Regulatory Focus™ > News Articles > 2021 > 4 > Recon: Regeneron seeks EUA for antibody cocktail to prevent COVID; Sanofi to build €400M vaccine sit

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Posted 12 April 2021 | By Michael Mezher 

Recon: Regeneron seeks EUA for antibody cocktail to prevent COVID; Sanofi to build €400M vaccine site in Singapore

2741 Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Regeneron to seek US OK for COVID-19 cocktail to be used for prevention (Reuters) (STAT)
  • White House says J&J COVID-19 shot shipments to be low until U.S. vaccine plant cleared by regulators (Reuters)
  • Eli Lilly to focus on selling COVID-19 antibody drug combination (Reuters)
  • CEO at troubled vaccine plant received 51 percent compensation boost in 2020 (Washington Post)
  • Gilead Assistance Programs For HIV, Hep B Drugs Will Dial Back Reimbursement To 340B Providers (BioPharmaDive)
  • Sage touts first win in $3B Biogen pact, but safety profile, doubts over data cloud road ahead (Endpoints) (STAT)
In Focus: International
  • J&J begins COVID-19 vaccine supplies to EU, 50 million doses expected in second quarter: lawmaker (Reuters)
  • EU seeks clarification from AstraZeneca on supply shortfalls (Reuters)
  •  
  • Bulgarian PM reveals price for EU's new vaccine contract with Pfizer (Reuters)
  • Sanofi to invest 400 million euros in new vaccine production site in Singapore (Reuters)
  • AstraZeneca's diabetes drug Farxiga fails in COVID-19 study (Reuters)
  • Four Italian firms can activate bioreactors for vaccine production (Reuters)
  • Indian panel gives emergency approval for Russia's Sputnik V vaccine: sources (Reuters)
  • India bans Remdesivir exports as coronavirus rages on; rallies continue (Reuters)
  • China considers mixing COVID-19 vaccines to boost protection rate (Reuters) (NYTimes) (Politico)
  • 'The right path' - Chile defends Sinovac use amid fresh efficacy questions (Reuters)
Coronavirus Pandemic
  • South African variant may evade protection from Pfizer vaccine, Israeli study says (Reuters)
  • Brazil, Mexico, Philippines among those due to get Pfizer shots from COVAX in Q2 – statement (Reuters)
  • Spain's Rovi to make ingredients for Moderna's COVID-19 vaccine (Reuters)
  • Asthma drug budesonide speeds recovery for at-home COVID-19 patients (Reuters)
  • Australia abandons COVID-19 vaccination targets after new advice on AstraZeneca shots (Reuters)
  • South Korea to begin producing Novavax COVID-19 vaccine as early as June (Reuters)
  • Rollout of eye-scan test for coronavirus targeted by German firm (Reuters)
  • Bharat Biotech to raise Covaxin's production to 12 million a month by July (Economic Times)
  • Maduro says Venezuela has secured funds to complete COVAX payment (Reuters)
  • Ireland set to restrict use of AstraZeneca vaccine: RTE (Reuters)
  • Shhh! It’s a Secret! FDA is Not Providing Key Details in the EUA Templates (FDA Law Blog)
Pharma & Biotech
  • Clinical study reports hold more details about the side effects of cancer drugs (STAT)
  • Revolution Medicines seeks to bolster case for its lead cancer drug (STAT)
  • AACR21: iTeos busts out early human data for anti-TIGIT antibody. Is it enough to match up with Roche, Merck? (Endpoints)
  • AACR21: Eli Lilly blazes new trail for RET inhibitor, ginning up a response in 9 solid tumor types in early data (Endpoints) (STAT)
  • AACR: OncoMyx's engineered rabbit pox virus shows promise in lung cancer model (Fierce)
  • AACR: MD Anderson team uncovers new target for blocking mutant KRAS and p53 in pancreatic cancer (Fierce)
  • Jazz Pharmaceuticals pushes to expand label on Xywav; FDA eyes October for decision on Seagen's latest ADC (Endpoints)
  • AZ showcases data for next-generation PARP inhibitor AZD5305 (PMLive)
  • European Medicines Data Standards Offer Business Opportunities For Life Science Firms (Pink Sheet)
  • Revised US Approach For Parenteral Drug Leachables Could Prevent Regulatory Missteps (Pink Sheet)
  • Sanofi teams with virtual reality biotech on oral Dupixent successor (Endpoints)
  • IPO market continues to churn with a pair of Covid-19 biotechs seeking Nasdaq, while mitochondria-focused Reneo debuts (Endpoints)
  • Taysha Gene Therapies gears up to approach regulators with a new candidate for a debilitating neurodegenerative disease (Endpoints)
  • W.Va. legislators call on Gov. Justice to help rescue Mylan plant in Morgantown (Post-Gazette)
Medtech
  • Italy's DiaSorin strikes $1.8B Luminex buy to add multiplex molecular testing assets (MedtechDive)
  • FDA clears its first plug-in AI video system for spotting polyps during colonoscopy (Fierce) (FDA)
  • South Korean chipmaker bats US FDA approval of its non-invasive glucose monitoring device (mobihealthnews)
  • Activ Surgical lands FDA clearance for imaging device to enhance endoscope observations (Fierce)
  • FDA puts Medtronic Valiant Navion stent graft recall in Class I category (MedtechDive) (FDA)
  • Medtronic Recalls Evera, Viva, Brava, Claria, Amplia, Compia, and Visia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy (CRT-Ds) Due to Risk of Shortened Battery Life (FDA)
  • Akili to study EndeavorRx as a COVID-19 brain fog treatment (mobihealthnews)
Government, Regulatory & Legal
  • FTC Says Moving Illumina Suit To Calif. Is Risky Amid COVID (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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