Recon: FDA places Gilead’s blood cancer drug trials on hold; FDA found quality control lapses at Catalent’s Bloomington plant
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Studies cited in abortion pill case are retracted due to flaws and conflicts of interest (STAT)
- HHS leaves vacant more than half the slots on a key vaccine advisory panel (STAT)
- New pharma CEOs in the hot seat (STAT)
- As Medicare drug pricing negotiations begin, AstraZeneca stays mum on government’s offer (STAT)
- AstraZeneca CEO calls opening IRA drug price offer 'relatively encouraging' in first characterization of talks (Endpoints)
- Wall Street: GLP-1 competitors’ pain is Eli Lilly’s gain (Endpoints)
- Madrigal reports new safety data for NASH candidate resmetirom weeks ahead of PDUFA date (Endpoints)
- US FDA puts hold on Gilead's blood cancer therapy trials (Reuters)
- EU watchdog looking into impact on drug availability from Catalent-Novo deal (Reuters)
- Canada's Conservative leader supports ban on puberty blockers for minors (Reuters)
- Dengue spreads fast in Brazil prompting emergency health measures (Reuters)
- Insulet wins CE mark for integration of insulin pump with Abbott CGM (MedTech Dive)
- France Takes Action As Drug Shortages Soar (Pink Sheet)
- Global Pharma Guidance Tracker – January 2024 (Pink Sheet)
- Astrazeneca says Catalent deal shows need for in-house capacity (Reuters)
- US FDA finds control lapses at Catalent plant being sold to Novo (Reuters)
- Gilead sours on the ‘don’t eat me’ business (STAT)
- Could testosterone be a useful treatment for menopause? (STAT)
- A gene therapy designed to heal skin wounds helped preserve a boy’s vision (STAT)
- Neurona raises $120M to take epilepsy cell therapy to late-stage development (Endpoints)
- ‘Ruthless’ pipeline cuts, obesity and China: Three takeaways from AstraZeneca’s Q4 (Endpoints)
- Lilly picks a Foghorn target; Mineralys’ $120M PIPE; Sana's $165M offering (Endpoints)
- BioNTech, Autolus strike wide-ranging licensing and manufacturing deal for CAR-T therapies (Endpoints)
- Exclusive: Mental health startup Headlight raises $18M in a round backed by PillPack cofounder TJ Parker (Endpoints)
- Exclusive: Primary care rivals Marathon Health and Everside Health merge (Endpoints)
- Zimmer Biomet restructures, outlines cost-cutting strategy (MedTech Dive)
- How Edwards’ Evoque valve won an early nod from the FDA (MedTech Dive)
- Boston Scientific’s spinal cord stimulators approved for non-surgical back pain (MedTech Dive)
- Invitae hires advisers, considers bankruptcy: WSJ (MedTech Dive)
- Globus Medical names Keith Pfeil as chief operating officer (MedTech Dive)
- Environmental Regulations May Create Barriers To Onshoring More Rx Manufacturing (Pink Sheet)
- Stop the Presses! DEA and DOJ Fine eBay for not Reporting Sales of Tableting and Pill Press Machines (FDA Law Blog)
- Government warns Medicare Advantage insurers not to deny care based on AI (STAT)
- Why Novartis is going to walk away from its acquisition of MorphoSys (STAT)
- Catalent’s Indiana site closes out three Form 483s in past two years (Endpoints)
- US FDA finds control lapses at Catalent plant being sold to Novo (Reuters)
- Eli Lilly to offer low-cost insulin, donate to clinics in Minnesota settlement (Reuters)
- Walgreens Boots pockets $992 mln after cutting Cencora stake for third time (Reuters)
- Gene Therapy: US FDA Willing To Accept Single-Arm Trials For Approval, But Sponsors May Hesitate (Pink Sheet)
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