rf-fullcolor.png

 

May 2, 2024
by Jason Scott

Recon: Novartis set to purchase Mariana for $1B; FDA requests more data on Dupixent for COPD

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • Pasteurization inactivates H5N1 bird flu in milk, new FDA and academic studies confirm (STAT)
  • FDA asks for more data on Dupixent in COPD in move that could delay a decision (Endpoints)
  • Cigna lifts annual profit forecast (Reuters)
  • CVS cuts annual profit forecast and flags challenges in 2025, shares fall 18% (Reuters)
  • Pfizer lifts profit view on cost cuts, demand for COVID products (Reuters)
  • US judge blocks some North Carolina restrictions on abortion pill (Reuters)
  • J&J advances $6.48 billion settlement of talc cancer lawsuits (Reuters)
  • Healthcare and drugmaker groups seek to revive challenge to US drug-pricing law (Reuters)
  • UnitedHealth says hackers potentially stole a third of Americans' data (Reuters)
  • Novo Nordisk: Wegovy, Ozempic prices in US fell in Q1 (Reuters)
In Focus: International
  • UK’s MHRA To Use AI In Regulatory Review Process & RWD Analysis (Pink Sheet)
  • Shionogi: Other Countries Must Follow UK’s Lead On Antimicrobial Incentives (Pink Sheet)
  • Industry Calls For Caution Over EMA Supply Chain Recommendations (Pink Sheet)
  • Industry Slates Decision To Exempt Parallel Importers From New Danish Stockpile Rules (Pink Sheet)
  • Asian Industry Groups Push For Universal Care, E-Labeling, Flexible Supply Chain (Pink Sheet)
  • Avid Bio fielding client inquiries due to China bill; Oxford Bio wants to double its revenues (Endpoints)
Pharma & Biotech
  • Novartis’ $3 billion MorphoSys boondoggle (STAT)
  • Novartis extends radiopharma plans with $1 billion acquisition (STAT)
  • Regeneron's blockbuster eye drug posts weaker sales due to inventory impact (Reuters)
  • Novo’s GLP-1 sales boost profits, yet full potential still curbed by supply squeeze (Endpoints)
  • BridgeBio spins out oncology company as it focuses on heart drug (STAT)
  • Moderna ends collaboration with CRISPR company Metagenomi, parts ways with gene editing chief (STAT)
  • Moderna expects CDC to view its RSV vaccine as equal to rival shots (Reuters)
  • Transcarent, Glen Tullman’s health tech unicorn, raises $126 million (STAT)
  • Exclusive: Spark co-founder launches new CNS gene therapy biotech with $54M (Endpoints)
  • Context Therapeutics' $100M placement; Blueprint raises guidance for rare disease drug (Endpoints)
  • As it cuts costs and pipeline, Bristol Myers hands back a cancer drug to Schrödinger (Endpoints)
  • Biotech vets raise $67M to develop targeted activators for cancer (Endpoints)
  • A once-public psychedelic biotech reemerges with $103M from MPM and Novo Holdings (Endpoints)
  • Epigenetic editing startup Chroma lays off staff, focusing on reaching the clinic (Endpoints)
Medtech
  • Cardinal receives FDA warning letter over unapproved syringes (MedTech Dive)
  • Medline to buy Ecolab’s surgical products for nearly $1B (MedTech Dive)
  • Senseonics gets FDA clearance to pair CGM implant with insulin pumps (MedTech Dive)
  • Labcorp gains FDA approval for companion diagnostic to Pfizer gene therapy (MedTech Dive)
Government, Regulatory & Legal
  • The U.S. needs a reliable supply of baby formula. A new bill in Congress can help (STAT)
  • Brain biopsies on ‘vulnerable’ patients at Mount Sinai set off alarm bells at FDA, documents show (STAT)
  • Bayer's Monsanto wins reversal of $185 million PCBs verdict in Washington court (Reuters)
  • Sarah Wicks Returns to HPM to Elevate Drug Development and Regulatory Practice (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.
×

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.