‘Keep calm and develop vaccines’: Meet the scientists behind the Oxford jab – Telegraph.co.uk
The Oxford team is led by Sarah Gilbert, professor of vaccinology at the universitys Jenner institute. She has hailed thefirst authorisation of use of the vaccine outside clinical trialsas aday for the team developing the vaccine to celebrate, after a year of extremely hard work under difficult circumstances. Although in the same sentence she struck a typically cautionary note: We still have more to do
Even after their vaccine has become just the third in the world to be granted regulatory approval (following the Pfizer/BioNTech and Moderna vaccines), nobody could accuse the Oxford researchers of being swept away in the hype. Indeed Gilbert and others in her team have spoken openly about how little they have enjoyed the constant attention over the past year, preferring instead to focus on their life-saving work.
During that time, lucrative offers for after dinner speaking gigs have started to roll in for Gilbert, which she has rejected in turn. Another key member of the Oxford group, Professor Catherine Green, who heads the universitys clinical biomanufacturing facility, recently described the media attention as awful. Of their new-found fame, she added: Its not something that we got into our careers to do.
The motivations of the Oxford team can instead be neatly surmised by a mug that Gilbert keeps in her office at the Jenner Institute, which says: Keep calm and develop vaccines. It is a mantra that has served her and her colleagues well this year, juggling the exhaustion of constant work with family life.Gilbert, after all, is the mother of 21-year-old triplets (biochemistry students at Oxford and Bath Universities) who took part in the phase 1 clinical trials of the vaccine. Her regime has involved getting up at about 4am each day, cycling to the laboratory and returning home at about 8pm.
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'Keep calm and develop vaccines': Meet the scientists behind the Oxford jab - Telegraph.co.uk
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IAEA Highlights and Achievements in 2020 a Year in Review | IAEA – International Atomic Energy Agency
A new global initiative will use nuclear science to better manage pandemic threats, such as COVID-19.
In February, the IAEA and the Joint United Nations Programme on HIV/AIDS (UNAIDS) pledged to increase collaboration to tackle cervical cancer, especially to help low- and middle- income countries, where 85 per cent of annual cervical cancer deaths occur.
The IAEA and the United Nations Environment Programme (UNEP) joined forces in April to better protect human health and global ecosystems from sustained releases of mercury and its toxic derivative compounds into the environment.
In June, the IAEA launched the Zoonotic Disease Integrated Action (ZODIAC) project, an initiative to support countries inpreventing and quickly responding to future outbreaks of diseases that spread from animals to humans. ZODIAC will expand and make globalthe VETLAB network, through which veterinary labs exchange information, share best practices and support each other.
This year, the Renovation of the Nuclear Applications Laboratories (ReNuAL) project achieved important milestones. In June, Director General Rafael Mariano Grossi opened a state of the art laboratory building named after his late predecessor, Yukiya Amano. The new facility will increase the IAEAs capacity to assist countries to fight and prevent transboundary animal and zoonotic diseases like COVID-19 and to tackle challenges related to climate change and food safety.
In September, Mr Grossi announced to Member States ReNuAL 2, a new effort to tackle the laboratories that have not yet been modernized under the ReNuAL Project. This includes the construction of a new building to house the Plant Breeding and Genetics Laboratory, the Terrestrial Environment Laboratory and the Nuclear Sciences and Instrumentation Laboratory. To achieve ReNuAL 2, the IAEA is calling for the mobilisation of 14.8 million by mid-2021.
The Biological Dosimetry Model Laboratory (BDML) was established at the IAEA Seibersdorf site. A new advanced microscope-based platform capable of identifying and quantifying radiation exposure in people was donated to the IAEA and installed at the BDML.
The IAEA designated three new collaborating centres: in the United Kingdom, Italy and Portugal.
In November, the International Conference on Molecular Imaging and Clinical PET-CT in the Era of Theranostics (IPET-2020)highlighted important clinical aspects and appropriate use of medical imaging in the management of patients with breast, lung, lymphoma, neuroendocrine tumours, paediatric, prostate and thyroid cancers.
To mark the milestone of twenty-five years, 180 analytical experts from around the world shared knowledge and expertise and discussed new ways of expanding the Networks capacity at the annual Coordination Meeting of ALMERA. In addition, the Global Network of Isotopes in Precipitation (GNIP) turned sixty this year.
The IAEA has launched its updated Database on Industrial Irradiation Facilities (DIIF), featuring an interactive map with information on nearly 300 gamma irradiators and electron accelerators from around the world.
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New Year honours 2020: citizens awarded for response to pandemic crisis – The Guardian
Hundreds of key workers and community champions who battled the pandemic have been recognised in the New Year honours list for the UK which celebrates peoples extraordinary response to the Covid-19 crisis.
Lewis Hamilton, the Formula One driver, and the cinematographer Roger Deakins are among the celebrities knighted, while the architect David Chipperfield gets the Companion of Honour. The actor Toby Jones and Jed Mercurio, creator of the TV series Line of Duty, are given OBEs for services to drama. On being made a dame for services to drama the actor Sheila Hancock said she feared she was slightly miscast.
Nina Wadia, who performed in the BBC soap EastEnders, and Sally Dynevor, a stalwart of ITVs Coronation Street series, also received honours an OBE for Wadia, and MBE for Dynevor. The music producer and DJ Craig David is recognised with an MBE.
Among the political figures honoured are Geoffrey Cox, the ToryMP for Torridge and West Devon, who becomes a knight, while Labours Angela Eagle, who became MP for Wallasey in 1992, is made a dame for parliamentary and political service.
But while many of this years 1,239 award recipients have names that few would recognise, none would argue with the decision to honour their sacrifice and commitment in a year that truly tested the resolve and determination of those on the frontline.
Public sector workers, including medics, teachers, local government workers, police officers and firefighters, make up 15% of the list, recognised for making a huge individual impact.
Among the 123 health and social care workers honoured is 62-year-old Cath Fitzsimmons, from Eccles, a former palliative care nurse who came out of retirement when the pandemic struck. She described the struggle with trying to help patients without being able to hug them in the most difficult moments, and learning to smile with her eyes. She gets a BEM (British empire medal). Prof Farah Bhatti, 55, the first female consultant cardiac surgeon in Wales, receives an OBE.
Also honoured are people who have helped NHS staff. They include Emma Henderson, the airline pilotwho co-founded Project Wingman, creating first-class lounges in 80 hospitals for exhausted workers; she receives an MBE.
An OBE goes to 28-year-old Azeem Alam, a doctor, who provides, with a team, free medical education through BiteMedicine; and an MBE goes to deputy director of nursing Jacky Copping, 55, for initiating safety procedures for fitting personal protection equipment (PPE) at the James Paget University hospitals NHS foundation trust.
Recalling the early days of the pandemic, when UK supplies of PPE were low, an OBE has been awarded to Katherine Dawson, founder of the garment business All-in-One Company, for setting up 120 Scrub Hubs to make uniforms. And Manoj Varsani, founder of the property management tool Hammock, was made an MBE for setting up the voluntary organisation SOS Supplies to help provide more PPE.
Scientists also feature in the 2020 list, with Prof Wendy Bickmore, head of the University of Edinburghs MRC Human Genetics Unit, given a CBE, and Prof Wendy Burn, former president of the Royal College of Psychiatrists, getting the same honour for predicting the mental health impact of the pandemic. Phillippa Spencer, senior principal statistician at the Defence Science and Technology laboratory, at Porton Down, is made an OBE for services to defence during the crisis.
Prof David Stuart, a structural biologist at Oxford University, who has spent his career studying the nature of viruses, has been given a knighthood, and forensic psychologist Prof Laurence Alison, director of the Centre for Critical and Major Incident Psychology, at Liverpool University, was made an MBE for his work, which he said he did for the love of doing it and because it provides purpose.
Ocados chief executive, Mel Smith, is made a CBE for services to the food supply chain during the pandemic, and Kate Nicholls, chief executive of industry body UKHospitality, becomes an OBE for speaking up for the embattled hospitality industry.
Community champions feature heavily in the 2020 honours list, some with extraordinary stories. Nadeem Sadiq Khan, a 40-year-old housing adviser for the charity Shelter is given a BEM, after continuing to help homeless people using his laptop on a Lahore rooftop after being unable to return to the UK after visiting Pakistan early in March.
Mark Owen, 57, a retired police officer from Llanynys, Clwyd, is given an MBE for coming out of retirement to lead the volunteer response to Covid-19 across north Wales.
Caroline Halfhide, 51, from Ash, Somerset, receives an MBE for changing her pub in to a village shop, while Jennifer Sims, 76, receives a BEM for providing hot meals and free bags of food to vulnerable people during the pandemic.
Women represent 49% of the total honours, while 14.2% come from a BAME background; 6.9% have a disability and 4% identify as being LGBT.
Among the diversity champions is Karen McDowell, 46, station commander at Northern Ireland Fire & Rescue Service, given an MBE for, among other work, building support networks for employees transitioning their gender. And Khakan Munir Qureshi, a senior independent living officer for Midland Heart, is given an MBE for services to LGBT equality.
Organisers said there were no plans to remove the words British empire from the honours system, despite critics saying that it glorified Britains colonial past and that there are increasing number of recipients choosing to turn down the honour.
Both old and young are recognised in the 2020 honours list. The eldest is Anne Baker, 106, from Salisbury, Wiltshire, who receives an MBE for fundraising for the NSPCC. And 104-year-old Ruth Saunders gets an MBE for walking a marathon to raise money for Thames Valley Air Ambulance.
At the younger end of the age scale, 20-year-old Samah Khalil, the youth mayor for Oldham, receives a BEM for working to empower young people.
Boris Johnson said the outstanding efforts of those who had received honours was a a welcome reminder of the strength of human spirit, and of what can be achieved through courage and compassion.
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New Year honours 2020: citizens awarded for response to pandemic crisis - The Guardian
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St. Paul authors Fossil Men is a tale of discovery thats anything but old and dry – TwinCities.com-Pioneer Press
In Ethiopias hot Afar region, Kermit Pattison watched with amazement as a fossil hunter spotted a quarter of a tooth the size of a pea in the middle of a dry field with little vegetation.
I dont know how he recognized it as a tooth, Pattison said. Finding this stuff on the ground takes a lot of skill. I followed these guys when we were walking and tried to see things on the ground. I turned out to be really bad at it. Some are really, really good. You dont just find a nice skeleton.
A nice skeleton, a very old one, was the reason Pattison lived with a fossil-hunting team in Ethiopia for several weeks in 2013 and 2016.
Pattison, a former Pioneer Press reporter who lives in St. Paul, was researching his first book, Fossil Men: The Quest for the Oldest Skeleton and the Origins of Humankind (Morrow, $32.50).
The story begins in 1994, in a valley near the Awash river, when an Ethiopian graduate student named Yohannes Haile-Selassie found a tiny bone that is located below the pointer finger. It was the first of 110 pieces of a 4.4 million-year-old female skeleton the Middle Awash team of fossil hunters classified as Ardipithecus ramidus, nicknamed Ardi.
Ardi was 1.2 million years older than Lucy, the famous skeleton found in 1974 by Donald Johanson in Ethiopia, making her the oldest skeleton of a human ancestor found up to that time. (Pattison points out that Ardi is no longer the oldest species in the human family but she remains the oldest skeleton. There are now three older named species, but theyre represented by only fragmentary fossils.)
When Ardi was finally introduced to the public in 2009, she rocked the world of those who study human evolution. Pattison calls her an inconvenient woman.
Ardi had parts that were missing from Lucys skeleton. Hers was a time in human history that was entirely blank and she filled that gap, Pattison said. What made Ardi unique is that her anatomy had a weird hodge-podge of features never before seen in that combination. She was a transitional creature, climbing with grasping feet but walking upright in a weird way. This combination of arboreal and bipedal features had never been seen before.
As the discovery team later reported, Ardi was so rife with anatomical surprises that no one could have imagined it without direct fossil evidence.
Fossil Men is not only about old bones. Its a fascinating and sometimes exciting story thats praised by critics in national publications, which makes Pattison happy because he had no idea if his book would get any attention. Kirkus Reviews gave the book a starred review and Science News picked it for the list of favorite books of 2020. The New York Times said: Despite ample opportunity, Fossil Men never devolves into gonzo journalism. This is a function of Pattisons uncanny ability to write evocatively about science. In this, he is every bit as good as the best scientist-writers. He describes the intricacies of the human wrist and foot with the skill of a poet. He breezes through the biomechanics of how chimps clamber and humans walk. The Christian Science Monitor was enthusiastic, saying that In his recounting of the characters and science involved in Ardis discovery and the controversies that followed it, Pattison reveals the imperfect, all-too-human nature of science itself.(weaving) the multiple intrigues of science, politics, and personalities into a masterly structured tale.
This is not the book Pattison set out to write. He certainly didnt expect to spend eight years researching and writing it. But everything about Ardis story grabbed his journalistic instincts.
I was going to write a tidy little book about the evolution of human locomotion with a bit of background, he recalls. The more I learned, the more intrigued I got. First, Ardi led to a lot of revelations that undermined conventional wisdom of where we came from that disturbed the world of science. Then there was the sheer drama of the search and discovery of this skeleton, a story that was still mostly untold. There was the teams difficulty working in the field during a civil war, and tribal conflicts in which people were literally being killed. That was eye-opening. It made me realize there was a lot more behind the science. So was the academic politics a revelation. I realized I should abandon the original idea and focus on Ardis story.
Pattison ended up with a 420-page hardcover with a text complemented by maps, photos, drawings of skeletal parts and skeletons, and timelines. He combines the history of theories of when humans split from our ape relatives, explanations of which bones are important to researchers and why (with Ardi it was hands and feet), how the fossil hunters searched for tiny bone fragments in the desert where it can hit 100 degrees. Then there are the rivalries between these scientists with big egos. They argued about the meaning of the bones, which teams would get funded by the National Science Foundation, and who would be given access to fossil-rich turf controlled by the constantly changing attitudes of the Ethiopian government.
Pattisons biggest challenge was understanding science well enough to converse intelligently with the scientists, which meant he had to spend years learning about the disciplines of (take a breath): anthropology, paleoanthropology, paleontology, anatomy, osteology (study of the structure and function of the skeleton and bony structures), genetics, taxonomy, geology, stratigraphy (branch of geology concerned with the structure of a particular set of strata), primatology, and archeology.
After he absorbed all that knowledge, Pattison says he had to disengage and write in a way that an intelligent lay person could read and comprehend. I had to span two worlds; making it a faithful look at science through a lens accessible to everyday readers.
Many of his questions were answered by paleoanthropologist Tim White, one of the prominent characters in the book. An internationally-known fossil hunter, White gave Pattison permission to visit the teams digs after getting approval from his three Ethiopian co-leaders. When Pattison began his research, White didnt even want to meet with him. But like a good reporter, Pattison persisted until they finally got together in Whites office at the University of California, Berkeley. Pattison describes White as having a reputation for a razor intellect, hair-trigger bullshit detector, short temper, long list of discoveries and longer list of enemies.
