Recon: AstraZeneca lines up EU accelerated assessment for COVID prevention drug; India expert panel urges local approval of Lilly’s Mounjaro
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Congress called for an ALS moonshot. The plan for it doesn’t leave Earth (STAT)
- Supreme Court’s gutting of Chevron doctrine could mean headaches for drug industry (STAT)
- Medicare should wait on approving coverage for new obesity drugs (STAT)
- Q&A: Vertex’s pain research chief on moving beyond opioids, AI and how pharma acquisitions thrive or fail (Endpoints)
- Cassava Sciences forms internal panel after US probe into two employees (Reuters)
- Rite Aid bankruptcy plan approved, cutting $2 bln in debt (Reuters)
- U.K. pharma increasingly violates voluntary industry marketing codes, and probes are taking longer (STAT)
- India’s Drug Regulatory Apparatus Set For ‘Big Ticket’ Changes (Pink Sheet)
- India panel urges drug regulator to approve Lilly's obesity drug Mounjaro (Reuters)
- AstraZeneca's COVID prevention drug application gets EU fast-track assessment (Reuters)
- Sanofi eyes German insulin investment of up to $1.6 bln, source says (Reuters)
- Hemophilia Gene Therapy Hemgenix Gets Funding In England, With More Talks Underway In Europe (Pink Sheet)
- EMA Seeks Input on Modernizing 17-Year-Old Psoriatic Arthritis Guide (Pink Sheet)
- EU CHMP Opinions And MAA Updates (Pink Sheet)
- Japan's Eisai developing dementia drug for US market, Nikkei reports (Reuters)
- Scientists wary of bird flu pandemic 'unfolding in slow motion' (Reuters)
- Bristol Myers to pay $2.7 mln to settle Israel anti-competition charges (Reuters)
- The maddening saga of how an Alzheimer’s ‘cabal’ thwarted progress toward a cure for decades (STAT)
- Boehringer Ingelheim enters 'triple-G' race with Phase 1 trial (Endpoints)
- Lilly inks radiopharma deal with Radionetics, with rights to buy the biotech (Endpoints)
- Aerovate plans to lay off nearly all employees after trial failure (Endpoints)
- EU regulator backs approval for ARS Pharma's nasal spray alternative to EpiPen (Reuters)
- Eisai takes over development of ADC after Bristol Myers ends $650M collaboration (Endpoints)
- UniQure sells Massachusetts manufacturing site to Genezen as it continues to downsize (Endpoints)
- Tracon to seek ‘strategic’ options; Ovid to lay off 17 workers (Endpoints)
- Dianthus teases preclinical data for autoimmune drug as it starts clinical trials (Endpoints)
- Therapy developer Alumis seeks up to $1 bln valuation in US IPO (Reuters)
- Novel amputation procedure makes walking with a prosthetic leg feel more seamless (STAT)
- Masimo COO says he’ll resign if CEO Kiani is forced out (MedTech Dive)
- Medtech M&A may pick up after mixed start to 2024: analysts (MedTech Dive)
- Philips BiPAP recall now linked to 65 deaths, 952 injuries (MedTech Dive)
- Steward Health Care spent millions on surveillance of its critics — even amid financial crisis (STAT)
- Ascension is racing to unload hospitals as execs work to stem losses (STAT)
- Medicare’s big experiment to fix kidney failure care hasn’t worked so far, studies say (STAT)
- Cancer victims lose bid to block proposed J&J talc bankruptcy (Reuters)
- US professor charged with manipulating data for Alzheimer’s drug trial (Reuters)
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
