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Ecnoglutide, which Pfizer licensed from Sciwind Biosciences, is already approved in China for type 2 diabetes mellitus, and a marketing application for weight loss has been accepted by regulatory authorities in the country.
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Sales of Merck’s longtime oncology blockbuster Keytruda will erode more starkly in about 2033 rather than 2029, predicts Bloomberg Intelligence, translating to some $22 billion more in revenue.
The necessity of delivering medicine days after it’s produced drives decisions about where to build facilities and how to ship radioactive materials to healthcare providers.
The first gene therapies approved to treat sickle cell disease in December 2023 are struggling on the market. But there are glimpses of forward momentum as Vertex and Genetix Bio provide updates.
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Following the FDA’s refusal to review Moderna’s investigational mRNA flu vaccine last week, Commissioner Marty Makary faced questions from the U.S. president about the agency’s handling of vaccines. It’s a clear signal that the tension long brewing at the drug regulator has now gone all the way to the top.
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Big Pharma had plenty of drama to keep journalists busy this quarter, which painted an accurate portrait of the wild and wonderful world of biopharma.
Trump’s HHS pick, Robert F. Kennedy Jr., is an anti-vaccine campaigner who has previously said that he plans to gut the FDA on allegations of corruption and reduce the NIH’s headcount.
BMS has so far been on a winning streak in the contingent value right cases, which allege that the pharma intentionally delayed regulatory activities for Breyanzi in order to avoid a $6.4 billion payout to Celgene shareholders.
Gilead’s layoffs include 72 employees at its Seattle location, which will close. Kite will shut down its Philadelphia facility. The layoffs are attributed to aligning resources with long-term strategic goals.
The November layoffs are the second known workforce reduction this year for Marinus Pharmaceuticals, which previously announced disappointing Phase III results for ganaxolone in two clinical trials.
Allogene is ceasing enrollment in a Phase I trial of cema-cel for patients with relapsed or refractory chronic lymphocytic leukemia after Bristol Myers Squibb’s Breyanzi was approved in the indication earlier this year.
Despite recent enthusiasm around the PD-1/VEGF space, BMO Capital Markets analyst Evan Seigerman noted that Merck’s pact with LaNova Medicines is more “conservativism” on the pharma’s part than confirmatory of recent data in the drug class.
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GSK is carving out a niche for Blenrep in the second-line multiple myeloma setting, for which it projects multi-blockbuster potential for the antibody-drug conjugate.
Following strong treatment response data for Adaptimmune’s lete-cel, the biotech is planning to initiate a rolling BLA submission to the FDA, set to start by the end of 2025.