Pattison says his good relationship with White and other scientists happened gradually: I engaged them about science and they realized I was seriously interested in all the things they were interested in and had devoted their careers to. I sort of trickled into their lives a little at a time, like water under a door. And I was still there years later, asking questions, which I think surprised them.
Anyone who thinks bones are boring will be surprised at the people Pattison met along the way, including Afar tribesmen.
That was one aspect of the story I found fascinating, Pattison says. There was the Afar warrior Elema, who at first threatened the team because he wanted to show who was boss, then joined them as one of their most-trusted field workers. He was still there when Pattison visited 20 years later. And Gadi, a feared hunchback known as Zipperman because he was draped with zippers taken off the clothing of his victims. He, too, became a friend and protector of the team.
Pattison dedicated his book to his keen-eyed editor and wife, Maja Beckstrom, a former Pioneer Press reporter working as an associate producer at Minnesota Public Radio. Beckstrom pulled him back when he got too jargony and pointed out things that werent clear. The couple lives in the St. Anthony Park neighborhood with sons, Eli and Alistair, and daughter, Siri.
Pattison admits its a little surreal to finally have his book out in the world. You work on it for so long in isolation, nobody really knows what you are doing, he jokes. It took so many years, people wonder, Does this guy really have a job?
Fossil Men ends at the Ethiopian National Museum, Ardis final resting place. The museum stores so many unexamined fossils it will take years for scientists in many disciplines to pry out the meaning of all the bones.
Ardi, the strange creature who stood four feet high, is only another chapter in the ongoing search for human origins.
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St. Paul authors Fossil Men is a tale of discovery thats anything but old and dry - TwinCities.com-Pioneer Press
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World Alopecia Market Segmentation & Impact Analysis, by Gender, Application and Region – Featuring Profiles of Key Players Cipla Inc, Johnson AG,…
DUBLIN, Dec. 29, 2020 /PRNewswire/ -- The "Alopecia Market Share, Growth & Analysis, By Disease, By Application, By Sales Distribution, By Gender And Segment Forecasts, 2016-2026" report has been added to ResearchAndMarkets.com's offering.
The growing prevalence of diseases that trigger alopecia, such as hyperthyroidism, hypopituitarism, lupus, acute stress disorder, and diabetes, are stimulating market growth.
Market Size - USD 9.08 billion in 2019, Market Growth - CAGR of 5.1%, Market Trends - Growing focus on aesthetic appearance and rise in disposable incomes.
The Global Alopecia Market size is expected to reach 13.65 Billion from USD 9.08 Billion in 2019, delivering a CAGR of 5.1% through 2027. The market growth is driven by the growing prevalence of chronic disorders, such as celiac disease, hypothyroidism, hyperthyroidism, Hodgkin's disease, acute stress disorder, hypopituitarism, Hashimoto's disease, lupus, diabetes, Addison's disease, and others, which trigger alopecia in patients.
Changing lifestyle habits, such as overconsumption of alcohol and tobacco and growing stress levels, are resulting in an increased number of alopecia cases globally. Increasing focus on physical appearance and rising disposable incomes are favoring industry growth.
The increasing prevalence of oral treatments, licensed topical treatments, such as minoxidil, finasteride, and surgical procedures, such as hair transplantation or replacement, is expected to boost alopecia market growth over the forecast period.
Further key findings from the report suggest
The growing prevalence of alopecia areata on account of the rising incidences of autoimmune diseases among the populace, including diabetes, Down's syndrome, hyperthyroidism, and others, is driving alopecia market growth.
Growing focus on the aesthetic appeal and physical appearance among individuals is the key factor contributing significantly to the alopecia market revenue share.
The growing popularity of laser treatments as a common non-invasive approach for alopecia is likely to boost the growth of the androgenetic segment.
On the basis of disease type, the alopecia areata segment accounted for around 39.30% of the alopecia market share in 2019.
Based on application, the dermatology clinics segment contributed a revenue share close to USD 4.69 billion in 2019 and is estimated to gain major traction over the analysis period. The growth can be attributed to effective and suitable medication or therapy prescribed by dermatologists for positive results.
In the regional landscape, the Asia Pacific region is estimated to exhibit the fastest growth rate of 5.4% through 2027 on account of a vast population suffering from alopecia along with growing awareness among patients regarding the available therapeutic options in the region.
The rise in economic development, coupled with increasing per capita healthcare spending in emerging countries such as China, Singapore, and India, is anticipated to offer major opportunities for the alopecia market.
North America region accounted for around 22.30% of the alopecia market share in 2019 and is forecast to grow significantly through 2027 on account of the increasing consumer disposable incomes, rise in the introduction of new drugs, and the complementary initiatives taken by relevant organizations like NAAF and AHLA in the region.
Prominent players in the global alopecia market are Cipla Inc., Transitions Hair Pty Ltd., Johnson and Johnson AG, Sun Pharmaceutical Industries Ltd., Cirrus Hair Centers, Merck & Co., Inc., Lexington International LLC, Follica, Inc., Capillus, and Vita-Cos-Med Klett-Loch GmbH, among others.
Key report features:
Story continues
A robust analysis and estimation of the Alopecia Market with four levels of quality check - in-house database, expert interviews, governmental regulation, and a forecast specifically done through time series analysis
A holistic competitive landscape of the all the major players in the Alopecia market. The report covers their market shares, strategic initiatives, new product launches, R&D expenditure, M&As, Joint ventures, expansionary plans, product wise metric space analysis and key developments
Go-to-market strategies specifically formulated in line with location analysis which takes into the factors such as government regulations, supplier mapping, supply chain obstacles, and feedback from local vendors
Most deep dive segmental bifurcation available currently in the market. Our stellar methodology helps us understand the overall gamut of the supply chain and will help you explain the current market dynamics
Special focus given on vendor landscape, supplier portfolio, customer mapping, production capacity, and yearly capacity utilization
Key Topics Covered:
Chapter 1. Market Synopsis
Chapter 2. Executive Summary
Chapter 3. Indicative Metrics
Chapter 4. Alopecia Market Segmentation & Impact Analysis
Chapter 5. Alopecia Market By Disease Insights & Trends
Chapter 6. Alopecia Market By Sales distribution Insights & Trends
Chapter 7. Alopecia Market By Gender Insights & Trends
Chapter 8. Alopecia Market By Application Insights & Trends
Chapter 9. Alopecia Market Regional Outlook
Chapter 10. Competitive Landscape
Chapter 11. Company Profiles
Cipla Inc.
Johnson AG
Transitions Hair Pty Ltd.
Sun Pharmaceutical Industries Ltd.
Merck & Co. Inc.
Cirrus Hair Centers
Lexington International LLC
Vita-Cos-Med Klett-Loch GmbH
Follica Inc.
Capillus.
For more information about this report visit https://www.researchandmarkets.com/r/17nnqu
About ResearchAndMarkets.comResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.
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SOURCE Research and Markets
Recommendation and review posted by Bethany Smith
Vape Flavorings Are Cardiotoxic and Can Damage the Heart – SciTechDaily
The vape flavorings so popular with kids and young adults are cardiotoxic and disrupt the hearts normal electrical activity, a University of South Florida Health preclinical study finds.
The appealing array of fruit and candy flavors that entice millions of young people take up vaping can harm their hearts, a preclinical study by University of South Florida Health (USF Health) researchers found.
Mounting studies indicate that the nicotine and other chemicals delivered by vaping, while generally less toxic than conventional cigarettes, can damage the lungs and heart. But so far there has been no clear understanding about what happens when the vaporized flavoring molecules in flavored vaping products, after being inhaled, enter the bloodstream and reach the heart, said the studys principal investigator Sami Noujaim, PhD, an associate professor of molecular pharmacology and physiology at the USF Health Morsani College of Medicine.
In their study published on November 20, 2020, in the American Journal of Physiology- Heart and Circulatory Physiology, Dr. Noujaim and colleagues report on a series of experiments assessing the toxicity of vape flavorings in cardiac cells and in young mice.
The flavored electronic nicotine delivery systems widely popular among teens and young adults are not harm-free, Dr. Noujaim said. Altogether, our findings in the cells and mice indicate that vaping does interfere with the normal functioning of the heart and can potentially lead to cardiac rhythm disturbances.
Dr. Noujaims laboratory is among the first beginning to investigate the potential cardiotoxic effects of the many flavoring chemicals added to the e-liquids in electronic nicotine delivery systems, or ENDS. He recently received a five-year, $2.2-million grant from the NIHs National Institute of Environmental Health Sciences to carry out this laboratory research. Commonly called e-cigarettes, ENDS include different products such as vape pens, mods, and pods.
Sami Noujaim, PhD, associate professor of molecular pharmacology and physiology at the University of South Florida Health (USF Health) Morsani College of Medicine, has begun investigating preclinically the potential cardiotoxic effects of many flavoring chemicals added to the e-liquids in electronic nicotine delivery systems. Credit: Photo courtesy of USF Health
Vaping involves inhaling an aerosol created by heating an e-liquid containing nicotine, solvents such as propylene glycol and vegetable glycerin, and flavorings. The vaping devices battery-powered heat converts this e-liquid into a smoke-like aerosolized mixture (e-vapor). Manufacturers tout e-cigarettes as a tool to help quit smoking, but evidence of their effectiveness for smoking cessation is limited, and they are not FDA approved for this use. E-cigarettes contain the same highly addictive nicotine found in tobacco products, yet many teens and young adults assume they are safe.
Among the USF Health study key findings:
Whether the mouse findings will translate to people is unknown. Dr. Noujaim emphasizes that more preclinical and human studies are needed to further determine the safety profile of flavored ENDS and their long-term health effects.
A partial government ban on flavored e-cigarettes aimed at stopping young people from vaping focused on enforcement against flavored e-cigarettes with pre-filled cartridges, like those produced by industry leader JUUL. However, teens quickly switched to newer disposable e-cigarettes still sold in a staggering assortment of youth-appealing fruity and dessert-like flavors.
Our research matters because regulation of the vaping industry is a work in progress, Dr. Noujaim said. The FDA needs input from the scientific community about all the possible risks of vaping in order to effectively regulate electronic nicotine delivery systems and protect the publics health. At USF Health, in particular, we will continue to examine how vaping may adversely affect cardiac health.
In 2020, 3.6 million U.S. youths still used e-cigarettes, and among current users, more than eight in 10 reported using flavored varieties, according to the Centers for Disease Control and Prevention.
Reference: In Vitro and In Vivo Cardiac Toxicity of Flavored Electronic Nicotine Delivery Systems by Obada Abou-Assali, Mengmeng Chang, Bojjibabu Chidipi, Jose L. Martinez-de-Juan, Michelle Reiser, Manasa Kanithi, Ravi Soni, Thomas Vincent McDonald, Bengt Herweg, Javier Saiz, Laurent Calcul and Sami F. Noujaim, 20 November 2020, American Journal of Physiology-Heart and Circulatory Physiology.DOI: 10.1152/ajpheart.00283.2020
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Vape Flavorings Are Cardiotoxic and Can Damage the Heart - SciTechDaily
Recommendation and review posted by Bethany Smith
Equinor stakes NOK 3 billion to improve Statfjord Ost oil recovery – WorldOil
12/22/2020
Statfjord st
Equinor and its license partners have decided to invest NOK 3 billion in the North Sea Statfjord st field to improve recovery by 23 million barrels of oil equivalent.
Written notification of material changes to the Plan for Development and Operation Statfjord st was submitted to the Ministry of Petroleum and Energy 16.12.2020.
The decision to improve recovery on Statfjord st will add considerable value to society and owners and will create positive effects for suppliers. Our ambition is to maintain safe and profitable production and secure valuable activity from the Norwegian continental shelf (NCS) for several decades, says Kjetil Hove, Equinors senior vice president for Field Life eXtension (FLX).
Statfjord st is tied back to the Statfjord C platform by pipelines. A total of four new wells will be drilled from existing subsea templates. The project also includes modifications on Statfjord C and a new pipeline for gas lift.
We will be a leading late life operator on the NCS. In order to achieve this, we must work in new ways to reduce costs, thereby offering new opportunities for investments in late life fields ensuring profitable reservoir management. The Statfjord st decision is a good example of this, says Hove.
This decision enables an improvement of the recovery factor on Statfjord st and gives an important contribution to extending the life of the Statfjord C platform and the Statfjord st field towards 2040.
The original oil volume in place on Statfjord st was 415 million barrels of oil. The current recovery factor is 56 percent. As a result of this project, the expected recovery factor is increased to 62 percent.
Plans call for installation of a pipeline for gas lift, modifications on Statfjord C and drilling of new wells in 2022 - 2024. Production start is scheduled for 2024.
The Statfjord st development comprises subsea installations that include three templates. The field is located five kilometres north-east of Statfjord C. The field came on stream in 1994.
The licence partners in Statfjord st Unit: Equinor Energy AS (31.6875%), Petoro AS (30.0000%), Vr Energi AS (20.5500%), Spirit Energy Norway AS (11.5625%), Idemitsu Petroleum Norge AS (4.8000%), Wintershall Dea Norge AS (1.4000%).
After several extensions of the Statfjord field life, the current goal is to maintain safe and profitable operation until 2040. Statfjord is part of FLX, which was established to meet the strategic opportunities and challenges of late life fields in relation to Equinors competitiveness.
FLX aims to ensure that Equinor is the leading company in safe and efficient operations with low carbon emissions from late life fields on the NCS.
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Equinor stakes NOK 3 billion to improve Statfjord Ost oil recovery - WorldOil
Recommendation and review posted by Bethany Smith
Antibody study aims to protect those exposed to coronavirus from illness – The Jerusalem Post
Two new clinical trials in the UK are examining whether administering an antibody combination after someone has already been exposed to the novel coronavirus could protect them from developing COVID-19, the disease caused by the virus.
The University College London Hospitals (UCLH) NHS Trust announced on Friday that it is running the trials at a new vaccine research center.
Both trials are examining AZD7442, a long-acting antibody (LAAB) combination developed by AstraZeneca.
The first study, called STORM CHASER, is examining whether the antibody can provide immediate and long-term protection to people recently exposed to the SARS-CoV-2 virus.
We know that this antibody combination can neutralize the virus, so we hope to find that giving this treatment via injection can lead to immediate protection against the development of COVID-19 in people who have been exposed when it would be too late to offer a vaccine, said study leader UCLH virologist Dr. Catherine Houlihan in a press release from the hospital.
STORM CHASER had recruited 10 people as of Friday. Key participants will include healthcare workers, students in group housing, patients exposed to anyone with the virus, residents of long-term care facilities and those in industrial or military settings.
THE SECOND study, called PROVENT, is examining whether people who may not respond to the vaccine, including immuno-compromised people, or at-risk groups, such as the elderly or those with preexisting conditions, may be helped by AZD7442, even prior to exposure.
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We will be recruiting people who are older or in long-term care, and who have conditions such as cancer and HIV, which may affect the ability of their immune system to respond to a vaccine," said UCLH infectious diseases consultant Dr. Nicky Longley, the head of the study. "We want to reassure anyone for whom a vaccine may not work that we can offer an alternative, which is just as protective.
