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September 26, 2024
by Jason Scott

Recon: Pfizer withdraws sickle cell drug Oxbryta from worldwide markets; Evotec, Novo Nordisk partner on stem cell therapy manufacturing

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US
  • Head of national stockpile addresses Congress’ criticisms of outbreak response (STAT)
  • AbbVie Parkinson’s drug helps improve symptoms in late-stage study (STAT)
  • Why Biohaven will test the FDA’s regulatory limits (STAT)
  • US Senate votes to hold Steward Health CEO in criminal contempt (Reuters)
  • Merck's colorectal cancer therapy fails late-stage trial (Reuters)
  • Exclusive: J&J folds cardiovascular and metabolic drug unit (Endpoints)
  • FDA adcomm votes to limit Opdivo, Keytruda use in stomach cancer based on key biomarker (Endpoints)
  • CSL Seqirus inks fifth contract with BARDA, making the partnership now worth $1.14B (Endpoints)
In Focus: International                                                                                                       
  • The little-known Chinese biotech whose cancer drug beat Keytruda has global ambitions (STAT)
  • Pfizer pulls sickle cell treatment Oxbryta off global markets (STAT) (Reuters)
  • EU regulator recommends suspension of Pfizer's sickle cell disease treatment (Reuters)
  • EMA Discusses Fatal Events That Prompted Pfizer To Pull Oxbryta From Global Markets (Pink Sheet)
  • Pfizer v Moderna COVID vaccine patents battle to go to appeal in UK (Reuters)
  • Slow progress on Pfizer's plan to sell drugs to low-income nations at not-for-profit price, says CEO (Reuters)
  • Bavarian Nordic signs agreement with UNICEF for one million mpox vaccines (Reuters)
Pharma & Biotech
  • Evotec and Novo Nordisk in technology development partnership (Reuters)
  • Amid push to redefine itself, Sanofi names new chief scientific officer (STAT)
  • ARCH Venture Partners raises $3 billion for a new biotech fund (STAT)
  • AstraZeneca in AI collaboration with Immunai to inform cancer drug trials (Reuters)
  • Healthcare firm Guardian Pharmacy raises $112 mln in US IPO (Reuters)
  • Masimo founder Joe Kiani resigns as CEO following ouster from board (Reuters)
  • Obesity drug developer BioAge Labs aims up to $640 mln valuation in upsized US IPO (Reuters)
  • KKR, GIC hire banks to sell stakes in $3.2 bln Metro Pacific Health, sources say (Reuters)
  • Biogen walks away from Sage's essential tremor drug after mid-stage flop, pill's future in question (Endpoints)
  • AGC Biologics to lay off 95 workers; Vertex taps Lonza to manufacture Casgevy (Endpoints)
  • SIGA is 'deeply angered' by former exec's 'inaccurate' comments about mpox antiviral (Endpoints)
  • Repair, Genevant ink deal worth up to $107M; 858 Therapeutics raises $50M (Endpoints)
  • Instacart partners with 9amHealth to combine weight loss drugs with healthy foods (Endpoints)
Medtech
  • Can MRIs ensure prostate cancer screening does more good than harm? (STAT)
  • Sleep apnea alert on Apple Watch: What does it mean, and how does it work? (STAT)
  • Congress again delays steep cuts in Medicare lab payments (MedTech Dive)
  • FDA proposes reclassifying hepatitis B assays (MedTech Dive)
Government, Regulatory & Legal
  • Two reports, two dramatically different views of nonprofit hospitals’ tax breaks (STAT)
  • Biotech’s real estate market is still upside down (STAT)
  • Generic drug lobby taps former BIO exec as new CEO (STAT)
  • Washington state's abortion pill stockpile is insurance against Trump win, governor says (Reuters)
  • A New Book on Hatch-Waxman – Breaking the Medicine Monopolies: Reflections of a Generic Drug Pioneer (FDA Law Blog)
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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