Recon: Pfizer recalls migraine drug over packaging issues; UK lobby group suspends Novo Nordisk after rule violation

• FDA says Pfizer COVID pill EUA for adolescents to stay even after nod for adults (Reuters) (FDA)
• Biden says ‘more coming’ on drug pricing after inflation fines (Reuters)
• Abortion-Pill Challenge Hearing Ends Without Judge Ruling (Bloomberg)
• Explainer: How recent lawsuits could affect access to abortion pills (Reuters)
• US FDA Opens OTP Director Search Again (Pink Sheet)
• Califf criticizes insurers for doing too little on drug research (STAT)
• FDA offers radio silence on question of spring Covid boosters, as other countries push ahead (STAT)
• Rural Hospital Closures Prompt Bipartisan Bid to Shore Up System (Bloomberg)
• SVB Corporate Clients Reveal Exposure Spanning Biotech to Media (Bloomberg)
• Pfizer recalls migraine drug over packaging issues – CPSC (Reuters)
• Even over the counter, Narcan may be too costly to reach many drug users (Washington Post)
• Brookings panel of experts lays out case for onshoring manufacturing (Endpoints)
• U.S. issues initial Medicare drug price negotiation guidance (Reuters) (Bloomberg) (Endpoints)
• Alzheimer’s Association lobbies for Medicare coverage of Leqembi and other drugs (Reuters)

• EU weighs plan to incentivize drugmakers to fight superbugs (MedWatch)
• EU lays out pros and cons to onshoring more API production (Endpoints)
• Patient Groups Back EU Cross Border Clinical Trials Access Initiative (Pink Sheet)
• £10m Cash Boost For UK Regulator To Speed Up New Drug Approvals (Pink Sheet)
• UK R&D credit increase, faster drug approvals promised in budget speech (Endpoints)
• Japan Price Revision: Mixture of Cuts And Increases Amid Supply Crisis (Pink Sheet)
• Exodus of healthcare workers from poor countries worsening, WHO says (Reuters)

• Novo Nordisk suspended from UK industry group after rule violation (Financial Times) (Reuters)
• Royalty Pharma nabs $475M milestone from Pfizer upon migraine nasal spray OK (Endpoints)
• FDA partially lifts dosing hold on Stoke Therapeutics' pediatric Dravet syndrome study (Endpoints)
• Vaxart cans oral COVID-19 vaccine plans, lays off 27% of staff to go all in on norovirus program (Fierce) (Endpoints)
• The delisting dilemma: Why do so many biotechs face being kicked off the Nasdaq? (Fierce)
• India’s Eris buys nine dermatology brands from Dr. Reddy’s for $33 mln (Reuters)
• German biotech launches with ‘seamless’ gene editing platform built on evolving enzymes (Endpoints)
• Eli Lilly’s alopecia drug Olumiant off to positive start with doctors, Spherix research finds (Endpoints)
• Bristol Myers blasts off with SpaceX to study biomanufacturing in space (Endpoints)

• Official Sign-Off For EU Medical Device Regulation Amending Text Due Today (MedTech Insight)
• The EU NIS 2 Directive Is Here. What Does It Mean For Medtech? (MedTech Insight)
• TEAM-NB Membership Increases By Over a Quarter Within Six Months (MedTech Insight)
• Medtronic wins CE mark for ablation device, invests in heart failure monitoring company (MedTech Dive) (Fierce)
• FDA Clears Diagnostic Aimed At Reducing STDs In Women (MedTech Insight)
• PerkinElmer completes $2.45B spinoff to create new diagnostics, life sciences company (Fierce)
• Novo, Medtronic add $25M in fuel to FIRE1 and its heart failure monitoring device (Fierce)

• Amgen sued in federal court for allegedly hiding $10.7B IRS bill from investors (Endpoints)
• Eli Lilly Must Hold Proxy Votes on Abortion, Diversity, SEC Says (Bloomberg)
• Aquestive Defeats Investor Suit Over Seizure Drug’s FDA Failure (Bloomberg)
• Third Bard Hernia Mesh Injury Test Case Cleared for Trial (Bloomberg)