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)
- 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)
- 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)
- ‘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)
- 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)
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