to address the challenges and opportunities in this innovative field.

"As an industry, we are on the brink of achieving some extraordinary breakthroughs in cell and gene therapy for cancer and other diseases," said GenScript Biotech CEOFrank Zhang, PhD. "Four gene and cell therapies have recently been approved by the FDA, bringing new hope to patients, and this is only the beginning. Our vision is to make cancer a chronic or curable disease rather than a deadly one, and to transform the treatment of cancer, autoimmune and other diseases by leveraging the advantages of cell and gene therapy."

While significant advances are being made, the Forum also tackled some of the more pressing challenges, such as mitigating treatment side effects, improving treatment efficacy in solid tumors and scaling up manufacturing. Panelists from Kite Pharma, GE Healthcare Life Sciences, Ziopharm Oncology, Oxford Biomedica, Genethon, CARsgen Therapeutics, J&J Innovation Asia Pacific, the American Society of Gene & Cell Therapy, Loncar Investment, Lilly Asia Ventures, and many others participated in the event.

In the U.S. alone, the U.S. Food and Drug Administration is expected to approve 40-60 cell and gene therapies by 2030. During a panel discussion focused on regulatory issues, experts considered what regulators will need to do to keep up with the rapid pace of innovation, the new hospital-based regulatory pathway inChina, how to ensure quality through the manufacturing process, and the challenges and opportunities that come with regulatory harmonization among different countries.

Chinacontinues to attract significant attention from industry and investors and is poised to grow even more. During his welcoming remarks, Zhang notedChina'semergence as a global economic leader, with a projected$1.1 trillionspend on healthcare this year, as well as the growing disease burden inChina. By 2030, an estimated 4.3 million Chinese will be diagnosed with one of the 14 major cancers, according to research from IMS Health. Panelists addressed issues such as the amount of capital required to achieve scale inChina, and advantages of the market inChina.

"The drug development business is changing rapidly andChinais at the fore in a number of ways," Zhang said. "Biotech and pharma companies do not need or desire to have the infrastructure to scale their drugs through commercialization. With lower costs,Chinais a natural place for companies to contract out costly development and manufacturing to organizations that have the expertise and experience to collaborate with them through the entire discovery to development lifecycle."

For its part, GenScript has put significant resources into its Contract Development and Manufacturing Organization (CDMO) business to meet the increasing demand. In 2018, the company officially launched its biologics CDMO segment, and last year opened a new GMP compliant biologics research center. GenScript is also leading the way in cell therapy through its antibody discovery service and plasmid and virus production capabilities.

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Advances in Cell and Gene Therapy and Opportunities in China - BSA bureau

Recommendation and review posted by Bethany Smith

SAN FRANCISCO Novartis sparked a new round of drug pricing criticism last May when the Swiss pharma revealed its new gene therapy Zolgensma would cost $2.1 million per patient.

In the eight months since then, however, insurers have reimbursed treatment for all but one eligible infant who have received the one-time therapy, according to company CEO Vas Narasimhan, speaking Monday at the J.P. Morgan Healthcare Conference.

Commercially, it seems, Novartis' launch has gone according to plan.

But the drugmaker is still awaiting the Food and Drug Administration's judgment on a scandal that erupted last summer following revelations preclinical testing data for Zolgensma had been inappropriately altered. And a clinical hold from the regulator on another study of the gene therapy has slowed plans for expanding treatment into older children.

Resolving both will be key tests in 2020, as will be expanding newborn screening for spinal muscular atrophy, the genetic disease that Zolgensma treats.

David Lennon

Novartis

This year could also feature the start of human testing for two new gene therapies from AveXis, the biotech developer of Zolgensma that Novartis bought in 2018 to gain access to its drug pipeline.

AveXis President David Lennon spoke with BioPharma Dive about the challenges the business is facing, along with how Novartis' ownership has accelerated its ambitions.

This interview has been condensed and edited for clarity.

What's the latest progress on newborn screening for spinal muscular atrophy?

LENNON: It's still a key priority with the states, as it was approved last July. There's been a lot of progress. Sixteen states have implemented newborn screening that represents about 32% of new births in the U.S. that are screened. That's our internal estimate of what we see. We estimate that number will get to 70% over the course of this year as more states implement it.

There's an amazing impact when you have newborn screening. In states where we have newborn screening, [there is] a two- to three-fold higher utilization of gene therapy for newborns than in states where we don't. A lot of that has to do with, when newborn screening gets set up, a dedicated referral pathway to the best institutions also gets created. The parents are informed of the diagnosis and get referred to a geneticist to get counsel.

Do you think the newborn screening process should be reformed, given the state-to-state disparities?

LENNON: It's a travesty. You're just waiting for these kids to present clinically. The bureaucracy that limits the adoption of these kinds of policies is silly in many cases.

RUSP [The Recommended Uniform Screening Panel] recommends and has a two-year implementation requirement that's soft, there's no enforcement around it. It's up to the states to put it in place. Implementation often takes active patient groups and an active physician to advocate for it getting into the state.

How do you grade Novartis' job on communicating Zolgensma's price to payers and the public?

LENNON: With payers, which were the folks we had to really convince, we did an outstanding job. Payers understand the value it provides, they readily wrote policies to cover the product even with a broad label at launch, very positive discussions and good coverage in general very early. I'd give us strong marks on the payer side.

In the public domain, I think it's more problematic. Healthcare cost transparency and understanding of healthcare costs in the general public is not great. It's very easy to just go to the extreme and say, '$2.1 million, I don't understand; that must be ridiculous.' If I was to say it cost $2 million to do a heart transplant, people might say 'I totally get that.'

We anticipate about 300 or 400 [will be treated with Zolgensma], basically the same number of pediatric heart transplants that get done every year. When you start to try to draw some comparisons, it quickly gets lost in the 'but it's $2.1 million dollars.' We have to do a better job of helping people generate relevant transparency that allows us to put these things in context.

How did you choose the pipeline products to prioritize?

LENNON: Our next two programs take on different challenges and opportunities. One is Rett syndrome, where organic [gene] expression needs to be much more targeted. If we overexpress this protein, you actually create a similar syndrome to the one we are trying to address. There's a kind of 'Goldilocks' area of expression. That program is using a promoter that is more controlled and has a natural feedback mechanism that limits the amount of expression.

The third program, called AVXS-301, is for a genetic form of Lou Gehrig's disease amyotrophic lateral sclerosis or ALS. That is actually an inhibitory construct. The first two programs we've had are gene replacement the gene's defective, we're adding back protein. In this case, the defect leads to overexpression or active expression of a mutated form of SOD1 that drives inflammation and degradation of the neurons of these patients. We are inhibiting that by introducing a short hairpin RNA that actually inhibits the expression of the defective gene.

Those programs existed as part of the acquisition of AveXis. Since then, we started partnering with [the Novartis Institutes of Biomedical Research] to apply this platform to different diseases. The first one we announced is a project for Friedreich's ataxia, a muscle-wasting disease.

You took over AveXis in 2018, coming from Novartis. What was AveXis particularly skilled at doing, and what's an area that Novartis' ownership could help in?

LENNON: Technically, this organization was very skilled at taking a problem, breaking it down, developing options to address it and agreeing on the best solution forward. It was an organization that was optimistic it could continually find that. Whether you believe in optimism or luck, the organization was very effective at finding that.

Where the organization really benefits from the Novartis backbone is then: How do you take the process that you developed and make that an industry-leading, highly reproducible and globally scalable system? That's where Novartis is brilliant. That experience has allowed us to bring in quality systems, management talent that knows how to scale, and financial wherewithal that allows us to scale to now multiple sites around the country.

When you look at AveXis, we could do one thing at a time. Now we can start to do seven or eight things at a time, because Novartis has the backbone and scale because they're used to managing 143 projects at once.

Ned Pagliarulo contributed to this article.

Read the rest here:
Novartis' David Lennon on next steps for AveXis, selling Zolgensma's price to the public - BioPharma Dive

Recommendation and review posted by Bethany Smith

All News

January 13, 2020

We expect that a satellite cell with the corrected DMD gene would quite quickly and continuously propagate the edited gene throughout the muscle tissue, said Prof. Amy Wagers, who leads the research. (Photo credit: Jon Chase/Harvard Staff Photographer.)

Cambridge, Mass. January 13, 2020 Harvard University stem cell researchers led by Amy Wagers, PhD, are embarking on a major study of Duchenne muscular dystrophy (DMD). Supported by research funding from Sarepta Therapeutics, under a multi-year collaboration agreement coordinated by Harvards Office of Technology Development (OTD), the project aims to use in-vivo genome editing, in mouse models of DMD, to fully and precisely restore the function of the dystrophin protein, which is crucial for proper muscular growth and development. Approaches validated by this work may point the way to an eventual therapeutic strategy to reverse DMD in humans.

