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July 11, 2024
by Jason Scott

Recon: FDA rejects Novo Nordisk’s weekly insulin; Pfizer to develop once-daily GLP-1 weight-loss drug

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

In Focus: US
  • Novo Nordisk’s weekly insulin rejected by FDA (STAT)
  • Biden administration ignores calls to bolster hospital price transparency (STAT)
  • Researchers identify ‘molecular switch’ in lupus that could stymie harmful immune response (STAT)
  • Pfizer presses forward with once-daily GLP-1 pill in long-awaited move (Endpoints)
  • Novartis to shut down San Diego technical research and development facility (Endpoints)
  • AbbVie CSO Tom Hudson to retire, replaced by medical chief (Endpoints)
  • Congress Pushes US FDA On Trial Diversity, Accelerated Approval In Approps Report (Pink Sheet)
  • FTC’s PBM Investigation Could Yield Litigation Over Insulin Contracting (Pink Sheet)
  • US FDA flags shortage of Becton Dickinson's blood test tubes (Reuters)
  • US Senator Sanders optimistic Novo Nordisk can be pressured to cut Wegovy, Ozempic prices (Reuters)
  • US FTC to sue drug middlemen over insulin prices, source says (Reuters)
In Focus: International
  • U.K. pharma increasingly violates voluntary industry marketing codes, and probes are taking longer (STAT)
  • Ipsen takes on another ADC, this time from a China-based biotech (Endpoints)
  • Almost all patients quit weight loss shots within two years, analysis finds (Endpoints)
  • Thermo Fisher closes $3.1B Olink acquisition after UK antitrust review is cleared (Endpoints)
  • Hong Kong Enhances Expedited Drug Licensing Process; Adopts Refuse-To-File Tool (Pink Sheet)
  • EFPIA: EU Must Up The Budget Of Next R&D Funding Framework (Pink Sheet)
  • Another Funding Win For Chiesi In Europe As Scotland OKs Elfabrio (Pink Sheet)
Pharma & Biotech
  • Roche’s TIGIT study was a bust. What’s the outlook for its next big bet? (STAT)
  • How the world's biggest pharma and biotech companies paid their typical worker in 2023 (Endpoints)
  • Novo-partnered 3D bioprinting biotech gets $70M+ from Canadian government (Endpoints)
  • Flagship's Noubar Afeyan on uncertainty, AI and biotech’s future (Endpoints)
  • Are 'next-gen' biotech acquirers experiencing their moment? (Endpoints)
  • Exclusive: Courier Health raises $16.5M Series A to help biopharma companies bring together patient data (Endpoints)
  • Indivior shares dive on profit warning, dropping of schizophrenia drug (Reuters)
  • Move over, oncology: Obesity, diabetes meds will take over 2030's top drug rankings, Evaluate forecasts (Fierce Pharma)
Medtech
  • Musk's Neuralink says tiny wires of brain chip in first patient now stable (Reuters)
  • Roche wins CE mark for its first CGM (MedTech Dive)
  • Illumina buys Fluent Biosciences, adding single-cell analysis tech (MedTech Dive)
  • Federal officials step down from health AI group’s board (MedTech Dive)
  • Endoron Staples Down $10M To ‘Revolutionize’ Abdominal Aortic Aneurysm Repair (MedTech Insight)
  • Sinaptica’s Breakthrough Device Could Slow Brain Atrophy In Alzheimer’s Patients – Study (MedTech Insight)
  • Orange Book Is The New Spat: FTC Seeks Removal Of ‘Improperly’ Listed Medical Device Patents (MedTech Insight)
Government, Regulatory & Legal
  • Sanford Health aims to shake off a run of failed deals by snapping up a $3 billion Wisconsin health system (STAT)
  • Medicaid is paying millions for salty, fat-laden ‘medically tailored’ cheeseburgers and sandwiches (STAT)
  • Doctors ‘overprescribing’ opioids isn’t the cause of the overdose epidemic — and it never was (STAT)
  • Preparing schools for the H5N1 bird flu they’re likely to face (STAT)
  • US FDA’s Genetic Metabolic Diseases Adcomm Debuts With Zevra’s Arimoclomol (Pink Sheet)
  • Power to the Patient with Patient Generated Health Data (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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