Fierce Pharma

As the biopharma industry braces for a second term under President-elect Donald Trump, speculation is swirling around the returning administration’s effect on issues like Medicaid spending, the future of drug price negotiations and, of course, the great Robert F. Kennedy Jr. "wildcard." Still, given Trump’s focus on matters beyond healthcare and a more hands-off approach to government regulation, the life sciences realm is unlikely to face a major shakeup—at least for now—Baird’s biotech specialist Mike Perrone said in a research report.

A bispecific antibody has entered the HER2 fray with a differentiated profile from traditional agents and a chance to challenge AstraZeneca and Daiichi Sankyo’s star antibody-drug conjugate Enhertu.

Ferrer is using Pulmonary Hypertension Awareness Month to sound the alarm about the shortcomings of the current pathways for diagnosing and treating the blood pressure condition.

As a council of outside experts prepares to meet Thursday to discuss AstraZeneca’s Andexxa, the FDA has flagged “major safety findings” linked to the British drugmaker’s bleeding reversal agent.

After a labeling mix-up prompted a recall of a popular panic disorder drug this summer, Endo’s U.S. subsidiary is widening the scope of its product pull.

Just three days after Syndax Pharmaceuticals revealed data from a trial of revumenib in one indication of acute leukemia which chilled investors, the FDA has approved the small molecule in another indication of the disease.  

This year's Fiercest Women in Life Sciences special report is now live. Despite persistent barriers to equity, women continue to lead with incredible, groundbreaking work across pharma, biotech and medtech. Congratulations to the 2024 honorees! Eli Lilly and Company, Genentech, Mural Oncology, AstraZeneca, Schrödinger, Novo Nordisk, Altoida, Inc., Synchron, Andreessen Horowitz, eGenesis, Inc.

In a flurry of activity, Europe’s human medicines committee has done an about-face on Eisai and Biogen’s Alzheimer’s disease med Leqembi, endorsed a clutch of biosimilars, recommended a slew of label expansions and put forward new cancer and COVID drugs for approval.

GSK’s 3 billion pounds sterling peak sales goal for its multiple myeloma drug Blenrep appears increasingly attainable thanks to a key patient survival win.

As a wave of patent expirations encroaches upon many of the world’s top drugmakers, companies will need to be diligent in acquiring external products with the potential to launch in the near term. Meanwhile, those pharmas facing greater generic threats in the coming decade may be more inclined to pick up earlier-stage candidates from beyond their own pipelines.