Recon: Pfizer raises outlook by $1.5B over renewed Paxlovid sales; Lilly touts new dosing regimen for Alzheimer’s drug as potentially safer
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Eli Lilly says modified dosing of its Alzheimer’s drug may be safer (STAT)
- Pfizer bumps up revenue outlook by $1.5B in Paxlovid rebound amid criticism from activist investor Starboard (Fierce Pharma) (Endpoints)
- Dreams of cancer vaccines are becoming more real. Here are 9 scientists making it happen (STAT)
- 6 races to watch that could shape health care policy (STAT)
- I’m the director of the Center for Medicare. Here’s how we executed the first round of drug price negotiation (STAT)
- Harris vs. Trump: How Will the Presidential Election Impact Biopharma? (BioSpace)
- Biden’s Cancer Moonshot’s Last Acts: Easing Pediatric Drug Shortages (The Wall Street Journal)
- Tuberculosis returns as top infectious disease killer, WHO says (Reuters)
- Japan's Shionogi says Phase 3 study showed COVID pill reduces transmission (Reuters)
- Japan Eases Local Clinical Data Requirements For Rare Disease Drug Filings (Pink Sheet)
- EMA Should Lead AI Oversight In Pharma & Align With Global Regulators, Says EFPIA (Pink Sheet)
- Regulatory Reviewers In Europe Face Overtime & Cancelled Vacations Due To Submission Delays (Pink Sheet)
- Bristol Myers partner Zai Lab plots KarXT filing in China after trial win (Fierce Pharma)
- Regulatory tracker: NICE endorses new meds from Pfizer, AstraZeneca (Fierce Pharma)
- Olympus CEO ousted after allegation of illegal drug purchase, shares slump (Reuters)
- GSK acquires autoimmune drug candidate (STAT)
- Nvidia-backed AI firm Iambic unveils drug discovery ‘breakthrough’ (Reuters)
- Paragon launches another company in hot PD-1xVEGF space that goes straight to reverse merger (Endpoints)
- Incyte raises 2024 sales forecast for top-selling drug Jakafi (Reuters)
- Novartis takes $800M MorphoSys writedown mere months after closing acquisition (Endpoints)
- Novartis highlights overall M&A track record following MorphoSys impairment (Endpoints)
- Biogen appoints insider as CFO after Michael McDonnell to retire next year (Reuters)
- Vera’s $300M offering; Abeona resubmits treatment for rare skin disease (Endpoints)
- Coya Therapeutics reports positive immune response, safety in mid-stage Alzheimer's drug trial (Reuters)
- Fog clears to reveal Parabilis, a rebranded cancer biotech with big name backers (Fierce Pharma)
- After prior trial flop, EyePoint's Duravyu bounces back with promising data in DME (Fierce Pharma)
- Revolution Medicines Targets Hard-to-Treat Pancreatic Cancer With Two Early-Phase Readouts (BioSpace)
- Layoff Tracker: Dublin-Based CRO With US Offices Signals Upcoming Layoffs (BioSpace)
- Edwards data show benefit of early TAVR over ‘watchful waiting (MedTech Dive)
- J&J to seek FDA approval after small-bore Impella heart pump hits trial goal (MedTech Dive)
- Boston Scientific to close Silk Road Medical headquarters, lay off 138 people (MedTech Dive)
- Guardant’s CMO On Future Of Liquid Biopsy, CDx, And Next Directions For Shield Test (MedTech Insight)
- Woodcock Throws Weight Behind Push For New Legislative ‘Substantial Evidence’ Standard For Rare Disease Drugs (Pink Sheet)
- Uncertainty Abounds With SEC Climate Reporting Rule Tied Up In Courts (MedTech Insight)
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