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