Recon: EMA recommends Novo’s Wegovy for heart risks; Mankind to buy Bharat Serums for $1.6B

• 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)