Eric Sagonowsky

3 days ago | fiercepharma.com | Eric Sagonowsky

Spring has been bountiful at Cleveland's Abeona Therapeutics. Two weeks after the company picked up FDA approval for its first commercial product, Abeona has inked a deal to sell the FDA Priority Review Voucher (PRV) it gained along with the approval. Abeona agreed to sell the PRV for $155 million, the company said in a Monday press release. The company didn't disclose the name of the buyer. PRVs can be used to speed up the review process for drug applications at the FDA.

1 week ago | fiercepharma.com | Eric Sagonowsky

As Novo Nordisk works through a period of transition in the U.S. GLP-1 drug market, sales from the company's star obesity medicine Wegovy came in below expectations in the first quarter of 2025. Still, the Danish drugmaker is undeterred and is keeping its optimism intact for the second half of the year. Global Wegovy sales reached 17.36 billion Danish kroner during the first quarter of 2025, coming in 7% below analyst expectations, according to a note from analysts with ODDO BHF.

1 week ago | fiercepharma.com | Eric Sagonowsky

In the wake of the high-profile departure of Peter Marks, M.D., Ph.D., the FDA has a new leader for its Center for Biologics Evaluation and Research. FDA commissioner Marty Makary, M.D., has named Vinay Prasad, M.D., to the post, he said in a post on X. "Dr. Prasad brings the kind of scientific rigor, independence, and transparency we need at CBER," Makary said in the post. Endpoints News first reported the appointment on Tuesday, citing an internal email from Makary to agency staffers.

1 week ago | fiercepharma.com | Eric Sagonowsky

As BioNTech progresses with its goal to grow into a “fully integrated immunotherapy powerhouse,” the German biotech is eying a 2025 regulatory filing for what could become its first approved cancer drug. But with tariffs raising uncertainties around global trade, the company is responding with plans to diversify its long-term supply for the drug.

2 weeks ago | fiercepharma.com | Eric Sagonowsky

Amid a slew of recent shake-ups at the FDA—including the agency’s reduction in force and high-profile leadership exits—the regulator is ushering in "radical" changes to how it signs off on new vaccines. “Under Secretary Kennedy’s leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to licensure—a radical departure from past practices,” the Department of Health and Human Services (HHS) said in a statement to CNN.