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June 29, 2023
by Michael Mezher

Recon: Lilly to buy Sigilon Therapeutics; FDA adcomm recommends approval of Ipsen’s fibrodysplasia drug

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • Biotech firm Tevogen Bio enters $1.2 billion SPAC deal for US listing (Reuters)
  • Eli Lilly to buy Sigilon Therapeutics to expand diabetes treatments (Reuters)
  • US abortion pill access could hinge on whether doctors had right to sue (Reuters)
  • US CDC OKs use of new Pfizer, GSK vaccines for RSV in older adults (Reuters)
  • BioXcel shares plunge after issues at trial site for Alzheimer's-related drug (Reuters)
  • Pfizer-OPKO's growth hormone drug gets US approval in kids (Reuters)
  • Catalent Is Linked to Regeneron’s Eye-Drug Rejection in Latest Misstep (Bloomberg)
  • FDA adcomm votes in favor of Ipsen's fibrodysplasia drug (Endpoints)
  • FDA plots challenges in implementing new laws targeting pharma supply chain (Endpoints)
  • FDA Approves First Cellular Therapy to Treat Patients with Type 1 Diabetes (FDA)
  • They Followed Doctors’ Orders. Then Their Children Were Taken Away. (NYTimes)
In Focus: International
  • China's CSPC Pharma partners with Pfizer for oral COVID treatment (Reuters)
  • Sanofi reaffirms target to deliver over $10.9 billion in annual vaccine sales by 2030 (Reuters)
  • Sanofi says it's back to the drawing board on mRNA flu vaccines (Reuters)
  • Touting programs from Novartis, Laekna bags $100M in Hong Kong IPO while Merck-partnered Kelun seeks up to $208M (Endpoints)
  • Japan Mulls Pricing Changes, Generic Sector Review Amid Ongoing Shortages (Pink Sheet)
  • WHO's cancer research agency to say aspartame sweetener a possible carcinogen -sources (Reuters)
Pharma & Biotech
  • Alkermes wins battle against Sarissa in closely watched boardroom fight (Reuters)
  • Preparing For FDA's Surprise Foreign Drug Inspection Regime (Law360)
  • BioNTech, OncoC4 start late-stage lung cancer drug trial (Reuters)
  • Gates Foundation to fund trial of long-awaited new tuberculosis vaccine candidate (STAT)
  • AbbVie, Genmab's Epkinly shows promise in follicular lymphoma. Will FDA get on board? (Fierce)
  • FDA issues warning to wholesaler sued by Gilead and J&J for distributing counterfeit medicines (STAT)
  • Drug wholesaler owner indicted for alleged role in diverting Gilead and J&J HIV medicines (STAT)
  • Counter-culture or pharma: Group behind MDMA therapy for PTSD wrestles with its identity (STAT)
  • The cancer drug shortage isn’t new — and neither are the solutions: ‘It’s like Groundhog Day’ (STAT)
  • Fujifilm Diosynth names Lars Petersen to replace Martin Meeson as CEO (Endpoints)
  • Eiger BioPharmaceuticals to focus on GLP-1 candidate, cut workforce by 25% (Endpoints)
  • ICER taps new president as Steve Pearson announces plans to step down (Endpoints)
  • Meet ‘Fanzor,’ a cousin of CRISPR and Feng Zhang’s new gene editing tool (Endpoints)
  • With just one response in 47 patients, Foghorn stops work on lead candidate in advanced eye cancer (Endpoints)
  • Eton handed second CRL for methanol poisoning treatment (Endpoints)
  • With approval supplement on deck, Reata dives into launch of its first commercial product Skyclarys (Fierce)
Medtech
  • Manufacturers Of Annex XVI Non-Clinical Devices Get Extra Time (MedtechInsight)
  • Roche nabs FDA nod for another pair of CSF biomarker tests for Alzheimer's disease (Fierce)
  • International Harmonization: Industry Needs To Take The Lead, MEDIcept’s Trautman Says (MedtechInsight)
Government, Regulatory & Legal
  • Trump demands the U.S. pay no more for drugs than other countries … again (STAT)
  • Judge Says Pharma Industry Has 'Perverted' Hatch-Waxman (Law360)
  • Ex-Pfizer employee charged with illegal trading based on unreleased Covid pill trial data (CNBC)
  • Regenxbio, UPenn file patent suit against Sarepta related to new Duchenne gene therapy (Endpoints)
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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