Policy

Following the withdrawal of billions of dollars in investments from Boehringer Ingelheim and Eli Lilly, German lawmakers have proposed a clause to the country’s healthcare reforms set to take effect Jan. 1.
A new proposal from the U.S. government seeking to address investment in Chinese biotech as a matter of national security drew cautious statements from across the industry, with leaders vowing to ensure innovation isn’t stifled.
The $100,000 H-1B visa fee has significantly affected who biopharma companies hire, according to two experts. It’s not the only program adjustment affecting foreign-born job seekers’ odds of working in the U.S.
Just one-third of patients prescribed new medicines filled them within 30 days, with a new report from the Institute for Clinical and Economic Review and West Health suggesting that cost is the problem.
China may be taking the majority of licensing deals this year but those transactions don’t tell the whole story, according to Locust Walk, which points to the spike in M&A among U.S. biotechs as leveling the playing field.
FDA
Following several recent initiatives, the FDA’s newest rare disease framework sets out to standardize the agency’s approach to scientific evidence and bring rare disease therapies to patients faster.
In this episode of Denatured, you’ll hear from Jennifer McMahon, partner at Seroba and Joey Mason, venture partner at Claret Capital. We dig into how venture debt buys time when equity can’t and how Europe’s funding gaps, tranching habits and slower urgency shape who uses it well.
In this episode of Denatured, you’ll hear from Max Bronstein, CEO of Aviva Strategies and Teresa Barnes, Chief Executive Warrior of PF Warriors. We dig into why U.S. patients are losing access to rare disease trials happening abroad and how the FAIR Act’s accelerated, harmonized reviews could help the U.S. keep pace while getting lifesaving studies to patients faster.
While increases in the interest rate from the Federal Reserve are usually bad for biotech, the sector at this moment is poised to withstand the blow, according to analysts, though earlier stage companies may be left in the lurch.
The FDA gathers Wednesday to hear what industry stakeholders and the public want included in the latest iteration of the Prescription Drug User Fee Act that sets the agency’s priorities for fiscal years 2028–2032.
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