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

• 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)

• 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)

• 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)

• 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)

• 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)