Biotech: Page 88
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Dufour, Tia. (2020). "White House Coronavirus Update Briefing" [Photograph]. Retrieved from Flickr.
Slaoui steps down from two more biotechs after harassment claim
The former Warp Speed leader resigned from leadership roles at VaxCyte and Centessa Pharmaceuticals after being fired by GlaxoSmithKline over harassment allegations.
By Ned Pagliarulo • March 25, 2021 -
Crunching the numbers on a busy first quarter for biotech IPOs
Seven gene or cell therapy developers have now gone public in the first quarter, outpacing each of the past three years. Biopharma Dive examined the class of 2021's performance.
By Ben Fidler • March 19, 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 -
Yujin Kim/BioPharma Dive
With new results, Sarepta's 2nd gene therapy holds steady
Stung by a clinical trial miss in Duchenne muscular dystrophy, the biotech now has promising, if early, data to back a gene therapy for a different rare neuromuscular disease.
By Jonathan Gardner • March 19, 2021 -
A first-of-its-kind mRNA drug falls short in cystic fibrosis
A treatment that sprays synthetic messenger RNA into the lungs failed to help cystic fibrosis patients, a blow to efforts to use the technology for more than vaccines.
By Ben Fidler • March 18, 2021 -
Kendall Davis/BioPharma Dive
Gilead, still aiming at NASH, broadens an alliance with Novo
With positive safety data in hand, the partners will advance work pairing the diabetes medicine Ozempic with two experimental treatments to see if they can reverse the liver disease, which has proven a tough target for drugmakers.
By Jonathan Gardner • March 18, 2021 -
Bluebird's top doctor to depart as company grapples with safety review
David Davidson has served as Bluebird's chief medical officer since 2012. He'll leave in one month, per a separation agreement with the company.
By Ned Pagliarulo • March 17, 2021 -
Global Blood takes on more sickle cell drugs through Sanofi deal
Global Blood says the two acquired programs could complement Oxbryta, its marketed sickle cell drug that gained approval in late 2019.
By Jacob Bell • March 16, 2021 -
Elevate Bio raises half a billion dollars to fuel cell, gene therapy expansion
Softbank and Fidelity joined a large group of investors in a $525 million Series C investment into Elevate, a high-powered genetic medicine startup with an unusual business model.
By Ned Pagliarulo • March 15, 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 breaks through with study success for COVID-19 antibody
A data monitoring board said a study testing Vir's drug should be stopped early because of an overwhelming benefit from treatment.
By Kristin Jensen • March 11, 2021 -
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 -
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
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