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February 26, 2024
by Jason Scott

Recon: DoJ subpoenas BioMarin over sponsored testing programs; Boehringer, Zealand’s weight loss drug shows promise in mid-stage MASH study

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • BioMarin Pharma gets DOJ subpoena on sponsored testing programs for two therapies (Reuters)
  • Oregon suspends a portion of its drug transparency law found to be unconstitutional (STAT)
  • Amgen’s rheumatoid arthritis drug Enbrel targeted for first-in-the-nation price limit in Colorado (STAT)
  • UnitedHealth cyberattack impedes pharmacies’ and hospitals’ ability to process insurance claims (STAT)
  • Bipartisan group of lawmakers opposes Biden's plan to use 'march-in' to lower drug prices (Endpoints)
  • What Alabama ruling means for patients with frozen embryos: one woman's story (Reuters)
  • Oncopeptides’ Pepaxto Withdrawal Speeds Through In 7 Months Under Expedited Procedures (Pink Sheet)
  • In Washington, The Answer Is Drug Shortages But What Is The Question? (Pink Sheet)
In Focus: International
  • Uzbek court sentences 23 over contaminated cough syrup deaths (Reuters)
  • US hospital chain Providence Health bulks up India services unit to tap more clients (Reuters)
  • EMA Addresses Need For Guideline On Antivirals & MAbs For COVID-19 (Pink Sheet)
  • Travere's Filspari, J&J's Carvykti win support from CHMP in blitz of positive recommendations (Fierce Pharma)
  • NICE Recommends Endoscopic Sleeve Gastroplasty To Treat Obesity (MedTech Insight)
  • New EU Regulation Extending IVD Deadlines Expected In April (MedTech Insight)
Pharma & Biotech
  • Human reproductive cloning: The curious incident of the dog in the night-time (STAT)
  • Obesity treatment from Boehringer Ingelheim, Zealand Pharma succeeds in study in liver condition MASH (STAT) (Endpoints) (Reuters)
  • Ocular Therapeutix moves in the right direction, and Alnylam tries to calm some nerves (STAT)
  • Gilead bid against itself in $4.3B deal for CymaBay, filing shows (Endpoints)
  • Teva and Alvotech's interchangeable Humira biosimilar joins the party (Endpoints)
  • AbbVie’s next CEO; $100B club refresh; Top 100 VCs, 2023; More hope for CAR-T in autoimmune; and more (Endpoints)
  • GSK’s antibiotic succeeds in late-stage gonorrhea trial with eye to addressing resistance (Endpoints)
  • Clade Therapeutics cuts staff and appears to shut down European subsidiary (Endpoints)
  • Roche's Xolair reduces reactions to severe food allergies in study (Reuters)
  • Venatorx, Melinta's BARDA-funded antibiotic combo falls short with manufacturing-related rejection (Fierce Pharma)
  • To BioMarin CEO Alexander Hardy, hemophilia A gene therapy Roctavian needs 3 stars to align (Fierce Pharma)
  • TL1A Inhibitors Could Usher in New Era for IBD Treatment (BioSpace)
Medtech
  • New GT Medical CEO Per Langoe on driving adoption of brain tumor therapy (MedTech Dive)
  • FDA warns against using smart wearables that claim to measure blood sugar (MedTech Dive)
  • 3M to spin off health unit April 1 (MedTech Dive)
  • Canary Speech’s Voice AI Can Help Detect Alzheimer’s With 40-Second Conversation (MedTech Insight)
  • FDA Guidance Doc Would Waive Registration Fees For Bankrupt Small Businesses (MedTech Insight)
Government, Regulatory & Legal
  • FDA Knows Its Own Strength—and It Includes Concentration (FDA Law Blog)
  • Gilead settles with Maryland distributor over alleged counterfeit HIV drugs (Endpoints)
  • Lilly’s ‘High Quality’ Donanemab Data Supports Unrestricted Medicare Coverage, Firm Says (Pink Sheet)
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.
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