Recon: FDA approves Orchard’s gene therapy Lenmeldy; Pfizer sells partial stake in Haleon
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- FDA approves first gene therapy for a fatal neuron disease in children (STAT)
- As Humira biosimilars take over the market, CVS has created a new ploy: the drug ‘rebate credit’ (STAT)
- Pfizer sells off partial stake in Haleon, potentially raising $2B+ (Endpoints)
- Updated: FDA adcomm backs benefits of Abecma and Carvykti in earlier patients (Endpoints)
- Artificial Intelligence: US FDA Plans Guidances On Algorithm Bias, Product Development (Pink Sheet)
- Moderna embarks on new vax push in long COVID prevention campaign (Fierce Pharma)
- I was wrong about Geron’s blood cancer drug. Now, is it a takeover target? (STAT)
- EU Institutions Reach Provisional Agreement On Proposed Health Data Regulation Amendments (MedTech Insight)
- EC Defends Data Protection Cut As EU ‘Pharma Package’ Nears Crucial Milestone (Pink Sheet)
- Vertex Resolves To Reverse English Funding Rejection For CRISPR Sickle Cell Gene Therapy (Pink Sheet)
- EU Reaches Last-Minute Agreement On Health Data Space After Tough Negotiations (Pink Sheet)
- Novartis lays out $256M for antibody plant expansion in Singapore, plots 100 hires (Fierce Pharma)
- Contineum Therapeutics files for IPO (STAT)
- Bluebird's $175M loan; Spyre reveals second private placement this year (Endpoints)
- GSK’s new PhIII data support bid for wider endometrial cancer label for Jemperli (Endpoints)
- AstraZeneca, GSK make case for broad immunotherapy uses in endometrial cancer. But questions remain (Fierce Pharma)
- WuXi fallout reverberates; Pharma's top R&D spenders; Lilly teams up with Amazon; Historic NASH approval; and more (Endpoints)
- Novo Nordisk foundation to place more grants outside Denmark (Reuters)
- AstraZeneca follows rival Boehringer in capping out-of-pocket costs for inhalers (Reuters)
- BeiGene’s Tevimbra And The End Of The COVID Inspection Era (Pink Sheet)
- BMS-backed radiopharma specialist Ratio expands manufacturing deal with CDMO PharmaLogic (Fierce Pharma)
- W.R. Grace debuts expanded operations at Michigan API facility (Fierce Pharma)
- GLP-1s on track to take drug sales throne from PD-1 inhibitors in 2024: analyst (Fierce Pharma)
- As AI marches into medicine, investors eye security, privacy startups (STAT)
- Health tech unicorn Color Health pushes deeper into cancer care (Endpoints)
- Guardant posts data for colon cancer blood test amid push from rivals (MedTech Dive)
- Leading The Way From A Singular Position - An IWD Perspective (MedTech Insight)
- The Boston area built a ton of lab space. Now many of those buildings are opening empty (STAT)
- The latest twist in John Green’s anti-tuberculosis story: working with governments (STAT)
- US agency urges interim payments for healthcare providers hit by UnitedHealth hack (Reuters)
- Reckitt says many cases filed against baby formula makers (Reuters)
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