News
FEATURED STORIES
Regulators on both sides of the Atlantic are pushing for the withdrawal of the rare disease treatment that accounted for just 1% of Amgen’s 2025 revenue. Nevertheless, Amgen continues to defend the medicine, which was acquired in the $3.7 billion buyout of ChemoCentryx.
Psychedelics are gaining momentum in depression, with one treating physician predicting that the drug class could “wipe out the SSRIs” if safety and durability hold up.
Saol Therapeutics is the latest biotech to resubmit for approval of a drug rejected under former FDA Commissioner Marty Makary, following REGENXBIO and Replimune.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
THE LATEST
The FDA has greenlit the use of Johnson & Johnson’s Tecvayli in heavily pretreated adult patients with relapsed or refractory multiple myeloma.
BioSpace checked in with some of the members of our NextGen Bio Class of 2022 to see what they’ve done to earn their place on the list - and what’s on the horizon.
Ipsen hit another stumbling block in its bid for an FOP approval as the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee postponed its meeting on the NDA for palovarotene capsules.
GSK terminated its cell therapy pact with Lyell Immunopharma. It’s opting to advance its own programs without use of Lyell’s T-cell modulating technologies that were at the center of the partnership.
AstraZeneca reported Tuesday that its Phase III MESSINA trial hit one primary endpoint but missed the other. The study was evaluating Fasenra in eosinophilic esophagitis.
Novartis’ positive-third quarter growth report was slightly marred by several clinical setbacks that resulted in the termination of studies in liver transplant and non-small cell lung cancer.
Taysha Gene Therapies has entered into a strategic equity investment and licensing deal with Astellas. The latter stands to gain access to Taysha’s gene therapy development programs for Rett syndrome and GAN.
Data from two Phase I trials indicate Gritstone Bio’s samRNA vaccine can safely induce a strong and durable immune response against COVID-19.
In the near future, painful jabs and muscle soreness that persists for days could be replaced by new immunization approaches including intradermal delivery, edible and intranasal vaccines.
Mirum Pharmaceuticals announced that Livmarli oral solution met its primary endpoint in the Phase III MARCH study in young patients with progressive familial intrahepatic cholestasis.