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)
- 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)
- 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)
- 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)
- 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)
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