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)
- 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)
- ‘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)
- 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)
- 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)
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