Recon: FDA approves OTC switch for naloxone for opioid reversal; ICU Medical bids against GE Healthcare for Medtronic units valued at $8B

• US FDA approves over-the-counter sale of overdose reversal drug Narcan (Reuters) (Pink Sheet) (Endpoints)
• Otsuka, Lundbeck eye Alzheimer's indication in FDA adcomm for Rexulti label expansion (Endpoints)
• Batch Testing Of All Imported Drugs Floated At House Appropriations Hearing (The Pink Sheet)
• FDA lifts partial hold on Blueprint's CDK2 inhibitor (Endpoints)
• HHS Streamlines Kids Research Review Process Across Department (Bloomberg)
• Shortage of monkeys for early-stage research jeopardizes timelines for developing some drugs (STAT)
• FDA’s Marks hopes to align global regulators to boost gene therapy (Reuters)
• New lupus partnership with FDA aims to end drug trials’ history of failure (STAT)
• To deal with the next pandemic, the FDA needs an Office of Preparedness and Response (STAT)
• House committee chair requests info from FDA on funding for trials involving 'viral manipulation' (Endpoints)

• EU Sets New Date For Publication Of Delayed Pharma Revision Proposals (Pink Sheet)
• India cancels licences of some drug firms in crackdown on fake products, says source (Reuters)
• UK government, private investors dole out $340M+ to drug, diagnostic manufacturers (Endpoints)
• NICE Confirms English Funding For Three COVID-19 Drugs, But Rejects Four Others (Pink Sheet)
• Canadian Action On Rare Disease Is A ‘Step Forward,’ Says Industry (Pink Sheet)
• GSK licenses companies to make cheap copies of HIV prevention drug (Reuters)

• J&J Drops Out of RSV Race, Cuts Late-Stage Vaccine Candidate (BioSpace) (Endpoints)
• Daiichi Sankyo inks $183M discovery deal with GPCR biotech for CNS target (Endpoints) (Fierce)
• Clinical trial diversity craters out to lowest level in 10 years, IQVIA finds (Fierce)
• GSK sees $500 mln peak sales for yeast infection pill licensed from Scynexis (Reuters) (Endpoints) (BioSpace)
• Former J&J exec, an in-demand free agent, takes the helm at privately held FogPharma (STAT) (Fierce)
• European investment group closes €260M raise for dementia fund (Endpoints)
• Eisai, Biogen’s Leqembi set to generate $12.9B in sales through 2028: report (Fierce)
• Alector cuts 11% of workforce as it doubles down on late-stage neuro programs partnered with GSK, AbbVie (Endpoints)
• Three Firms Sign Up With MPP For Long-Acting Cabotegravir (Pink Sheet)
• Nanoscope’s phase 2 win for gene therapy shows potential of light-sensitive approach to eye disease (Fierce)

• ICU Medical challenges GE HealthCare for Medtronic units valued at $8B: report (MedTech Dive) (Reuters)
• Why Adding A Legacy Device To Eudamed Now, Before It is Mandatory, Is A Shrewd Move (MedTech Insight)
• Surmodics receives FDA feedback weeks after layoffs (MedTech Dive)
• Philips expects to reach recall settlements this year (Reuters) (Fierce)

• Teva-GSK Drug Labeling Fight Needs High Court Review, DOJ Says (Bloomberg)
• Court Sides with Vanda Against FDA in Freedom of Information Act Case (BioSpace)
• Biogen Dodges Investor Suit on Failed Alzheimer’s Drug Rollout (Bloomberg)
• California’ Vaccine Site Buffer Law Partially Halted by Court (Bloomberg)
• Esperion Sues Daiichi Sankyo Over $300M Milestone Payment (FDAnews)
• Texas judge strikes down major Obamacare provision protecting birth control, PrEP coverage (STAT) (Bloomberg)