Recon: EU extends vaccine export checks; Vir, GSK to seek EUA for COVID antibody treatment

• Insider alleges Eli Lilly blocked her efforts to sound alarms about US drug factory (Reuters)
• Americans seek compensation for failed COVID-19 treatments from US fund (Reuters)
• House Gives Final Approval To $1.9 Trillion COVID-19 Relief Package (NPR)
• Pfizer/BioNTech say COVID-19 vaccine likely to prevent asymptomatic infection (Reuters)
• Vir, GSK plan to seek emergency use nod for COVID-19 antibody therapy (Reuters)
• Biden says Americans will be first to get vaccines; any surplus to be shared (Reuters)
• Biden administration extends U.S. tariff exclusion on Chinese medical goods (Reuters)
• Moderna starts dosing in COVID-19 booster vaccine study (Reuters) (WSJ)

• EU drugs regulator clears J&J's single-shot COVID-19 vaccine (Reuters) (FT) (EMA)
• EU extends vaccine export checks by three months until end-June (Reuters) (EC)
• EMA starts rolling review of Eli Lilly antibodies bamlanivimab and etesemivab for COVID-19 (EMA)
• Roche says Actemra-remdesivir trial fails to cut hospital stays (Reuters)
• Denmark, Norway and Iceland suspend AstraZeneca COVID shots after blood clot reports (Reuters) (FT)
• Britons told to keep getting vaccines after some countries suspend AstraZeneca shots (Reuters)
• Spain to keep using AstraZeneca vaccine, no blood clot cases reported (Reuters)
• Italy bans AstraZeneca batch following two deaths in Sicily: source (Reuters)
• Pfizer to consider new production sites only after 'pandemic supply phase' (Reuters)
• US curbs on raw material exports could dent new Quad alliance's vaccine push (Reuters)

• Activists, drug groups in waiver war over COVID-19 shot patents (Reuters)
• Single Covid vaccine dose less effective for cancer patients, study finds (FT)
• India agrees 'significantly lower' AstraZeneca vaccine price (Reuters)
• India's drug regulator panel eases use condition for home-grown vaccine (Reuters)
• Switzerland expecting 1 million COVID vaccine doses from Moderna, Pfizer in March (Reuters)
• China will continue to work with WHO to seek COVID-19 origins: premier (Reuters)
• South Korea extends use of AstraZeneca COVID-19 vaccine to people aged 65 and over (Reuters)
• Azerbaijan plans to import AstraZeneca and Sputnik V vaccines (Reuters)
• Hungary hails Sinopharm COVID-19 shot as new infections hit a record high (Reuters)

• Vertex begins human testing for diabetes cell therapy (BioPharmaDive) (PMLive)
• Dr. Reddy's pulls hundreds of thousands of bottles of Lipitor generic over impurity fears (Fierce)
• Recall report: BRP Pharma pulls 47 bottles of generic diuretic spironolactone after mixing different strength pills (Endpoints)
• FDA Relying More On Predictive Analytics To Help Monitor Quality Risks Of Sites During Pandemic (Pink Sheet)
• FDA delays Kadmon’s priority review as apparent clampdown continues (Endpoints)
• In race for in vivo sickle cell cure, Intellia unveils (very) early proof-of-concept (Endpoints)
• Spectrum Pharma Climbs as FDA to Fast-Track Cancer Drug Review (The Street)
• Antibiotic prescribing during the pandemic raises concern about drug resistance (STAT)
• ‘Deeply problematic’: AmerisourceBergen rewards its CEO despite the ravages of the opioid crisis (STAT)
• Aveo extends gains to 106% after drug maker wins FDA approval for kidney cancer treatment (BI) (FDA)
• Alex Gorsky earned a whopping $29.6M in 2020 as drugmaker pivoted around Covid-19 vaccine R&D (Endpoints)
• News from Abroad: Eurasian Patent Office Launches Its Pharmaceutical Register (Patent Docs)
• GSK to expand cell and gene therapy manufacturing capacity at CGT Catapult's Stevenage site (Pharmafile)
• Synthetic DNA player Touchlight scores $60M round to more than triple manufacturing capacity as mRNA gets hot (Endpoints)
• NULIBRY: Issuance of Priority Review Voucher: Rare Pediatric Disease Product (FDA)
• AMONDYS 45: Issuance of Priority Review Voucher: Rare Pediatric Disease Product (FDA)

• Medicare’s New Device-Coverage Pathway — Breakthrough or Breakdown? (NEJM)
• GE Healthcare predicts growth, hike in digital investment as pandemic eases (MedtechDive)
• Half Of Eudamed3 Modules To be Available By September (MedtechInsight)
• Cognito Therapeutics touts positive Phase 2 results for device-delivered Alzheimer's treatment (mobihealthnews)
• Roche awarded WHO prequalification for the HIV and HCV tests on the cobas 6800/8800 Systems (Press)

• 7th Circuit Evaluates the “Patent Thicket” (Big Molecule Watch)
• US FDA And Congressional Oversight: Will Democrats Be Tougher Than The GOP? (Pink Sheet)
• Vanda Pharma Can't Nix Investors' Off-Label Fraud Suit (Law360)