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October 29, 2024
by Jason Scott

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)
In Focus: International                                                                                                       
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Government, Regulatory & Legal
  • 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)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.

A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
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