Both UCLH studies will examine whether AZD7442 reduces the risk of developing COVID-19 and/or reduces the severity of the infection compared to a placebo.
Trial participants will be able to safely leave the study in order to get licensed vaccines if it is deemed medically beneficial, according to UCLH.
Antibodies are produced by the body to help fight infections. Monoclonal antibodies are artificially produced in laboratories for possible medical treatments in patients already infected with the virus and could provide protection before exposure as well.
While vaccines train the body over a matter of weeks to produce its own antibodies, antibody injections skip that step, aiming to provide immediate protection against viruses.
AZD7442 is a combination of two LAABs derived from recovering patients that were discovered by Vanderbilt University Medical Center and then licensed to AstraZeneca, according to the company, which then optimized the LAABs with half-life extension in order to increase the durability of the therapy for six to 12 months. The combination is also designed to reduce the risk of resistance developed by the virus.
In pre-clinical experiments published in Nature, the LAABs in AZD7442 were shown to block the novel coronavirus from binding with host cells, protecting against infection.
UCLH'S NEW Vaccine Research Center, which opened in December, is operating under the patronage of the National Institute of Health Research (NIHR) UCLH Biomedical Research Center and the UCLH Research Directorate, and represents an extension of the NIHR UCLH Clinical Research Facility led by Prof. Vincenzo Libri.
Libri is also a principal investigator on the Oxford/AstraZeneca vaccine trial and provides oversight of all COVID-19 vaccine/preventative treatment trials.
Mene Pangalos, AstraZeneca's executive vice president of BioPharmaceuticals Research & Development, stated in the UCLH release that AZD7442 has the potential to be an important preventative and therapeutic medicine against COVID-19, focusing on the most vulnerable patients."
"The STORM CHASER trial in particular is a unique approach, with enrollment initiated on site following the identification of a confirmed case to halt the spread of COVID-19 in the facility or community," Pangalos said. "We offer our appreciation and gratitude to everyone involved in these trials from the scientists, researchers and clinicians, to the trial participants and study sites as we all work together to help end this pandemic.
Antibody treatments have been evaluated since nearly the beginning of the pandemic.
In May, the Israel Institute for Biological Research (IIBR) completed a groundbreaking scientific development, identifying an antibody that neutralizes the coronavirus.
Maayan Jaffe-Hoffman, Anna Ahronheim and Idan Zonshine contributed to this report.
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Antibody study aims to protect those exposed to coronavirus from illness - The Jerusalem Post
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Five Persistent Misconceptions About Modernizing The US ICBM Force – Forbes
Unarmed Minuteman III ICBM Test Launch 2020
Since the 1960s, the nuclear triad has served as the bedrock of American national security. The triad represents nuclear deterrence in-depth for the nation: intercontinental ballistic missiles, nuclear-equipped bomber aircraft and sea-launched ballistic missiles. Yet, over the last 30 years, U.S. nuclear modernization programs were truncated, deferred, or outright canceled in favor of other priorities. Now, having put off modernization for decades, nearly every part of our nuclear triad is serving well beyond its original service life.
That might be bad enough, but the circumstances today are dire. Russia is pursuing multiple nuclear weapon modernization programs. China is developing its own nuclear triad. And North Korea and Iran continue to pursue their own destabilizing nuclear programs. The U.S. must stop any further delays in modernizing our geriatric nuclear forces in order to maintain a credible nuclear deterrent strategy in the face of these threats.
The good news is that senior U.S. military leaders and civilian defense officials have grown more forceful in recent years in designating nuclear force modernization a top priority. As Lieutenant General Frank Klotz, USAF (Ret.), former Under Secretary of Energy for Nuclear Security and former Commander of Air Force Global Strike Command, recently remarked: It's time to bite the bullet and to finally stop admiring the problem and start solving the problem.
The bad news is the same cast of critics that argued against modernization in the past are now using the upcoming change in administration to rehash the need to modernize Americas nuclear enterprise. The focus of much of their criticism is the Ground Based Strategic Deterrent (GBSD) program, which will recapitalize the Minuteman III missile force that was first fielded 50 years ago. As in the past, their arguments gravitate around five key misconceptions about ICBMs that merit correction.
Misconception No. 1: A land-based ICBM force is superfluous since a dyad of nuclear-capable bombers and ballistic missile-launching submarines are sufficient for deterrence.
Arguments based on this misconception overlook the fact that a land-based ICBM force has unique attributes that significantly strengthen nuclear deterrence. As Admiral Charles Richard, Commander of U.S. Strategic Command (USSTRATCOM) put it, If you take away the ICBM leg, in fact, if you take away any leg, you just took away a stack of attributes that we have found useful in the past and see being useful in the future which means you just narrowed the range of situations that we were able to effectively deter.
An important characteristic that the other two legs of the triad do not provide is that the ICBM force is widely dispersed across a huge swath of the country and as a result establishes a very highand likely prohibitivethreshold for an adversary to launch a nuclear attack against the U.S. homeland. A preemptive, counterforce strike against the U.S. ICBM force requires an enemy to attack 495 hardened and dispersed ICBM facilities450 silos and 45 launch control centers spread across five states. To strike those with a moderate to a high degree of confidence, an adversary would have to launch 900 to 1,000 nuclear warheads.
This would be a massive and unambiguous nuclear ballistic missile attack guaranteeing an overwhelming U.S. response from the other two legs of the triadAir Force bombers and Navy submarines. This reality significantly complicatesand detersa potential aggressors attack.
As Admiral Richard points out: We have a triadin part because of the flexibility it provides, the ability to hedge inside of itwhat it also enables you to do is address the threat or the risks you didn't see coming. We always built margin into our strategic forces to make sure that we could account for the unknown risks that may be out there alongside the risk that we could reasonably see.
Misconception No. 2: ICBMs are inherently destabilizing because they increase the risk of our possibly stumbling into a nuclear war.
Do ICBMs significantly increase the risk of a mistaken or accidental launch in comparison to the other two legs of the triad? No. As noted above, unlike an enemy's targeting of the other legs of our triad, neutralizing our ICBM force would require a massive and unambiguous nuclear strike on the U.S. homeland. Furthermore, the United States maintains an overlapping network of multi-domain, multi-phenomenology sensors that jointly validate indications of a hostile missile launch to ensure that timely missile attack warning and assessment information is not susceptible to a single point of failure. Additional political-military levels of scrutiny and confirmation are also in place to prevent misidentification.
A U.S. ICBM launch can only occur after an essential series of extremely deliberate, disciplined and cooperative actions are undertaken in proper sequence by many personnel ranging from the National Command Authority to individual ICBM launch crews. As retired Gen. Kevin Chilton, former Commander of USSTRATCOM, explains, People who describe our ICBMs as being on hair-trigger alert either do not know what they are talking about or are intentionally attempting to frighten the uninformed.
Misconception No. 3: Extending the Minuteman III's service life would be more cost-effective.
The most common argument voiced by critics against the GBSD program is that it would cost less to extend the current ICBM force through a service life extension program (SLEP) that would give the Minuteman IIIs propellant stages new fuel cores, modernize its guidance systems, and upgrade is ground support facilities.
Yet the U.S. Air Forces analysis of alternatives conducted in 2014 determined that the total lifecycle cost of the Minuteman III force, including the SLEP, would exceed the cost to procure and sustain the GBSD over its projected 60-year service life. Critics took issue with the Air Forces methodology because it included the cost of building new replacement missiles as part of its cost estimate. However, doing so was sensible because of the four to five live-fire tests conducted annually to ensure the missiles remain viable and safe. Considering this test rate, the refurbished Minuteman III missile inventory would fall below the Department of Defense (DOD) required force of 400 operationally deployed ICBMs by the year 2040. By contrast, the GBSD missile inventory would remain above 400 through 2075. Hence, new Minuteman III missiles had to be included in any honest cost assessment.
Most importantly, the U.S. needs a viable threat to be effective. As General Chilton has pointed out, for deterrence to be effective both capability and the will to use it must be made believable in the mind of the adversary. The 1970s-era Minuteman IIIs were not designed for todays operating environments that now include electronic warfare, cybernetic countermeasures, and advanced missile interceptor threats. A retaliatory weaponwhether nuclear or conventional, ballistic or otherwisemust be able to reach its designated target to be a credible, effective deterrent. If it cannot, it is useless.
Further Minuteman III life extension is not cost-effective nor will it provide a weapon system capable of adapting to advancing technology and changing adversary threats, said then-Commander of USSTRATCOM, Gen. John Hyten in testimony before the House Armed Services Strategic Forces Subcommittee in 2019. Only GBSD is the right choice because it would answer current and expected threats and cost about the same as extending the life of the Minuteman III.
Misconception No. 4: There is no rush for a Minuteman III replacement.
It is foolhardy to believe there is no urgency to this requirement. The GBSD is literally a just-in-time replacement for the Minuteman III; there is no margin remaining for further delay.
Elements of the guidance system, solid rocket motor, and propulsion system rocket engine in the current Minuteman III inventory cannot be refurbished nor easily replaced. As a result, the U.S. may not be able to support the required ICBM force of 400 operationally deployed missiles very far beyond 2030. Delaying the GBSD by just a couple of years would force the Air Force to develop, manufacture, test, and certify replacements for some critical Minuteman III components resulting in new costs estimated between $6 billion to $8 billion.
Alternatively, the Air Force could simply accept an ICBM inventory shortfall or keep existing Minuteman III missiles beyond their expiration date or by bridging the gap by means of a heavier reliance on the airborne and submarine legs of the triad. All of these options increase risks to the security of the nation. The former option increases the probability of failure during launch and the latter would require placing a number of bombers on nuclear alert status, incurring significant financial and opportunity costs, since missiles are less costly to maintain and assigning more bombers to the nuclear alert mission means they are no longer available for other critical missions.
Adding risk, raising costs, and reducing reliability do not improve national security.
Misconception No. 5: The GBSD award was non-competitive.
Some critics have faulted the GBSD acquisition process, arguing that because Northrop Grumman NOC was the only company to ultimately bid for the contract, the government went into negotiations in a weak position.
This is incorrect. The GBSD acquisition process was competitive. Although the Air Force received only one final proposal, Boeing BA had every opportunity to compete. Controversy over this issue is rooted in the fact that both Boeing and Northrop selected Orbital ATK to produce the solid rocket motors for their GBSD designs. When Northrop acquired Orbital ATK in 2018, Boeing notified the Air Force it would not respond to its request for proposal. The Air Force was willing to modify its GBSD competition process, but when no mutually satisfactory agreement could be reached, it chose not to delay the program further.
Northrop, meanwhile, could not be sure Boeing would not come through with a competitive bid at the last moment and had to make a competitive offer. And because only one company bid, standard government audit procedures took effect to ensure pricing was fair. Single-bid contract awards are not that unusual: About 15 percent of all DOD competitive acquisitions have just a single bidder.
The deterrent power of Americas nuclear triad is the foundation of our national defense. Preserving it is essential to securing our future.
Should we, as a nation, fail to modernize the ICBM force in a timely manner with GBSD, we would be choosing to diminish our national security and nuclear deterrence posture at the very moment when the international security environment is growing more dangerous, when Russia and China are growing more aggressive and assertive and when rogue powers are investing heavily to acquire nuclear arms.
When the Minuteman III entered service, I was in seventh grade. I am now 61, Gen. John Hyten, now Vice Chairman of the Joint Chiefs of Staff, noted recently. It must be replaced...and we must continue to invest substantially to ensure that all three legs of the nuclear triad stand strong.
Awarding the GBSD contract was a crucial milestone toward modernizing the missile force, Hyten added. Given the critical role the GBSD will play in deterring China and Russia, we can't rest until we deliver this capability to the field.
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Five Persistent Misconceptions About Modernizing The US ICBM Force - Forbes
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I’m a doctor who tried to plan an extremely safe Thanksgiving for 3 people. It wasn’t worth the scare it put u – Business Insider India
I'm a physician in Boston, and I've been obsessed with the coronavirus pandemic since the first stories trickled out of China into my consciousness. Every day I listen to podcasts and medical lectures by a long line of virologists, epidemiologists, and infectious-disease doctors. Every week, I write an essay for my friends and family in my area about what we've learned about COVID-19 and how to protect ourselves.
My sons - Mackenzie, 24, and Cooper, 21 - live nearby and have been what I call "COVID-conscious" since the start. Both kids work and study from their apartments, have small friend pods, have excellent COVID-19 hygiene, particularly with me and anyone who falls into a high-risk group, and both had stayed mostly bubbled at home the previous two weeks.
In fact, we were masked except when actively putting food in our mouths, pulling our masks back up into place between servings and when chatting during the meal.
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But then on Saturday morning, while I was walking with a friend, Kenzie texted me saying, "Sooooo, I have bad news." Half a minute later he sent a second text that read, "I feel horrible."
Read more: COVID-19 threatens to create a 'lockdown generation' in Europe: Here's why young people could be the ones paying for yet another crisis
All I could think was, "Why, why, why didn't we just skip Thanksgiving this year? And now it's too late to stop whatever tsunami is coming our way."
This is exactly how COVID-19 spreads: A person, like my beloved son, can have it, be contagious, but have no symptoms at all, not a single clue, for several days before getting sick.
This is why we were so meticulously careful about our Thanksgiving. We knew it was possible one of us could be that asymptomatic contagious person - not likely, not even probable. Kenzie has five friends in his bubble. All had been tested the week before for travel and were negative. All have been tested since and stayed negative, and all were asymptomatic. He had shopped, carefully, at only a couple of large stores.
And as it turned out, the precautions we did have in place worked. Cooper and I are COVID-19 negative. And Kenzie had a rough week but is getting better. We're all getting better.
Was it worth it to have Kenzie feel immense guilt about potentially exposing us? Was it worth the discomfort of having to tell his contacts they needed to be tested and then go into 10 days of quarantine?
And Christmas in 2020?
No possible way. Not a bit. Not a chance.
This story originally appeared on Schoenthaler's Facebook page and on The Boston Globe website. It has been republished with permission.
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Tips for staying healthy and managing stress over the holidays – WYDaily
Feeling stressed out around the holidays? These tips might help. (WYDaily/ Courtesy of Unsplash)
As we head into the holidays, W&M News spoke with Dr. Elizabeth De Falcon to learn about ways relieve stress and practice self-care over winter break, to strengthen our collective immune systems. Dr. De Falcon is a practicing physician with William & Marys Health Services. She is a licensed pediatrician and Fellow of the American Academy of Pediatrics.
In the simplest terms, stress is just your bodys reaction to any change that requires response. So, it could be anything: a mental strain, a physical strain or even an emotional strain. Honestly, its different for every person. What stresses me out may not stress you out, but if were talking about physiology, then our stress response would be mostly the same.
Without going into the specific names of all the different parts of your brain, its just that your brain perceives stress or danger or threat. Then it sends out a signal from what is essentially the command center of your brain to the rest of your body, through the nervous system. Then the nervous system starts acting on a fight or flight response and all these different neurotransmitters and hormones get released. All these different substances start flowing through your body just to get you prepared to respond to that stressor.
