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FDA
Pfizer will go toe-to-toe with CSL Behring following the FDA’s Friday approval of its hemophilia B gene therapy Beqvez and will launch a warranty program based on the durability of response.
The genetic engineering startup, recently honored by BioSpace readers for its work environment, is downsizing as it seeks to launch its first clinical trials.
Is there a connection between Bristol Myers Squibb’s announcement that it will reduce its headcount by 6% and the company’s recent acquisitions of Karuna, Mirati and RayzeBio?
Ketabon is working to develop a medication that harnesses ketamine’s antidepressant effects without the safety issues that currently prohibit its at-home use.
Several companies—including Roche, Curemark and Yamo Pharmaceuticals—are running clinical trials of treatments that aim to offset the myriad challenges of autism.
Sanofi is dropping its Sjögren’s syndrome candidate due to disappointing Phase II efficacy data, while AstraZeneca is stopping work on some early-stage assets amid a portfolio reprioritization.
Merck’s bestselling immunotherapy raked in $6.9 billion in the first quarter of 2024. Analysts had been expecting $6.71 billion in Keytruda sales, according to estimates from FactSet.
Regeneron will use Mammoth Biosciences’ tiny Cas enzymes to deliver in vivo CRISPR-based gene editing therapies to tissues and cell types beyond the liver, the companies announced Thursday.
Bristol Myers Squibb announced Thursday it is implementing major cost-cutting measures including thinning out its management layers. The pharma also reported modest revenue growth despite taking a 6% sales hit for lung cancer therapy Opdivo.
Sen. Bernie Sanders (I-Vt.) on Wednesday launched an investigation into the exorbitant prices of Novo Nordisk’s Ozempic and Wegovy blockbusters, and has asked the Danish drugmaker to justify their price tags.
FDA
The regulator on Wednesday gave its approval for a new oral antibiotic to treat uncomplicated urinary tract infections in women. UTILITY therapeutics expects to launch Pivya in the U.S. in 2025.
The FTC’s final rule banning most new noncompetes should go into effect later this year, although it faces opposition from the U.S. Chamber of Commerce.
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