rf-fullcolor.png

 

March 18, 2024
by Jason Scott

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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Government, Regulatory & Legal
  • 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)
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.
×

Welcome to the new RAPS Digital Experience

We have completed our migration to a new platform and are pleased to introduce the updated site.

What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.

We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.

We welcome your feedback. Please let us know how we can continue to improve your experience.