Duchenne muscular dystrophy is a genetic disease caused by the lack of a protein called dystrophin that normally helps to support the structural integrity of muscle fibers, including those in the heart. Without the dystrophin protein, cells are weaker and degenerate more quickly. Over time, affected individuals boys, typically, as it is a recessive X-linked disorder lose their capacity to move independently.

Its really a devastating disease; it robs young boys of their capacity to be young boys, said Wagers, who is the Forst Family Professor of Stem Cell and Regenerative Biology, Co-Chair of the Department of Stem Cell & Regenerative Biology, and an Executive Committee Member of Harvard Stem Cell Institute. Though it is early days, Im hopeful that through this work we may identify and validate new avenues for therapy to completely rescue the proper expression and function of the dystrophin protein and regenerate healthy muscle tissue.

Researchers worldwide have pursued a variety of promising approaches such as cell and gene therapies, small-molecule therapies, and others to lessen or prevent the disease and improve patients quality of life.

The strategy pursued by the Wagers Lab at Harvard aims to fully correct the genetic template for dystrophin at its source, in the DNA of stem cells (satellite cells) that create and regenerate muscle cells. Combining cutting-edge CRISPR/Cas9 genome editing technologies with a deep knowledge of stem cell science and regenerative biology, this approach if successful might offer a permanent restoration of muscular function.

In skeletal muscle, muscle fibers are terminally post-mitotic, meaning they cannot divide and they cannot reproduce themselves, Wagers explains. If you lose muscle fibers, the only way to produce new muscle is from stem cells, specifically the satellite cells. The satellite cells are self-renewing, self-repairing, and ready to spring into action to create new muscle fibers. So we expect that a satellite cell with the corrected DMD gene would quite quickly and continuously propagate the edited gene throughout the muscle tissue.

At present, research conducted in mice has shown promising results. In June, the Wagers Lab published the results of editing stem cells in vivo, demonstrating that stem cell genes can be edited in living systems, not only in a dish. In that work, Wagers and her team delivered genome editing molecules to the cells using adeno-associated viruses (AAVs). Her lab has also successfully used gene editing in heart, muscle, and satellite cells to partially restore the function of the DMD gene that encodes dystrophin, by chopping out faulty sequences of code that are disrupting the proper reading frame.

The new stem-cell approach pursued in collaboration with Sarepta would build on these achievements and use more precise genome editing approaches, in animal models of DMD, to entirely replace genetic mutations in the DMD gene with correctly encoded sequences. The project will also explore alternate delivery methods and strategies to mitigate immune effects of in vivo genome editing.

This ambitious project will benefit greatly from the resources and insights of a company with deep clinical experience in the development of therapeutics for muscular dystrophy, said Vivian Berlin, Managing Director of Strategic Partnerships at Harvard OTD. Preclinical discoveries by Harvard researchers may open entirely new possibilities for lifesaving treatments in the long run, offering much-needed hope to patients and families in the future. Were grateful to be able to sustain the important momentum already established in Prof. Wagers lab, through this collaboration.

As we work to bring forward new treatments for patients with DMD, Sarepta is excited to support Prof. Wagers and her lab to accelerate the development of a gene editing approach, which has shown significant potential in early studies, said Louise Rodino-Klapac, Sareptas Senior Vice President of Gene Therapy. This multi-year collaboration is part of Sareptas broader commitment to pursuing all therapeutic modalities and advancing our scientific understanding of gene editing in order to maximize the potential of this approach to help patients.

Under the terms of the agreement between Harvard and Sarepta, the company will have the exclusive option to license any arising intellectual property for the purpose of developing products to prevent and treat human disease. As with any research agreement facilitated by OTD, the right of academic and other not-for-profit researchers to use the technology in further scholarly work is preserved.

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Muscular dystrophy collaboration aims to correct muscle stem cells' DNA - Harvard Office of Technology Development

Recommendation and review posted by Bethany Smith

19 January 2020 11min read

But ethical and economic challenges could limit the benefits medtech brings to healthcare.

The Nobel Prize in Medicine 2019 was awarded to three men for their discoveries of how cells sense and adapt to oxygen availability. The Nobel Prize in Medicine 2018 was given to two men for their discovery of cancer therapy by inhibition of negative immune regulation. The Nobel Prize in Chemistry 2017 went to a trio for developing cool microscope technology that revolutionises biochemistry by allowing researchers to study three-dimensional structures of biomolecules in their search for a cure for the Zika and other viruses. One of the three chemistry winners of 2017, Joachim Frank of the US, said at the time that he thought the chance of winning a Nobel Prize was minuscule because there are so many innovations and discoveries happening.

Frank is still right about that. Technological leaps in medicine dubbed medtech are accelerating as researchers find better ways to treat more diseases, in more ways, for more people. Advances are occurring in biotechnology, immunotherapy, surgery, and foetal and neonatal care to name just some areas. Artificial-intelligence software trained on data from digitalised health records and devices can spot problems faster and more reliably than can humans. HCA Healthcare, the largest for-profit hospital operator in the US, for instance, now uses algorithms trained on 31 million cases to detect the sepsis infection that kills about 270,000 people a year in the US.

More medtech advances are certain. Money is pouring into research and development overseen by regulators and doctors to ensure benefits outweigh risks. Common sights soon might be robot physicians, remote surgery and mini 3D-printed organs. Bacteria genetically reprogrammed to destroy tumours in mice could one day work on humans. Genome scans and gene therapies could become routine.

For all this promise, however, medtech comes with two certain and one likely drawback. The first definite disadvantage is that medtech is raising ethical issues that could stop the deployment of key advances. The two most sensitive are the gene-editing of foetuses (superbabies) that could alter human experience and protecting the privacy of patient data, an issue highlighted in November when it emerged that US healthcare provider Ascension had secretly handed over the records of tens of millions of patients to data crunchers at Google. Medtechs other certain shortcoming is the cost. Many advancements might never become mainstream because they could prove too expensive for governments burdened with budget deficits and heavy debt loads that are already facing rising healthcare costs as their populations age.

Medtechs contentious disadvantage is doctors are finding that self-monitoring via devices, which often detects harmless abnormalities and fuels hypochondria, is leading to unwarranted anxiety, incorrect diagnoses and unneeded treatments. All up, medtechs value to society will be tied to the extent to which these disadvantages limit the spread of its unquestionable benefits.

Many of medtechs ethical issues could be resolved, to be sure, but that wont be easy. Some medtech advancements, especially those based on AI, are economical. Medtech needs to be assessed with the perspective that there is much it is not solving. Medtech advances, for example, arent enough to avert the recent decline in life expectancy in western countries due to heart attacks tied to obesity. Medtech pharmaceutically does little for autoimmune diseases such as arthritis that afflict one in four US adults though it is improving joint-replacement surgery. Researchers are yet to find a cure for infections made drug-resistant due to the overuse of antimicrobial drugs that the World Health Organisation says could kill 10 million people a year by 2050. Nothing medtech has come up with is usurping MRI scans and X-rays.

Be these as they may, medtech advancements are ushering in treatments that produce better outcomes for patients. Only time will tell how much ethical, economic and other possible drawbacks limit mainstream access to medtechs benefits.

The biotech era

Eras become known for their medical advancements. From the 1920s to the 1950s, for example, the key medical leaps were vaccines and antibiotics. Later epochs might regard todays advances to be centred on cell and gene therapy, robotic surgery and perhaps AI.

Hope for cures from gene therapy, an area of research that emerged from the late 1980s, accelerated in the early 2000s when the human genome was sequenced. And treatments are underway now and more are likely. Biopolymers (nucleic acid) are injected into cells to treat inherited eye diseases and immune deficiencies while researchers are studying how gene therapy could treat cancer, heart disease and diabetes. A stellar example of gene therapy improving lives is that a Novartis subsidiary has developed a one-time gene-based treatment (Zolgensma) that is a curing treatment for children born with spinal muscular atrophy (who without this advance constantly need treatment over their short lives). The problem is one dose costs US$2.1 million.

Aside from the costs, gene therapy comes with other challenges too. The finicky nature of genes has made progress slow. Other hindrances are rejection, side effects such as cancer, and the risk that other genes might be delivered to a cell. Some treatments are so risky authorities have halted them. Some breakthroughs have proved false a recent study debunks that a certain gene causes depression. That the ethical issues surrounding gene therapy are unresolved became an urgent issue in 2018 when two Chinese babies were born with modified genes.

Inventions to assist surgeons have proved faster to everyday use (and less problematic). Robots have aided orthopaedic surgeons since the mid-1980s and now help with general, transplant, urological and other procedures. One measure of their widespread use is that Intuitive, the US-based maker of the 1999-launched da Vinci surgical system, counts that tens of thousands of surgeons have conducted more than six million procedures in at least 66 countries using its equipment. The benefits of robotic-assisted surgery are less invasive, more precise and safer procedures due to fewer and tinier incisions (microsurgery) and reduced human error.

