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FDA
As tariffs, HHS workforce cuts and the ouster of CBER Director Peter Marks threaten the “lifeblood” of the cell and gene therapy space, experts express wariness over the unknowns and optimism that Marks’ legacy will carry on.
FDA
As Marty Makary nears the end of his first month on the job, the FDA Commissioner sat down for two interviews, offering statements that alternatively contradict and jibe with reported events.
Presentations at this year’s American Association for Cancer Research meeting could have a broad impact on the treatment landscape for head and neck and lung cancer, and implications for specific drug modalities like TIGIT and VEGF.
Job Trends
ImmunityBio will part with 10 employees this quarter. Last fall, it cut 31 employees. The moves come as the biotech works to advance Anktiva in non-small cell lung cancer.
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As I ran from interview to interview across San Francisco, I was consistently warmed by the stories I was told by biotech and pharma executives—and the general comradery in the air throughout the chaotic event.
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Vertex has recorded some 25,000 prescriptions for Journavx since its January approval and is in the process of getting big PBMs to cover the non-opioid pain drug.
The biotech’s Huntingtin-targeting molecule lowered blood levels of the protein and elicited functional improvements in earlier-stage patients, but results were not as robust in other biomarkers or with patients at later stages of the disease.
Bristol Myers Squibb has made significant cuts to its workforce since last year as part of a strategic reorganization aimed at saving $3.5 billion through 2027. The latest cuts in Lawrenceville, New Jersey, bring that area’s total number of disclosed cuts this year to 806.
BNT327, a PD-L1/VEGF therapy, is still currently being manufactured in China, but BioNTech is working to establish a diversified supply chain, executives said during the company’s Q1 investor call.
The cell and gene therapy space in recent months has hit several speedbumps, including layoffs, dropped drugs and discontinued partnerships.
The FDA accepted Novo Nordisk’s NDA for an oral formulation of Wegovy. The agency is expected to release its verdict on the drug in the fourth quarter of this year.
The FDA’s user free programs account for just under half of the agency’s budget—money that could be imperiled by the recent staffing exodus.
On the FDA’s docket this month are two expansion bids, one for GSK’s asthma drug Nucala into COPD and another for Merck’s oral cancer drug for a pair of rare tumors.
Beam Therapeutics and Verve Therapeutics have each built their lead candidates on a technique billed as a safer alternative to conventional CRISPR. Clinical results have so far been promising.
Following challenges with its drug candidate bexotegrast and announcement of a limited-duration stockholder rights program, Pliant is paring back its workforce.