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March 25, 2021
by Michael Mezher

Recon: Pfizer begins pediatric trial of COVID vaccine; AstraZeneca revises vaccine efficacy rate to 76%

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Pfizer hopes for a happy ending for an osteoarthritis drug with a troubled history (STAT)
  • Behind the scenes, companies helping big Covid-19 vaccine makers are getting rich (STAT)
  • HHS is urged to use its patents for the Moderna Covid-19 vaccine to widen global access (STAT)
  • HHS inspector general signs off on Novartis paying for pricey Kymriah (Endpoints)
  • US to no longer distribute Eli Lilly’s bamlanivimab alone due to coronavirus variants (Endpoints)
  • Pfizer Begins Testing Its Vaccine in Young Children (NYTimes)
In Focus: International
  • AstraZeneca updates COVID-19 vaccine efficacy rate to 76% (Reuters) (STAT)
  • EU to further study blood clot cases linked to AstraZeneca's COVID-19 vaccine (Reuters) (EMA)
  • With a Police Raid and the Threat of Export Curbs on Vaccines, the EU Plays Tough (NYTimes)
  • After inspection, AstraZeneca says 29 million COVID-19 doses in Italy are for EU, poorer nations (Reuters)
  • Trial set to start of AstraZeneca Covid vaccine as nasal spray (FT)
  • Vaccine failures cast shadow over EU summit as COVID-19 surges (Reuters)
  • India blocks vaccine exports in blow to dozens of nations (FT)
  • Brazil's Anvisa says Janssen files for emergency use of its COVID-19 shot (Reuters)
  • Thailand approves Johnson & Johnson's COVID-19 vaccine (Reuters)
Coronavirus Pandemic
  • U.S. says hopes WHO report on virus origins is 'based on science' (Reuters)
  • Vaccines alone won't end Covid. Biden's new testing strategy could help finish the job. (Politico)
  • Caribbean appeals to Biden to share vaccines with U.S. 'third border' (Reuters)
  • CanSinoBIO offered tens of millions of COVID-19 vaccine doses to COVAX: exec (Reuters)
  • Ukraine procurement agency says cannot accept first batch of China's Sinovac vaccine (Reuters)
  • Canada says AstraZeneca COVID-19 vaccine safe, but adds blood clot warning (Reuters)
  • Sweden to resume AstraZeneca jabs for over 65s (Reuters)
  • Denmark to extend suspension of AstraZeneca COVID shot amid doubts (Reuters)
  • Russia reaches deal to produce Sputnik V vaccine at Serbia's Torlak Institute: RDIF fund (Reuters)
  • Belarus starts mass production of Russia's Sputnik V vaccine: ministry (Reuters)
Pharma & Biotech
  • Novartis corrects chairman's comments about kickbacks case (Reuters)
  • Teva sees room for growth with FDA communications and complex generics, COO says (Endpoints)
  • FDA adds Guillain-Barré syndrome warning to GlaxoSmithKline’s shingles vaccine (Endpoints)
  • Novartis is shutting down Colorado plant, laying off 400 employees after overestimating gene therapy demand (Fierce)
  • Benzedrex (propylhexedrine): Drug Safety Communication - FDA Warns that Abuse and Misuse of the Nasal Decongestant Causes Serious Harm (FDA)
  • Bristol Myers Squibb outraces the pack to a late-stage trial win for its LAG-3/PD-1 antibody combo in melanoma (Endpoints)
  • 'Protein printing' AbSci secures $125M crossover as it expands synthetic biology ambitions (Endpoints)
  • Ex-Warp Speed chief exits two more drug companies (The Hill) (Endpoints)
  • In a first for upstart synthetic biology field, Zymergen files for $100M IPO (Endpoints)
  • MHLW Notifies of Guidelines on Use of Registry Data in Regulatory Submissions (PharmaJapan)
  • Is a 'super-seasonal' flu vaccine on the horizon? The NIH and UW are taking a shot into the clinic this April (Endpoints)
  • Broad Institute launches $300 million effort to harness AI to fight diseases (STAT)
  • Neuro upstart launches out of RA Capital’s low-profile incubator with Big Pharma vets, clinical drugs and $80M (Endpoints)
  • RiverVest off to the races with $275M to invest in early-stage biotech (Endpoints)
  • GV wagers on seasoned team's intranasal 'temporary' preventative approach to viruses — with ex-Gilead CEO John Martin jumping on board (Endpoints)
  • Following the flow of the biotech industry, Lava heads to Nasdaq with a gamma delta T cell promise (Endpoints)
  • Apnimed raises $25M to take sleep apnea drug into phase 3 (Fierce)
  • T cell therapy player Lyell prepares to open $65M manufacturing facility in the Seattle area (Endpoints)
  • Zydus Pharmaceuticals (USA) Inc. Issues Voluntary Nationwide Recall of Acyclovir Sodium Injection, 50 mg/mL Due to Crystallization (FDA)
Medtech
  • US FDA Panel Grapples With Dermal Filler Adverse Events (MedtechInsight)
  • FDA No Longer Accepting Certain Face Mask EUAs, Signaling A More Manageable Pandemic (MedtechInsight)
  • Thermo Fisher pivots COVID-19 approach with air detection, school testing (MedtechDive)
  • Medtronic Recalls Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Balance™ Biosurface for Possible High Levels of Endotoxins (FDA)
  • BD Expands Voluntary Recall of ChloraPrep™ 3 mL Applicator Nationwide to Include All U.S. States (FDA)
Government, Regulatory & Legal
  • Lundbeck Loses EU Appeal Over €146M 'Pay For Delay' Fine (Law360)
  • Purdue, Sackler Opioid Suits Paused For Another Month (Law360)
  • Pharma Industry Can Expect More Scrutiny From State AGs (Law360)
  • GSK Says No Link Between Zofran, Defects Undermines MDL (Law360)
  • Court Dismisses Lanham Act Claims Brought By Device Manufacturer Against Competitor (Drug & Device Law)
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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