Policy
On Wednesday, the CDC’s Advisory Committee on Immunization Practices voted to recommend Valneva’s chikungunya virus vaccine Ixchiq for certain high-risk patient groups.
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Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.
The upheaval of the Health and Human Services workforce and leadership leaves much to be desired in terms of delivery, recently retired FDA Chief Information Officer Vid Desai tells BioSpace, but the regulatory agency is evolving to be more open to much needed change.
Having seen Congress spend money to onshore semiconductor production, pharma groups are pushing for similar incentives for domestic drug manufacturing.
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Following a year-long legal battle, Illumina is dropping the intellectual property allegations against Guardant. The companies have also entered into a new long-term purchase and supply commitment.
Following reports of destroyed and discarded data, the U.S. regulator issued a warning letter to India’s Intas Pharmaceuticals regarding violations of current good manufacturing practice.
The settlement agreement between the companies follows three patent-infringement lawsuits filed by Bristol-Myers Squibb over the blockbuster cancer immunotherapies.
The Federal Trade Commission seeks to codify its heavier-handed approach, already displayed by its actions regarding Amgen’s acquisition of Horizon, among other deals.
Amid U.S. shortages in crucial drugs, House Republicans have filed their own draft bill that seeks to increase the accountability of the FDA and provide more flexibility for generics manufacturers.
Biogen’s $7.3 billion Reata acquisition and layoffs dominated this week’s news, while BMS and Roche reported second-quarter earnings and BioSpace looked at 12 late-stage neuro companies.
The FDA has three upcoming action dates in the next two weeks, including a highly anticipated decision regarding Biogen and Sage’s depression drug zuranolone.
The first half of this year saw milestone approvals for rare disease therapies, and the FDA has several more such decisions on its calendar in the second half of 2023.
The company reported second-quarter revenue Wednesday that included $248.4 million of back royalties and associated interest related to the successful outcome of an arbitration case with J&J’s Janssen.
On the heels of a European Union investigation, the UK’s health agency is reviewing safety data for GLP-1 receptor agonists after reports of self-harm and suicidal thoughts.