While less-invasive surgery shortens hospital stays and robotic surgerys lower margins of error reduce the need and costs of further treatment, robotic-assisted procedures are expensive. Assuming cost issues can be overcome, technology will expand its role in surgery and robots could use AI more extensively to help surgeons make more decisions.

AIs use in healthcare goes well beyond surgery too. AI programs including chatboxes are diagnosing heart disease and cancer, identifying retinal damage, analysing suicide risk, streamlining drug-development processes, proposing remedies for multiple sclerosis, even helping the dumb speak. AI s promise is more timely, economical, convenient and streamlined treatments.

AIs usual drawbacks apply, however. Personal data needs privacy protection, which can impede research. Data can be dodgy and data-training algorithms can be flawed and biased, which could lead to misdiagnosis. AI is vulnerable to hacking, whereby malicious tweaks lead to errors. AIs deployment often runs ahead of peer review and ethical considerations.

A neurotic world?

One medtech achievement is to elevate the practitioner Doctor Me. The term (sometimes stated as Doctor You) is for when people use devices and self-testing to monitor their health or genetic risks.

Self-monitoring comes with many advantages. It can save lives. The unwell can gain comfort if their vital signs are normal. The data collected can help everyones health and allow people to find others with similar issues, which could provide clues for treatments and moral support.

The problem, however, is that Doctor Me has ushered in the nocebo effect, essentially a form of hypochondria. The nocebo effect occurs when patients think they are experiencing a side effect to a greater degree than possible or when people fret they are suffering from an ailment that a test showed they are at risk of say people self-tested as prone to Alzheimers imagine they have the affliction when they forget something.

A Stanford study of 2018 found the nocebo effect is ripe in self-testing genetics, a flagship area of medtech that is not foolproof. The expression could become ubiquitous soon because more people are testing their disposition to Alzheimers, cancer and obesity by 2017, already one in 25 in the US knew their genetic data. If the nocebo effect becomes widespread, authorities may need to limit self-testing.

While future Nobel Prizes await those making medtech advances, perhaps others lie ahead for those who find ways to resolve medtechs ethical, economic and hypochondriac challenges.

Published by Michael Collins, Investment Specialist, Magellan Group

See the original post here:
Technology is reshaping modern medicine - TheBull.com.au

Recommendation and review posted by Bethany Smith

As the annual JP Morgan Healthcare Conference draws to a close, lets celebrate the remarkable innovation that drives the biopharma industry. Heres a look at the top 10 companies noted in the BioSpace Ideal Employer 2019 survey for being the most innovative and what theyve been up to recently.

Regeneron Pharmaceuticals. Ranked as the top innovator in the survey, Regeneron has long had a reputation for innovation, and is often cited as Sanofis innovation engine because of its numerous collaborations with the French-based company. Regeneron has seven marketed products, including Arcalyst for rare autoinflammatory disease, Eylea for a common cause of blindness, Praluent for high cholesterol, and Dupixent for atopic dermatitis. It also has REGN-EB3, a three-antibody therapy used to treat Ebola.

On January 9, Regeneron announced results from LUMINA-1, a Phase II trial of garetosmab in patients with fibrodysplasia ossificans progressive (FOP), an ultra-rare genetic disorder that leads to abnormal bone formation. After 28 weeks, the drug decreased total lesion activity compared to placebo by 25%.

Verily Life Sciences. Formerly known as Google Life Sciences, Verily is Alphabets life science research company. It was originally a division of Google X. At this point, the company doesnt have any marketed products and its not completely clear on the companys overall focus. It has numerous partnerships, such as one with Sanofi to develop products for managing diabetes, a disease-detecting nanoparticle platform called project Tricorder, and a partnership with Johnson & Johnson on surgical robotics. It also has partnerships with Alon, 3M, Allergan, Biogen, Dexcon, GlaxoSmithKline, Mayo Clinic, Brigham and Womens Hospital and many others.

On December 23, 2019, Verily partnered with Emory Healthcare to deploy new solutions to help improve cost-effectiveness, operational efficiency and quality. This deal with utilize Emorys academic medical center and partner with Verilys expertise in data science, analytics, user experience and product development. The initial focus is a deep analysis of existing drugs and lab-ordering patterns at Emory.

Illumina. Illumina develops, manufactures, and markets laboratory devices, with particular emphasis on DNA sequencing, genotyping, gene expression and proteomics. On January 4, 2020, Illumina announced a 15-year, non-exclusive deal with Roche. Not only will that increase the availability of next-generation sequencing-based in vitro diagnostic (IVD) tests on Illuminas systems, but the two companies will collaborate to complement Illuminas pan-cancer assay TruSight Oncology 500 (TSO 500) with new companion diagnostic (CDx) claims.

That deal came only a short time after Illumina canceled a $1.2 billion merger with another next-generation sequencing company, Pacific Biosciences (PacBio). Illumina decided the deal was not likely to be approved by antitrust regulators in the U.S. and UK. Illumina holds about 80% of the global DNA sequencing market.

bluebird bio. Bluebird bio focuses on the nascent field of gene therapy. Currently its sole approved product is Zynteglo. It was approved by the European Commission (EC) on June 14, 2019 for patients 12 years or older with transfusion-dependent beta-thalassemia who did not have a 0/0 genotype and for patients where hematopoietic stem cell (HSC) transplantation wasnt appropriate, but a human leukocyte antigen (HLA-matched related HSC donor isnt available. Its a little difficult to mention bluebird without mentioning the price of Zynteglo, which is $1.8 million in Europe. In addition to its scientific innovation, bluebird bio is innovative in terms of pricing structure. Zynteglos price is spread out over five years, with an initial upfront price of 315,000 euros with the four additional yearly payments due only if the treatment continues to work.

The product launched in Germany on Jan. 13, 2020. Bluebird initiated the rolling Biologics Licensing Application for Zynteglo in the U.S. and is currently in discussions with the U.S. Food and Drug Administration (FDA) on the timing and various components of the submission. They hope to complete the BLA submission in the first half of this year.

Biogen. Biogen specializes in therapies for central nervous system disorders. Some of its most well-known products are Alprolix for hemophilia B, Avonex, Fampyra, Tecfidera and Tysabri for multiple sclerosis, and Spinraza for spinal muscular atrophy (SMA). However, most recently, the company has been in the headlines for its aducanumab for Alzheimers disease. The drug was declared a failure in March 2019, but was resurrected this year after some of the later trial data showed effectiveness at the highest dose. Still, its not a slam dunk to be approved by the FDA and there are plenty of skeptics.

Analysts expect Biogen to submit aducanumab to the FDA in a matter of weeks, although the company is being tight-lipped about the timetable.

Bayer. Based in Germany, Bayer is one of the largest pharma companies in the world. In 2018, Bayer acquired U.S.-based Monsanto, which no longer exists under the Monsanto name. The companys business units include Bayer Crop Science, Consumer Health, Pharmaceuticals, Animal Health and Business Services.

On Jan. 16, 2020, Bayer sold one of its last Germany-based manufacturing facilities to Shanghai, China-based WuXi Biologics. The plant will be run by WuXi Biologics and act as a backup site for the manufacture of Bayers Kovaltry (antihemophilic factor). The primary site for Kovaltry product is Bayers facility in Berkeley, California.

Novartis. Based in Switzerland, Novartis has a well-known portfolio of drugs, including Clozaril, Voltaren, Tegretol, Diovan, Gleevec, and Ritalin. Its Sandoz Division is a global leader in generic drugs and biosimilars.

Last year, the FDA approved Zolgensma, a gene therapy for SMA, which was developed by its subsidiary, AveXis. Although there was some controversy over data manipulation in preclinical studies, it was determined not to affect the safety or efficacy of the therapy.

In late November 2019, Novartis acquired The Medicines Company for $9.7 billion, only a week after The Medicines Company announced positive data from its ORION-10 Phase III trial for inclisiran for lowering cholesterol.

GlaxoSmithKline. Headquartered in London, GSK markets drugs for numerous major diseases, such as asthma, cancer, infections, diabetes and mental health. Its best-known drugs include Advair, Augmentin, Flovent, Lamictal and others.

At the recent JP Morgan Healthcare Conference, Emma Walmsley, GSKs chief executive officer, predicted it will have six regulatory approvals in the U.S. this year.

I am pleased with the progress and the momentum that weve been able to make over the past couple years, she told CNBCs Jim Cramer.

Walmsley noted positive data for a number of programs, including ones gained from its $5.1 billion acquisition of Tesaro Oncology in 2018. She also noted a two-drug regimen for HIV that the companys subsidiary ViiV Healthcare has been developing.

