Recon: J&J touts ‘pretzel’ drug-device combo results for bladder cancer; FDA hands Zydus another Form 483 over facility deficiencies
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- UnitedHealth CEO downplays his company’s control over physicians (STAT)
- 4 burning questions about Amgen’s obesity drug, a potential Wegovy and Zepbound competitor (STAT)
- J&J showcases more bladder cancer results from 'pretzel' drug-device combo (Endpoints)
- US FDA Inspectors, Product Centers Working Closer Together Ahead Of ORA Reorg (Pink Sheet)
- Medicare Negotiation Second Cycle Draft Guidance Offers Options For ‘Effectuating’ Prices (Pink Sheet)
- Medicare Negotiation Timeline For Prices To Be Implemented In 2027 (Pink Sheet)
- FDA flags 10 observations in another Form 483 for a Zydus plant (Fierce Pharma)
- EU Urban Wastewater Directive Update ‘Unfairly Targets Pharmaceutical Industry’ (Pink Sheet)
- Hologic to lay off 190 workers as it closes European facilities (MedTech Dive)
- ICER Debuts Clinical Trial Diversity Assessment Framework (MedTech Insight)
- UK MHRA’s Strategic Approach To AI Will Be ‘Proportionate’ And Fit Well Internationally (MedTech Insight)
- BioNTech says 90% of 2024 revenues will accrue at end of year (Reuters)
- Indian drugmaker Lupin misses quarterly profit estimates as costs rise (Reuters)
- Merck may have a competition for ever-scarce BCG (STAT)
- Alzheimer’s risk gene APOE4 may cause a distinct form of the disease, study suggests (STAT) (Reuters)
- Pfizer hires Citi analyst Baum to oversee portfolio strategy (Endpoints)
- Exclusive: New York biotech debuts with $16M to find new ways to make solid cancer cell therapies (Endpoints)
- Gates, Novo Nordisk, Wellcome foundations put $300M in global health; BioNTech stops prostate cancer study (Endpoints)
- AstraZeneca-allied Eccogene targets early 2025 Nasdaq IPO with multiple NASH candidates (Endpoints)
- GlycoMimetics' AML drug flunks Phase 3 trial, quashing filing plans as stock sinks (Endpoints)
- AstraZeneca expands stake in cell and gene therapy partner Cellectis (Endpoints)
- Novartis’ radiopharma gambit; Weight loss battle plays out; Spark co-founder’s new startup; Q1 earnings highlights; and more (Endpoints)
- Chiesi bets $160M on Gossamer Bio’s make-or-break late-stage PAH drug (Endpoints)
- EyePoint reports midstage trial fail for Duravyu, raising serious questions about the prospect (Fierce Pharma)
- Virtual first is flaming out. A virtual-second model can refresh telehealth (STAT)
- Digital devices can help clinicians prescribe physical activity (STAT)
- What’s The Key To Successful R&D With Artificial Intelligence? ‘Bilingual’ Scientists (Pink Sheet)
- EtO causes cancer. Device sterilizers are scrambling to find alternatives (MedTech Dive)
- FDA qualifies Apple Watch AFib feature for use in clinical trials (MedTech Dive)
- Karius raises $100M to expand access to multi-pathogen blood test (MedTech Dive)
- QuidelOrtho names ex-Abbott exec Brian Blaser as CEO (MedTech Dive)
- Senseonics Wins Marketing Authorization For Novel Insulin Delivery System (MedTech Insight)
- NYU professors who defended vaping didn’t disclose ties to Juul, documents show (STAT)
- ORA’s Chief Says Without Additional Funding, Inspections Are In Jeopardy (MedTech Insight)
- Attorney: Proposed Data Privacy Law Would Ultimately Reduce Regulatory Burden (MedTech Insight)
- Amneal agrees to $272.5M settlement to resolve opioid lawsuits (Fierce Pharma)
- DEA Concurs: Marijuana Meets Schedule III Criteria (FDA Law Blog)
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