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BioNTech envisioned the site making hundreds of millions of vaccines a year, but has since shifted its pipeline to other modalities while mRNA technology continues to face headwinds in the U.S.

While some large companies could start paying the full tariff in 120 days, many products, including orphan drugs, cell and gene therapies, and antibody-drug conjugates, will enjoy exemptions that waive or greatly reduce the levies.

After a flurry of deals over the past week from Eli Lilly, Merck and Biogen, analysts predict more M&A action from other big names, including Novartis, Amgen and AbbVie.

After Eli Lilly achieved the milestone approval of the weight loss pill Foundayo, Novo Nordisk launched a full-court press to defend oral Wegovy, which has been enjoying a record-breaking launch since January.

With CBER director Vinay Prasad set to depart the agency at the end of the month, a coalition of patient groups and biotech executives penned a letter imploring the Trump administration to “restore regulatory clarity” for rare disease therapies. Experts on a BioSpace panel last week also acknowledged the challenges faced by a more stringent FDA.

As Big Pharma companies consider foregoing European drug launches to avoid reducing drug prices in the U.S. in alignment with Trump’s Most Favored Nation policy, patients will suffer.

COVID-19 partners Pfizer and BioNTech have been unable to recruit healthy adults aged 50 to 64 fast enough to deliver relevant post-marketing data. Moderna is apparently also facing enrollment challenges.

In this episode of Denatured, you’ll listen to Dr. Marc Hedrick, President and CEO of Plus Therapeutics and Dr. Phil Kantoff, CEO & Co-founder of Convergent Therapeutics. They discuss breakthroughs like alpha-emitting isotopes, supply chain solutions and why radiotherapeutics is biotech’s next big frontier.

Drug discovery can be an uphill battle, especially lately given recent upheaval at the FDA and muted investment activity. BioSpace spoke to four industry executives about key issues facing those working in this space, starting with planning around uncertainty.

As Novo Nordisk cuts 400 jobs at the troubled site, Scholar Rock has seen enough progress that it included the facility in a resubmission for FDA approval.

The FDA approved Eli Lilly’s orforglipron—to be known as Foundayo—on Wednesday, officially igniting what analysts believe will be a fierce rivalry with Novo Nordisk’s oral Wegovy.

Of the 11 companies participating in the spring cohorts of the Drive program run by MassBio and SCbio, eight have locations in Massachusetts. One cohort focuses on biotech and the other on biomarkers and diagnostics.

• Appointment strengthens medical, regulatory, and commercial leadership as Company prepares to complete early market access regulatory filings in the U.S., U.K, Europe and Australia in anticipation of OST-HER2 approval decisions expected by year-end 2026 • Upcoming FDA Pre-BLA meeting will focus on the use of recent seroconversion biomarker data as a key surrogate clinical efficacy endpoint to support a BLA for OST-HER2 under the Accelerated Approval Program • Commercialization and reimbursement preparations well underway for the U.S., U.K., and Europe in parallel with ongoing partnership discussions

• Quarterly revenue up 8% year over year; Annual revenue guidance range remains at $42-$48 million • CDMO fragrance and Saffron projects reach successful milestones; First quarter CDMO revenue grew 135% YoY • VINIA brand customer base grows to 90,000 active users as of the end of April • Two-lens framework enacted in Q1 to optimize performance across CDMO and D2C businesses

Business development appointment is aligned with securing long-term customers for development and manufacturing partnerships

Another major milestone in its continuous global IP strategy, advancing protection of VIVI Cap Smart across international markets Highlights Granted Patent covers the design of VIVI Cap Smart™ across major international, growing market Strengthens the Company’s intellectual property position in one of the world’s largest healthcare and consumer markets Supports commercialization strategy and strategic discussions with appliance manufacturers Design term extends through May 16, 2039 Company enters into financing arrangement to support inventory build for growing portfolio