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December 18, 2023
by Jason Scott

Recon: Illumina agrees to divest Grail after antitrust battle; Indian retailer IndiaMART working with Novo to stop illicit Wegovy sales

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US
  • Illumina says it will divest Grail, starting a closing chapter for a disastrous deal (STAT)
  • Icahn aims to remove Illumina's legacy directors – letter (Reuters)
  • Here are the best biopharma CEOs of 2023 (STAT)
  • The biggest health care deals of 2023 (STAT)
  • FDA rejects Checkpoint Therapeutics' PD-L1 drug cosibelimab over manufacturing issues (Endpoints)
In Focus: International
  • Exclusive: IndiaMART is working with Novo Nordisk to halt illegal Wegovy sales - source (Reuters)
  • BioNTech aims to start mRNA vaccine output in Rwanda in 2025 (Reuters)
  • ‘Two Minutes To Midnight’ For Germany’s Medtechs – Spectaris At Medica 2023 (MedTech Insight)
  • Updated: Pear Therapeutics PDTs Reborn In PursueCare, Supported By Pear's Ex-CEO (MedTech Insight)
  • Classification And Equivalence Guidances Published For MDR’s Non-Medical Devices (MedTech Insight)
Pharma & Biotech
  • ‘We’ve exhausted all avenues’: A small biotech may give up on its ultra-rare disease drug over frustration with FDA (STAT)
  • Structure Therapeutics GLP-1 pill cuts blood sugar, weight in early diabetes study (STAT)
  • Structure's diabetes pill misses weight-loss expectations in mid-stage trial (Reuters)
  • Wegovy may have another helpful trick: fighting inflammation via the brain, study finds (STAT)
  • Novo owner commits $265 mln of Wegovy windfall to respiratory diseases (Reuters)
  • Novo Nordisk Foundation to launch $260M vaccine initiative in early 2024 (Endpoints)
  • GSK's cancer drug combination meets primary goal in late-stage trial (Reuters)
  • Checkpoint Therapeutics slides after US FDA declines cancer therapy approval (Reuters)
  • Point Biopharma’s closely watched prostate cancer radiopharmaceutical study disappoints, Lilly again extends offer (Endpoints)
  • Covid biotech’s stock jumps after positive early PhIII monoclonal antibody data reveal (Endpoints)
  • First Wave to merge with ImmunogenX; Caliway raises $100M; New deals for Replay’s Syena (Endpoints)
  • Exclusive: A longtime VC takes on his own rare disease as Sanofi, Boehringer commit $80M to launch new platform study (Endpoints)
  • Bristol Myers cuts PhIII PD-1/LAG-3 trial in colorectal cancer short after drug combo fails analysis (Endpoints)
  • VC firm Pivotal closes second $389M therapeutics fund to create companies and back public biotechs (Endpoints)
Medtech
  • Zimvie to sell spine business for $375M (MedTech Dive)
  • BTIG analysts optimistic medtech will rebound in 2024 after ‘string of rough years’ (MedTech Dive)
  • Glaukos wins FDA approval for drug-releasing eye implant to treat glaucoma (MedTech Dive)
  • Tandem completes US launch of revamped diabetes management platform (MedTech Dive)
  • MTI 100: Global Medtech Recovers Core Growth After A Year Like No Other (MedTech Insight)
  • News We’re Watching: Henry Schein Hack, New Codes For Shockwave And Eckso, Breast Implant Safety Update (MedTech Insight)
Government, Regulatory & Legal
  • The legal pathway for experimental, ultra-rare disease treatments is rocky and expensive (STAT)
  • Alzheimer’s drug approvals show we need a reevaluation of patient advocacy (STAT)
  • NIH panel calls for fewer, better-paid postdocs in bid to halt loss of scientists to industry (STAT)
  • New Jersey’s telehealth restrictions cut off access to lifesaving care, lawsuit alleges (STAT)
  • Governors’ Push President on Cannabis Rescheduling But Overlook What Schedule III Would Require (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.
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