Recon: EMA recommends Novo’s Wegovy for heart risks; Mankind to buy Bharat Serums for $1.6B
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Federal regulation of health data and AI expected to get a boost after HHS revamp (STAT)
- AstraZeneca says there's ‘very limited’ impact on Farxiga after US pricing negotiations (Endpoints)
- BioMarin snags expanded Brineura label, now approved for all kids regardless of symptoms (Endpoints)
- Ipsen pays Day One $111M upfront for ex-US rights to pediatric brain tumor drug (Endpoints)
- Republican-led states can't intervene in case on abortion pill restrictions, appeals court says (Endpoints)
- FDA Leadership Changes Tune On Pediatric Priority Review Voucher Benefit (Pink Sheet)
- EU regulator backs use of Novo's Wegovy to lower heart risks (Reuters)
- India's Mankind Pharma to buy Bharat Serums in a $1.6 billion deal (Reuters)
- European Commission reaches deal with Vifor for ‘disparaging’ its only rival in iron deficiency market (STAT)
- Jiankui He, creator of CRISPR-edited children, relocates to a Chinese medical tourism hub (STAT)
- EMA Sticks With JN.1 Variant For COVID-19 Vaccines, Despite US FDA's Choice of KP.2 (Pink Sheet)
- EMA Explores Optimizing Vaccine Development In Immunocompromised Patients (Pink Sheet)
- A potential rival for Wegovy and Zepbound enters the fray (STAT)
- Viking accelerates development of obesity drug that could rival Wegovy, Zepbound (STAT)
- Merck lays off workers amid rough pharma job market (STAT)
- Sage suffers pipeline setback with failure of drug to treat essential tremor (STAT)
- Roche cuts two more TIGIT trials, plans accelerated timeline for obesity drugs (Endpoints)
- Viking to push obesity drug to Phase 3 in bid to reach market faster (Endpoints)
- Sanofi eyes RSV antibody for its next blockbuster while Dupixent brings in record sales (Endpoints)
- Exclusive: After selling Mirati to BMS for nearly $5B, Chuck Baum lands at another ‘undruggable’ company (Endpoints)
- Argenx to retest Vyvgart in autoimmune platelet disease after failure last year (Endpoints)
- Manatt scoops up health tech experts Christina Farr and Tom Cassels (Endpoints)
- Boston Scientific tips strong growth for Farapulse after successful launch (MedTech Dive)
- Top 5 medtech deals in the first half of 2024 (MedTech Dive)
- Magenta Medical Secures $105M To Advance ‘World's Smallest Heart Pump’ (MedTech Insight)
- FDA Publishes FAQs On Final Rule Establishing Oversight Of LDTs (MedTech Insight)
- How UnitedHealth harnesses its physician empire to squeeze profits out of patients (STAT)
- Adding psychotherapy to drug therapy works, but the FDA may not be able to handle it (STAT)
- Sponsored genetic testing programs are under fire, further complicating life for people with rare diseases (STAT)
- ACI’s 10th Anniversary Paragraph IV Disputes Master Symposium (FDA Law Blog)
- Decoding Regulatory Agency Decisions: The Case of Amylyx’s Relyvrio/Albrioza in the US and EU (Pink Sheet)
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