Each week we highlight five things affecting the life sciences industry. Here’s the latest.
FDA unveils fast-track review voucher for national health priorities
- According to Pharmaceutical Technology, the U.S. Food and Drug Administration has introduced the Commissioner’s National Priority Voucher program—granting non‑transferable vouchers that reduce drug review time from 10 to 12 months to just one to two months for companies addressing U.S. national priorities.
- To qualify for the non-transferrable voucher, companies must address a health crisis in the U.S., produce an innovative cure for American patients, meet public health needs or increase manufacturing capabilities in the U.S. as part of a national security issue.
Could the FDA regulate lab-developed tests indirectly?
- The FDA faced a recent court setback as a U.S. district court in Texas vacated a rule that would have reclassified lab-developed tests, or LDTs, as medical devices, ruling the agency lacked authority under the Federal Food, Drug, and Cosmetic Act, reports MedTech Dive.
- The agency recently issued warning letters to labs for distributing instruments labelled “for research use only” into clinical settings, highlighting an alternate regulatory route by targeting device components.
Biopharma M&A surge signals a potential return of deal flow
- Reports BioSpace, the first half of 2025 has already seen over $36 billion in biopharma mergers and acquisitions—nearly matching total deal value for all of 2024—as major deals have reignited industry momentum.
- Analysts note that Big Pharma is still holding substantial dry powder which could be deployed if macroeconomic conditions calm during the second half of 2025.
Direct-to-consumer pharma ad ban gains momentum in Congress
- According to PharmaVoice, two senators introduced the End Prescription Drug Ads Now Act, which would ban all direct-to-consumer pharmaceutical advertising across television, radio, print, digital platforms and social media.
- The legislation is backed by Health and Human Services Secretary Robert F. Kennedy, Jr.’s prior calls for such a ban, noting public support—nearly 60% favor ending TV drug ads—and highlights the industry’s annual $10 billion direct-to-consumer ad spend, raising concerns over misleading claims and inflated drug costs.
U.S. pharma turns to China for pipeline boost
- U.S. pharmaceutical companies have signed 14 licensing deals with Chinese biotech firms worth up to $18.3 billion through mid‑June—up from only two during the same period last year—aimed at replenishing a pipeline set to lose $200 billion in revenue from patent expirations by 2030.
- Reuters notes that Chinese biotechs now represent nearly 30% of global drug development.
For more insights in life sciences, check out RSM’s industry outlook.
