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July 1, 2024
by Jason Scott

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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Government, Regulatory & Legal
  • 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
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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