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)
- 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)
- 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)
- 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)
- 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)
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