Recon: FDA delays decision on Ascendis’ hormone disorder drug; Edwards faces EU antitrust complaint
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- USDA, FDA turf battles hamper responses to outbreaks like H5N1 bird flu (STAT)
- Pfizer submits trademark application that suggests it could be launching a direct-to-patient program (Endpoints)
- US reclassification could drive fresh research funding into pot sector (Reuters)
- US FDA’s Califf Says Adcomm Votes Not Vanishing Completely (Pink Sheet)
- US FDA extends review of Ascendis Pharma's hormone disorder therapy (Reuters)
- WuXi AppTec cuts 'small percentage' of workers at US site as market shifts (Endpoints)
- Bayer cuts 1,500 staffers companywide in campaign to reduce bureaucracy (Endpoints)
- Edwards Lifesciences hit with Meril's EU antitrust complaint (Reuters)
- EU Announces Fifth MDR Notified Body Designation In Five Weeks (MedTech Insight)
- Grifols swings to profit, says debt reduction on track (Reuters)
- Pandemic Treaty Negotiators Plan Five More Days Of Talks On ‘Critical’ Issues (Pink Sheet)
- EMA Consults On Using RWD In Non-Interventional Studies (Pink Sheet)
- Egypt’s First Decentralized Trials Guideline Addresses Using Off-Site Nurses (MedTech Insight)
- Is Novavax a new meme stock? (STAT)
- Element Biosciences, an Illumina rival, on its genomics ambitions — and why it hasn’t gone public (STAT)
- The Endpoints Slack interview: Siddhartha Mukherjee on the doctor-writer worldview, AI, and the future of cancer (Endpoints)
- Sands Capital raises $555M for third life sciences fund (Endpoints)
- Allogene's $110M offering; Apellis refinances (Endpoints)
- Exclusive: Harvard startup raises $26M, strikes three pharma partnerships for AI antibody design (Endpoints)
- Pliant touts additional Phase 2a data for oral IPF drug that’s already in a pivotal study (Endpoints)
- Novo Nordisk's Wegovy helps keep weight off over four years, new analysis shows (Endpoints)
- Amazon veteran Missy Krasner shares why now is the time for young health startups to go shopping (Endpoints)
- Unlike Regeneron, Bayer doesn't feel as much of a pinch from Roche's Vabysmo (Fierce Pharma)
- Et voilà! New name takes top spot in reputation ranking by US patient groups (Fierce Pharma)
- Bayer taps ex-NFL star Julian Edelman to lead One A Day social campaign tackling wellness pseudoscience (Fierce Pharma)
- ‘Do It Or We’re Not Going To Approve Your Drug:’ Industry Reps Ask FDA For Trial Diversity Sticks (Pink Sheet)
- US FDA's Delay In Acting On Moderna RSV Vaccine Adds To Growing List of User Fee Goal Misses (Pink Sheet)
- Cue Health’s Covid-19 tests could give false results, FDA warns (STAT)
- Philips sues CPAP cleaning product maker, saying it should pay part of settlements (Reuters)
- Digital Health Review Founder Blair Hirst Focuses On Health Equity (MedTech Insight)
- Hospital At Home: Great On Paper, Not In Practice (MedTech Insight)
- Value Of Vaccines ‘Underestimated’ By Policymakers, Economic Researchers Find (Pink Sheet)
- US relaxes regulations for labs handling bird flu samples to ease virus response (Reuters)
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