Policy
Leerink analysts hailed the deals as a sign that President Trump “is unlikely to attack the industry in 2026.”
FEATURED STORIES
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.
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.
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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.
The Federal Trade Commission’s increased scrutiny of mergers has now hit IQVIA, whose proposed acquisition of Propel Media has been challenged by the watchdog agency.