Genentech. Generally viewed as the first modern biotechnology company, Genentech is a subsidiary of Swiss-based Roche, although Genentech is based in South San Francisco. It has a laundry list of successful drugs, often in the oncology market, such as Avastin, Tarceva, Zelboraf, Kadcyla, Alecansa, Venclexta and Tecentriq. It also has antivirals, such as Xofluza, Hemlibra for hemophilia A, and Esbriet for idiopathic pulmonary fibrosis.

On Dec. 12, 2019, Genentech announced that its Phase III IMspire150 trial in patients with previously untreated BRAF V600 mutation-positive advanced melanoma, hit its primary endpoint of progression-free survival (PFS). It showed adding Tecentriq to Cotellic and Zeleboraf decreased the risk of the disease getting worse or death, compared to placebo plus Cotellic and Zelboraf.

Amgen. Based in Thousand Oaks, California, Amgens best-selling products are Neulasta, an immunostimulatory for patients undergoing chemotherapy, and Enbrel, used to treat rheumatoid arthritis and other autoimmune diseases. Other products include Epogen, Aranesp, Prolia and XGeva.

On Nov. 1, 2019, the company expanded its presence in China by taking a 20.5% stake in China-based BeiGene Co. Amgen paid $2.7 billion in cash for the stake. As a result of the deal, BeiGene will commercialize Xgeva, Kyprolis and Blincyto in China.

On Jan. 13, 2020, the company inked strategic collaborations with Guardant Health and QIAGEN to develop blood- and tissue-based companion diagnostics for investigational cancer treatment AMG 510. AMG 510 is the first KRASG12C inhibitor to advance to the clinic for multiple cancer types.

Read more from the original source:
Who are the 10 Most Innovative Biopharma Companies? - BioSpace

Recommendation and review posted by Bethany Smith

(MENAFN - Ameliorate Solutions)

The report presents an in-depth assessment of the Global Red Biotechnology including enabling technologies, key trends, market drivers, challenges, standardization, regulatory landscape, deployment models, operator case studies, opportunities, future roadmap, value chain, ecosystem player profiles and strategies. The report also presents forecasts for Global Red Biotechnology investments from 2020 till 2025.

Industry Overview-

The Red Biotechnology Market is expected to register a CAGR of 5.7% during the forecast period. Red biotechnology is a process that utilizes organisms to improve health and helps the body to fight against diseases. Red biotechnology has become a very important part of the field of diagnostics, gene therapy, and clinical research and trials. Genetic engineering and the development and production of various new medicinal products to treat life-threatening diseases are also part of the benefits of red biotechnology. Severe Combined Immune Deficiency (SCID) and Adenosine deaminase (ADA) deficiency are genetic disorders that were successfully treated with gene therapy. Several promising gene therapies are under development for the treatment of cancer and genetic disorders. According to the World Health Organization (WHO), approximately 6,000 to 8,000 rare diseases found and out of them, nearly 80% are genetic disorders. Rising incidence and prevalence of chronic and rare diseases and increased funding in the healthcare industry are the key driving factors in the red biotechnology market.

Click the link to get a free Sample Copy of the Report:

https://www.marketinsightsreports.com/reports/01091744865/red-biotechnology-market-growth-trends-and-forecast-2020-2025/inquiry?Mode=21

Top Leading Manufactures-

Pfizer Inc, AstraZeneca PLC, F. Hoffmann-La Roche Ltd, Celgene Corporation, Takeda Pharmaceutical Company Limited, Biogen Inc, Amgen Inc, Gilead Sciences Inc, Merck KGaA, CSL Limited

Biopharmaceutical Industry Segment is Expected to Hold a Major Market Share in the Red biotechnology Market

- Biopharmaceuticals are medical drugs that are produced by using biotechnology. Biopharmaceuticals are proteins, antibodies, DNA, RNA or antisense oligonucleotides used for therapeutic or diagnostic purposes, and these products are produced by means other than direct extraction from a native (non-engineered) biological source.- The first biopharmaceutical product approved for therapeutic use was recombinant human insulin (Humulin), which was developed by Genentech and marketed by Eli Lily in the year 1982 and in the year 2019, Novartis received FDA approval for gene therapy product in the treatment of spinal muscular atrophy (SMA) condition. Using an AAV9 viral vector, called Zolgensma, which delivers SMN protein into the motor neurons of afflicted patients.- According to the World Health Organization (WHO), globally Cancer is the second leading cause of death and an estimated 9.6 million deaths in the year 2018.- Increasing incidence and prevalence of chronic and rare diseases and rapid expansion of the biopharmaceutical industries are the key driving factors in the biopharmaceutical industry segment.

North America is Expected to Hold a Significant Share in the Market and Expected to do Same in the Forecast Period

North America expected to hold a major market share in the global red biotechnology market due to the rising prevalence of chronic and rare diseases, increased expenditure in the healthcare industry in this region. According to the National Institutes of Health (NIH), in the year 2019, approximately 1.8 million people will be diagnosed with cancer in the United States and estimated 268,600 women and 2,670 men will be diagnosed with breast cancer. Moreover, the rise in the adoption of advanced technologies in gene therapy and increasing investments in research and development is fueling the growth of the overall regional market to a large extent.

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Key Strategic Developments : The study also includes the key strategic developments of the market, comprising R & D, new product launch, M & A, agreements, collaborations, partnerships, joint ventures, and regional growth of the leading competitors operating in the market on a Global and regional scale.

Key Market Features: The report evaluated key market features, including revenue, price, capacity, capacity utilization rate, gross, production, production rate, consumption, import/export, supply/demand, cost, market share, CAGR, and gross margin. In addition, the study offers a comprehensive study of the key market dynamics and their latest trends, along with pertinent market segments and sub-segments.

Analytical Tools: Global Red Biotechnology Market report includes the accurately studied and assessed data of the key industry players and their scope in the market by means of a number of analytical tools. The analytical tools such as Porter's five forces analysis, feasibility study, and investment return analysis have been used to analyzed the growth of the key players operating in the market.

The research includes historic data from 2014 to 2020 and forecasts until 2025 which makes the reports an invaluable resource for industry executives, marketing, sales and product managers, consultants, analysts, and other people looking for key industry data in readily accessible documents with clearly presented tables and graphs.

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Red Biotechnology Market Size, Status and Recent Advancements, Forecast 2020 to 2025 - MENAFN.COM

Recommendation and review posted by Bethany Smith

Zacks Investment Research downgraded shares of Axovant Gene Therapies (NASDAQ:AXGT) from a hold rating to a sell rating in a report released on Wednesday morning, Zacks.com reports.

According to Zacks, Axovant Sciences Ltd. is a biopharmaceutical company which focuses on the acquisition, development and commercialization of therapeutics for the treatment of neurodegenerative disorders. Its product candidate includes RVT-101 which is in different clinical trial for the treatment of Alzheimers disease and other forms of dementia. Axovant Sciences Ltd. is based in Hamilton, Bermuda.

Other equities research analysts also recently issued reports about the stock. ValuEngine raised shares of Axovant Gene Therapies from a hold rating to a buy rating in a report on Friday, January 3rd. Chardan Capital upped their price objective on shares of Axovant Gene Therapies from $10.00 to $15.00 and gave the company a buy rating in a report on Monday, October 28th. One investment analyst has rated the stock with a sell rating, one has issued a hold rating and nine have issued a buy rating to the company. The stock currently has a consensus rating of Buy and an average price target of $24.66.

NASDAQ AXGT traded down $0.22 during trading on Wednesday, hitting $4.43. 227,466 shares of the companys stock traded hands, compared to its average volume of 146,417. Axovant Gene Therapies has a 12-month low of $3.81 and a 12-month high of $19.60. The company has a debt-to-equity ratio of 0.69, a current ratio of 1.41 and a quick ratio of 1.41. The business has a 50 day moving average of $5.14 and a 200-day moving average of $6.11.

Axovant Gene Therapies (NASDAQ:AXGT) last released its quarterly earnings data on Friday, November 8th. The company reported ($0.61) EPS for the quarter, beating the Thomson Reuters consensus estimate of ($1.15) by $0.54. Research analysts predict that Axovant Gene Therapies will post -3.58 earnings per share for the current year.

A number of hedge funds and other institutional investors have recently added to or reduced their stakes in the business. BlackRock Inc. purchased a new stake in shares of Axovant Gene Therapies in the second quarter worth about $1,482,000. Tower Research Capital LLC TRC lifted its holdings in shares of Axovant Gene Therapies by 955.3% in the second quarter. Tower Research Capital LLC TRC now owns 4,221 shares of the companys stock worth $27,000 after buying an additional 3,821 shares in the last quarter. Jane Street Group LLC lifted its holdings in shares of Axovant Gene Therapies by 28.8% in the second quarter. Jane Street Group LLC now owns 46,455 shares of the companys stock worth $289,000 after buying an additional 10,375 shares in the last quarter. Barclays PLC purchased a new stake in shares of Axovant Gene Therapies in the third quarter worth about $65,000. Finally, Woodstock Corp purchased a new stake in shares of Axovant Gene Therapies in the fourth quarter worth about $83,000. 14.80% of the stock is currently owned by institutional investors and hedge funds.