A lot of times, youre not even aware of it. Most of the time the threat comes and goes, and as the threat goes away, the stress response decreases. Think of a car whizzing past you on the street. Its stressful for a second, but the feeling is very short-lived. Its important to understand that not all stress is bad. It serves an important biological purpose. The stress response has been vital to our survival and evolution. When the saber-toothed tigers were hunting us down, our bodies learned how to respond to that.
If you translate that to now, lets say youre taking a test and you feel a little bit stressed. Youre supposed to have a certain level of stress, because its your bodys way of motivating you to focus on something important. After the test is done, theres this sigh of relief because that stress is gone and your body just goes back to a kind of homeostasis where its feeling ok.
But sometimes that stress hangs around for a little while. Thats when you start running into problems. You may find that even though the threat is gone, youre not feeling better. You may be experiencing increased heart rate and breathing or generally feeling edgy all the time. Thats a sign that youre bumping over into a low-level, acute stress or chronic stress state.
Thats when we start to think about cortisol. Youve probably heard about cortisol as a stress hormone. In the moment, it actually helps your body boost its immune system and decrease inflammation, but if its there for a long time, then you start to get into different problems.
I always tell people to seek medical help if they start seeing signs of chronic stress. Some of the red flags would be that you feel in a low mood all the time. You may stop hanging out with your friends or your family. Youre just kind of retreating and not interested in the things you used to be interested in. You may be sleeping too much or too little. Some people experience physical symptoms. They have an upset stomach or heartburn or headaches, because their blood pressure is up. They might feel a knot in their chest. All of those things could be signs that youre experiencing anxiety, so you would definitely want to see your doctor at that point.
It comes down to the basics of general healthy living. For example, if youve not been on a good sleep schedule over the semester, you really need to prioritize getting on a healthy sleep scheduleand make it a realistic schedule that you can keep doing once we get back on campus. If you were not addressing your dietary needs during the semester, start to incorporate healthy, nutrient-dense types of foods into your diet.
Also, exercise is super important. Just from a perspective of improving your cardiovascular health and improving your circulation, regular exercise will help get all those immune cells pumped around your body. You dont want to smoke and try to minimize your alcohol intake.
Then, of course, what weve all been focused on over these last nine month is taking steps to minimize infections. So, being very diligent about washing your hands, keeping your distance from pretty much anyone who doesnt live in your house, and wearing a mask if you have to go out and about.
When you have a healthy immune system, when its functional, you dont even know its there. Its protecting you from things that are trying to kill you, viruses and bacterial infections, but you arent even aware of it.
But just like a car runs out of gas when left idling, if you are not fully addressing the things that boost your immune system, eventually that car will run out of gas and then that leads to a whole host of problems. You might start noticing that youre getting more colds or struggling to get over minor illnesses. Thats really just because when your stress response is revved up all the time, it has the opposite effect on your health and it starts down-regulating your immune system.
This is something I always recommend to my patients: practice gratitude. Its such a simple, easy thing that anyone can do. It doesnt have to be complicated. Just get a little notebook, or even make mental notes, and focus on three things that youre grateful for in a day. No matter how crummy the day is, theres always something that we can find that we can be grateful for.
Studies show that if you practice gratitude, there are positive changes in your brain that actually change your outlook on things. Along those lines, theWellness Centerhas all kinds of wonderful mindfulness, meditation and exercise resources available online. They make it really easy to access, so Id also recommend trying out some of those offerings.
Adrienne Berard is a research communications specialist at William & Mary News and this story was published on Dec. 18.
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Tips for staying healthy and managing stress over the holidays - WYDaily
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5 tips to get thicker hair and common causes of hair loss or thinning – Insider – INSIDER
There is no proven way to permanently thicken hair if you are healthy and have no underlying health conditions. But, there are lifestyle adjustments to improve your overall hair health and prevent breakage.
Here are common causes of thin hair and five tips for healthier, thicker hair.
The causes of thin hair include:
If you are concerned about frequent hair loss, reach out to a dermatologist, says Sara Wasserbauer, MD, a hair restoration surgeon and President of the Board of Directors for the American Board of Hair Restoration Surgery.
"The earlier someone starts therapies, the more likely they are to be effective," Wasserbauer says. "If you are losing more than 100 hairs per day, or if your hair is less thick when you run your hand through it, it is worth seeing a hair expert."
A doctor can determine if you can treat thin hair without medical intervention, or if it is a sign of alopecia a more severe condition in which hair falls out in patches or causes balding.
If your hair loss is not due to an underlying health condition, you may be able to thicken your hair with the following lifestyle changes:
A nutritious diet is critical to hair health, says Sanusi Umar, MD, CEO and medical director of Dr. U Skin and Hair Clinic in Manhattan Beach, California. This is because adequate nutrition ensures hair follicles construct hair shafts of normal thickness.
According to Umar, certain nutrients are essential to the thickness and growth of hair, like:
Cortisol, the stress hormone, disrupts the functioning of the hair follicle and contributes to thinning hair. A 2016 study found high levels of cortisol can cause certain proteins in hair to break down.
It is important to differentiate between different types of stress, Wasserbauer says. If you experience a stressful event, you may notice a period of hair loss and accelerated thinning, but the hair usually recovers within a year. Ongoing hair loss is more serious, and unless it is caught, diagnosed, and treated, it may result in permanent loss.
If you're concerned stress may be causing hair thinning, you can alleviate stress and lower cortisol levels by:
A hormone imbalance, such as during pregnancy or menopause, can cause thinning hair. A decrease in estrogen or an increase in testosterone levels can thin hair as well, Umar says.
Research found an imbalance of hormones like estrogen, progesterone, and prolactin can all contribute to hair loss. Hair loss can also be due to an imbalance of thyroid hormones, Umar says.
Signs of a hormone imbalance, like a thyroid condition, include:
If you think a hormone imbalance may be causing thin hair, reach out to your doctor, Umar says. A primary care physician may refer you to a dermatologist, who specializes in skin and hair, or an endocrinologist who specializes in hormonal imbalances.
Heat styling products, like blow dryers, straighteners, and curling irons all weaken the hair shaft and fiber, Umar says. These products damage the cuticle on the outer layer of the hair, especially if the heat setting is set too high or you use a heating product daily.
"Using heating styling products excessively can cause breakage and cause the scalp to become stressed thus leading to thinning hair," Umar says.
A 2004 study found using a curling iron causes hair to weaken and break, though hair treated with a conditioner showed less damage than hair that was not.
Another 2011 study found using a blowdryer caused more surface damage to hair than natural drying, but how you use a blowdryer matters. For instance, the study found blow drying hair at a distance of 15 cm with continuous motion caused less damage than letting hair air dry or using a hair dryer without motion very close to your hair.
If you use heat styling products regularly and have noticed your hair thinning, try reducing how often you use these products. To prevent damage, you should also limit other treatments, like hair dye, bleach, and chemical treatments.
Sulfates are chemicals found in most shampoos and soaps that provide the "sudsy" effect when you lather them up.
Sulfates also strip hair of its natural oils and moisture, Umar says, causing it to become dry and brittle, which makes it break more easily.
However, switching to a sulfate-free shampoo won't stop hair loss, Umar says. Using a sulfate-free shampoo can help preserve the natural oils in your hair, reduce irritation, and potentially prevent future damage, like hair breakage.
If you have no underlying health conditions causing hair loss, there is no proven way to thicken your hair. However, you can improve overall hair health by eating a nutritious diet, limiting heat styling, and using a sulfate-free shampoo. Healthier hair means less damage and breakage, which can help hair grow longer and thicker.
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5 tips to get thicker hair and common causes of hair loss or thinning - Insider - INSIDER
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How to Break a Sugar Addiction | INTEGRIS – Integris
Those cookies you smell at the holidays, the ice cream that makes your eyes light up in the summertime and the candy jar full of tempting chocolates all have one thing in common they're loaded with sugar.
There's something about sugar that speaks to your brain, evoking feelings of happiness with each bite of food or each sip of your favorite sugary drink you consume. It's part nostalgia and part chemical reaction. The more you eat, the more you crave, which can lead you down a road of long-term health problems.
We're here to discuss what makes sugar so habit-inducing, how you can kick your cravings and which foods you can substitute to please your sweet tooth.
What's wrong with sugar, you ask? Everything. Outside of making things taste better, sugar has no nutritional value and is full of empty calories. These calories can create weight problems and, in turn, heighten your risk of heart disease and stroke.
That's only the physical downside. The psychological component is real, too. Sugar releases dopamine and can increase serotonin production, a hormone that can boost your mood.
In reality, sugar isn't any different than comfort food or a satisfying fast food meal loaded with simple carbohydrates. These carbohydrates are high on the glycemic index, meaning it takes less time to turn them into glucose. During this quicker digestion process, you may feel good in the short term, but hunger will quickly set in since sugary foods lack nutrients and leave you unsatisfied.
It can turn into a vicious cycle. At first, the sugar you eat tastes good, bringing on a "high" when your brain initiates the dopamine release. Then, the sugar causes your insulin levels to increase, leading to a drop in blood sugar levels. As your blood sugar falls, your appetite and hunger levels increase. Your body then craves sugar again to fix any hunger deficiencies or feelings of unease, even if the fix is only temporary.
According to the American Heart Association, eight out of 10 adults are trying to lower their sugar intake. On average, adults consume around 77 grams of sugar a day. That equals about 60 pounds of sugar over the course of a year. Imagine lugging around a dozen five-pound sacks of sugar. That's what you're putting in your body!
If you're determined to kick your sugar habit, it's OK to stop cold turkey. The Mayo Clinic recommends taking a two-week break from sugar to reset your body. This doesn't have to be an outright cleanse, but try to limit yourself to foods with little to no added sugars or sweeteners shoot for less than 5 grams of added sugars per serving.
Start by cutting out sugary drinks. They are the biggest culprit, accounting for almost half of the added sugars Americans consume. A 12-ounce can of soda can contain as much as 10 teaspoons of sugar. Think of it this way: The American Heart Association recommends men eat only nine teaspoons of added sugar each day, while women and children should consume six teaspoons. Just like that, you can exceed your daily sugar allotment in five or six gulps of your favorite soda.
The spoonfuls and spoonfuls of sugar in soda explain why there are so many calories in a drink the size of your hand. There are four calories in a gram, so a soda containing 40 grams of sugar has 160 calories. It's easy to see how calories add up when that 12-ounce soda turns into a 44-ounce drink at your favorite fast food restaurant.
You should also stay away from any baked goods, desserts and candy. Cereals, even the so-called "healthier" options, still have added sugars that can creep up on you. Then there are unassuming foods, such as pizza or pasta sauces, that you wouldn't normally associate with having added sugars. A half-cup of a store-bought marinara sauce contains anywhere from 2 to 4 grams of added sugar, which amounts to a teaspoon.
As a general rule, look for words that end in "ose" sucrose, fructose, glucose, maltose, lactose or dextrose. This is an easy indicator to spot added sugars. Don't let ingredients that sound better for you fool you, either. Honey, agave, maple syrup, brown rice syrup and juice concentrate are still added sugars.
Now that you've reduced your sugar intake, what comes next? For starters, introduce more whole foods whole grains, fruits, vegetables and lean meats to your diet. Many fruits and vegetables still contain natural sugars, but the starch and fiber in these foods slows the digestion process and leaves you feeling more full. You can learn more by reading our blog post on healthy carbs.
Eating fruit for an after-dinner snack can satisfy your cravings for sugar without leaving you feeling like you've cheated. Certain fruits, such as grapes and bananas, have high sugar contents. Berries are generally a low-sugar choice, so sneak some blueberries, raspberries or blackberries into your yogurt or oatmeal.
Ditching sugary drinks isn't easy, but try swapping them for water or sparkling water. Better yet, try flavored sparkling water. The carbonation will mimic the fizz from soda without the added sugar or calories. For more on sparkling water, check out our blog post on carbonated drinks.
When making food selections at the grocery store, be wary of hidden sugars that are often added to low-fat products. Things with fat tend to have flavor, so removing fat from products can leave them bland. Food manufacturers add sugars back into products to make them more enjoyable. Any benefit you think you're getting from a product with less fat may be just as bad for you if it's loaded with additives or sugars.
It's important to remember correcting bad sugar habits doesn't mean an outright boycott of sweet foods. Instead, take control by adding small amounts of sugar. For example, drizzle a small amount of honey on your yogurt to treat yourself. It's better than the alternative, which is pre-packaged flavored yogurts loaded with added sugar.
If you place an order at your local coffee shop, it's no longer a question of if you want cream or sugar added. Artificial sweetenersare just as popular of an option nowadays to help curb sugar habits.
These synthetic sugar substitutes received a bad reputation years ago for their link to cancer, but subsequent studies haven't found a clear connection to causing cancer in humans, according to the National Cancer Institute.
With those concerns out of the way for now, the FDA has approved five artificial sweeteners for use: aspartame (Equal), acesulfame-K (Sweet One), neotame, saccharin (Sweet'N Low) and sucralose (Splenda).
But just because the FDA approves their use doesn't mean you should swap sugar for artificial sweeteners and keep the same diet. Artificial sweeteners can temporarily help by weaning you off added sugars, but long-term use could play a role in how you view foods.
Think of artificial sweeteners as a concentrated version without the calories a little goes a long way. According to Harvard Health, the sweetness from artificial additives can make you more likely to develop a sweet tooth and crave sweets even more. Plus, the psychological component can alter the way you think. For example, if you tell yourself you're saving calories by drinking a diet soda instead of a regular soda, you may be more inclined to eat cake for dessert. In this case, you cancel out any benefits of drinking a diet soda with something full of added sugars.
Before you make any dietary changes or consider cutting sugar from your daily routine, connect with an INTEGRIS Health primary care physicianto learn more about how to implement changes.
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Outlook on the Biopreservation Global Market to 2026 – Profiling Avantor, BioLife Solutions and ThermoGenesis Among Others – GlobeNewswire
Dublin, Dec. 21, 2020 (GLOBE NEWSWIRE) -- The "Biopreservation Market by Type, Application, End-user, and Geography - Global Forecast to 2026" report has been added to ResearchAndMarkets.com's offering.
Biopreservation is a process that assists in the conservation of biospecimens such as DNA, saliva, and plasma. This process of biopreservation generally increases the durability, shelf life, and purity of the biosamples. The types of equipment in this process include freezers, liquid nitrogen, consumables, and also media & laboratory information management systems.
This process is also used to preserve food and extend its shelf life, specifically by using lactic acid bacteria. Growth in healthcare spending is assumed for better access to quality healthcare and advanced technology products such as biopreservation facilities, thereby widening the growth expectations. Moreover, the bio-banks, hospitals, and gene banks, which are major end-users for this market, are stimulating the key providers to establish technologically advanced biopreservation products to improve patient outcomes. The Biopreservation Market is projected to grow at a rate of 9.2% CAGR by 2026.
