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)
- 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)
- 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)
- 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)
- 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)
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