Policy
The US dramatically altered its recommendations for a series of vaccines, which drive billion-dollar earnings for giants like Merck and Pfizer.
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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The FDA approved Merck’s Keytruda for the treatment of stage IB, II or IIIA non-small cell lung cancer after resection or platinum-based chemotherapy.
A group of 25 senators, led by Sen. Elizabeth Warren (D-MA), is requesting that HHS Sec. Xavier Becerra exercise march-in rights for Xtandi (enzalutamide), a prostate cancer therapeutic.
The FDA’s Peripheral and Central Nervous System Drugs advisory committee will discuss the merits of Biogen and Ionis’s ALS candidate tofersen on March 22nd.
Thursday, Astellas announced that the FDA had lifted its clinical hold for the company’s experimental gene therapy trial for late-onset Pompe disease.
The FDA issued a complete response letter Thursday refusing accelerated approval for Eli Lilly’s Alzheimer’s disease candidate donanemab.
The neurodegenerative drug development space saw incremental victories in 2022. Leaders from Eisai, Voyager and QurAlis discuss upcoming milestones.
The FTC issued a Notice of Proposed Rulemaking (NPRM) that could change the landscape for employer-employee relationships nationwide, specifically in the biopharma industry.
The FDA granted Moderna’s RSV vaccine candidate Breakthrough Therapy Designation Monday.
The FDA approved Eisai and Biogen’s lecanemab (Leqembi) Friday afternoon. It is the second anti-amyloid antibody to be approved for Alzheimer’s disease in two years.
BrainStorm Cell Therapeutics appoints a new co-CEO as it prepares for a January 11th Type A meeting for ALS hopeful NurOwn.