Axovant Gene Therapies Company Profile

Axovant Gene Therapies Ltd., a clinical-stage gene therapy company, focuses on developing a pipeline of product candidates for debilitating neurological and neuromuscular diseases. The company's current pipeline of gene therapy candidates targets GM1 gangliosidosis, GM2 gangliosidosis, Parkinson's disease, oculopharyngeal muscular dystrophy, amyotrophic lateral sclerosis, and frontotemporal dementia.

Further Reading: What are the qualifications of a portfolio manager?

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Axovant Gene Therapies (NASDAQ:AXGT) Downgraded to Sell at Zacks Investment Research - Riverton Roll

Recommendation and review posted by Bethany Smith

Axovant Gene Therapies (NASDAQ:AXGT) was upgraded by stock analysts at ValuEngine from a hold rating to a buy rating in a report released on Friday, January 3rd, ValuEngine reports.

A number of other equities research analysts have also commented on the company. Chardan Capital increased their price target on Axovant Gene Therapies from $10.00 to $15.00 and gave the company a buy rating in a research report on Monday, October 28th. Zacks Investment Research raised Axovant Gene Therapies from a hold rating to a strong-buy rating and set a $6.00 price target for the company in a research report on Wednesday, November 13th. One equities research analyst has rated the stock with a sell rating, one has issued a hold rating and nine have assigned a buy rating to the companys stock. The company currently has a consensus rating of Buy and a consensus target price of $24.66.

Shares of NASDAQ:AXGT opened at $4.43 on Friday. The company has a quick ratio of 1.41, a current ratio of 1.41 and a debt-to-equity ratio of 0.69. Axovant Gene Therapies has a twelve month low of $3.81 and a twelve month high of $19.60. The stocks 50 day moving average is $5.14 and its 200-day moving average is $6.11. The firm has a market capitalization of $105.98 million, a price-to-earnings ratio of -1.00 and a beta of 1.18.

Large investors have recently made changes to their positions in the business. Tower Research Capital LLC TRC grew its stake in shares of Axovant Gene Therapies by 955.3% during the 2nd quarter. Tower Research Capital LLC TRC now owns 4,221 shares of the companys stock worth $27,000 after acquiring an additional 3,821 shares during the period. Barclays PLC bought a new position in shares of Axovant Gene Therapies during the 3rd quarter worth $65,000. Jane Street Group LLC grew its stake in shares of Axovant Gene Therapies by 28.8% during the 2nd quarter. Jane Street Group LLC now owns 46,455 shares of the companys stock worth $289,000 after acquiring an additional 10,375 shares during the period. Woodstock Corp bought a new position in shares of Axovant Gene Therapies during the 4th quarter worth $83,000. Finally, BlackRock Inc. bought a new position in shares of Axovant Gene Therapies during the 2nd quarter worth $1,482,000. Hedge funds and other institutional investors own 14.80% of the companys stock.

Axovant Gene Therapies Company Profile

Axovant Gene Therapies Ltd., a clinical-stage gene therapy company, focuses on developing a pipeline of product candidates for debilitating neurological and neuromuscular diseases. The company's current pipeline of gene therapy candidates targets GM1 gangliosidosis, GM2 gangliosidosis, Parkinson's disease, oculopharyngeal muscular dystrophy, amyotrophic lateral sclerosis, and frontotemporal dementia.

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Axovant Gene Therapies (NASDAQ:AXGT) Upgraded to Buy by ValuEngine - Slater Sentinel

Recommendation and review posted by Bethany Smith

The Electrical Shielding Tape market is an intrinsic study of the current status of this business vertical and encompasses a brief synopsis about its segmentation. The report is inclusive of a nearly accurate prediction of the market scenario over the forecast period market size with respect to valuation as sales volume. The study lends focus to the top magnates comprising the competitive landscape of Electrical Shielding Tape market, as well as the geographical areas where the industry extends its horizons, in magnanimous detail.

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Daimler AGSchmitz CargobullGreat DaneUtility TrailerPaccarVolvoWabash National CorporationFontaineHyundai TransleadNavistarKogel Trailer GmbhSchwarzmuller GroupFAW SipingHuida HeavyCIMCSinotrukLiangshan Huayu

Segment by RegionsNorth AmericaEuropeChinaJapanSoutheast AsiaIndia

Segment by TypeUp To 50 T50-100 TAbove 100 T

Segment by ApplicationCement IndustryFood IndustryChemical IndustryLogistics IndustryOil and Gas IndustryOther

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In accordance with a competitive prospect, this Electrical Shielding Tape report dispenses a broad array of features essential for measuring the current Electrical Shielding Tape market performance along with technological advancements, business abstract, strengths and weaknesses of market position and hurdles crossed by the leading Electrical Shielding Tape market players to gain leading position. Other aspects such as customer base, sales reach, local coverage, production price trends, and production cost layout are also analyzed to bestow accurate rivalry perspective.

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Gene Therapy Market 2020 Industry Size, Regions,Trends and Top Manufacturers Bluebird Bio, Sangamo, Spark Therapeutics, Dimension Therapeutics,...

Recommendation and review posted by Bethany Smith

Global Gunshot Detection System Marketwas valued US$ 920.2 Mn in 2017 and is expected to reach US$ 7120.7 Mn by 2026, at CAGR of 29.2% during forecast period.

The major growth drivers of the gunshot detection system market include the rise in demand for advanced security systems, increasing demand for security in various industry verticals, and rising criminal activities in urban areas. In addition, Increased incidences of gun-firing, especially at school premises, have led to various security measures, such as warning people in close proximity and alerting authorities to the location of the shooting all these factors will drive the growth of Gunshot Detection system market during the forecast period. Increasing government initiative side has led to the growth of the Gunshot Detection system across the globe. The latest trend for smart cities across the globe is resulting in the quantitative increase in demand of Gunshot across the nation.

Growing investment in border security is also likely to drive the market growth in the coming years, as gunshots systems can help border security forces to detect and stop any attempts of smuggling, infiltration, and illegal immigration. Also, with a little amendment of the system, it might be possible for the manufacturers to help forces identify criminals and detect illegal entry even in the absence of gunshots. Various law enforcement agencies across global are now deploying various strategies in order to control the increased incidents related to the mass shooting, which will further increase the demand and interest in advanced gunshot detection technology.

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At the same time, the factors that are limiting the market are the scarcity of gunshot detection professionals, the high installation cost of gunshot detection systems. Also, worldwide financial uncertainty and macroeconomic situations such as currency exchange rates and economic difficulties are some of the major challenges which are hampering the growth of Gunshot Detection System Market.

Based on the installation, the vehicle installations segment is expected to account for the largest share of the gunshot detection system market over the period. The growth in the vehicle installations segment is due to the upgradation of existing armored vehicle fleets. The increasing delivery of new armored vehicles is also leading to increasing demand for armored vehicles. Increasing soldier modernization programs are also contributing to the demand for overall GDS.

The global gunshot detection systems market is mainly dominating by Raytheon products, both in military and civilian applications. Shotspotter, which sells civilian versions of Raytheons gunshot detection system through the license, generated a revenue of around XX million in 2017. The product obtaining cost for gunshot detection systems is very low. The civilian usage of gunshot detection systems is gradually increasing across various countries, with the threat from random shooters and terrorists augmenting the demand from civilians.

North America is expected to drive the growth of the gunshot detection system market during the forecast period, 2017 to 2026. The gunshot detection system market in North America is expected to witness growth, because of the largest civilian gunfire deaths in the region, especially in the US where the firearm-related death rate is 25 times higher than other countries. Major US cities are planning to install indoor gunshot detection systems at universities, corporate office locations, and financial facilities, among others, over the next few years.

The objective of the report is to present a comprehensive assessment of the market and contains thoughtful insights, facts, historical data, industry-validated market data and projections with a suitable set of assumptions and methodology. The report also helps in understanding the Global Gunshot Detection System Market dynamics, structure by identifying and analysing the market segments and project the global market size. Further, the report also focuses on the competitive analysis of key players by product, price, financial position, product portfolio, growth strategies, and regional presence. The report also provides PEST analysis, PORTERs analysis, and SWOT analysis to address questions of shareholders to prioritizing the efforts and investment in the near future to the emerging segment in the Global Gunshot Detection System Market.

