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November 2, 2020
by Michael Mezher

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)
Coronavirus Pandemic
  • US surpasses 9 million Covid cases (Politico)
  • T-cell study adds to debate over duration of COVID-19 immunity (Reuters)
  • Johnson locks down England as UK COVID-19 cases pass 1 million (Reuters)
  • UK plans to use AI to process adverse reactions to Covid vaccines (FT)
  • A Rapid Virus Test Falters in People Without Symptoms, Study Finds (NYTimes)
  • HHS relaxed oversight of problematic Covid-19 tests despite being told of accuracy concerns (STAT)
  • Israel starts human trials on COVID-19 vaccine as schools slowly reopen (Reuters)
  • Brazil will buy China COVID-19 vaccine, VP Mourão says, contradicting Bolsonaro (Reuters)
  • Brazilians protest mandatory COVID-19 immunization, Chinese vaccine (Reuters)
  • Bharat Biotech plans to launch vaccine candidate in second quarter of 2021 (Reuters)
  • Hologic wins $119M from HHS, DOD to help double COVID-19 test production (MedtechDive)
Pharma & Biotech
  • Royalty Pharma tops its record-setting $3.3B deal with CF Foundation, betting $575M more on Vertex's drugs (Endpoints)
  • MHLW to Introduce Vaccination Facilitation System for Wholesalers, Medical Institutions (PharmaJapan)
  • New EU approval for GSK's Zejula (PharmaTimes)
  • 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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