But that clock is already ticking as the House Oversight and Accountability Committee prepares to mark-up the bill and a likely reconciliation effort with the Senate looming.
Many biotech firms would have nearly eight years to unwind contracts with questionable foreign firms under a new version of the BIOSECURE Act, a dramatic shift from earlier drafts that is a likely nod to industry’s requests and the reality of business.
The House
As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.
After almost seven years, China’s NMPA has once again published draft measures for clinical trial data protection, opening these up to public comments. While specific protection periods by drug category are proposed, some clarifications are still needed.
A new annual report from China's CDE shows a rise in overall product approvals but a fall in the transition rate for conditional to full approvals, possibly signalling more stringent requirements.
While CMC glitches linger over a US NDA for Elevar/Hengrui’s novel liver cancer combination following a second complete response letter, the separate issue of underrepresentation of US patients in multiregional trials is looming large after new FDA draft guidance last year.
Japan's trade ministry is providing new support to build domestic capacity for new modalities including cell and gene therapies, as part of wider efforts to support the national bioventure ecosystem.
US-based Colossal Labs has claimed to bring back the dire wolf from extinction. While the science is not as dramatic in India yet, cell and gene therapies are making progress as treatments for cancer and other diseases. Pink Sheet takes a look at what is driving CGT success and growth.
Artesunate for malaria, TB drug pretomanid and omadacycline for pneumonia and skin infections are among the drugs identified by Japanese regulatory authorities in urgent need of domestic development.
