Recon: BMS to buy Mirati for up to $5.8 billion; Alnylam drops expanded indication for heart disease drug after FDA rejection
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- FDA rejects Alnylam’s heart disease treatment over insufficient data (STAT)
- Alnylam gives up on expanded use of heart-disease drug in US after FDA declines approval (Reuters)
- U.S. employers covering weight-loss drugs could nearly double in 2024 – survey (Reuters)
- Walmart expands online healthcare facility for US employees (Reuters)
- Bristol Myers Squibb buys Mirati for up to $5.8B as I-O giant branches out into targeted therapy for cancer (Fierce Pharma)
- Novo Nordisk's Wegovy bonanza looms large in Denmark (Reuters)
- Drugmaker Teva does not see big impact on business from Israel-Hamas war (Reuters)
- Contentious Pricing Mechanism Adopted In Canada But Only For ‘A Brief Period’ (Pink Sheet)
- Global Pharma Guidance Tracker – September 2023 (Pink Sheet)
- Want a biotech buyout? Target cancer (STAT)
- Akero’s treatment for NASH falls short in cirrhosis study (STAT)
- Merck says Keytruda improves survival before and after lung cancer surgery, awaits FDA decision next week (Endpoints)
- Bayer takes next step in cell therapy, opening new $250M facility in Berkeley (Endpoints)
- MarketingRx roundup: Pharma brands get creative on Instagram; J&J reups health equity challenge (Endpoints)
- Health tech is going through a hype cycle, and it’s not necessarily a bad thing, a new Bessemer report found: #HLTH23 (Endpoints)
- Verily lays out 'Chapter 3', streamlining its business under a new CEO and focusing on commercial side: #HLTH23 (Endpoints)
- Exclusive: Andreessen Horowitz-backed startup is using AI to design lipid nanoparticles that go beyond the liver (Endpoints)
- CEPI puts $25M into Rift Valley fever vaccine; Gates invests in AI for scientists in Africa in equity bid (Endpoints)
- How CVS and Walgreens are becoming pharma’s new big advertising strategy (Endpoints)
- Ventyx unveils positive PhII ulcerative colitis data but stock is down 20% due to competitive space (Endpoints)
- ‘Transparency-Rx’: Meet The PBM Execs Breaking Rank And Backing Reforms (Pink Sheet)
- Regulatory tracker: Novartis' Cosentyx approved in IV form (Fierce Pharma)
- Amid Eylea showdown, Roche's Vabysmo shows durability in retinal vein occlusion (Fierce Pharma)
- How “Regulatory Sandboxes” Offer Hope For New Technologies That Don’t Fit The Regulatory Mold (MedTech Insight)
- To protect chickens from bird flu, researchers try to CRISPR in immunity (STAT)
- The ‘model-eat-model world’ of clinical AI: How predictive power becomes a pitfall (STAT)
- How doctors and nurses shape Google’s AI, DEA extends telehealth flexibilities (STAT)
- Sanofi adds another AI alliance, this time for biologics with Baidu CEO’s startup (Endpoints)
- Clinicians ‘love yet fear’ AI, say medtech leaders (MedTech Dive)
- J&J-backed HistoSonics gets de novo clearance for liver cancer treatment (MedTech Dive)
- Insulet wins preliminary injunction against EOFlow in patent suit (MedTech Dive)
- J&J could reach market-leading medtech growth after consumer spinoff: analysts (MedTech Dive)
- D.C. Court Strikes Down Copay Accumulator Rule (FDA Law Blog)
- Connecticut’s comptroller explains his thinking about GLP-1s for state employees (STAT)
- Former VA Secretary, Biogen Exec On IRA And Politics, Price Clamps In Europe (Pink Sheet)
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.
