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Recon: FDA approves first generic version of AbbVie’s Restasis; Biden relaunches cancer ‘moonshot’

ReconRecon | 02 February 2022 |  By 

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)
In Focus: International
  • 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)
Coronavirus Pandemic
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Government, Regulatory & Legal
  • 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)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
 
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

 

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