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July 23, 2024
by Jason Scott

Recon: MHRA approves Novo’s Wegovy for heart risks; Merck says RSV antibody succeeds in Phase 2b/3 study

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

In Focus: US
  • To get a fair deal on Wegovy, buying Novo Nordisk might not be Medicare’s worst option (STAT)
  • U.S. Patent Office software mistakes extend patent life for drugs and need to be fixed, researchers say (STAT)
  • Merck, without sharing details, says RSV antibody successfully protected infants (Endpoints) (Reuters)
  • US FDA Not Ready For Sponsors Citing Others’ Platforms Yet, Marks Says (Pink Sheet)
  • US drug industry middlemen defend business model amid accusations of raising patient costs (Reuters)
  • House hearing keeps pressure on PBM practices while Congress considers reforms (STAT)
In Focus: International                                                                                                       
  • European Commission reaches deal with Vifor for ‘disparaging’ its only rival in iron deficiency market (STAT)
  • Indian manufacturer Brassica hit with warning letter after employees faked data results (Endpoints)
  • Pfizer lifts curtain on $740M+ extension at API manufacturing site in Singapore (Endpoints)
  • EU Moment Of Truth For Lecanemab & 14 Other Drugs (Pink Sheet)
  • Novo Nordisk's Wegovy gets UK approval for use to lower heart risks (Reuters)
  • EMA Proposes Guidance On Oligonucleotide Drugs Amid Growing Role In Personalized Medicine (Pink Sheet)
  • Challenges Persist in EU Clinical Trials Regulation Rollout (Pink Sheet)
  • Drug giants eye China for deals despite growing Sino-US tensions (Reuters)
Pharma & Biotech
  • Biotech led by J&J veterans launches with $165 million for cancer, autoimmune therapies (STAT)
  • The obesity drug race is being fought on the manufacturing floor as GLP-1 rivals make plans to catch leaders (Endpoints)
  • Cellectar to seek approval for radioactive iodine-based therapy in rare blood cancer (Endpoints)
  • At Third Arc Bio, former J&J leaders raise $165M to test oncology, autoimmune biologics (Endpoints)
  • Neurology startup from OrbiMed collab nabs $65M in Series A (Endpoints)
  • Telix's $397M convertible bond offering; Scynexis records a $10M milestone (Endpoints)
  • Bob Langer, Flagship's Stephen Berenson to depart Moderna's board as Carlyle co-founder joins (Endpoints)
  • Flagship launches AI-powered biologics biotech with $50M backing (Endpoints)
Medtech
  • ‘Our next frontier is prediction’: Medtronic on AI and heart disease (MedTech Dive)
  • Cook Medical to sell reproductive health business to private equity firm (MedTech Dive)
  • Medical Supply Giant Medline Is Said to Explore IPO in 2025 (Bloomberg)
  • Quest Diagnostics raises 2024 profit, revenue forecasts on health tests demand (Reuters)
  • ICU Medical to close Minnesota facility, cut 83 jobs (MedTech Dive)
  • Owens & Minor to buy medical equipment firm Rotech for $1.36 bln (Reuters)
  • Guardant settles allegations it violated the False Claims Act (MedTech Dive)
  • ‘Our next frontier is prediction’: Medtronic on AI and heart disease (MedTech Dive)
Government, Regulatory & Legal
  • Epic, Abridge, and Mayo Clinic to leverage AI to ease nursing workflow (STAT)
  • Contradictory coverage decisions in North Carolina (STAT)
  • VA disputes claim that removing race from lung tests would greatly alter disability payments (STAT)
  • Robitussin maker settles lawsuit in US over 'non-drowsy' claim (Reuters)
  • Medical groups are divided over Biden plan to loosen DEA restrictions on marijuana (STAT)
  • Health insurer Centene's upbeat quarterly profit forecast fails to impress (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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