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