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February 16, 2021
by Michael Mezher

Recon: Australia provisionally authorizes AstraZeneca vaccine; BMS, Sanofi ordered to pay Hawaii $834M over Plavix warning label

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Moderna expects to supply second 100 million vaccine doses to US by May-end (Reuters)
  • Low vaccine supply pushes US vaccination timeline to at least late May: Fauci (Reuters)
  • Bristol-Myers, Sanofi ordered to pay Hawaii $834M over Plavix warning label (Reuters) (STAT)
  • Bluebird suspends studies of sickle cell gene therapy following cancer diagnoses in two more treated patients (STAT)
  • Once again, senators want GAO to probe the role of PBMs in prescription drug pricing (STAT)
  • Novavax to complete US vaccine trial enrolment in record time (FT)
  • How scientists saved Trump's FDA from politics (The Hill)
In Focus: International
  • EU adds anti-variant clauses to new COVID vaccine supply deals (Reuters)
  • EU seeks new COVID-19 vaccine deal with Moderna, AZ flags doses made outside EU (Reuters)
  • Australia approves AstraZeneca vaccine, bolstering inoculation programme (Reuters)
  • Japan to start inoculation drive Wednesday amid shortage of special syringes (Reuters 1, 2)
  • UK auditing Indian vaccine site amid scramble for shots – sources (Reuters)
  • Hong Kong advisory panel approves China's Sinovac COVID-19 vaccine for emergency use (Reuters)
  • North Korean hackers tried to steal Pfizer vaccine know-how, lawmaker says (Reuters)
  • Ebola vaccination campaign begins in Democratic Republic of Congo (Reuters) (BBC)
  • WHO alerts six African countries after Ebola outbreaks (Reuters)
  • Five dead in new Ebola outbreak in Guinea (Reuters)
Coronavirus Pandemic
  • Why the three biggest vaccine makers failed on Covid-19 (FT)
  • Covid-Linked Syndrome in Children Is Growing and Cases Are More Severe (NYTimes)
  • Scientists Are Trying to Spot New Viruses Before They Cause Pandemics (NYTimes)
  • Potential for New Coronaviruses May Be Greater Than Known (NYTimes)
  • My Teens are Coronavirus Vaccine Guinea Pigs (NYTimes)
  • Another new coronavirus variant seen in the UK (BBC)
  • New Coronavirus Variants Appear To Have Evolved In The US (NPR)
  • China arrests leader of fake vaccine scam (BBC)
  • First 550,000 doses of Chinese Sinopharm's vaccine arrive in Hungary (Reuters)
  • The search for new Covid drugs — and a researcher’s reason for optimism (STAT)
  • Palestinians accuse Israel of preventing COVID-19 vaccine transfer to Gaza (Reuters)
  • South Africa wants to return 1 million AstraZeneca vaccine doses to Serum Institute: report (Reuters)
  • South Africa plans to share AstraZeneca vaccine, first J&J shots expected (Reuters)
  • South Africa medical association says J&J vaccines could arrive on Tuesday (Reuters)
  • Eyeing variants, Adagio starts phase 1 trial of COVID-19 antibody (Fierce)
  • Germany plans to offer free rapid coronavirus tests from March 1 (Reuters)
  • US FDA ‘Project Post COVIDity’ Will Track Infection Impact On Cancer Patients Using Real-World Data (Pink Sheet)
Pharma & Biotech
  • Trump’s vaccine tsar launches European biotech roll-up (FT) (STAT) (BioPharmaDive)
  • Pfizer, Verily-backed Alzheimer's biotech Cortexyme hit by FDA partial hold over liver toxicity (Fierce)
  • AstraZeneca hands chief £15.4m pay package (FT) (Endpoints)
  • EU Fast-Track Fail For Another BMS CAR-T Cell Therapy (Pink Sheet)
  • Khosla bets big on SPAC boom, raising $1.2 billion for 3 vaguely targeted blank-check companies (Endpoints)
  • Cortexyme's unorthodox Alzheimer's approach tripped up by FDA hold (Endpoints)
  • Celltrion's inflammatory disease drug Yuflyma gets EU approval for 13 indications (Pharmafile)
  • Pazdur Unplugged: US FDA’s “Project Livin’ Label” Shows Back Story On Cancer Drug Approvals (Pink Sheet)
  • Industry Urged To Use ICH Q12 Protocols To Ease Post-Approval Changes For Analytical Methods (Pink Sheet)
  • MHRA launches public consultation on reclassification of two contraceptive pills (PharmaTimes)
  • Japan’s 1st Humira Biosimilar Hits Market (PharmaJapan)
  • Daiichi Sankyo and AstraZeneca's breast cancer drug Enhertu approved in UK (Pharmafile)
  • 'I’m not trying to rebuild an ego': Neil Woodford appeals to professionals for his comeback biotech fund (Endpoints)
  • Cellectis signs $760M milestone deal with NK upstart; Immunocore brings on AstraZeneca vet to shepherd bispecific launch plans (Endpoints)
  • Sesen Bio, after years on the edge of irrelevancy, scores speedy review for long gestating bladder cancer program (Endpoints)
  • GSK starts Phase III RSV candidate vaccine programme for older adults (Press)
Medtech
  • BD drug-coated balloon faces uphill battle in FDA panel review (MedtechDive)
  • BD secures EUA, CE Mark for molecular test for both COVID-19 and flu (MassDevice)
  • Axonics implantable neurostimulator wins FDA PMA supplemental approval (MassDevice)
Government, Regulatory & Legal 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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