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Scope of Global Gunshot Detection System Market:

Global Gunshot Detection System Market, By Type:

Indoor OutdoorGlobal Gunshot Detection System Market,By Installation:

Fixed Installation Wearable Installation Vehicle Mounted InstallationGlobal Gunshot Detection System Market, By Application:

Military Law EnforcementGlobal Gunshot Detection System Market, By Region:

North America Europe Asia-Pacific South America Middle East & AfricaKey Players Operated in Market Include:

Raytheon Company Thales Group Battelle Memorial Institute Rafael Safran Electronics & Defense Rheinmetall AG ELTA Systems Ltd

MAJOR TOC OF THE REPORT

Chapter One: Gunshot Detection System Market Overview

Chapter Two: Manufacturers Profiles

Chapter Three: Global Gunshot Detection System Market Competition, by Players

Chapter Four: Global Gunshot Detection System Market Size by Regions

Chapter Five: North America Gunshot Detection System Revenue by Countries

Chapter Six: Europe Gunshot Detection System Revenue by Countries

Chapter Seven: Asia-Pacific Gunshot Detection System Revenue by Countries

Chapter Eight: South America Gunshot Detection System Revenue by Countries

Chapter Nine: Middle East and Africa Revenue Gunshot Detection System by Countries

Chapter Ten: Global Gunshot Detection System Market Segment by Type

Chapter Eleven: Global Gunshot Detection System Market Segment by Application

Chapter Twelve: Global Gunshot Detection System Market Size Forecast (2019-2026)

Browse Full Report with Facts and Figures of Gunshot Detection System Market Report at:https://www.maximizemarketresearch.com/market-report/global-gunshot-detection-system-market/29340/

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Global Gene Therapy Market 2019 exhibiting a CAGR of 22.07% till 2025 - Fusion Science Academy

Recommendation and review posted by Bethany Smith

DURHAM, N.C. -- Few singers reach their sunset years with the same voice they had in younger days. Singing sparrows are no different. Duke University-led research reveals that elderly swamp sparrows dont sound quite like they used to -- nor do they strike the same fear in other males who may be listening in.

Humans are remarkably good at guessing a persons age just by hearing their voice. But this is the first time the phenomenon has been demonstrated in wild animals, said Duke biology professor and study co-author Steve Nowicki.

The findings were published on January 7 in the journal Behavioral Ecology.

During the early spring, a male swamp sparrow stakes out a breeding territory and threatens any male who dares to trespass on his turf. If a potential rival enters another males territory and starts to sing, the resident male says "Get out! by singing back with a rapid weet-weet-weet and flying toward the intruder. Eventually, if all else fails, he attacks.

Previous research by this team showed that male swamp sparrows reach their peak as vocalists at age two, and start to decline after that, singing less frequently and less consistently as they get older.

To find out if other males take note of such changes, the team set up a speaker in the territories of 35 male swamp sparrows in a Pennsylvania marsh and played them 5-minute audio clips of stranger males recorded at age two and again at age 10.

The team measured the birds responses, noting how closely each male approached the speaker. They found that males approached seven feet closer when they heard a potential rival singing at age two. This suggests that males are more aggressive towards younger-sounding rivals.

Males in their prime pose an obvious threat: if a resident male isnt assertive, theres a good chance that the other guy could steal his mates, said first author Matthew Zipple, a doctoral student at Duke. But apparently the song of a 10-year-old -- a centenarian in bird years -- doesnt warrant getting as worked up over.

If decreases in song quality in later life reflect the inevitable consequences of physical decline, the researchers believe that such changes could indicate to other males that a once-formidable male is no longer a match.

Whether song changes after mid-life make males more or less attractive to females is still unknown. One interesting question would be, is the equation a little different from the females point of view? Nowicki said.

Males accumulate genetic mutations in their sperm as they age that could make them less desirable mates. On the flip side, Nowicki said, The mere fact that hes lived this long means he must be doing something right.

This research was supported by the National Science Foundation (IBN-0315377) and Duke University.

CITATION: "Sounds of Senescence: Male Swamp Sparrows Respond Less Aggressively to the Songs of Older Individuals," Matthew N. Zipple, Susan Peters, William A. Searcy, Stephen Nowicki. Behavioral Ecology, Jan. 7, 2020. DOI: 10.1093/beheco/arz218.

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Male Sparrows Are Less Intimidated by the Songs of Aging Rivals - Duke Today

Recommendation and review posted by Bethany Smith

Because the queen was just as likely to be executed in both colonies, it showed that by mating with two males the queen actually doubled her chance of being executed.

Francis Ratnieks, Professor of Apiculture (beekeeping) at the University of Sussex, said: By studying test colonies, we found that queen stingless bees will have an increased chance of being executed by the workers in their colony if they mate with two males instead of the one male they normally mate with.

The reasons for this are fairly complex, but in short, it is due to the genetics of sex determination in bees and the risk of what is known as 'matched mating'.

The project tests a long standing idea of mine that if stingless bee queens mate with two males instead of one that it will increase their chances of being executed. It was quite satisfying that an idea that was thirty years old could finally be tested, especially when the hypothesis was found to be correct, Prof Ratneiks added.

The study, published in theAmerican Naturalist, helps biologists to understandwhy some species mate with multiple males, while others only remain with one.

The Honey Bee, which can be found in parts of the UK, is a species known for its queens mating with between ten and twenty males.

Queen stingless bees are closely related to honeybees and bumblebees, but are found in tropical climates such as Brazil.

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Queen bees more likely to be executed by their workers if they mate with multiple males, research shows - The Telegraph

Recommendation and review posted by Bethany Smith

"Having sex weekly may delay your menopause: Scientists say not getting enough action 'makes the body choose to stop ovulating'," reports the Mail Online.

Women enter the menopause when they stop releasing eggs, usually in their 40s or 50s. Some of the timing seems to be down to genetics, while lifestyle factors such as smoking are also important.

This study was designed to test the theory that women's bodies may stop releasing eggs when the body senses that a woman is no longer likely to get pregnant for example because she is no longer having sex.

The researchers also wanted to look into a theory that exposure to male pheromones (for example, from living with men) delays menopause.

Researchers analysed information about 2,936 women in their 40s and 50s who lived in the US. The women answered questions about their health, lifestyle, who else lived in their household, and their sexual activity. They were followed up for 10 years.

The researchers found that women were less likely to have gone through the menopause if they had weekly sex. However, the study only shows a link between how often women had sex and their age at menopause. It cannot prove that having more sex directly causes a later menopause.

The researchers did not find any evidence that exposure to male pheromones was linked to timing of the menopause.

Find out more about the menopause.

The researchers who carried out the study were from University College London.

The study was published in the peer-reviewed journal Royal Society Open Medicine on an open access basis, meaning it is free to read online.

Most of the media headlines suggested that regular sex could delay the menopause, or reduce risk of an early menopause. But the study only shows a link between sexual activity and timing of menopause, not that sexual activity can actually delay menopause.

The news stories themselves gave a more accurate picture of the research, although none pointed out that early menopausal symptoms can affect how likely a woman is to want to have sex.

This was a cohort study. Cohort studies are good ways to look for links between behavioural factors (such as sexual activity) and outcomes (such as menopause). However, they cannot tell us that one directly causes the other. The relationship may be more complex.

Researchers recruited women aged 42 to 52 in 1996 to 1997.

The 2,936 women were all pre-menopausal, although half were experiencing early signs of approaching menopause, such as hot flushes or irregular periods.

The women were asked a range of questions at the start of the study and at 10 follow-up visits over the following 10 years.

Questions included:

Researchers also checked whether the women had been through the menopause at any point during the study.They used the information to calculate:

The first question was to investigate whether menopause might be delayed by the presence of male pheromones in a woman's living space, while the second looked more directly at whether sexual activity was linked to menopause.

The researchers adjusted the results to take account of a range of factors, including:

Most of the women in the study (78%) were married or in a relationship at the start of the study, and 68% lived with their partner. 64% of the women reported weekly sexual activity.

During the study, just under half (45%) of women went through the menopause, with the average age at menopause being 52.

The researchers found no link between women living with men and the likelihood of having gone through the menopause at any point.

However, women who said they had regular sexual activity were less likely to have gone through the menopause than women who said they had sexual activity less than once a month:

The researchers explained their results in an evolutionary framework.

"During ovulation, the woman's immune function is impaired, making the body more susceptible to disease. Hence, if a pregnancy is unlikely owing to a lack of sexual activity, then it would not be beneficial to allocate energy to a costly process, especially if there is the option to invest resources into existing kin," they said.

On the other hand, if a woman is engaging in regular sex which could lead to pregnancy, "then it may be better to maintain the function of her menstrual cycle for slightly longer".

They point out that menopause is "an inevitability" that cannot be prevented by any behaviour.

Menopause, when women stop releasing eggs and are no longer able to get pregnant, happens to all women eventually. For most women, it happens during their 40s or 50s, but there is a lot of variation.

This study was an attempt to explain part of the reason for the variation in timing of menopause, looking at the question from an evolutionary perspective.

