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

ReconRecon | 16 March 2023 |  By 

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
  • 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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Government, Regulatory and Legal
  • 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)
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.


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