Biotech: Page 77
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Vertex begins human testing for diabetes cell therapy
While Vertex is confident in the therapy, which came via the $1 billion acquisition of Semma Therapeutics, it will still be a few years before the company has a good read on its effects in Type 1 diabetes patients.
By Jacob Bell • March 10, 2021 -
Acadia shares plunge after unexpected FDA feedback
According to Acadia, the FDA had said multiple times that there were no problems with its drug approval application. But last week, the agency surprisingly reversed course.
By Jacob Bell • March 9, 2021 -
Explore the Trendline➔
Spencer Platt via Getty Images
TrendlineEmerging biotech
New biotechs continue to emerge despite a challenging market environment that has forced venture firms to build their drug startups more cautiously.
By BioPharma Dive staff -
Galapagos reports long-awaited safety data for inflammation drug
The data show similar declines in sperm counts among patients on the Belgian biotech's drug, filgotinib, or a placebo. But it's unclear whether that finding will appease the FDA, which surprisingly rejected filgotinib last year.
By Jacob Bell • March 4, 2021 -
National Institute of Allergy and Infectious Disease. (2020). "Novel Coronavirus SARS-CoV-2" [Microscope image]. Retrieved from https://www.flickr.com/photos/nihgov/49565158853/.
Vir shares tumble after apparent setback for COVID-19 drug
The NIH stopped enrolling patients hospitalized with coronavirus disease into a study of Vir's antibody drug after data monitors questioned its effectiveness.
By Jonathan Gardner • March 3, 2021 -
Takeda takes full control of drug for rare epilepsies
A new agreement with Ovid Therapeutics has Takeda paying almost $200 million to secure global rights to soticlestat, an experimental treatment for certain brain diseases.
By Jacob Bell • March 3, 2021 -
FibroGen shares sink as FDA meeting decision suggests another delay for top drug
The biotech expected the FDA to rule on approval of its anemia drug by March 20. But a newly announced advisory committee meeting seems to make a decision by then unlikely.
By Ned Pagliarulo • March 2, 2021 -
A closely watched schizophrenia drug fails key test
Though a mid-stage study read out negative, Neurocrine still sees a path forward for the drug, which it licensed from Takeda last summer.
By Jacob Bell • March 2, 2021 -
Courtesy of Sarepta
Sarepta wins FDA approval of another drug for rare muscular dystrophy
Amondys 45 is now cleared for the estimated 8% of Duchenne patients eligible for treatment. Like other Sarepta drugs, it comes with a high price tag and its clinical benefits haven't been confirmed.
By Jacob Bell • Feb. 25, 2021 -
Top Moderna executive to leave company later this year
Tal Zaks, the biotech's chief medical officer for the past six years, will depart in September after playing a high-profile role in the company's coronavirus vaccine development.
By Ned Pagliarulo • Feb. 25, 2021 -
Regeneron wins FDA OK in lung cancer for immunotherapy rival to Merck's Keytruda
The approval of Libtayo in first-line lung cancer will pit Regeneron's drug, developed in partnership with Sanofi, against Merck's top-selling immunotherapy Keytruda.
By Ben Fidler • Feb. 22, 2021 -
Jacob Bell/BioPharma Dive
After FDA feedback, a biotech's ALS therapy faces murky path forward
Brainstorm Cell Therapeutics said that, following a review of Phase 3 data, the agency felt the results were not enough to support an approval application.
By Jacob Bell • Feb. 22, 2021 -
Getty Images
Sponsored by SGSAnalytical quality by design: Development of cell-based bioassays
Care needs to be taken during analytical development to ensure methodologies firstly, reflect the MoA, and are also reproducible, accurate, and robust.
By Alex Perieteanu, Ph.D. and Aanchal Mehra, M.Sc • Feb. 22, 2021 -
Courtesy of Novavax
Novavax broadens reach of global coronavirus vaccine alliance with new deal
As more transmissible variants spread across the globe, there's growing urgency to equitably allocate vaccine supplies. A deal between Novavax and COVAX will significantly bolster that effort.