The study has limitations that mean we cannot read too much into it. As with all observational studies, it cannot tell us whether sexual activity is directly linked to age of menopause.

That's because many factors affect whether someone is having sex, and when the menopause happens. For example, if someone is experiencing anxiety or vaginal dryness both common symptoms of the menopause they may be less likely to want to have sex.

The findings of the study are interesting for scientists investigating the biology of the menopause and how it might be affected by lifestyle. But they are not particularly relevant to women. We do not know whether changing behaviour to have sex more frequently, for example, could change a woman's time of menopause.

There's no suggestion from this study that women should change their behaviour to delay menopause, even if they wanted such a delay.

Find out more about the menopause.

Analysis by BazianEdited by NHS Website

Read more:
Weekly sexual activity linked to later menopause - NHS Website

Recommendation and review posted by Bethany Smith

Comedy star Amy Schumer, who has rarely hesitated at sharing intimate medical issues, from her current desire for in vitro fertilization to the pregnancy-long hyperemesis vomiting she experienced while pregnant with her first child, talked IVF-related constipation Saturday at a wellness event hosted by Oprah Winfrey.

"I had my egg retrieval on Monday," the Rockville Centre-raised Schumer, 38, told media mogul Winfrey, 65, at "Oprah's 2020 Vision: Your Life in Focus" at the Spectrum Center in Charlotte, North Carolina. "Which is also the last time I pooped," Schumer added. "I said I wasn't gonna say it, but I did. Yeah, can't poop after."

In a backstage video Winfrey posted on Instagram, the comedian assures her, "I feel so much better. I can't even complain, except that I haven't pooped since Monday." Oprah gives the camera a look, and Schumer rushes to hug her. "We'll save that for the audience. We'll save that for the 15,000 people. Charlotte needs to know!" Schumer said jocularly.

In the same video, when Winfrey asks if Schumer has tried teas said to help. "I was going to do Smooth Move," the comic said, referring to one such brand. "But then I was scared it would hit while we were onstage, so I'm waiting until after." Winfrey mentions that a type of airplane Schumer will be on soon has a good bathroom. "I'll use any bathroom if it happens, the comicanswers lightheartedly. "I will not be precious about whatever bathroom!"

"Listen, I heard @amyschumer hadn't [poop emoji] and I thought it was TMI but then she told a sold-out arena about it and apparently people love to talk about [poop emoji](or not)," Winfrey wrote in an accompanying post. "Amy, thank you so much for spending your Saturday making US laugh and sharing your journey through motherhood, marriage, and yes [poop emoji]. And Charlotte, you guys were EPIC!"

The full 40-minute interview is scheduled to run Wednesday at 8 p.m. on Winfrey's Facebook channel and the WW Now Facebook channel.

According to the Mayo Clinic, in vitro fertilization consists of a series of treatments to deal with infertility or prevent genetic problems and assist with the conception of a child. IVF procedures include harvesting mature eggs from a woman and then fertilizing thosein a lab setting. The resulting embryos are then implanted inside the future mother's uterus or a gestational carrier at a later date. One cycle of IVF can take two to three weeks and more than one cycle may be required for a viable pregnancy.

Schumer, who gave birth to son Gene Attell in May, is married to celebrity chef and cookbook author Chris Fischer. She said to Winfrey during the event that she'd like to have a daughter.I picture us all on the beach together," Schumer said. "And teaching maybe a little girl how to play volleyball.

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"What an amazing day with @oprah who is still to this day making people's lives better including mine and my family's," Schumer wrote on her own Instagram account. "Check stories for some clips and the whole thing will be available Wednesday! I'm wearing @russwest44 on my feet and Charlotte was a great time! The comics I mentioned people checking out are @miacomedy @janellejamescomedy @rachelfeinstein_ @bridgeteverett @marinayfranklin @ejthecomic and @chelsanity."

By Frank Lovece Special to Newsday

Read more:
LI's Amy Schumer talks effects of IVF treatments - Newsday

Recommendation and review posted by Bethany Smith

The Fulton County Health Department has scheduled the following health clinics and services. Please call the number listed with each service for an appointment or more information.

CANTON The Fulton County Health Department has scheduled the following health clinics and services. Please call the number listed with each service for an appointment or more information.

All offices of the Fulton County Health Department will be closed Monday, Jan. 20, 2020 in observance of the Martin Luther King holiday.

Maternal child health: Health screenings, WIC nutrition education and supplemental food coupons for women, infants and children. To make an appointment or for more information call 647-1134 (ext. 254). For Astoria clinic appointments call 329-2922.

Canton - WIC Nutrition Education - Tuesday, Jan 21 - 8-4 - Appt needed

Astoria - Clinic, WIC Nutrition Educ. - Wednesday, Jan 22 - 9-3 - Appt needed

Canton - Clinic - Thursday, Jan 23 - 8-4 - Appt needed

Adult Health Immunizations: Various vaccines are available. There is a fee for immunization administration. Medicaid cards are accepted. To make an appointment or for more information call 647-1134 (ext. 254).

Other times available by special arrangement at Canton, Cuba and Astoria.

Blood Lead Screening: Blood lead screenings are available for children ages one to six years. A fee is based on income. To make an appointment or for more information call 647-1134 (ext. 254). For Astoria appointments call 329-2922.

Family Planning: Confidential family planning services are available by appointment at the Canton office for families and males of child-bearing age. Services provided include physical exams, pap smears, sexually transmitted disease testing, contraceptive methods, pregnancy testing, education and counseling. Services are available to individuals of all income levels. Fees are based on a sliding fee scale with services provided at no charge to many clients. Medicaid and many insurances are accepted. After hours appointments are available. To make an appointment or for more information call the 647-1134 (ext. 244). *Program funding includes a grant from the US DHHS Title X.

Pregnancy testing: Confidential urine pregnancy testing is available at the Canton and Astoria offices. This service is available to females of all income levels. A nominal fee is charged. No appointment is needed. A first morning urine specimen should be collected for optimal testing and brought to the health department. Services are provided on a walk-in basis on the following days each week:

Canton: Every Wednesday & Thursday, 8-3:30 (for more information call 647-1134 ext. 244)

Astoria: Every Wednesday, 9-2:30 (for more information call 329-2922)

Womens Health: A womens clinic for pap tests, clinical breast examinations and vaginal examinations is available by appointment. There is a nominal fee for this service. Medicaid cards are accepted. Financial assistance is available for a mammogram. Cardiovascular screenings may be available to age and income eligible women. To make an appointment or for more information call 647-1134 (ext. 244).

Mammograms: Age and income eligible women may receive mammograms at no charge. Speakers are available to provide information to clubs and organizations. For more information or to apply for financial assistance, call 647-1134 (ext. 254).

Mens Health: Prostate specific antigen (PSA) blood tests are available for men for a fee. To make an appointment or for more information call 647-1134 (ext. 224).

Sexually Transmitted Disease (STD) Clinic: Confidential STD and HIV testing services are available by appointment to males and females at the Canton office. Services include physical exams to identify STDs, a variety of STD testing, HIV testing, education, counseling, medications and condoms. There is a nominal fee for services. Services are available to individuals of all income levels. Medicaid cards are accepted. To make an appointment or for more information call 746-1134 (ext. 224).

HIV Testing and Counseling: Confidential HIV testing and counseling services are available by appointment through the sexually transmitted disease (STD) clinic at the Canton office. To make an appointment or for more information call 647-1134 (ext. 224).

Tuberculosis (TB) Testing: TB skin tests are available at no charge by appointment. To make an appointment or for more information call 647-1134 (ext. 254).

Blood Pressure Screenings: The Fulton County Health Department provides blood pressure screenings at no charge on a walk-in basis during the following times:

Astoria - Screening - Wednesday, Jan 22 - 9-12 - Walk in

Health Watch Wellness Program: The Health Watch Program provides low cost lab services. Through this program adults can obtain venous blood draws for a variety of blood tests. Blood tests offered without a doctors order Comprehensive Metabolic Panel (CMP), Complete Blood Count (CBC), Lipid Panel, Prostate Specific Antigen (PSA) test, Hepatitis C test, and Thyroid Stimulating Hormone (TSH). A wide variety of blood tests are also available with a doctors order. There is a charge at the time of service. To make an appointment or for more information call 647-1134 (ext. 254).

Dental Services: The Dental Center offers a variety of basic dental services to children and adults. An appointment is needed. Medicaid and Kid Care cards are accepted. To make an appointment or for more information call 647-1134 (ext. 292).

