Recon: China-US health regulatory dialogue at Biden-Xi summit; Pan-EU launch requirement could bring challenges
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- China-US Health Regulatory Dialogue In Crosshairs Amid Biden-Xi Summit (Pink Sheet)
- To get things done fast at FDA: ‘Don’t tell anybody,’ cancer chief says (STAT)
- Can post-market evidence generation be streamlined? FDA-commissioned report proposes solutions (Endpoints)
- Backed by ex-Google CEO Eric Schmidt, a new nonprofit looks to 'solve science' with AI (Endpoints)
- U.K. approves world’s first CRISPR-based medicine, giving green light to therapy for sickle cell, thalassemia (STAT)
- Ozempic shortages have European countries exploring bans on use of popular drug for weight loss (Endpoints)
- WHO Working On ‘Evolved’ Model For COVID-19 Licensing Platform (Pink Sheet)
- New African Platform To Build Up Drug Production & Supply Chains (Pink Sheet)
- Stakeholders To ‘Voice Concerns’ On Future Guidelines For Canada’s Controversial Pricing Mechanism (Pink Sheet)
- RWE Accepted As ‘Primary Evidence’ In 20% Of NICE Appraisals Over Past Year (Pink Sheet)
- Korea’s Powerhouse Ambitions Build On Innovation-Fostering Policies (Pink Sheet)
- Eli Lilly plans new 2 billion euro German plant (Reuters)
Pharma & Biotech
- EU Legislative Reform: Pan-EU Launch Requirement Will ‘Take Two To Tango’ (Pink Sheet)
- FDA hands down approval for Bristol Myers' lung cancer drug from Turning Point buyout (Endpoints)
- Pharmas and physicians value medical affairs and MSLs, but have different content priorities, survey says (Endpoints)
- How viral TikTok trends are catching on in pharma marketing (Endpoints)
- FDA cites Dr. Reddy’s for quality control problems at a biologics plant (STAT)
- Bristol wins U.S. approval for lung cancer drug targeting rare genetic mutation (STAT)
- 3M names new healthcare spinoff as Solventum (Reuters)
- Abbott study links aspirin-free regimen to better outcomes in heart pump patients (MedTech Dive)
- Olympus receives Class I recall label for another bronchoscope safety issue (MedTech Dive)
- House panel passes PBM reforms, ratcheting up chance for passage (STAT)
- House moves to limit so-called gain-of-function research (STAT)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
