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April 25, 2024
by Jason Scott

Recon: Senate committee probes Novo’s Ozempic and Wegovy pricing; GSK sues Pfizer, BioNTech over COVID vaccine tech

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

In Focus: US
  • GlaxoSmithKline sues Pfizer and BioNTech over Covid-19 vaccine technology (Reuters)
  • US Senate committee investigates pricing of Novo's Ozempic and Wegovy (Reuters) (STAT)
  • Takeda is fourth big company to leave BIO since December (STAT)
  • McKinsey faces US criminal probe over opioids work, sources say (Reuters)
  • Shortages of generic drugs can’t be blamed solely on group purchasing organizations (STAT)
  • Another quarter, another Keytruda win for Merck (Endpoints)
  • Merck raises 2024 profit forecast on surging sales of cancer drug Keytruda (Reuters)
  • Medicare beneficiaries could be eligible for Wegovy coverage, study shows (Reuters)
  • US FDA sends warning to Cardinal Health for marketing unapproved devices (Reuters)
In Focus: International
  • Why a British hospital, and not a drugmaker, is trying to get a rare disease therapy approved (STAT)
  • Merck KGaA to expand German headquarters with €300M+ research center (Endpoints)
  • EU launches probe of China’s medical device market (MedTech Dive)
  • Changes To EU Pharma Reform: More Questions Than Answers? (Pink Sheet)
  • Australia Calls For Companion Testing Plans For Drugs Requiring A CDx (Pink Sheet)
  • AstraZeneca leaps after smashing first-quarter forecasts (Reuters)
Pharma & Biotech
  • Bashing accelerated approval isn’t supported by the data (STAT)
  • Amid layoffs and a hit to earnings, Bristol’s new CEO shares his vision for the future (STAT)
  • Updated: Bristol Myers plans $1.5B in cost cuts, including 2,200 jobs, as CEO promises more ‘agile’ company (Endpoints)
  • Cerevance's $47M raise; Parexel's AI pact (Endpoints)
  • Astellas cuts a bispecific in cancer and a mitochondria-focused asset from Mitobridge deal (Endpoints)
  • Shareholder Capital asks Vanda Pharma's board to reconsider Future Pak's offer (Reuters)
  • Regeneron to collaborate on gene editing therapies with Doudna-founded Mammoth (Reuters)
  • Haleon names Dawn Allen as CFO (Reuters)
Medtech
  • Generative AI is supposed to save doctors from burnout. New data show it needs more training (STAT)
  • Philips failed to report corrections of CT machines, FDA says in warning letter (MedTech Dive)
  • Freenome to cut more than 100 employees in restructuring (MedTech Dive)
  • Exo adds FDA-cleared AI tools to handheld ultrasound system (MedTech Dive)
  • Boston Scientific gives first look at Farapulse US rollout (MedTech Dive)
  • The Aspirin Test For AI? (Pink Sheet)
Government, Regulatory & Legal
  • H5N1 bird flu virus particles found in pasteurized milk but FDA says commercial milk supply appears safe (STAT)
  • Profiting from ‘legal’ insider trading isn’t always easy (STAT)
  • Judge slashes $857 mln Monsanto verdict to $438 mln in PCBs case (Reuters)
  • Plaintiffs' lawyers chosen to lead Ozempic litigation (Reuters)
  • UBS faces new lawsuit by Appaloosa over Credit Suisse $17 bln bond wipeout (Reuters)
  • Insurer Humana pulls 2025 profit forecast on disappointing Medicare rates (Reuters)
  • Pharma Can Pursue Claims Against Providers For 340B Duplicate Discounts In Medicaid Managed Care, HRSA Says (Pink Sheet)
  • Mary Beth Clarke, CDER Exec Programs Office Director And Generic User Fee Shepherd, Will Retire (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.
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