The biopreservation market has been analyzed by utilizing the optimum combination of secondary sources and in-house methodology, along with an irreplaceable blend of primary insights. The real-time assessment of the market is an integral part of our market sizing and forecasting methodology. Our industry experts and panel of primary participants have helped in compiling relevant aspects with realistic parametric estimations for a comprehensive study. The participation share of different categories of primary participants is given below:
In the market for biopreservation, the application of biopreservation consists of therapeutic applications, research applications, clinical trials, and other applications. The biopreservation is primarily applied in therapeutics due to the advancements in regenerative medicine & customized medicine, an increase in the shift of cord blood banking, and the rising incidence of chronic diseases.
The end-users of the biopreservation market include biobanks, gene banks, hospitals, and other end users. The biobanks segment is expected to have a major share in the market. The major share of this segment is attributed to the increasing preference for the preservation of stem cells and the rising numbers of sperm and egg banks.
Further, according to the regional market of biopreservation, the North American region is recorded for the colossal share in the market. This is due to the continuous drug developments and the arrival of advanced therapies in the domain of biomedical research. Additionally, the increasing requirement of expensive and improved treatment for patients' chronic diseases is the key factor.
The rising incidence of chronic diseases, including cardiac, renal diseases, diabetes, and obesity, is the crucial factor that will propel the biopreservation market growth in the prevailing period. Government initiatives to encourage stem cell therapies to treat the disease, which will again propel market growth. Conversely, the strict regulations for producing biopreservation products and the evolution of room temperature storage procedures may limit the biopreservation market growth.
Merck KGaA, Avantor, Inc., Bio-Techne Corporation, BioLife Solutions, Inc., Thermo Fisher Scientific Inc, ThermoGenesis Holdings, Inc., Worthington Industries, Inc., Chart Industries, Inc, So-Low Environmental Equipment Co., Inc., Princeton BioCision, LLC, Shanghai Genext Medical Technology Co. Ltd, Exact Sciences Corporation, Helmer Scientific, Inc., CryoTech, Inc., Arctiko, Nippon Genetics Europe, PHC Holdings Corporation, STEMCELL Technologies, Inc., AMS Biotechnology, and OPS Diagnostics. These are the few companies list of the biopreservation market.
Since the rapid increase in the number of research and developments gives the way of potentials for market growth, the biopreservation of biological samples has become a crucial segment. This helps the researchers to access the data of the number of people by the preserved biological samples.
This research presents a thorough analysis of market share, the present trends, and forthcoming evaluations to explain the approaching investment pockets.
This research provides market insights from 2020 to 2026, which is predicted to allow the shareholders to capitalize on the forthcoming opportunities.
This report further offers comprehensive insights into the region, which helps to understand the geographical market and assist in strategic business planning and ascertain future opportunities.
Key Topics Covered:
1. Executive Summary
2. Industry Outlook2.1. Industry Overview2.2. Industry Trends
3. Market Snapshot3.1. Market Definition3.2. Market Outlook3.2.1. PEST Analysis3.2.2. Porter Five Forces3.3. Related Markets
4. Market characteristics4.1. Market Evolution4.2. Market Trends and Impact4.3. Advantages/Disadvantages of Market4.4. Regulatory Impact4.5. Market Offerings4.6. Market Segmentation4.7. Market Dynamics4.7.1. Drivers4.7.2. Restraints4.7.3. Opportunities4.8. DRO - Impact Analysis
5. Type: Market Size & Analysis5.1. Overview5.2. Biopreservation Media5.2.1. Nutrient Media5.2.2. Sera5.2.3. Growth Factors & Supplements5.3. Biospecimen Equipment5.3.1. Temperature Control Systems5.4. Freezers5.5. Cryogenic Storage Systems5.6. Thawing Equipment5.7. Refrigerators5.7.1. Accessories5.7.2. Alarms & Monitoring systems5.7.3. Incubators5.7.4. Centrifuges5.7.5. Other Equipment
6. Application: Market Size & Analysis6.1. Overview6.2. Therapeutic Applications6.3. Research Applications6.4. Clinical Trials6.5. Other Applications
7. End User: Market Size & Analysis7.1. Overview7.2. Biobanks7.3. Gene Banks7.4. Hospitals7.5. Other End Users
8. Geography: Market Size & Analysis8.1. Overview8.2. North America8.3. Europe8.4. Asia Pacific8.5. Rest of the World
9. Competitive Landscape9.1. Competitor Comparison Analysis9.2. Market Developments9.2.1. Mergers and Acquisitions, Legal, Awards, Partnerships9.2.2. Product Launches and execution
10. Vendor Profiles10.1. Merck KGaA10.1.1. Overview10.1.2. Financials10.1.3. Products & Services10.1.4. Recent Developments10.1.5. Business Strategy10.2. Avantor, Inc10.2.1. Overview10.2.2. Financials10.2.3. Products & Services10.2.4. Recent Developments10.2.5. Business Strategy10.3. Bio-Techne Corporation10.3.1. Overview10.3.2. Financials10.3.3. Products & Services10.3.4. Recent Developments10.3.5. Business Strategy10.4. BioLife Solutions, Inc10.4.1. Overview10.4.2. Financials10.4.3. Products & Services10.4.4. Recent Developments10.4.5. Business Strategy10.5. Thermo Fisher Scientific Inc10.5.1. Overview10.5.2. Financials10.5.3. Products & Services10.5.4. Recent Developments10.5.5. Business Strategy10.6. ThermoGenesis Holdings, Inc10.6.1. Overview10.6.2. Financials10.6.3. Products & Services10.6.4. Recent Developments10.6.5. Business Strategy10.7. Worthington Industries, Inc10.7.1. Overview10.7.2. Financials10.7.3. Products & Services10.7.4. Recent Developments10.7.5. Business Strategy10.8. Chart Industries, Inc10.8.1. Overview10.8.2. Financials10.8.3. Products & Services10.8.4. Recent Developments10.8.5. Business Strategy10.9. So-Low Environmental Equipment Co.,Inc10.9.1. Overview10.9.2. Financials10.9.3. Products & Services10.9.4. Recent Developments10.9.5. Business Strategy10.10. Princeton BioCision, LLC10.10.1. Overview10.10.2. Financials10.10.3. Products & Services10.10.4. Recent Developments10.10.5. Business Strategy
11. Companies to Watch11.1. Shanghai Genext Medical Technology Co. Ltd11.1.1. Overview11.1.2. Products & Services11.1.3. Business Strategy11.2. Exact Sciences Corporation11.2.1. Overview11.2.2. Products & Services11.2.3. Business Strategy11.3. Helmer Scientific, Inc11.3.1. Overview11.3.2. Products & Services11.3.3. Business Strategy11.4. CryoTech, Inc11.4.1. Overview11.4.2. Products & Services11.4.3. Business Strategy11.5. Arctiko11.5.1. Overview11.5.2. Products & Services11.5.3. Business Strategy11.6. Nippon Genetics Europe11.6.1. Overview11.6.2. Products & Services11.6.3. Business Strategy11.7. PHC Holdings Corporation11.7.1. Overview11.7.2. Products & Services11.7.3. Business Strategy11.8. STEMCELL Technologies, Inc11.8.1. Overview11.8.2. Products & Services11.8.3. Business Strategy11.9. AMS Biotechnology11.9.1. Overview11.9.2. Products & Services11.9.3. Business Strategy11.10. OPS Diagnostics11.10.1. Overview11.10.2. Products & Services11.10.3. Business Strategy
12. Analyst Opinion
13. Annexure13.1. Report Scope13.2. Market Definitions13.3. Research Methodology13.3.1. Data Collation and In-house Estimation13.3.2. Market Triangulation13.3.3. Forecasting13.4. Report Assumptions13.5. Declarations13.6. Stakeholders13.7. Abbreviations
For more information about this report visit https://www.researchandmarkets.com/r/pl06wm
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Outlook on the Biopreservation Global Market to 2026 - Profiling Avantor, BioLife Solutions and ThermoGenesis Among Others - GlobeNewswire
Recommendation and review posted by Bethany Smith
These Families Raised Millions To Fund Treatment For Their Kids’ Genetic Disorders. It Hasn’t Happened. – KCUR
Over the last several years, parents from across the country have appeared on television and news outlets to raise money to develop treatments for their children with rare genetic disorders.
Many of these families, including one from Kansas City, Missouri, have pinned their hopes on one Texas researcher, Dr. Steven Gray of the University of Texas Southwestern Medical Center in Dallas, who claims to be on the verge of treating a number of rare conditions. They've raised millions of dollars to fund his research, although breakthroughs haven't happened to the extent many had hoped.
While gene therapy holds great promise, the growing trend of family-funded research concerns some medical ethicists, who say that suggestions to parents that treatments may be imminent can raise thorny ethical issues.
These are parents. They are desperate. says Mayo Clinic bioethicist Megan Allyse. They are willing to try almost anything. They are in a pretty vulnerable position for somebody to come along and say, Give me your money, and I can make this better.
Further complicating the picture is the recent entry into the field of a private company, Taysha Gene Therapies, which says it will accelerate Grays research. That has divided his supporters and raised concerns about families who might be left behind.
Kim Fry, of Kansas City, Missouri, has a video on her phone of her son, Charlie, that was made in 2018 when he was 5 months old. It shows her bright-eyed boy gently shaking in his father's lap, as if shivering from cold.
Those little tremors sent the family on a year-long odyssey that led to a frightening diagnosis. A genetic test showed Charlie had an incredibly rare mutation in a single gene, SLC6A1. The mutation typically causes intellectual disabilities and epilepsy starting around the age of three-and-a-half that can severely affect patients for the rest of their lives.
Doctors told Kim and Nate there was no treatment available to help their son.
At that moment, you just feel crushed and kind of begin grieving for the life you think your childs going to have, Kim said.
Rare genetic disorders have generally received little attention from biotech companies because the markets for treatments are so small.
But shortly after the diagnosis, Kim met Amber Freed, a mother from Denver who seemed to have found a solution. After her son, Maxwell, was diagnosed with the same mutation a year earlier, Freed met Gray, a molecular biologist who had focused on gene therapy while doing a post-doctoral fellowship at UNC Chapel Hill.
Gray was developing treatments or even possible cures for conditions caused by single-gene mutations, and he had agreed to work on SLC6A1. But it would be up to Freed to provide Gray with the millions of dollars he would need to do this work.
With the possibility of a treatment suddenly on the table, Kim and Nate immediately joined Amber in raising money through the organization she started, SLC6A1 Connect, and their own campaign, A Cure For Charlie. Their goal was to create a treatment and bring it to clinical trial before Charlie turned three-and-half, hoping to block the severe effects of the mutation and giving him a chance to live a regular life.
Once the funding is there, then all the science is going to move into place, so really the only hurdle that were facing right now between us and the cure is the funding, Nate said in fall of 2019.
Family fundraisers
Family fundraisers are a departure from how medical research is usually funded, typically through the National Institutes of Health, large foundations and advocacy groups.
Nevertheless, families like the Frys have appeared on news outlets and in publications throughout the country in recent years, from Good Morning America and ABC News to People magazine and countless local news shows, to raise money for research.
The children have been diagnosed with many different genetic disorders, but their stories are similar. They all have rare gene mutations that will lead to serious mental or physical declines or early death, and their parents are pinning their hopes on Gray to develop treatments.
They call themselves the Steve Gray Parents.
Gray himself has appeared in articles and videos, including one produced by UT Southwestern about Willow Canaan, a girl from Mississippi who has multiple sulfatase deficiency.
A lot of the families that we interact with, they are coming to us with really sick kids. I think knowing their story, knowing that one child, gives us a face, gives us a mission that if we can move fast enough theres hope that we could treat and we make things different for that specific child, Gray said in one video.
Gray became a go-to researcher for rare disease families after his treatment of Hannah Sames, a girl from New York with a degenerative genetic disorder called giant axonal neuropathy.
In a 2016 clinical trial, Sames was injected with a manufactured virus that contained a working copy of the gene that was mutated. Through this adeno-associated virus delivery method, the normal gene would take over from the mutated one and stop the degeneration from happening.
The treatment slowed the progress of Hannahs disease, according to Gray, but it wasnt a cure. In a 2019 interview on Connecticut Public Radio, Hannahs mother, Lori, said the family was seeking additional treatment.
But Gray thinks the same method could be used to treat and possibly cure all kinds of genetic disorders, including the SLC6A1 mutation
Were due for another leap in technology, Gray told KCUR in 2019. Were going to have a better virus technology, better ways to deliver genes, and I can see that just making a further leap for the whole field.
Gray, who says he has been involved in developing treatments for two dozen diseases, has accepted money from families to pay for the high costs of manufacturing viruses, doing toxicology studies and running clinical trials. Many of these family groups had raised more than a $1 million each from their friends, relatives and neighbors.
Though these families have been effective at raising money, bioethicist Allyse worries that without the peer review process that traditional funders use, they may not be in the best position to decide what research is likely to get results.
The potential problem with going around that process is that its possible to sort of go down avenues that are less supported by the literature, that are less in line with the scientific consensus, Allyse said.
But those doubts have done little to discourage dedicated parents like Amber Freed.
In early December 2019, Freed hosted the second annual SLC6A1 research symposium in a hotel conference room in downtown Baltimore. Freed quit her job in finance after her sons diagnosis to dedicate herself to advancing a treatment, and she began organizing annual SLC6A1 research symposiums in 2018 to drum up interest in the work.
Shes also held charity golf tournaments, set up fundraising campaigns with companies like Amazon and Pizza Hut, and helped arrange the creation of genetically altered mice in China for research.
During the last two years, Freed has cultivated relationships with genetic researchers from all over the world, and as the sleepy scientists who traveled to Baltimore to take part in the symposium wandered into the conference room early on a Friday morning, she greeted them like family, with big hugs and smiles.
Alex Smith
Despite Freeds seemingly endless enthusiasm, she made clear in her welcoming speech to the scientists that, unlike them, her involvement in SLC6A1 research didnt happen by choice.
But to be honestI dont want to be here, read a slide projected behind her at the end of her remarks.
Some improvements but no 'home run'
Toward the end of the day, Gray took the podium to deliver an update on research from his lab. For many in the audience, this was the days main event.
His teams early research using the treatment showed some improvements in motor and behavioral skills in young, genetically altered mice that were treated before symptoms had appeared. But there was no change in mice that already had symptoms.
I think treating at an early age, were seeing some signs of improvements and some nice signals that our vector is doing something positive, but, you know, its not a home run, Gray explained.
Though it wasnt the result Freed dreamed of, she was encouraged that the research appeared to be on the right path.
Gray insisted he had tried to be careful about managing expectations for families funding his work, but between symposium talks, he also said he had recently shifted course on working with them.
Im really having to say no a lot now, Gray told KCUR. Im kind of moving into a point where we were trying not to say no, and we were trying to work on everything that the science made sense. But there is a point where you just have to say, You know Ive got to focus on what Im doing, and theres a limit.
While Grays work did lead to a treatment for Hannah Sames, similar breakthroughs havent come in time for other families.
Laura King Edwards of Charlotte, North Carolina, started working with her family to raise money for Grays work after her baby sister, Taylor, was diagnosed with a form of a rare disorder called infantile Batten disease in 2006.
The family didnt have a lot of hope the research would lead to a treatment in time to help Taylor, and she died two years ago at age 20.
