Recon: Moderna posts profits, sets sights on RSV jab; United sues FDA over rival Liquidia’s NDA
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Alabama hospital pauses IVF treatments in wake of ruling saying frozen embryos are children (STAT)
- Colorado could cap payments for Amgen’s Enbrel (STAT)
- United Therapeutics starts litigation with FDA over rival Liquidia's drug application (Reuters)
- Florida policy set amid measles outbreak alarms vaccination proponents (STAT)
- Moderna’s ‘year of transition’: Changing gears from Covid-19 to RSV as vaccine approval date looms (Endpoints)
- Moderna reports surprise profit, sets out road map for RSV vaccine (Reuters)
- US FDA warns against using smartwatches to measure blood glucose (Reuters)
- For Psychedelics, US FDA Is Open To Creative Thinking But Firm On Approval Standards (Pink Sheet)
- Lykos’ MDMA NDA Leads Upcoming Tests Of US FDA’s Psychedelics Draft Guidance (Pink Sheet)
- Novavax and Gavi end a bitter dispute over Covid-19 vaccines with a refund up to $400 million (STAT)
- India pharma companies develop versions of Wegovy to get in on weight-loss windfall (Reuters)
- What Does The UK’s ‘Flexible’ Approach To AI Regulation Mean For Pharma? (Pink Sheet)
- Denmark Leads The Way On Speeding Up Approvals For Drug/IVD Combination Trials (Pink Sheet)
- First-In-Class Vorasidenib Among Bumper Crop Of New EU Filings (Pink Sheet)
- Australia Gears Up For More Action On Drug Shortages (Pink Sheet)
- Novavax’s money is going in the wrong direction (STAT)
- Small study adds to growing hope CAR-T cell therapy could revolutionize autoimmune disease treatment (STAT)
- Researchers detail data from first 15 autoimmune disease patients treated with CAR-T — and outstanding questions (Endpoints)
- Scientists take a (small) step toward universal antivenom (STAT)
- Like Gilead, AbbVie gets its tentacles into pact with Tentarix (Endpoints)
- Amylyx’s ALS drug tastes bitter. What would make it better? More patent life (Endpoints)
- Simone Song's ORI Capital closes $260M second fund after CG Oncology success (Endpoints)
- MD Anderson buys tech from Bellicum; Tarsus’ Lyme disease trial data; Rigel takes Gavreto (Endpoints)
- Space manufacturing returns to Earth; Charles River expands antibody manufacturing offerings (Endpoints)
- Adaptive Biotechnologies trims handful of jobs as strategic review nears completion (Endpoints)
- The top 100 venture players in biopharma today. Who's in? What's out? (Endpoints)
- Sofinnova’s Maha Katabi on recent M&A and IPO success and how deal flow has ‘never been any better’ (Endpoints)
- Agilent’s McDonnell to succeed retiring CEO McMullen (MedTech Dive)
- Zimmer receives FDA clearance for robotic shoulder system (MedTech Dive)
- Better Therapeutics wins breakthrough status for health app to treat liver disease (MedTech Dive)
- QuidelOrtho fires CEO Doug Bryant (MedTech Dive)
- CDRH’s Shuren backs expansion of TAP program to speed device approval (MedTech Dive)
- A lawsuit over a controversial Sanofi drug shortage is unexpectedly revived (STAT)
- Actually Wegovy is good for dialysis companies, dialysis provider says (STAT)
- War zone or not, Ukraine seeks to reclaim its role as a hub for clinical trials (STAT)
- NIH study of ME/CFS points to immune dysfunction and brain abnormalities at core of long-dismissed disease (STAT)
- Ex-Mazor exec convicted of insider trading conspiracy linked to $1.6B Medtronic deal (MedTech Dive)
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