Recon: FDA ends use of GSK’s COVID drug due to BA.2 spread; EU regulators recommend 4th COVID shots only for those over 80

ReconRecon | 06 April 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • FDA pulls authorization for GSK-Vir's COVID therapy as BA.2 cases rise (Reuters) (Endpoints) (Inside Health Policy)
  • Current COVID vaccines not 'well-matched' against BA.2 -FDA (Reuters)
  • Future of Boosters Comes Down to Key Meeting of FDA Advisors (Bloomberg)
  • A Win for AI: FDA Approves BioXCel Therapy for Bipolar Disorder and Schizophrenia (Biospace) (Bloomberg)
  • Novartis' PI3K drug, already approved in breast cancer, nabs a speedy OK to treat ultra-rare condition (Endpoints)
  • FDA grants Sanofi’s blockbuster priority review in a new indication (Medwatch) (Pharmaceutical Technology)
  • Nanovi submits cancer biomarker for marketing approval in the US (Medwatch)
  • Biden announces long covid strategy as experts push for more (Washington Post) (STAT)
  • Pfizer’s $5 Billion Bill for US Takes Big Bite From Covid Aid (Bloomberg)
  • Monoclonal Antibodies May Soon Become Less Available (Bloomberg)
  • Novartis manufacturing facility in North Carolina gets FDA all-clear to produce, ship gene therapies (Endpoints)
  • Senators call on HHS to investigate McKinsey's alleged ties with FDA, opioid manufacturers (Endpoints)
In Focus: International
  • Fourth Covid Shots Recommended Only for Those 80 and Over in EU (Bloomberg) (EMA)
  • Russia Sanctions, China Lockdown To Pinch Globally With Higher Freight, API Costs (Scrip)
  • New UK Pathway Use Has ‘Far Exceeded Expectations’ (The Pink Sheet)
  • EQRx Price Disruptor Business Model Faces The Costly Reality Of FDA Drug Development Standards (The Pink Sheet)
  • Drugmaker GSK cuts ties with Russia government over Ukraine crisis (Reuters)
  • Canadian HTA Consults On Improvements To Drug Review Process (The Pink Sheet)
  • Colombian government faces calls to issue compulsory license for Pfizer’s Covid-19 pill (STAT)
Coronavirus Pandemic
  • Second booster shields elderly from COVID but protection wanes quickly – study (Reuters)
  • Canada's Ontario to expand second COVID booster shot eligibility from Thursday (Reuters)
  • Greece offers second COVID booster for people over 60 (Reuters)
  • China Kintor's COVID drug candidate cuts hospital, death risk in trial (Reuters)
Pharma & Biotech
  • Big Pharma partnerships, record $22.7B investment raise profile of regenerative medicine in 2021 (Fierce)
  • Can Novartis Break Back Into The US Top Five? It Is Going To Need Bigger Blockbusters (Scrip)
  • Boehringer Ingelheim boosts R&D commitment, promises up to 15 new product launches by 2025 (Endpoints)
  • Merck looks to cardiovascular pipeline for $10B-plus peak sales -- and diversification from Keytruda (Fierce)
  • Takeda Teams With Evozyne On Protein Design For Gene Therapy (Scrip) (Endpoints)
  • Troubles mount for Cassava Sciences, as patient enrollment lags for Alzheimer’s drug studies (STAT)
  • Fierce Biotech Layoff Tracker: Novartis, bluebird add to pile of 30-plus biotechs laying off staff (Fierce)
  • Rough biotech market won’t stop 5AM Ventures’ new $750M life science funds (Fierce)
  • GlaxoSmithKline keeps trucking alongside AI with new, multi-year pathology partnership with Boston outfit (Endpoints)
  • Building on its retinal disease expertise, Regeneron signs eye-focused gene therapy pact with German biotech (Endpoints) (Fierce)
  • Researchers identify new genetic link to schizophrenia (Washington Post)
  • After seeing reprocessed duodenoscope contamination data, FDA pushes for switch to disposable (MedTech Dive)
  • 'Where's the patient?': Experts question FDA's final recall guidance (MedTech Dive)
  • Medtronic posts positive 3-year data in renal denervation ahead of pivotal readout (MedTech Dive)
Government, Regulatory & Legal
  • Akebia Drops Bid to Bar AstraZeneca From Anemia Drug Patent Suit (Bloomberg)
  • FTC v. Endo: Exclusive Licenses, ‘Supracompetitive Prices’ Are Protected By Patent Laws (The Pink Sheet)
  • Mylan, CVS, Express Scripts, Optum Trim EpiPen Price-Gouge Case (Bloomberg)
  • ‘Tomorrow Is A New Day,” Theranos Judge Tells Balwani Atty (Law360)
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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