Edwards says that looking back, she sometimes regrets all the time she spent running a fundraising organization.
Id spend hours up at night dealing with tech issues on our website, for example, or responding to emails from people all over the world, knowing that thats time that maybe I couldve spent with my little sister while she was still here, Edwards says.
Nevertheless, even after Taylor was gone, her family continued to support Grays work through their organization, Taylor's Tale.
A new player
Not long after the conference in Baltimore, however, the race for a SLC6A1 treatment slowed to a crawl.
When the COVID-19 pandemic hit, scientific studies and medical trials across the country were stopped and research funds were directed to coronavirus research.
The therapists who work with Amber and Kims sons were unable to meet with them in person, and the boys started to backslide on some of their developmental progress.
Then, after the initial waves of the coronavirus subsided, hopes for Grays research came roaring back to life when a new company, Taysha Gene Therapies, announced it would partner with UT Southwestern, offering a boost to the research and development beyond what families could provide.
They could get it to a certain place, said Taysha founder R.A. Session II, But when it needs to get to kind of the meaningful level in order to get it into late-stage clinical trials, this is where they just dont necessarily have the capability. And so I think this is where you would see programs then transitioning into a companys hands in order to kind of pursue them and move them forward.
In April, Taysha announced a partnership with UT Southwestern that would fund Grays research and work to move it more quickly into clinical trials and possible treatment. Gray was named chief scientific officer.
The company said the family fundraising would no longer be needed.
For some parents, like Doug and Kasey Woleben of Dallas, that was great news. Theyve raised around $1 million for research to treat Leigh syndrome, which affects their 8-year-old son, Will.
We were excited, thrilled to know that were now off the hook for millions and millions and millions of dollars. And that Taysha and UT Southwestern are trying to push this program and move it forward as quickly as possible. So for us, it was a miracle, Kasey said.
But Taysha's involvement and its timeline have brought disappointment for other families. The company's first clinical trials, to treat a mutation that causes Tay Sachs disease, were planned to start in Canada at the end of 2020 but only received approval from the Canadian government this week.
The company says it plans to seek permission to test treatments for three other conditions, including the SLC6A1 mutation, by the end of 2021, but it has not announced any dates for beginning trials.
For Amber Freed and Kim Fry, Tayshas timeline is problematic. Both of their sons were expected to exhibit epilepsy symptoms before the end of next year and so they would see little benefit from treatment initiated after that.
Im very disappointed, Freed said in September. If you had asked me this time last year, I would have fully expected to be in a clinical trial right now.
Different priorities
Session insists that Tayshas timeline and priorities on are based on what the research shows is safe and effective.
Weve allowed the science to kind of move forward at the pace the science moves, Session says. Then we move it forward into the clinic based on that science.
But to Freed, the goal of fast-tracking to trial, even one that would have only resulted in a slight improvement for her son, appears much less likely now that Taysha is involved.
Once you hand over the reins to a biotech, you lose decision-making power as a nonprofit organization, and you abide by their timeline and not necessarily your own, Freed said. In my case, we are racing to get this therapy into children like Maxwell and Charlie as quickly as possible, so we need it done tomorrow.
For other Gray supporters, however, the future is even less clear. Tayshas development pipeline does not include treatments for some of the conditions that Gray had previously been working with families to develop, including Charcot-Marie Tooth, Krabbe disease and multiple sulfatase deficiency.
UT Southwestern researchers will continue to research those conditions, according to a university spokesman, and Taysha says it plans to expand its pipeline in the future.
Terry Pirovolakis, who had enlisted Grays help to develop a treatment for spastic paraplegia 50, which affects his son, Michael, will not be involved with Tayshas work. Hell only continue to work with UT Southwestern directly.
From my perspective, it was, thats great. Tayshas gonna come in and maybe save the world, but I dont want to be part of it 'cause theyve got a lot of stuff they gotta work out, and Im not going to wait around for them to figure it out, Pirovolakis said.
Pirovolakis, who lives in Toronto, has raised more than $1.5 million since May 2019 through his online campaign, Cure Michael, which was the most successful GoFundMe campaign in Canada last year.
Expectations vs. reality
He says that while he has been comfortable working with Gray, he believes that drug companies, which depend on the involvement of families for rare disease research, can mislead parents about what might be possible for their children.
The industry, as a whole, I think, maybe sets expectations that are higher than reality," Pirovolakis said. "We see these presentations at the conferences of these kids doing amazing things, like a 4-year-old that has no brain function pretty much, going to school two years later. Its remarkable.
"But that was five or 10 years of research. So I think that expectations from the industry are maybe what cloud us as parents in the hope that something amazing is gonna happen for our kids.
CureCMT4J, a foundation created to advance research on Charcot-Marie Tooth by parent advocate Jocelyn Duff, an early supporter of Gray, also is no longer involved with the researchers work. Duff said the organization had moved in a different direction, but she declined the provide details. The group had raised $1.3 million as of fall 2020.
Some ethicists have also raised questions about the costs of rare disease treatment, and they point to a drug previously developed by members of the Taysha team as a prime example of their concern.
Several members of the Taysha team, including Session, directors Sean Nolan and Phillip Donenberg, and others, earned their reputation for success as part of a AveXis, a company that developed the breakthrough treatment for spinal muscular atrophy, Zolgensma.
Zolgensma was introduced by drug giant Novartis last year with a price tag of more than $2.1 million, making it the most expensive drug in the country.
On the one hand, you could say thats a winning team, said Megan Allyse. On the other hand, you could say is that the team you want to be on if what youre trying to do is generate not just effective treatments, but accessible treatments?
Session says that Taysha currently has no plans regarding the pricing or accessibility of any treatments the company might develop.
We should be so blessed to be able to have a discussion on pricing because then were talking about an approved therapy, Session says. But were not there yet. So what I would say is the company is focused on getting these drugs into patients effectively and safely as efficiently as possible.
Taysha announced in November that it raised more than $275 million in private financing and an initial public offering.
For Kim Fry and Amber Freed, however, the focus is still very much on what can be done for their sons.
The women are continuing to raise money, but they have shifted to other researchers and technologies. And they have adjusted their expectations.
Frys son, Charlie, started having more significant seizures earlier in the year and is now taking medication to reduce them.
She still thinks a treatment within the next year or two could help her son and others like him, although not in the way she had once imagined.
It may not be a 100% home run where they live 100% the life we hoped. But theyll still have a better life than they are living today, Fry said. I lose sleep every night over the thought that it might be too late, but Im still hopeful that there will be benefit for them.
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These Families Raised Millions To Fund Treatment For Their Kids' Genetic Disorders. It Hasn't Happened. - KCUR
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Taysha Gene Therapies Announces Queen’s University’s Receipt of Clinical Trial Application Approval from Health Canada for Phase 1/2 Clinical Trial of…
TSHA-101 will be the first bicistronic vector to enter a first-in-human clinical study, which is a significant milestone for Taysha and for the field of gene therapy, said Suyash Prasad, MBBS, M.SC., MRCP, MRCPCH, FFPM, Chief Medical Officer and Head of Research and Development of Taysha. GM2 is a devastating lysosomal storage disease with no approved treatments and todays CTA approval marks a formative moment for children suffering from this rapidly progressive and fatal disease.
The trial will be a single arm, open-label Phase 1/2 trial evaluating the use of TSHA-101 for the treatment of infants with GM2. The study will be sponsored by Queens University and led by Jagdeep S. Walia, MBBS, FRCPC, FCCMG, Clinical Geneticist and Associate Professor Head, Division of Medical Genetics (Department of Pediatrics) at Queens, and Director of Research (Department of Pediatrics), at the Kingston Health Sciences Centre.
Preclinical evidence to date supports our belief that TSHA-101, when given intrathecally as a bicistronic transgene packaged into a single AAV9 vector, has the potential to address the lysosomal enzyme deficiency, to change the disease trajectory and to improve patient survival, said Dr. Jagdeep S. Walia. We are pleased to have the support of Health Canada as we continue to advance TSHA-101.
Todays CTA approval is a culmination of our teams and Dr. Walias tireless efforts and a momentous occasion for children affected by GM2 along with their parents and caregivers, said RA Session II, Founder, President and CEO of Taysha. We are grateful to our partners at Queens University for their work to advance this gene therapy into the clinic.
About GM2 Gangliosidosis
GM2 gangliosidosis is a rare and fatal monogenic lysosomal storage disorder and a family of neurodegenerative genetic diseases that includes Tay-Sachs and Sandhoff diseases. The disease is caused by defects in the HEXA or HEXB genes that encode the two subunits of the -hexosaminidase A enzyme. These genetic defects result in progressive dysfunction of the central nervous system. There are no approved therapies for the treatment of the disease, and current treatment is limited to supportive care.
About TSHA-101
TSHA-101 is an investigational gene therapy administered intrathecally for the treatment of infantile GM2 gangliosidosis. The gene therapy is designed to deliver two genes HEXA and HEXB driven by a single promoter within the same AAV9 construct, also known as a bicistronic vector. This approach allows the simultaneous expression of a 1:1 ratio of the two subunits of protein required to generate a functional enzyme. It is the first and only bicistronic vector currently in clinical development and has been granted Orphan Drug and Rare Pediatric Disease designations by the U.S. Food and Drug Administration (FDA).
About Taysha Gene Therapies
Taysha Gene Therapies (Nasdaq: TSHA) is on a mission to eradicate monogenic CNS disease. With a singular focus on developing curative medicines, we aim to rapidly translate our treatments from bench to bedside. We have combined our teams proven experience in gene therapy drug development and commercialization with the world-class UT Southwestern Gene Therapy Program to build an extensive, AAV gene therapy pipeline focused on both rare and large-market indications. Together, we leverage our fully integrated platforman engine for potential new cureswith a goal of dramatically improving patients lives. More information is available at http://www.tayshagtx.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as anticipates, believes, expects, intends, projects, and future or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning or implying the potential of our product candidates, including TSHA-101, to positively impact quality of life and alter the course of disease in the patients we seek to treat, our research, development and regulatory plans for our product candidates, the potential for these product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies, and whether, if approved, these product candidates will be successfully distributed and marketed. Forward-looking statements are based on managements current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission (SEC) filings, including in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, which is available on the SECs website at http://www.sec.gov. Additional information will be made available in other filings that we make from time to time with the SEC. Such risks may be amplified by the impacts of the COVID-19 pandemic. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.
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Taysha Gene Therapies Announces Queen's University's Receipt of Clinical Trial Application Approval from Health Canada for Phase 1/2 Clinical Trial of...
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After years of potential, cell and gene therapy is ready for the pharmaceutical mainstream – PMLiVE
The argument for continued investment
C> is a high potential and maturing sector, and is an already crowded environment, playing host to numerous start-ups and now, through M&A, recognised big pharma firms. Much like the rush to find a COVID-19 vaccine that dominates headlines worldwide, not every company involved will be able to succeed.
But finnCaps finnLife watch list of 50 leading AIM-listed biotech companies demonstrates that there is room for numerous companies to contribute to, and profit from, C>. Examining three entirely different approaches to CAR-T therapy, it is possible to see just how much space there is for this exciting sector, therefore displaying the case for continued investment.
Innovative CAR-T therapy demonstrates the depth of C> potential
CAR-T therapy in its existing form is a relatively new and specialised approach at treating cancer. It takes T cells from a patients bloodstream and genetically modifies them in a laboratory. These T cells are then injected back into the bloodstream with the aim of targeting and killing cancer cells.
While it has been shown to be an effective treatment, there are risks and side effects. One is the two-step autologous process (the slow time it takes for cell expansion sometimes as long as two weeks) while another is cytokine release syndrome (CRS), which occurs when cytokine molecules are inadvertently released, but too quickly to target just the tumours and instead target healthy cells.
The next generation of CAR-T treatments shows that there is space for a multitude of start-ups to be active in the C> space as they all help find varied solutions to these problems without negating the effectiveness of CAR-T.
One example is Horizon Delivery, a company that is developing its CYAD-02 project, which will help transport T cells more effectively to the tumour via the use of SMARTvector products.
The product underwent its first phase 1 trial test in January 2020 with a patient who was suffering from acute myeloid leukaemia. Horizon Delivery is also an industry leader in CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) screenings, meaning they can identify key genes or genetic sequences that draw out specific functions of a cell type from thousands of potential variants.
In a cancer context, this means they can route out and exclusively eliminate problematic cells that may have shown signs theyd resist a future cancer treatment.
Another example is Maxcyte, a global cell- based therapies and life sciences company that is developing its CARMA process, where a patients peripheral blood mononuclear cells (PBMCs) are removed and modified. The modified cells can then be used to target an array of different cancers.
Currently the company is conducting a phase 1 trial for advanced ovarian cancer in a dose escalation trial that will treat four separate cohorts the fourth of which was administered in March 2020.
Another example which shows the versatility of new CAR-T innovation is provided by Oxford Biomedica, a gene and cell therapy company specialising in the development of gene-based medicines.
Rather than a contained project or platform, its contribution to CAR-T is through a contract manufacturing development organisation. Collaborating with pharma companies, Oxford Biomedica uses its infrastructure to produce other companies licensed products, including Novartis Kymriah treatment (alongside other undisclosed CAR-T-related products).
With fast-moving innovation finally allowing multiple C> treatments to gain regulatory approval, along with a huge pipeline of upcoming therapies and an influx of funding and M&A activity, investing in C> no longer entails taking a bet on potential the future is finally here.
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After years of potential, cell and gene therapy is ready for the pharmaceutical mainstream - PMLiVE
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Regenerative Medicine in Pharma 2020 – Opportunities, Challenges, and Unmet Needs – GlobeNewswire
Dublin, Dec. 23, 2020 (GLOBE NEWSWIRE) -- The "Regenerative Medicine in Pharma - Thematic Research" report has been added to ResearchAndMarkets.com's offering.
Regenerative medicine is a multidisciplinary field that seeks to develop the science and tools that can help repair, augment, replace, or regenerate damaged or diseased human cells, tissues, genes, organs, or metabolic processes, to restore normal function. It may involve the transplantation of stem cells, progenitor cells, or tissue, stimulation of the body's own repair mechanisms, or the use of cells as delivery vehicles for therapeutic agents such as genes and cytokines.
It is widely anticipated that Gene therapy is the most valuable regenerative medicine sector however, this market is also expected to be slowed down by high cost of therapies, which may limit its accessibility.Existing programs will facilitate the approval and development of regenerative medicines, however, a reimbursement system especially for curative therapies is warranted.
The Regenerative Medicine in Pharma report combines primary research from a cross-specialty panel of experts with in-house analyst expertise to provide an assessment of the development landscape.
This report assesses -
Scope
Key Topics Covered:
For more information about this report visit https://www.researchandmarkets.com/r/7trz9r
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Gene Therapy for Rare Disease Market Prospects Pinpoint Higher Traction from Developed Nations during 2020-2026 | Coherent Market Insights | Kite…
Global Gene Therapy for Rare Disease Market Report, Sales and Consumption Status and Prospects Professional Research, the report classifies the Global Gene Therapy for Rare Disease Market in a precise manner to offer detailed insights about the aspects responsible for augmenting as well as restraining market growth.