By Ben Fidler • Feb. 19, 2021 -
Courtesy of BioNTech
Pfizer, BioNTech ask FDA approval to ease temperature requirements for coronavirus shot
Testing showed the vaccine could be safely stored at normal freezer temperatures, rather than the roughly minus 70 degrees Celsius now specified. The change, if cleared by the agency, will help distribution.
By Jonathan Gardner • Feb. 19, 2021 -
Courtesy of Adjuvant Capital
Investment firm raises $300M to fund medical research for overlooked diseases
Adjuvant Capital's first fund drew interest from Merck and Novartis as well as philanthropies and other investment firms.
By Kristin Jensen • Feb. 18, 2021 -
GSK returns to Vir with expanded deal to develop drugs for flu, other viruses
The British drugmaker will pay the San Francisco-based biotech $225 million upfront, while also investing another $120 million in Vir shares.
By Kristin Jensen • Feb. 17, 2021 -
Getty / Edited by BioPharma Dive
Bluebird stops studies of sickle cell gene therapy after new cancer cases
The biotech is also suspending sales of its related treatment Zynteglo following a leukemia diagnosis in a clinical trial volunteer and a case of a cancer-like bone marrow disease in another.
By Ben Fidler , Ned Pagliarulo • Updated Feb. 16, 2021 -
Permission granted by Centessa Pharmaceuticals
10 biotechs become 1: Centessa launches with $250M to prove unorthodox R&D model
The new company will be led by Saurabh Saha, a former Bristol Myers executive, and Moncef Slaoui, who until recently led the U.S. government's coronavirus vaccine program.
By Ned Pagliarulo • Feb. 16, 2021 -
Danielle Ternes/BioPharma Dive
A gene therapy pipeline takes shape for a cluster of rare diseases
Lysosomal storage disorders, diseases of cellular metabolism gone wrong, are the focus of a fast-expanding lineup of experimental genetic medicines, a research boom that recalls biotech's roots.
By Ned Pagliarulo • Feb. 12, 2021 -
Courtesy of Galapagos
Gilead, Galapagos halt development of experimental drug, denting research alliance
Independent reviewers found the benefits of the lung disease drug didn't outweigh its risks, marking a second major setback in six months for the companies' partnership.
By Kristin Jensen • Feb. 11, 2021 -
Getty / Edited by BioPharma Dive
A new startup gets Takeda's backing to take complex genetic medicines 'off the shelf'
Ensoma debuts with a lucrative alliance with the Japanese pharma and an unusual way to deliver genetic medicines into the body.
By Ben Fidler • Feb. 11, 2021 -
Getty / Edited by BioPharma Dive
AbbVie exploring how CRISPR gene editing can improve cell therapies
Using technology from Caribou Biosciences, AbbVie hopes to engineer "off-the-shelf" CAR-T cells that can better withstand attacks from the immune system.
By Jacob Bell • Feb. 10, 2021 -
Elizabeth Regan/BioPharma Dive
Small biotech gets big win on treatment for rare swelling disorder
An oral hereditary angioedema treatment from KalVista Pharmaceuticals looks similarly effective to standard injectables, which could threaten big-selling drugs from Takeda and others.
By Jonathan Gardner • Feb. 9, 2021 -
Courtesy of Editas Medicine
Editas names new CEO in latest executive shakeup
James Mullen, chair of Editas' board and a former Biogen CEO, will replace Cynthia Collins in a critical year for the gene editing biotech.
By Ned Pagliarulo • Feb. 8, 2021 -
Jacob Bell/BioPharma Dive
PTC aims again for FDA review of Duchenne drug despite latest miss
The FDA has rejected PTC's treatment three times, but the biotech's CEO hopes the "totality" of the results it's now accrued will finally lead to a different outcome.
By Jonathan Gardner • Feb. 5, 2021
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