Recon: FDA proposes annual COVID shots; Takeda pledges up to $1.13B for Hutchmed’s fruquintinib

• 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)

• 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)

• 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)

• 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)