Recon: MHRA begins accelerated review of AZ COVID vaccine; Russian firm seeks compulsory license to make remdesivir
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
US approves combination of Pfizer's Upjohn and Mylan (Reuters)
Novavax lays out specific minority targets for US COVID-19 vaccine trial (Reuters)
J&J plans to test its COVID-19 vaccine in ages 12-18 soon (Reuters)
To Vaccinate Against Covid-19, US Enlists Pharmacy Chains (WSJ)
Trump threatens to fire Fauci ‘after the election’ (STAT) (NPR)
Trump admin. funds plasma company based in owner’s condo (AP)
Novartis move to defuse controversy over US drug discount program is rebuffed (STAT)
White House plots possible second-term Cabinet purge (Politico)
White House sidestepped FDA to distribute hydroxychloroquine to pharmacies, documents show. Trump touted the pills to treat covid-19. (Washington Post)
In Focus: International
CureVac's COVID-19 vaccine triggers immune response in Phase I trial (Reuters)
European Regulators Accept Aducanumab for Review: Biogen/Eisai (PharmaJapan)
Russian firm seeks to produce COVID-19 drug remdesivir without patent (Reuters)
Russia makes preliminary submission of COVID-19 vaccine to Brazil regulators (Reuters)
Britain starts accelerated review for AstraZeneca's potential COVID-19 vaccine (Reuters)
Sanofi inks $358M Kiadis takeover to acquire NK-cell platform (Fierce)
Japan's Sosei allies with ex-Novartis team to develop neurological drug pipeline (Reuters)
WHO Director-General Tedros Enters Quarantine, Self-Isolates (Bloomberg)
MHRA allows HAE patients early access to berotralstat (PharmaTimes)
Axovant shares sink on manufacturing delay for Parkinson's gene therapy (BioPharmaDive)
Roche’s Tecentriq/Avastin combination approved by European Commission (PMLive)
Biogen dodges a bullet in its controversial quest to gain an approval for their experimental Alzheimer’s drug aducanumab (Endpoints)
Regeneron slams the brakes on rare disease trial following patient deaths — casting more doubt on a drug with mixed results (Endpoints)
Makin’ Copies: FDA Revises RLD and RS Guidance (FDA Law Blog)
Orchard halts dosing of EMA-approved Strimvelis after patient develops leukemia (Endpoints)
FDA lifts a hold on Poseida study; Decibel adopts 2-AAV approach to hearing loss; AstraZeneca partners on combos, again (Endpoints)
Santhera axes half its employees and sees CMO depart after PhIII DMD fail (Endpoints)
Medtech
As Expected, FDA Misses Fourth Consecutive Deadline For Releasing Draft QSR (MedtechInsight)
PerkinElmer buys out British gene editing player for $383M, boosting its diagnostics and genomic capabilities (Endpoints)
Medtronic expands head, neck portfolio with new acquisition and FDA clearance (Fierce)
Stryker, NuVasive, Globus forge on with surgical robots through COVID-19 (MedtechDive)
Illumina defends Grail valuation amid much cheaper Exact-Thrive deal (MedtechDive)
Government, Regulatory & Legal
FDA, Homeland Security Agencies Take Additional Action to Prevent Import of Illegal and Harmful Medical Products Through International Mail Facilities (FDA)
Purdue law firm hires Justice Department lawyer who investigated the opioid maker (STAT)
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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