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