Biotech
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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 -
Moderna
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 -
Explore the Trendline➔
Getty Images
TrendlineThe BioPharma Dive Outlook on 2021
M&A appears to be ticking higher after a slow 2020, while a series of setbacks has renewed questions around gene therapy. Several key clinical trial readouts also loom. Here's what to watch in biotech and pharma this year.
By BioPharma Dive staff -
Regeneron
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 -
Reptile8488 via 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 -
GlaxoSmithKline
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 at 10:24 a.m. -
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 / Industry 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. 09, 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. 08, 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. 05, 2021 -
Permission granted by Gilead Sciences
Gilead sales propped up by COVID-19 drug Veklury
Sales of the antiviral drug accounted for a quarter of the biotech's product revenue in the fourth quarter, disguising hits to its business elsewhere.
By Ned Pagliarulo • Feb. 05, 2021 -
Nasdaq
With $588M IPO, Sana leads wave of new biotechs going public
Nine other drug developers are set to price initial public offerings this week, extending a record run of financing activity from last year. Sana's is one of the largest in recent history.
By Ben Fidler • Feb. 03, 2021 -
Permission granted by Biogen
Biogen laser-focused on Alzheimer's drug as rest of business falters
While the biotech prepares to launch aducanumab, its latest earnings report shows significant hits to top-selling drugs, plus another pipeline failure.
By Jacob Bell • Feb. 03, 2021 -
Jacob Bell
Jazz Pharma to buy GW Pharma, maker of CBD-based epilepsy drug, for $7.2B
The deal gives Jazz, best known for its sleep disorder drugs, access to Epidiolex, the first prescription cannabidiol medicine approved by the FDA.
By Ned Pagliarulo • Feb. 03, 2021 -
Ryan McKnight, Vertex Pharmaceuticals Inc.
Vertex comes to a crossroads
The biotech's cystic fibrosis business is booming. But with a pipeline of risky, disjointed assets, some on Wall Street aren't sure what Vertex's next move is, or why it hasn't been spending its massive amounts of cash.
By Jacob Bell • Feb. 02, 2021 -
Rita Elena Serda
Shifting strategy, Coherus buys rights to experimental cancer drug
The biosimilar maker will develop an immunotherapy rival to Merck's Keytruda via a deal with China's Junshi Biosciences.
By Jonathan Gardner • Feb. 01, 2021 -
Permission granted by Gilead Sciences
Gilead partners with a cancer biotech, seeking to develop an HIV immunotherapy
Gritstone Oncology, known for its cancer research, is drawing attention in infectious disease, signing a deal with Gilead two weeks after announcing plans to develop a coronavirus vaccine.
By Ned Pagliarulo • Feb. 01, 2021
