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April 30, 2024
by Jason Scott

Recon: FTC warns drugmakers over ‘junk’ Orange Book patents; FDA solicits public feedback on advisory committee reforms

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US
  • FTC issues warnings on ‘junk’ patent listings for Ozempic and other drugs (STAT)
  • Creating the next wave of antibody therapies requires innovative collaboration (STAT)
  • FDA wants to hear your thoughts on advisory committees (STAT)
  • US FDA grants full approval for Pfizer's cervical cancer drug (Reuters)
  • Weight-loss drug drives Eli Lilly to raise 2024 sales forecast by $2 billion (Reuters) (Endpoints)
  • FDA asks for public input on advisory committee reforms (Endpoints)
  • US FDA Adcomm Reform: Does Listening Session Suggest No Major Near-Term Changes? (Pink Sheet)
  • Lilly scraps trials of Verzenio, Jardiance and a gene therapy from Prevail (Endpoints)
  • Sandoz reaches agreement with Amgen over patent dispute (Reuters)
  • Walmart exits live and virtual care business, five years after push into care delivery (Endpoints)
  • Bristol Myers, Johnson & Johnson plot appeal after US judge dismisses IRA lawsuits (Fierce Pharma)
In Focus: International
  • Bird flu may infect cows outside the US, says WHO (Reuters)
  • GE HealthCare misses quarterly revenue estimates on weakness in China market (Reuters)
  • Australian regulator examines possible contamination of Indian spice mixes (Reuters)
  • EU Launches Critical Medicines Alliance But Prospect Of Act On Manufacturing Still Uncertain (Pink Sheet)
  • ‘Shocking’ MHRA Performance & Poor Data Transparency Blamed For UK’s Clinical Trial Crisis (Pink Sheet)
  • MHRA Needs ‘Rebuilding’ After Post-Brexit Loss Of Capacity And Industry Investment (Pink Sheet)
Pharma & Biotech
  • New, serious safety risk related to MorphoSys’ cancer drug complicates, potentially threatens, Novartis acquisition (STAT)
  • Akili to lay off 46% of its staff, explore strategic options amid sluggish sales (STAT)
  • Annovis tumbles as Alzheimer's treatment misses in mid-stage study (Reuters)
  • One dose of Novo Nordisk's Wegovy back in supply, FDA website shows (Reuters)
  • Harmony Biosciences buys small epilepsy biotech for $35M, plus milestones (Endpoints)
  • Daré's royalty deal; Qlaris Bio raises $24M (Endpoints)
  • Real Chemistry debuts a one-stop dashboard for all things GLP-1 (Endpoints)
  • In one of JP Morgan's first biotech bets, Enlaza raises $100M for its permanently binding protein drugs (Endpoints)
  • US FDA’s Vaccine Office Emerges From Non-COVID-19 Backlog (Pink Sheet)
Medtech
  • With younger women getting breast cancer, national panel lowers mammogram screening age to 40 (STAT)
  • Abbott Receives FDA Approval For Esprit BTK Drug-Eluting Resorbable Scaffold (MedTech Insight)
  • It’s Official: FDA Drops Final Rule On LDTs (MedTech Insight)
  • FDA defends LDT final rule, while critics fear it upends lab industry (MedTech Dive)
  • Hologic to buy Endomagnetics for $310M (MedTech Dive)
Government, Regulatory & Legal
  • Pfizer to pay $25.5 mln to settle remaining Effexor XR antitrust claims (Reuters)
  • AI is becoming the exclusive province of academic medicine. A new initiative aims to change that (STAT)
  • Biden cybersecurity plan for hospitals entails carrots first, then sticks, health official says (STAT)
  • Protect the health of pregnant people and their children by including them in research (STAT)
  • UnitedHealth CEO reveals cyberattack origins ahead of Change Healthcare hearings (Endpoints)
  • Florida abortion clinics and funds face uncertain future on eve of six-week ban (Reuters)
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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