Read more from the original source:
Health Department announces services for the week of Jan 20 - Galva News

Recommendation and review posted by Bethany Smith

The Celtics were No. 2 in team merchandise sold from October through December at NBA-Store.com, with Jayson Tatum fourth in jersey sales. The Los Angeles Lakers and LeBron James topped their respective lists, according to the latest numbers put out by the league. The top-10 jerseys belonged to James, reigning MVP Giannis Antetokounmpo, Golden States Stephen Curry, Tatum, Houstons James Harden, Luka Doncic of Dallas, new Los Angeles Clipper Kawhi Leonard, LeBrons new Lakers teammate Anthony Davis, Philadelphias Joel Embiid, and Brooklyns Kyrie Irving was 10th. Kemba Walker ranked 14th, just ahead of No. 1 overall pick Zion Williamson ... Changes to the NBA schedule in time for the 75th anniversary season in 2021-22 remain a real possibility, but the leagues board of governors likely wont vote on them in April, according to an Associated Press source. Suggestions include a 78-game regular season, an in-season tournament in November and December, and a reseeding of the playoffs prior to the final four ... Two-time All-Star Karl-Anthony Towns was in the starting lineup for Minnesota at Indiana after missing 15 games with a sprained left knee.

Major League Baseball has never issued a therapeutic use exemption for human growth hormone, the league and Major League Baseball Players Association announced in response to an allegation that four-time AL MVP Mike Trout has been secretly using HGH as treatment for a fabricated thyroid condition. An Instagram account purportedly run by David Brosius, son of 11-year major leaguer Scott Brosius, posted the claim, citing information gleaned while his father was Seattles third-base coach in 2017. (The elder Brosius was an assistant coach with the Mariners in 2017, and their third-base coach in 2018.) The account was deleted after social media site Reddit found the post, but then reactivated so David Brosius could apologize, claiming the story was a hypothetical with no evidence behind it. MLB issued 91 therapeutic use exemptions for ADHD drugs last season, according to the MLB/MLBPA annual report, plus one each for hypersomnia, hypogonadism, and kidney disease ... Houston Astros owner Jim Crane said he has interviewed a number of candidates, and expects to hire a replacement for fired manager A.J. Hinch by Feb. 3. He added that he expects most of Hinchs staff to stay in place ... Former Walmart Inc. chief executive David Glass, 84, who owned the Kansas City Royals for nearly two decades before selling the franchise for $1 billion last fall, died on Jan. 9 of complications from pneumonia. Glasss Royals reached the World Series twice and won it in 2015, but had just four winning seasons in his 20 years as owner ... The Colorado Rockies will retire the No. 33 of outfielder Larry Walker, a Hall of Fame contender in his final year on the writers ballot, on April 19 ... Reliever Craig Stammen finalized a $9 million, two-year contract to remain with the San Diego Padres.

The No. 5 Boston College mens hockey team weathered two UMass Lowell goals in the first 71 seconds at Tsongas Center, coming back to beat the No. 13 River Hawks, 3-2. Marc McLaughlin, Alex Newhook, and Logan Hutsko had the answer for the Eagles (14-5-0, 8-3-0 Hockey East), whove won 12 of 13 ... Mitchell Chaffee made it a hat trick with an empty-netter in the final seconds for No. 7 UMass (15-7-1, 8-4-1), which dominated host Vermont, 4-0 ... Third-period goals from sophomores Jake Wise and Jack DeBoer gave BU (8-7-5, 5-3-4) a 3-2, come-from-behind win at Merrimack ... No. 16 Harvard (9-5-2, 7-3-1 ECAC) scored three times on the power play, Jack Drury adding an assist in a 3-1 home win over St. Lawrence ... Sophomore Alexis Hills double-double, with 17 points and 16 rebounds, helped lead Northeastern (7-8, 3-1 Colonial Athletic) womens basketball to a 68-65, overtime victory over Elon at Cabot Center.

Two-time Atlantic Coast Conference player of the year Travis Etienne is returning to Clemson for his senior season, the junior running back announced on social media. Etienne was projected as a second-round selection after he gained 1,614 yards and 19 touchdowns this season ... Declaring of quarterback Joe Burrow, we call him young Tom Brady, president Donald Trump feted national champion LSU at the White House, saying the undefeated Tigers would long be remembered as one of the greatest in college football history ... Boston College announced Matt Thurin, an Ohio State defensive quality control coach the last five seasons, as its special teams coordinator under new coach Jeff Hafley. Hafley worked with Thurin on the OSU staff for one year.

Carolina Hurricanes defenseman Dougie Hamilton, a first-time All-Star, had surgery and is out indefinitely after he broke his left leg Thursday, getting tangled with Columbus Kevin Stenlund during a chase for the puck. The 26-year-old has 14 goals and 40 points in 47 games, second and fourth respectively among NHL defensemen ... Former Whitman-Hanson star midfielder Sam Mewis was named among the 20 players that will compete from the United States in the upcoming CONCACAF Olympic qualifying womens soccer tournament. Five of her teammates from the Womens World Cup champions last summer were not, including Alex Morgan, whos expecting her first child, and promising young forward Mallory Pugh. Eighteen of the 20 spots went to players from the World Cup squad, including one to Carli Lloyd, who will turn 38 before the Tokyo Games and was largely a reserve in France. The charges of Vlatko Andonovski, who took over last October after Jill Ellis stepped down, open qualifying on Jan. 28 in Houston against Haiti. The United States has made the field for every Olympic tournament since womens soccer was added to the Games in 1996, and has won four gold medals ... American star Christian Pulisics adductor injury appears likely to keep him out of Chelseas lineup until mid-February. The 21-year-old attacker has not played since New Years Day, and has six goals and six assists in all competitions this season.

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Jayson Tatum, Celtics really bringing in the green at merchandise stand - The Boston Globe

Recommendation and review posted by Bethany Smith

The opioidepidemic imposes scrutiny on clinicians and patients alike; with particularemphasis on cancer survivors who require the drugs to manage their pain. Howdoes the clinician determine who is at risk for persistent opioid use andabuse? A group of radiation oncologists and pain specialists from theUniversity of California San Diego (UCSD) conducted a study to answer thisvital question, and presented their findings at the 2019 American Society forRadiation Oncology (ASTRO) Annual Meeting, held in Chicago.1

More than 50% of oncology patients who receive curative treatmentsuffer from moderate to severe pain that can be relieved by opioids, according toWHO pain guidelines.2 Although these medications are accepted forrelief of such acute pain, their use in situations where patients have chronicpain (lasting for more than 3 to 6 months) is not so well defined. There arerisks of such long-term administration, such as medication tolerance and lossof efficacy over time. The potential of toxicity can lead to conditions such asdepression, difficulty concentrating, and sedation, and the patient may alsodevelop hyperalgesia or hypogonadism. There are also the well-known risks ofdependence, misuse and abuse, and accidental overdose. The authors of thisstudy support adopting the clinical practice guideline of the American Societyof Clinical Oncology (ASCO) when using opioids to achieve optimal pain management,using risk mitigation strategies such as judicious opioid use, drug screening,adherence monitoring, and strategies for alternative pain management.1,3

Creating a Risk Score

The radiation oncologists sought to identify clinical risk factors and create a risk score, utilizing an evidence-based risk stratification approach to identify patients who might benefit from a proactive approach by the oncology nurse or other clinician. Their efforts resulted in the Cancer Opioid Risk Tool, a validated prediction tool for assessing the risk of persistent opioid use 1 to 2 years after treatment, estimating risk aslow (less than 5%), intermediate (5% to 25%) and high (greater than 25%).

The researchers usedthe Veterans Affairs (VA) Informatics and Computing Infrastructure (VINCI)database, which contains detailed electronic health record information on allveterans within the VA health care system. This database provided data on106,732 veteran cancer survivors whose cancer had been diagnosed between 2000and 2015.1

Common diagnosesamong the VA patients were 1 of 12 noncutaneous, nonhematologic malignancies,including cancer of the bladder, breast, colon, esophagus, head and neck,kidney, liver, lung, pancreas, prostate, rectum, or stomach. The study groupincluded patients who were treated with surgery, radiation therapy (RT), orboth and who were alive without disease recurrence 2 years after treatment hadbegun.1

Two models of the Cancer Opioid Risk Tool are available on the website: Full and Lite. Using an automated algorithm, the risk for persistent opioid use is calculated based on data entered by the clinician. The lite model uses 5 variables: age, presence of depression, alcohol abuse, prior opioid use, and whether treatment included chemotherapy. The more complex, full, model uses these 5 variables plus employment status, psychiatric diagnoses, race, tobacco use, body mass index (BMI) category, type of cancer, disease stage, and local treatment. (Note, although improvements to the tool are ongoing, it is totally functional.) The full version is recommended if providers have time and access to all of the relevant information.

This article originally appeared on Oncology Nurse Advisor

The rest is here:
Emerging Clinical Tool Predicts Risk of Persistent Use of Opioids After Treatment in Patients With Cancer - Cancer Therapy Advisor

Recommendation and review posted by Bethany Smith