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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Citing insufficient safety evidence for one of the drug’s main ingredients, the regulator in a Complete Response Letter rejected the company’s application for Parkinson’s disease candidate IPX203.
The companies have filed their own suit against the Federal Trade Commission, claiming the FTC’s attempt to legally block their $28 billion merger is unconstitutional.
Pharmas, advocacy groups and regulatory bodies have made moves to put each other in legal crosshairs in 2023. Follow along with BioSpace’s Lawsuit Tracker to see what’s piling up on the docket.
The verdict, rendered by a California jury on Friday, found that the companies did not engage in an anticompetitive conspiracy to delay generic versions of HIV PreEP medicines.
The revised guidance comes amid lawsuits filed by drug manufacturers and industry groups, which claim the Inflation Reduction Act is unconstitutional. Prices negotiated will be effective as of 2026.
The company Thursday reported positive topline results for a Phase III trial of its Alzheimer’s-related agitation treatment, while also disclosing improprieties by a principal investigator.
The initiatives coincide with an increase in the volume of data submitted to CDER and CBER—particularly in cell and gene therapy.
Of the 30 patients given CellTrans’ Lantidra in two studies, 21 were insulin-free for at least a year and 10 were insulin-free for more than five years.
After a series of milestone approvals in the first half of 2023, the FDA is slated to decide on four more firsts before the year’s end.
The U.S. Equal Employment Opportunity Commission settled with Eli Lilly for $2.4 million after filing a suit in September over the company’s recruitment of younger workers.