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

ReconRecon
| 11 March 2021 | By Michael Mezher 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • 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)
In Focus: International
  • 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)
Coronavirus Pandemic
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Government, Regulatory & Legal
  • 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)
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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