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.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
The FDA’s agenda includes an advisory committee meeting for Sarepta’s delandistrogene moxeparvovec, which, if approved, would become the first gene therapy for Duchenne muscular dystrophy.
Many employers aren’t offering the high salaries employees had grown accustomed to in recent years, leaving workers to decide whether they should accept a pay cut.
For people with, or at risk for, SOD1-ALS, the FDA’s approval of Qalsody is an important step toward advancing gene-specific research for this uniformly fatal disease.
Merck and AstraZeneca are seeking broad approval for Lynparza in mCRPC regardless of BRCA status.
The proposed drug pricing legislations follow the Inflation Reduction Act, passed in August 2022.
The regulatory filing puts the company alongside Vertex and CRISPR, which also await FDA approval for their SCD gene therapy.
Tuesday, the FDA approved Qalsody—formerly tofersen—on a conditional basis to treat SOD1-ALS.
For those looking to transition out of academia, moving into a government role could be one of the most rewarding pathways available.
The partial clinical hold follows Foghorn’s voluntary pause of the study and is due to one patient developing irregular heartbeat following treatment with FHD-609.
Eplontersen halted ATTRv-PN disease progression and improved quality of life through 66 weeks. The drug has a PDUFA date of Dec. 22, 2023.