Recon: FDA warns CVS, other companies for marketing unapproved eye drugs; Health Canada approves Moderna’s updated COVID-19 vaccine
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- New obesity drugs are in the works trying to out-blockbuster Wegovy and Mounjaro (STAT)
- Pharmacy Middlemen Try to Divert Congressional Fee Crackdown (Bloomberg Law)
- Employers Point to Higher Costs After Medicare Drug Negotiations (Bloomberg Law)
- US FDA panel says popular decongestant used in cold medicines ineffective (Reuters)
- Timeline for supply limits on Novo Nordisk weight-loss drug unclear, US FDA says (Reuters)
- Generic Drugs Should Be Cheap, but Insurers Are Charging Thousands of Dollars for Them (The Wall Street Journal)
- FDA approves updated Covid vaccines (STAT)
- Patients might finally receive practical information with prescriptions — if the FDA doesn’t blow it (STAT)
- Ahead of adcomm, FDA questions efficacy of Alnylam's patisiran in disabling rare condition ATTR-CM (Endpoints)
- US CDC to decide who should get the new COVID shots (Reuters)
- FDA warns CVS, others against selling unapproved eye products (Reuters)
- FDA Issues Guidance On Biocompatibility Testing For Devices That Make Contact With The Human Body (MedTech Insight)
- Health Canada approves Moderna COVID-19 vaccine for Omicron, urges boosters (Reuters)
- Israel's health ministry recommends some wear masks indoors amid rise in COVID cases (Reuters)
- Centinel Spine to sell fusion business, focus on disc replacement (MedTech Dive)
- UK Considers US-Style Payment Reporting Obligations For Drug And Device Firms (MedTech Insight)
- Acelyrin, a rare IPO success, stumbles in its first big test (STAT)
- Nick Leschly departs Bluebird Bio spinout amid restructuring, layoffs (STAT) (Endpoints)
- Experts fear private equity will pour gas on cardiology’s overuse problem (STAT)
- Exelixis licenses small molecule from Insilico for $80M upfront; Vertex buys GPCR from Septerna (Endpoints)
- Avalon's latest biotech closes $58M round as it pursues treatments for autoimmune brain conditions (Endpoints)
- Roche to refile subcutaneous Tecentriq application with FDA before year’s end on the back of manufacturing tweaks (Endpoints)
- WCLC roundup: AstraZeneca, Amgen, J&J and Hutchmed tout new combination or confirmatory data (Endpoints)
- Renibus brings Series B total to $72M, securing registrational development for lead heart surgery candidate (Endpoints)
- San Diego biotech starts clinical study of self-replicating RNA vaccine for rabies (Endpoints)
- BioLineRx’s Aphexda approved to aid stem cell transplants for multiple myeloma patients (Endpoints)
- Lyra touts positive topline PhII data for chronic rhinosinusitis drug (Endpoints)
- Bausch + Lomb seeks funding for $1.75B eye drop acquisition from Novartis (MedTech Dive)
- PFA procedures expected to rise after Boston Scientific study results (MedTech Dive)
- As kids, they underwent a common test for UTIs. As adults, it haunts them as a traumatic ‘nightmare’ (STAT)
- Study suggests AI could provide second reading of mammograms (MedTech Dive)
- Spinning Around – One Company's Bid To Diagnostic-ify The Metabolism (MedTech Insight)
- Doctor asks court to toss J&J lawsuit against her over cancer research (Reuters)
- Is there a path forward for PEPFAR? (STAT)
- The food industry has tried to stack a key nutrition policy panel with its preferred experts, documents show (STAT)
- CMS digs deeper into impact of proposed breakthrough device pathway in JAMA paper (MedTech Dive)
- CMS Promises Actions To Support TCET Pathway (MedTech Insight)
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