Gene Therapy for Rare Disease Market report provides a thoroughly researched abstract of the key players with considerable shareholdings at a global level regarding demand, sales, and income by providing better products and services. Research Report outlines a forecast for the Gene Therapy for Rare Disease market between 2020 and 2027. In terms of value, the Gene Therapy for Rare Disease industry is expected to register a steady CAGR during the forecast period.
In recent past, most of the gene therapies received orphan drug designations. Orphan drugs are generally defined as those medicines with one or more indications approved under the Orphan Drug Act of 1983. The Orphan Drug Act supports the development of innovative treatments for rare disease patients. The creation of the orphan drug designation with the passage of the Orphan Drug Act in 1983 has facilitated the development and approval of drugs for rare diseases and 2017 and 2018, were marked by the highest number of orphan drug and indication approvals to date. Production of gene therapies is associated with use of high-end technologies, high research and development costs, and skilled scientists and researchers, which reflects in high prices of these therapies.
Note: *The Download PDF brochure only consists of Table of Content, Research Framework, and Research Methodology
Get PDF Brochure Of This Research Report @ https://www.coherentmarketinsights.com/insight/request-pdf/2321
The key players profiled in this report include: Kite Pharma, Inc. (Gilead Sciences, Inc.), Novartis International AG, Juno Therapeutics Inc. (Celgene Corporation), Bluebird Bio, Inc., Spark Therapeutics, Inc., uniQure N.V, Orchard Therapeutics Plc., PTC Therapeutics, Inc., and BioMarin Pharmaceutical Inc.
Regions included:
o North America (United States, Canada, and Mexico)
o Europe (Germany, France, UK, Russia, and Italy)
o Global (China, Japan, Korea, India, and Southeast Asia)
o South America (Brazil, Argentina, Colombia)
o The Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria, and South Africa)
Key Benefits:
o This study gives a detailed analysis of drivers and factors limiting the market expansion of Gene Therapy for Rare Disease
o The micro-level analysis is conducted based on its product types, end-user applications, and geographic
o Porters five forces model gives an in-depth analysis of buyers and suppliers, threats of new entrants & substitutes and competition amongst the key market players
o By understanding the value chain analysis, the stakeholders can get a clear and detailed picture of this Gene Therapy for Rare Disease market
Table of Contents
Report Overview: It includes the Gene Therapy for Rare Disease market study scope, players covered, key market segments, market analysis by application, market analysis by type, and other chapters that give an overview of the research study.
Executive Summary: This section of the report gives information about Gene Therapy for Rare Disease market trends and shares, market size analysis by region and analysis of Global market size. Under market size analysis by region, analysis of market share and growth rate by region is provided.
Profiles of International Players: Here, key players of the Gene Therapy for Rare Disease market are studied on the basis of gross margin, price, revenue, corporate sales, and production. This section gives a business overview of the players and shares their important company details.
Regional Study: All of the regions and countries analyzed in the Gene Therapy for Rare Disease market report is studied on the basis of market size by application, the market size by product, key players, and market forecast.
The research study can answer the following Key questions:
What will be the progress rate of the Gene Therapy for Rare Disease Market for the conjecture period, 2020-2027?What are the prominent factors driving the Gene Therapy for Rare Disease Market across different regions?Who are the major vendors dominating the Gene Therapy for Rare Disease industry and what are their winning strategies?What will be the market scope for the estimated period?What are the major trends shaping the expansion of the industry in the coming years?What are the challenges faced by the Gene Therapy for Rare Disease Market?
Major Highlights of TOC:
Chapter One: Global Gene Therapy for Rare Disease Market Industry Overview
1.1Gene Therapy for Rare Disease Industry
1.1.1 Overview
1.1.2 Products of Major Companies
1.2Gene Therapy for Rare Disease Market Segment
1.2.1 Industry Chain
1.2.2 Consumer Distribution
1.3 Price & Cost Overview
Chapter Two: Global Gene Therapy for Rare Disease Market Demand
2.1 Segment Overview
2.1.1 APPLICATION 1
2.1.2 APPLICATION 2
2.1.3 Other
2.2 Global Gene Therapy for Rare Disease Market Size by Demand
2.3 Global Gene Therapy for Rare Disease Market Forecast by Demand
Chapter Three: Global Gene Therapy for Rare Disease Market by Type
3.1 By Type
3.1.1 TYPE 1
3.1.2 TYPE 2
3.2Gene Therapy for Rare Disease Market Size by Type
3.3Gene Therapy for Rare Disease Market Forecast by Type
Chapter Four: Major Region of Gene Therapy for Rare Disease Market
4.1 Global Gene Therapy for Rare Disease Sales
4.2 Global Gene Therapy for Rare Disease Revenue & market share
Chapter Five: Major Companies List
Chapter Six: Conclusion
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Gene Therapy for Rare Disease Market Prospects Pinpoint Higher Traction from Developed Nations during 2020-2026 | Coherent Market Insights | Kite...
Recommendation and review posted by Bethany Smith
Gene Therapy Market Regions, Type and Application, Futuristic Study – Factory Gate
Global Gene Therapy Market Research Report provides an complete recent proceeding in the market. The analysis supplies important data with figurative tables, graphs, charts, and statistics, an in-depth analysis of the market. The analysis highlights this markets fundamental dynamics for the forecast period (2020-2026), involving the trends, opportunities, restraints, and a lot more. The Gene Therapy analysis introduces a thorough evaluation to forecast the current market size, share, value, volume, gross sales, drivers, restraints, opinions by industry experts, and invaluable insights by the industrys prospective rise.
Every section of this report particularly consists of the research key elements of the market. The Gene Therapy industry dynamics segment permeates deep by the drivers, restraints, trends, and opportunities from this market. The quantitative and qualitative analysis, we help you with detailed and in-depth research on the Gene Therapy market. We also have centered on SWOT, PESTEL, along with different analysis of the industry.
Checkout FREE Report Sample of Gene Therapy Market Report for Better Recognizing: https://www.futuristicreports.com/request-sample/106731
(Kite Pharma Inc., Spark Therapeutics Inc., Novartis, GlaxoSmithKline PLC, Applied Genetic Technologies Corporation, NewLink Genetics Corp, Transgene SA, Oxford BioMedica, Genethon, Bluebird biInc.)
Youre able to thoroughly measure the competitions weaknesses and strengths together with our competitive analysis. The report, we have used total production and dispatch analysis in point of origin. Additionally, youre advised about the latest Gene Therapy industry advancements that will help you stay ahead of the competition. Our analysts are always on the feet to always track and analyze developments or changes in the Gene Therapy market. The analysis is full of statistical demonstrations and market statistics associated with sales, volume, CAGR, and share and regional and global predictions.
Gasoline Electric Solar
Rare Diseases Neurological Disorders Oncological Disorders Cardiovascular Diseases Infectious disease Other
The report supplies how big the Gene Therapy market will be in 2026 considering the studys base year 2019 and 2020. The market dynamics predominant in North America, Europe, Asia Pacific, Middle East, and Africa, and Latin America were taken into consideration and estimating the rise of the worldwide sector.
Key Questions Answered in this Report:
Futuristic Reports
Name: Alex CubbinsTel: +1-408-520-9037Email: [emailprotected]
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Gene Therapy Market Regions, Type and Application, Futuristic Study - Factory Gate
Recommendation and review posted by Bethany Smith
News briefing: Merck buys into A2’s T cell therapy platform; Small Soligenix reports PhIII fail in head and neck cancer – Endpoints News
Merck is dipping its toes into a cell therapy partnership with A2 Biotherapeutics, with an offer to co-fund clinical development and allogeneic manufacturing activities through Phase I.
In particular, the pharma giant has its eyes on an undisclosed candidate utilizing A2s Tmod platform, which combines activation and blocking mechanisms in order to kill tumor cells while sparing healthy ones.
The deal features an upfront, an equity investment and reimbursement of certain expenses. Merck is also promising opt-in and milestone payments plus royalties, while keeping the door open for collaboration on a separate program.
A2 Biotherapeutics, which closed $71.5 million in Series B funding in October, has two other programs that are further along in the lead optimization phase.
The new pact brings Mercks immunotherapy and other expertise for the Tmod candidate especially in the later stages of development, manufacturing and commercialization and enables A2 to build allogeneic product development and manufacturing capabilities, said Scott Foraker, A2s president and CEO. Amber Tong
Small rare diseases biotech Soligenix $SNGX did not have a good Tuesday.
The Princeton, NJ-based company posted a Phase III fail in head and neck cancer, saying its SGX942 program did not produce a statistically significant outcome. Soligenix had been looking to treat severely inflamed mucous membranes resulting from other cancer therapies, but came up short.
Tuesdays news crushed the companys stock price, as shares were sliced by more than half at a 54% drop as the market opened. The price rebounded slightly by the end of the day, but still resulted in a 49% loss.
Soligenix did not report a p-value from the primary endpoint, which was the median duration of severe oral mucositis. They did note the data showed a 56% reduction compared to placebo, as the median in the control arm came in at 18 days and 8 days in the treatment arm.
The company tried to shine a light on a positive secondary endpoint 50% reduction in the duration of SOM in the per-protocol population. Soligenixs p-value came in here at 0.049, just clearing the statistically significant hurdle. The biotech said this endpoint may point to some evidence of biological activity.
The study enrolled 268 patients randomized 1:1 to receive either SGX942 or placebo. Soligenix said it will turn its attention toward another program, SGX301, in the treatment of cutaneous T cell lymphoma. Max Gelman
Tapping a new source for new gene therapy programs, BridgeBio has set up a three-year alliance with the University of California, San Francisco to identify early translational research that it can accelerate into the clinic.
BridgeBio, which is based in the Bay Area, said the deal follows a six-month pilot and is designed to formalize collaborative relationships with academic scientists.
The collaborations may initially take the form of sponsored research agreements with certain labs, it added, which may then lead to creation of new affiliate companies under the BridgeBio portfolio.
That pipeline currently lists three programs, utilizing AAV vectors to deliver corrective genes for congenital adrenal hyperplasia, Canavan disease and nonsyndromic hearing loss, respectively.
They are ready for more. Earlier this year, BridgeBio inked an agreement with Catalent to secure dedicated gene therapy development and manufacturing capacity to support its needs down the line. Amber Tong
Gritstone Oncology $GRTS has some new cash to play with.
The Emeryville, CA-based biotech announced Wednesday morning it had raised $110 million in private placement funding. Wednesdays deal valued company shares at $3.34 apiece, or Tuesdays closing price, and Gritstone said the funding would be primarily directed toward its GRANITE and SLATE pipeline candidates, two cancer immunotherapies.
News of the funding was met with cheers by investors, as Gritstones stock was up more than 13% in early Wednesday trading.
GRANITE, a personalized neoantigen-based immunotherapy, is being evaluated in combination studies in the Phase II portion of a Phase I/II study for microsatellite stable colorectal cancer. SLATE is also neoantigen-based and uses the same delivery system as GRANITE, but contains a fixed set of antigens rather than personalized. Its also being looked at in combination studies at the Phase II portion of a Phase I/II trial for NSCLC.
The financing was led by existing and new investors, including Redmile Group, Avidity Partners and EcoR1 Capital. The deal is expected to close by Dec. 28. Max Gelman
After closing its Series A round, Epsilon Molecular Engineering opened it back up, bagging 570 million ($5.5 million) total from investors, two bank loans and leasing.
The Saitama University spinout will use the funds for its work with heavy chain single domain antibodies, including collaborative research with Kitasato University and Kao Corporation on potential Covid-19 treatments.
EME aims to discover medium sized molecular bio-drugs with new modalities using its proprietary VHH technology, president Naoto Nemoto said in a statement. We will leverage this financing to accelerate collaborative research with pharmaceutical manufacturers and internal research using its own pipeline.
The round was led by Mitsubishi UFJ Capital, with help from Gunma Medical Engineering Vitalization Investments, Gunma Bank and Kao Corporation. EME also went forward with a subordinated loan from Shoko Chukin Bank, a loan from Saitama Resona Bank, and a lease from Syutoken Leasing. Nicole DeFeudis
Recommendation and review posted by Bethany Smith
Biopharma Money on the Move: December 16-22 – BioSpace
Last call for raising funds beforeChristmas, andthese companies didnt hesitate to scoop up their bags of cash.
TG Therapeutics
TG has been on the Nasdaq for over sevenyears now, but 2020 has been theyear for the New Yorkbiopharmato soar.With shares trading atless than $11 apiece in January, the stock is now well over $50 since theannouncementof positive topline results from two global Phase III trials for relapsing forms of MS.With a high probability of FDA approval, TG cashed inwith an upsized common stock offering,raising$300 millionto further develop and commercializetheir therapies.
BioAtla
This San Diego company hopped on the bandwagon of biopharma IPOs last week, offering 10.5M million shares at $18 apiece, a 38% increase, scooping up$189 millionin proceeds.BioAtlais developing a novel class of specific and selective antibody-based therapeutics.The companys conditionally active biologics only activate when they detect proximity to a tumor, thereby reducingsystemictoxicity.Funds will propel the companys two lead programs through three Phase II trials.
Cullinan Oncology
Breaking down the silos of drug research, Cullinan applies open innovation and collaboration to developa portfolio of first-in-class and best-in-classcancer therapies. With an oversubscribed$131.2 millionSeries C, the Cambridge company can advanceitsseven-candidatepipelineinto the clinic.Each candidate isstructured as a separate company managed by Cullinan. Two are currently in Phase I with an inhibitor drug for NSCLC and amonoclonal antibody reinvigorating the MICA/NKG2D axis.
Neurogene
New York-basedNeurogeneis establishing itself as a leader in gene therapies for neurological diseases. Last weeks$115 millionSeries B round willhelp advance multiple of the companys candidates into the clinic. The first of which targetslate infantileBattens Disease,a rare nervous system disorder that worsens over time and is fatal, usually 8-10 years old.The funds will also be used to build outNeurogenesadeno-associated virus vector GMP manufacturing capabilities.
Neuron23
Having worked undercover for two years, Neuron23 uncloakedlast weekwith$113.5 millionin financing for its launch.$30 million of the funds came from Westlake Village BioPartners, who just announcedtwo funds totaling$500 millionwith the intent to invest in Series A startups in the most promising companies.Neuron23 has hit the ground running, aiming to take on Parkinsons diseaseagainst giant Biogen, who recentlyorchestratedin a $1 billion dealwith Denaliwith the same target in mind. The plan is to start trials with healthy volunteers next year.
Neomorph
Established earlier this year, San Diego-based Neomorph raked in$109 millionin a Series A. The companys focus is on targeted proteindegradation, which offers opportunities for treatment developments across the board, including oncology.The Neomorph team has deep expertise in pharmacological approaches to targeted protein degradation and we are excited to be developing new therapeutics for patients with diseases that are currently difficult to treat, said scientific founderScottArmstrongMD, Professor of Pediatrics at Harvard Medical School and the Dana-Farber Cancer Institute.
