Regulatory Focus™ > News Articles > 2021 > 2 > Recon: Novavax completes enrolment in US COVID vaccine trial; Sanofi to help manufacture J&J vaccine

Recon: Novavax completes enrolment in US COVID vaccine trial; Sanofi to help manufacture J&J vaccine

Posted 22 February 2021 | By Michael Mezher 

Recon: Novavax completes enrolment in US COVID vaccine trial; Sanofi to help manufacture J&J vaccine

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Novavax completes enrolling 30,000 people in US trial of COVID-19 vaccine (Reuters)
  • AstraZeneca to withdraw Imfinzi US indication for advanced bladder cancer (Reuters) (Endpoints)
  • Pfizer promises to double supply as Biden pushes for quicker vaccine rollout (Reuters)
  • US administers 63.1 million doses of COVID-19 vaccines: CDC (Reuters)
  • Who Will Be the Next FDA Chief? (NYTimes)
  • Urgency to ramp up vaccination clashes with Biden’s equity focus (Politico)
  • Brainstorm’s cell therapy for ALS lacks convincing clinical data for FDA submission, agency concludes (STAT) (Endpoints)
In Focus: International
  • GSK and Sanofi start with new COVID-19 vaccine study after setback (Reuters) (Press)
  • EU agreed to pay 870M euros for supply of AstraZeneca vaccines by June, contract shows (Reuters)
  • Biovac Plans to Become a Vaccine Maker for Underserved Africa (Bloomberg)
  • 'Real-world' UK data shows 70% decline in COVID infections after first Pfizer shot (Reuters)
  • France's Sanofi to help Johnson & Johnson manufacture COVID-19 vaccine (Reuters)
  • Fujifilm to restart clinical trial of Avigan to treat COVID-19: media (Reuters)
  • Wrong address? Russia denies mistake in EU vaccine application (Reuters)
  • World Bank pushing for standard vaccine contracts, more disclosure from makers (Reuters)
  • India's Serum Institute says prioritising domestic vaccine needs, asks for patience (Reuters)
  • Over 43 million doses of Sinopharm's COVID-19 vaccines used globally: state media (Reuters)
  • Start of Ebola vaccinations in Guinea delayed by poor weather (Reuters)
  • No-fault compensation programme for COVID-19 vaccines is a world first (WHO)
Coronavirus Pandemic
  • COVID vaccine reducing risk of hospitalisations, Scottish study suggests (Reuters)
  • Racial diversity lags in clinical vaccine trials despite push for inclusion, JAMA study finds (NBC)
  • Feds OK’d Export of Millions of N95 Masks as U.S. Workers Cried for More (KHN)
  • Japan vaccine supplies to be limited, delaying shots for elderly: minister (Reuters)
  • Australia begins mass COVID-19 vaccination programme (Reuters)
  • Taiwan grants emergency authorisation for AstraZeneca COVID-19 vaccine (Reuters)
  • Argentina approves Sinopharm COVID-19 vaccine for emergency use (Reuters)
  • AI-based voiceprint screener for COVID-19 nets European approval (Fierce)
Pharma & Biotech
  • Drug companies look to AI to end 'hit and miss' research (The Guardian)
  • Sussex medicines firm takes production line abroad in white van to beat Brexit ban (The Guardian)
  • 3 Things To Know About FDA's Evolving Drug Inspections (Law360)
  • After a slow week, the IPO train is back up and running as 3 more biotechs hop aboard (Endpoints)
  • Is biotech the new bitcoin? A top analyst draws some uncomfortable comparisons to a certain cryptocurrency as 'biotech mania' flourishes (Endpoints)
  • Eli Lilly's David Ricks snared $24M pay package in a year turbo-boosted by Covid-19 antibody (Endpoints)
  • Pandemic Taking Its Toll On The US FDA’s Non-Pandemic Work, Alkermes CEO Says (Pink Sheet)
  • Vas Narasimhan gets a bump in pay, but still falls well below some rivals (Endpoints)
  • A diagnostics company completes its pharma makeover, rebranding as Fore with Immunomedics vet at the helm (Endpoints)
  • Daiichi Sankyo poaches Kite's research lead Takeshita from parent Gilead (Fierce)
  • Otonomy's resurrected ear drug is now dead again — and investors aren't hanging around (Endpoints)
  • FDA Warns 10 Companies for Illegally Selling Dietary Supplements Claiming to Treat Depression and Other Mental Health Disorders (FDA)
  • Catalent signs on to produce Aurinia's newly approved lupus nephritis drug (Fierce)
  • Amgen lines up expansion to Otezla's $13B franchise; China OKs 'breakthrough' use of PD-1 (Endpoints)
  • Ono President Apologizes to JPMA After 2 Employees Are Indicted for Bribery (PharmaJapan)
  • FDA slaps import alert on India's Shilpa after sterile injectables issues multiply (Fierce)
  • Amgen Submits Supplemental New Drug Application for Otezla® (apremilast) for Adults with Mild-To-Moderate Plaque Psoriasis (Press)
  • Boston Scientific's ICD recall gets 2nd Class I label from FDA (MedtechDive)
  • Q4 Recalls Snapshot: Fewer Devices Recalled By Industry, But Software Troubles Still Abound (MedtechInsight)
  • US FDA Eyes March For Submission Tracker Pilot Launch (MedtechInsight)
Government, Regulatory & Legal
  • Zantac Chronicles II – The Prevalence of Preemption (Drug & Device Law)
  • Amgen Inc. v. Sanofi (Fed. Cir. 2021) (Patent Docs)
  • Lundbeck Pursues Brintellix Infringement Charges In India (Scrip)
  • EU Clears Varian's $16.4B Sale To Siemens Unit With Fixes (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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