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)
- 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)
- 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)
- 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)
- 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)
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