Recon: Eli Lilly wins FDA nod for obesity therapy Zepbound; Fully synthetic genome nears completion
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Eli Lilly gets FDA approval to sell Mounjaro as obesity drug called Zepbound (STAT)
- Senator floats new models to manage costs of weight loss drugs like Ozempic (STAT)
- Republicans divided over financial crisis in Medicare (STAT)
- Senate panel clears PBM reforms, safety-net hospital payments (STAT)
- Weight loss drugs transforming healthcare, may help with addiction (Reuters)
- US Senator Elizabeth Warren expresses ‘disappointment’ in FTC’s Amgen decision (Reuters)
In Focus: International
- Landmark legal case will claim the AstraZeneca vaccine was ‘defective’ (The Irish Independent)
- Sanofi plots exit as Nigeria operation struggles (Business Day)
- US Pharma Lobby Group Urges Japan to Stop Cutting Drug Prices (Bloomberg Law)
- Eli Lilly is still seeking UK approval on pen for weight-loss drug (Reuters)
- India’s Aurobindo Pharma posts jump in profit on strong overseas demand (Reuters)
- Merck KGaA tempers 2023 sales expectations after underwhelming third-quarter performance (Endpoints)
- BioNTech’s ‘extensive’ cancer pipeline comes into focus, with emphasis on ADCs (Endpoints)
- NICE backs use of hybrid closed loop systems for Type 1 diabetes, if companies offer discounts (MedTech Dive)
Pharma & Biotech
- AstraZeneca raises stakes in obesity drug race with Eccogene deal (Reuters)
- AstraZeneca spotlights bispecifics in cancer as it raises guidance, while pruning rare disease pipeline (Endpoints)
- Sanofi CEO defends company’s move to abandon profit guidance and boost research (STAT)
- Bayer’s new CEO signals business shake-up, plans to slash management (BioPharma Dive)
- Eli Lilly tries a rare tactic: competing on price (STAT)
- In the fight against cancer, it’s boom times for radiopharmaceuticals (STAT)
- Intellia plans to file IND for AATD trial next year; Ascidian raises $40M (Endpoints)
- Recursion and Bayer to wind down fibrosis R&D pact after three years, refocusing on cancer (Endpoints)
- Charles River’s CDMO business slows; Lilly boosts GLP-1 capacity; Teva’s Israel sites 'unaffected' (Endpoints)
- Novavax’s troubles continue as Covid vaccine maker plans another $300M+ in cost-cutting (Endpoints)
- Atara Biotherapeutics' stock drops nearly 50% after PhII trial fail in MS (Endpoints)
Medtech
- Digital health startups need more doctor CEOs (STAT)
- Fully synthetic genome nears completion in a step toward unraveling genetic mysteries (Endpoints)
- J&J’s Ottava robot arriving too late to threaten Intuitive: analysts (MedTech Dive)
- Masimo lowers outlook, citing constrained hospital budgets (MedTech Dive)
- Siemens Healthineers’ Varian rebounds; execs mum on diagnostics sale rumors (MedTech Dive)
- Recor wins FDA approval for renal denervation system (MedTech Dive)
Government, Regulatory & Legal
- Lawsuit Challenges Federal Vaccine Injury Compensation Program (MedPage Today)
- 25 attorneys general urge FDA to act fact to mitigate risk of racial bias in pulse oximetry (MedTech Dive)
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.
