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March 21, 2024
by Jason Scott

Recon: Merck’s combination therapy for lung cancer falters in phase 3 trial; Medicare to cover Wegovy for heart disease

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

In Focus: US
  • Wegovy to be covered by US Medicare for heart disease patients (Reuters)
  • Medicare expected to negotiate obesity drug prices soon, new analysis predicts (STAT)
  • FDA sends 3 warning letters in probe of plastic syringes made in China (MedTech Dive)
  • Becton Dickinson ramps up syringe production in US amid China quality concerns (Reuters)
  • Merck combination treatment for lung cancer fails late-stage study (Reuters) (Fierce Pharma)
  • Gene-edited pig kidney transplanted into a living patient for the first time (STAT)
  • J&J sues former employee for allegedly taking thousands of documents to a new job at Pfizer (STAT)
  • Senate opens probe into how high-risk research poses national security threats (Endpoints)
  • FDA approves Idorsia’s high blood pressure drug for patients who need other options (Endpoints)
In Focus: International
  • Novo Nordisk's once-weekly basal insulin icodec recommended for marketing approval in Europe (Reuters)
  • U.K. health officials and researchers try to carve a path for more individualized genetic treatments (STAT)
  • Galderma targets one of this year's biggest European IPOs with top-of-the-range share price (Endpoints)
  • German health ministry says Ozempic exports not a concern (Reuters)
  • EU merger powers may be curbed after court adviser backs Illumina fight (Reuters)
Pharma & Biotech
  • BioNTech is having its Pfizer moment (STAT)
  • As focus shifts to oncology, BioNTech nabs Novartis exec as chief commercial officer (Endpoints)
  • Prometheus team launches new startup with $400 million to tackle immune-driven disorders (STAT)
  • A preview of Intra-Cellular Therapies’ depression drug, and sizing up the MASH opportunity (STAT)
  • Catalent cuts 130 workers in Indiana; Merck KGaA to build in South Korea; Schott expands US footprint (Endpoints)
  • Innate ends Ph1b in peripheral T cell lymphoma; Layoffs at NextCure (Endpoints)
  • Exclusive: ‘If you could hallucinate a protein’: Profluent snags $35M for generative AI models (Endpoints)
  • Boundless Bio seeks $88M in IPO as it runs two Ph1 cancer trials (Endpoints)
  • Bayer says 2024 sales of prostate cancer drug above $1 bln (Reuters)
  • Bayer's restructuring hits pharma leadership, shifting about half of execs off top team (Endpoints)
Medtech
  • Where Google thinks generative AI is headed in healthcare (Endpoints)
  • Musk's Neuralink shows first brain-chip patient playing online chess (Reuters)
  • Thermo Fisher, Bayer partner to develop companion diagnostics (MedTech Dive)
  • US FDA classifies recall of Abiomed's blood pumps as most serious (Reuters)
  • Insulet names Ana Maria Chadwick CFO (MedTech Dive)
  • Johnson Matthey to sell medical device components unit for $700M (MedTech Dive)
  • Intuitive aims to keep challengers at bay with new surgical robot (MedTech Dive)
Government, Regulatory & Legal
  • Ex-Aegerion drug salesman avoids further prison during 2nd sentencing (Reuters)
  • Pharma companies and their allies seek to exempt orphan drugs from state pricing limits (STAT)
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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