Recon: FDA approves first generic version of AbbVie’s Restasis; Biden relaunches cancer ‘moonshot’
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- FDA approves first generic form of AbbVie's eye drug (Reuters) (FDA)
- Gilead to fork over $1.24B, pay 3% royalty on Blockbuster Biktarvy in GSK patent settlement (Fierce) (Endpoints) (Law360)
- Experts question unusual authorization plan for Covid vaccine for kids under 5 (STAT)
- Biden once pledged to ‘cure cancer.’ His new approach is far more modest (STAT) (Reuters)
- FDA puts LogicBio genome editing therapy trial on hold after 2nd infant suffers adverse event (Fierce) (Endpoints)
- AliveCor’s credit-card-sized ECG snags FDA clearance for 30-second arrhythmia detection (Fierce)
- Controversial opioid Zohydro ER pulled from the market (Endpoints) (The Pink Sheet)
- FDA expands label for ViiV’s Cabenuva to cover bi-monthly administration HIV treatment (Endpoints)
- Novo Nordisk rejects US report on aggressive insulin price hikes (Reuters)
- British COVID trial deliberately infecting young adults found to be safe (Reuters)
- Blackstone, Carlyle Mull Joint Bid for Novartis Generics Arm (Bloomberg) (Endpoints) (FT)
- UK’s Early Access To Medicines Scheme To Get New Legal Basis (The Pink Sheet)
- Missed Opportunities Punctuate NICE Reform, Says UK Industry (The Pink Sheet)
- Australia Seeks Views On Revised National Medicines Policy (The Pink Sheet)
- New EU Bodies To Monitor Drug Supply In Health Crises (The Pink Sheet)
- MHRA consults on making first local vaginal HRT product available without a prescription (MHRA)
- Omicron infections slowing where variant first hit, says regional agency (Reuters)
- US Has Far Higher Covid Death Rate Than Other Wealthy Countries (NYT)
- Thermo Fisher raises COVID test revenue forecast by $1 billion (Reuters)
- Novartis axes a once 'first-in-class' prospect as another JAK program fails to clear a risk/benefit analysis (Endpoints)
- Biogen leaps into a showdown between Roche and Regeneron, betting on a potential new franchise player (Endpoints)
- Point unveils new Indy site to shore up supply chain in fight against prostate cancer (Endpoints)
- Cash-strapped antibiotics player Entasis could go private with a small-dollar buyout offer on the table (Endpoints)
- How UCB beat 2 other bidders to land $1.9B buyout of Zogenix and its epilepsy drug (Endpoints)
- A Cancer Treatment Makes Leukemia Vanish, but Creates More Mysteries (NYT) (STAT)
- Boston Scientific posts 15% gain in Q4 sales, expects 'headwinds' in 2022 (MedTech Dive)
- Edwards-backed Corvia fails pivotal heart failure trial but clings to subgroup efficacy signal (MedTech Dive)
- Minute Insight: Insulet Launches Long-Awaited Omnipod 5 Tubeless Insulin Pump (MedTech Insight)
- Medtronic’s Hugo surgery robot used in first European procedure (Fierce)
- Fractyl’s Type 2 diabetes device study shows HbA1c benefits sustained for 2 years (Fierce)
- Novartis, Amgen settle their dueling lawsuits over migraine drug Aimovig (Fierce)
- Shattuck Labs Sued for Misleading Investors on Takeda Partnership (Bloomberg)
- DOJ Sees $5 Billion Haul From Year’s False Claims Act (Bloomberg)
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