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Despite rehiring hundreds of FDA, CDC and NIH employees, the Department of Health and Human Services is still a skeleton of its former self under Health Secretary Robert F. Kennedy Jr.
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By far, the largest acquisition of 2024 was Novo Holdings’ yet-to-be-closed buyout of manufacturer Catalent at $16.5 billion. Outside of that, the leading pharmaceutical companies kept to less than $5 billion per deal.
The darlings of the weight loss and diabetes spaces, GLP-1 receptor agonists have shown promise against Alzheimer’s in recent studies—with Phase III results expected next year from Novo Nordisk.
By speeding lifesaving drugs’ way to market and focusing on the underlying causes of disease, the pathway has helped save many lives.
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Femasys Inc. today announced completion of enrollment in the LOCAL FemaSeed® pivotal clinical trial, designed to evaluate women undergoing FemaSeed cycles due to male factor infertility.
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Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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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.
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.
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.
Following challenges with its drug candidate bexotegrast and announcement of a limited-duration stockholder rights program, Pliant is paring back its workforce.
No Patient Left Behind says that drug value assessments used in countries like Canada and Germany undervalue innovative medicines by 90% and mislead U.S. policymakers into thinking Americans are overpaying.