AtsenaTherapeutics
Gene therapy startupAtsenaclosed on an oversubscribed$55 millionSeries A.The funds will be used to advance itsgene therapy for one of the most common cause of blindness in children through clinical trials.Leber congenital amaurosis (LCA) causes blindness in 2 to 3 out of 100,000 newborns.The company isalso planning for growth,looking to move into a larger space next yearto scale up gene therapy manufacturing. Ramping up across the board, theres a goal to hire 20 more positions with the move.
ONL Therapeutics
With support from Johnson & Johnson and more, Michigan-based ONL closed a$46.9 millionSeries B Preferred Stock financing round.The company is developing therapies for protecting the patients with retinal disease from vision loss.This funding supports the completion of a Phase 1 study in retinal detachment with ONLs lead compound ONL1204. In addition, the funding will advance ONL1204 in two chronic indications, glaucoma and dry age-related macular degeneration.
Peptilogics
Peptilogicsis the most recent biotech receiving investments fromPaypalsco-founder Peter Thiel. This week, Thiel participated in a$35 millionfinancing round for the Pennsylvania-basedcompany.The funds will be used to advancePeptilogicsproprietarycomputational peptide drug design and discovery platform. The platform discovers connections in diverse biomedical data and maps peptide sequences.
Octave Bioscience
Looking totakeitsfully integratedcare management platform to the next level, Octave completed a$32 millionSeries B financing round. The funds will allow thecompany to complete development of management products and services, expand clinical data and begin commercialization to neurologists and patients. Octaves first target has been multiple sclerosis patients, but will expand to other chronic, debilitating neurodegenerative diseases. Theplatformtracksblood-basedbiomarkers, enhanced MRI insights and mobile patient monitoring tools to feed intocare pathwaymodels to generatebetter patient outcomes and lower costs.
Vivace Therapeutics
Small molecule player Vivace closed a$30 millionSeries C for further development of its first-in-class therapies targeting the Hippo pathway. Funds will be usedto take its lead candidate into first-in-human studies in early 2021, targeting tumors dependent on activated YAP.Pre-clinical research has shown promise for the candidate both as a monotherapy and in combination with other anti-cancer therapies.
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Biopharma Money on the Move: December 16-22 - BioSpace
Recommendation and review posted by Bethany Smith
Ziopharm Oncology Announces Clearance of Taiwan’s First IND of Non-viral CAR-T for the Treatment of Relapsed CD19+ Leukemias and Lymphomas -…
Advances Eden BioCells clinical program to validate Rapid Personalized Manufacturing (RPM)
Clinical trial to study autologous CD19-specific CAR-T using RPM technology designed to reduce cost and simplify production for infusion the day after gene transfer
BOSTON, Dec. 21, 2020 (GLOBE NEWSWIRE) -- Ziopharm Oncology, Inc. (Ziopharm or the Company) (Nasdaq: ZIOP), today announced that the Taiwan Food and Drug Administration has cleared an investigational new drug application (IND) from Eden BioCell, a joint venture between Ziopharm and cell therapy company TriArm Therapeutics, for its phase 1 clinical trial to evaluate patient-derived CD19-specific CAR-T, using Ziopharms Rapid Personalized Manufacturing (RPM) technology. This is an investigational treatment for patients with relapsed CD19+ leukemias and lymphomas and the first clinical study of autologous non-viral CD19-specific CAR-T in Taiwan.
This trial will utilize Ziopharms non-viral Sleeping Beauty cell engineering technology to infuse autologous CAR-T the day after T cells have been genetically modified. Ziopharms RPM CD19-specific CAR-T therapy results from the stable, non-viral insertion of DNA into the genome of resting T cells to co-express the chimeric antigen receptor (CAR), membrane-bound IL-15 (mbIL15) and a safety switch. The trial is being conducted at National Taiwan University Hospital.
This study is a testament to the relationship Ziopharm has quickly established with Eden BioCell and TriArm and the progress using patients T cells under RPM to target malignancies, said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of Ziopharm. The results will help us understand the benefit of engineering T cells with membrane bound IL-15 which could benefit not only CAR-T, but also the engineering of T cells to express T-cell receptors.
Jay Zhang, Co-Founder and Chief Executive Officer of TriArm, added, We are very excited to receive clearance of our IND in Taiwan. The learnings from this study will build upon the encouraging early data we are seeing with patients treated with RPM CAR-T targeting CD19 malignancies under compassionate use. We believe our approach has the potential to transform CAR-T therapy by dramatically decreasing the amount of time needed for manufacturing engineered T cells, thereby increasing efficacy and decreasing cost.
CAR-T therapy has proved an effective therapy for B-cell cancers, noted Dr. Shang-Ju Wu, Division of Hematology, Department of Internal Medicine, National Taiwan University Hospital and Principal Investigator for the study. Further optimization by shortening the manufacturing time would be of great importance to make this therapy more available to patients. We are honored to be involved in the clinical development of this non-viral CAR-T therapy produced using RPM. We hope the data derived from this current trial will advance CAR-T therapy to benefit our patients.
Up to 24 patients with relapsed CD19+ leukemias and lymphomas will be enrolled in this phase 1 trial, with the goal of infusing 16 subjects (Taiwan FDA #1096030182). The primary endpoint of the study is to evaluate the safety and tolerability of autologous CD19-specific T cells manufactured using the RPM process.
About Eden BioCell In December 2018, Ziopharm and TriArm Therapeutics announced the launch of Eden BioCell to lead clinical development and commercialization of Sleeping Beauty-generated CAR-T therapies in Greater China. Ziopharm licensed the rights to Sleeping Beauty-generated CAR-T therapies targeting the CD19 antigen using Ziopharms RPM technology in Greater China to Eden BioCell. TriArm has committed up to $35 million to this joint venture, and Eden BioCell is owned 50-50 by Ziopharm and TriArm.
About TriArm TherapeuticsTriArm Therapeutics is a cell therapy company formed by Panacea Venture with R&D operations in Germany, United States and Greater China region. The company is dedicated to the treatment of cancer and autoimmune diseases.
About Ziopharm Oncology, Inc.Ziopharm is developing non-viral and cytokine-driven cell and gene therapies that weaponize the bodys immune system to treat the millions of people globally diagnosed with cancer each year. With its multiplatform approach, Ziopharm is at the forefront of immuno-oncology. Ziopharms pipeline is built for commercially scalable, cost effective T-cell receptor T-cell therapies based on its non-viral Sleeping Beauty gene transfer platform, a precisely controlled IL-12 gene therapy, and rapidly manufactured Sleeping Beauty-enabled CD19-specific CAR-T program. The Company has clinical and strategic collaborations with the National Cancer Institute, The University of Texas MD Anderson Cancer Center and Regeneron Pharmaceuticals. For more information, please visit http://www.ziopharm.com.
Forward-Looking Statements DisclaimerThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These statements include, but are not limited to, statements regarding the potential benefits of the Companys CAR-T therapy and the Companys expectations regarding the number of patients expected in this phase 1 clinical trial. Although Ziopharms management team believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Ziopharm, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, changes in Eden BioCells operating plans that may impact its cash expenditures, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Ziopharms product candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies and for which indication; the strength and enforceability of Ziopharms intellectual property rights; competition from other pharmaceutical and biotechnology companies as well as risk factors discussed or identified in the public filings with the Securities and Exchange Commission made by Ziopharm, including those risks and uncertainties listed in Ziopharms Quarterly Report on Form 10-Q filed by Ziopharm with the Securities and Exchange Commission. We are providing this information as of the date of this press release, and Ziopharm does not undertake any obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason.
Investor Relations Contacts:Adam D. Levy, PhD, MBAEVP, Investor Relations and Corporate CommunicationsT: 508.552.9255E: alevy@ziopharm.com
Media Relations Contact:LifeSci Communications:Patrick BurseyT: 646.876.4932E: pbursey@lifescicomms.com
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Recommendation and review posted by Bethany Smith
Ocugen Establishes Vaccine Scientific Advisory BoardLeading experts to evaluate the clinical and regulatory path to approval in the US market of…
MALVERN, Pa., Dec. 23, 2020 (GLOBE NEWSWIRE) -- Ocugen, Inc., (NASDAQ: OCGN), a leading biopharmaceutical company focused on discovering, developing and commercializing a pipeline of innovative therapies, today announced the appointment of a vaccine scientific advisory board comprised of leading academic and industry experts in the vaccine field to evaluate the clinical and regulatory path to approval in the US market of Bharat Biotechs COVAXIN, a whole-virion inactivated COVID-19 vaccine candidateto be co-developed by Ocugen and Bharat Biotech for the US market.
Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen remarked, We are thrilled to welcome this group of esteemed thought leaders to the Ocugen team to assist in our co-development with Bharat Biotech of COVAXIN. This unique yet traditional vaccine candidate is different from other options currently available in the US market with potentially broader coverage against multiple protein antigens of the virus.
The vaccine scientific advisory board consists of:
About Ocugen, Inc.Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing transformative therapies to cure blindness diseases. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug one to many and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. For more information, please visit http://www.ocugen.com.
Cautionary Note on Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as predicts, believes, potential, proposed, continue, estimates, anticipates, expects, plans, intends, may, could, might, will, should or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (the SEC), including the risk factors described in the section entitled Risk Factors in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.
Ocugen Contact:Ocugen, Inc.Sanjay SubramanianChief Financial Officerir@ocugen.com
Media Contact:LaVoieHealthScienceLisa DeScenzaldescenza@lavoiehealthscience.com+1 978-395-5970
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Allogene Therapeutics Receives IND Clearance from the U.S. Food and Drug Administration for ALLO-715 in Combination with Nirogacestat in…
SOUTH SAN FRANCISCO, Calif., Dec. 23, 2020 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) therapies for cancer today announced that theU.S. Food & Drug Administration(FDA) has cleared an Investigational New Drug (IND) application to study ALLO-715, Allogenes investigational BCMA AlloCAR T therapy, in combination with nirogacestat, SpringWorks Therapeutics investigational gamma secretase inhibitor (GSI), in patients with relapsed or refractory multiple myeloma. This combination is part of the companys multi-pronged strategy to develop a treatment for multiple myeloma and will be deployed in the ongoing UNIVERSAL trial. Enrollment in this cohort is expected to begin in the first quarter of 2021.
We are delighted that the FDA has cleared our IND application for ALLO-715 in combination with nirogacestat, said Rafael Amado, M.D., Executive Vice President of Research & Development and Chief Medical Officer of Allogene. We look forward to investigating this combination as part of our comprehensive anti-BCMA strategy aimed at optimizing cell therapy for patients with relapsed/refractory multiple myeloma.
Gamma secretase is an enzyme that cleaves BCMA from the surface of myeloma cells. In preclinical models, nirogacestat has been shown to prevent the cleavage and shedding of BCMA, leading to an increase in the cell surface density of BCMA and reduced levels of soluble BCMA.1 Increasing BCMA surface expression with gamma secretase inhibitor may enable deeper and more durable responses to ALLO-715 in patients with multiple myeloma.
Multiple myeloma is the second most common hematological malignancy in the United States, with 32,270 new cases and 12,830 deaths estimated in 2020.2
The Phase 1 combination trial is being advanced pursuant to a clinical trial collaboration agreement that Allogene and SpringWorks entered into in January 2020. Under the terms of the agreement, Allogene is sponsoring and conducting the Phase 1 study to evaluate the safety, tolerability and preliminary efficacy of the combination, and is assuming all development costs associated with the study, other than expenses related to the manufacturing of nirogacestat and certain expenses related to intellectual property rights. Allogene and SpringWorks have formed a joint development committee to oversee the clinical study.
About ALLO-715ALLO-715, an AlloCAR T therapy targeting B-cell maturation antigen (BCMA), is a potential novel treatment for multiple myeloma and other BCMA-positive malignancies. Multiple myeloma originates in the bone marrow and it is characterized by abnormalities in plasma cells that reproduce uncontrollably in the bone marrow and other disease sites.3 Multiple myeloma is incurable for most patients, as relapses occur despite most treatments available.4 Initial results from the Phase 1 UNIVERSAL study of ALLO-715 in relapsed/refractory multiple myeloma were presented at an oral session of the American Society of Hematology (ASH) annual meeting in December 2020. This study also uses ALLO-647, Allogene's anti-CD52 monoclonal antibody (mAb), as a part of its differentiated lymphodepletion regimen.
ALLO-715 utilizes the TALEN gene-editing technology pioneered and owned by Cellectis. Allogene has an exclusive license to the Cellectis technology for allogeneic products directed at the BCMA target. Allogene holds the global development and commercial rights for this investigational candidate.
About NirogacestatNirogacestat is an investigational, oral, selective, small molecule gamma secretase inhibitor in Phase 3 clinical development for desmoid tumors, which are rare and often recurrent, debilitating and disfiguring soft-tissue tumors. Gamma secretase cleaves multiple transmembrane protein complexes, including Notch, which is believed to play a role in activating pathways that contribute to desmoid tumor growth.
In addition, gamma secretase has been shown to directly cleave membrane-bound BCMA, resulting in the release of the BCMA extracellular domain, or ECD, from the cell surface. By inhibiting gamma secretase, membrane-bound BCMA can be preserved, increasing target density while reducing levels of soluble BCMA ECD, which may serve as decoy binding molecules for BCMA-directed therapies. Nirogacestats ability to enhance the activity of BCMA-directed therapies has been observed in preclinical models of multiple myeloma.
Nirogacestat has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of desmoid tumors (June 2018) and from the European Commission for the treatment of soft tissue sarcoma (September 2019). The FDA also granted Fast Track and Breakthrough Therapy Designations for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis (November 2018 and August 2019).
AboutAllogene TherapeuticsAllogene Therapeutics, with headquarters inSouth San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of off-the-shelf CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visitwww.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
Forward-Looking StatementsThis press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the ability and timing to initiate a clinical trial of ALLO-715 in combination with nirogacestat; ability to manufacture ALLO-715; the ability of ALLO-715 in combination with nirogacestat to enable deeper or more durable responses; and the potential benefits of AlloCAR T therapy. Various factors may cause differences between Allogenes expectations and actual results as discussed in greater detail in Allogenes filings with the SEC, including without limitation in its Form 10-Q for the quarter ended September 30, 2020. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
AlloCAR T is a trademark of Allogene Therapeutics, Inc.
Allogene Media/Investor Contact:Christine CassianoChief Communications Officer(714) 552-0326Christine.Cassiano@allogene.com
1 Eastman S, Shelton C, Gupta I, Krueger J, Blackwell C, Bojczuk. Synergistic activity of belantamab mafodotin (anti-BCMA immuno-conjugate) with PF-03084014 (gamma-secretase inhibitor) in Bcma-expressing cancer cell lines. Blood. 2019;134(supplement_1):4401. doi.org/10.1182/blood-2019-123705.2 https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html3 Multiple myeloma - Genetics Home Reference - NIH. Retrieved from https://ghr.nlm.nih.gov/condition/multiple-myeloma#4 Sonneveld P, Broijl A. Treatment of relapsed and refractory multiple myeloma. Haematologica. 2016;101(4):396-406
Recommendation and review posted by Bethany Smith