Recon: FDA proposes annual COVID shots; Takeda pledges up to $1.13B for Hutchmed’s fruquintinib
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- FDA scientists propose an annual Covid shot matched to current strains (STAT) (Reuters)
- With TheracosBio green light, another SGLT2 wades into diabetes arena (Fierce)
- Cidara’s Rezafungin: US FDA Panel Asked To Weigh ‘Limited Use’ Indication For Antifungal (Pink Sheet)
- FDA One Step Closer To Makena Withdrawal After Hearing Officer Echoes Advisory Panel’s Advice (Pink Sheet)
- Despite court ruling, FDA will continue with its approach to approving orphan drug exclusivity (STAT)
- US Patent Office To Consider Including Patient Voice In Patent Considerations (Pink Sheet)
- In Medicare Drug Price Negotiations, Industry Sees Drawbacks And Silver Linings (Pink Sheet)
- Abbott Under Federal Criminal Investigation Over Baby Formula (Wall Street Journal)
In Focus: International
- New Guidance To Clarify Transparency Provisions In EU Clinical Trials Portal (Pink Sheet)
- EU to aggregate cancer imaging data across bloc in new project (Reuters)
- World’s Most Expensive Drug Revives Push for New Payment Models (Bloomberg)
- WHO urges ‘immediate action’ after cough syrup deaths (Reuters)
- Industry Warns Of New Post-Brexit ‘Cliff Edge’ For Medicines Supply To Northern Ireland (Pink Sheet)
- UK's NICE stamps approval on Alnylam, PTC rare disease drugs (Endpoints)
- WHO seeks $2.5 billion to battle health emergencies (Reuters)
Pharma & Biotech
- Takeda pledges up to $1.13B for rights to Hutchmed’s cancer drug fruquintinib outside of China (Fierce) (Biospace)
- JPM23: Pfizer, Moderna and more look to combine COVID and flu vaccine markets (Fierce)
- Merck KGaA shrinks U.S. research team as layoffs continue to batter industry (Fierce)
- Alvotech raises $137M months after FDA rejected Humira biosimilar (Endpoints)
- Morphic loses another Big Pharma partner as J&J follows AbbVie out of the door (Fierce)
- India’s Gland Pharma misses Q3 profit view on supply chain issues (Reuters)
- Bayer investor criticizes company chair for lack of initiative (Reuters)
- Pliant claims early success in hard-to-treat progressive lung disease (STAT)
- Sanofi promises money back for discontinued blood disorder treatment – in some cases (Endpionts)
Medtech
- Ethylene oxide regulation may disrupt device supply, AdvaMed warns White House (MedTech Dive) (MedTech Insight)
- FDA demands additional data on Abbott rival to Medtronic balloon, setting back approval timeline (MedTech Dive)
- Medtronic asks HVAD users to return batteries with welding defects (MedTech Dive)
- German Notified Body Latest To Be Designated Under MDR (MedTech Insight)
- February Announcements On UK’s Medtech Regulatory System Change Awaited (MedTech Insight)
- The seer: AI tool from MIT, Mass General predicts lung cancer risk in nonsmokers 6 years out (Fierce)
- Abbot Says Whistleblower Waived False Claims Intent Argument (Bloomberg)
- Martin Shkreli runs afoul of FTC for potentially skirting lifetime pharma ban (Fierce) (Reuters)
- Beech-Nut Baby Food Heavy Metals Suits Must Await FDA Action (Bloomberg)
- Theranos’ Elizabeth Holmes labeled a ‘flight risk’ as she asks to delay prison sentence during appeal (Fierce) (Bloomberg)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
