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Partners Summit Therapeutics and Akeso are expected to steal the show at the American Society of Clinical Oncology’s annual conference with data from their potential Keytruda rival, alongside Revolution Medicine’s groundbreaking pancreatic cancer candidate and other assets that could reshape patient care.
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While the pathogen appears unlikely to trigger a pandemic, analysts see potential for Moderna to build goodwill amid a period of political pressure on vaccine manufacturers.
Clinical trial setbacks have limited the near-term opportunities for some of Daiichi Sankyo’s ADCs but the drug developer is betting near-term readouts will catapult it into the top tier of oncology companies in the coming years.
BioSpace analyzed the pay ratio across 10 major pharmaceutical companies to determine which CEOs were paid the most relative to typical employees. J&J, Eli Lilly and Pfizer once again topped the list.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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As the spread of the Omicron variant of COVID-19 picks up speed, vaccine makers are rushing to test their shots against the new mutation, with mixed results.
Novartis announced it has licensed BeiGene’s ociperlimab, a late-stage TIGIT inhibitor, to bolster its immunotherapy pipeline.
On Monday, Intra-Cellular Therapies announced that the FDA has approved CAPLYTA to treat the deep depressive episodes of patients with bipolar I or II.
The year kicked off with a bang as multiple companies raced to a public listing.
The decision comes after the FDA granted the drug, Tezspire (tezepelumab), Priority Review status on positive results from the PATHFINDER clinical trial program.
VYVGART is the first-and-only neonatal Fc receptor (FcRn) blocker to be approved by the FDA.
After their latest trial delivered disappointing results, Pfizer and BioNTech are ready to test if a third dose of their COVID-19 vaccine would trigger an immune response in very young children.
On December 28, the U.S. Food and Drug Administration reported there had been 50 novel drug approvals for the year, and that was just for new chemical entities.
Shares of Global Blood Therapeutics were up more than 10% in late-afternoon trading following regulatory approval of a supplemental New Drug Application for oral Oxbryta (voxelotor) tablets for the treatment of pediatric sickle cell disease.
Although the U.S. FDA largely cleared its calendar ahead of the holidays, it still has a couple open PDUFA dates leading up to January 1, 2022. Here’s a look.