Government
The funding, which follows the $176 million the government awarded Moderna in June 2024, aims to get mRNA vaccines ready before bird flu strains currently circulating in the wild and on farms can potentially cause human outbreaks.
Drugmakers will have until the end of February to decide whether they want to participate in the second round of Medicare negotiations or not. CMS has until June 1 to send an initial offer for the adjusted prices.
Along with its gene editing therapy Casgevy, Vertex is offering fertility preservation support for its patients—a program that the HHS claims violates anti-kickback statutes.
An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, Sarepta’s Exondys and Covis’ Makena.
Concurrently, a preprint from the industry-backed Vital Transformation found a 50% drop in company investments into small-molecule drug development.
Vanda called the attention of FDA Commissioner Robert Califf to what it termed the “sentiment that the agency avoids public scrutiny of its decisions.”
According to BMO Capital Markets, Medicare coverage of Lilly’s Zepbound opens the door to using secondary indications to secure CMS coverage for obesity drugs.
A post-marketing review by the FDA detected an increased risk of the autoimmune condition in patients inoculated with GSK’s Arexvy and Pfizer’s Abrysvo, prompting the regulator to require adjustments to the vaccines’ labels.
While layoffs have slowed in the second half of the year, according to BioSpace data, companies including Bayer, Bristol Myers Squibb and Johnson & Johnson are cutting hundreds or even thousands of employees in 2024.
AbbVie’s blockbuster Humira held 105 patents, shielding the anti-inflammatory drug from biosimilar competition for more than 20 years. Proposed reforms could help prevent companies from extending exclusivity with such patent thickets.
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