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RSS FeedPosted by Michael Wonder on 20 May 2021
FDA authorises longer time for refrigerator storage of thawed Pfizer-BioNTech COVID-19 vaccine prior to dilution, making vaccine more widely available
19 May 2021 - Based on a review of recent data submitted by Pfizer today, the U.S. FDA is authorising undiluted, ...
Posted by Michael Wonder on 20 May 2021
EMA, MHRA to review Vertex' Kaftrio for children with cystic fibrosis
20 May 2021 - The EMA and the MHRA have validated Vertex' applications to expand the scope of its cystic ...
Posted by Michael Wonder on 20 May 2021
NICE turns down Janssen's Erleada
20 May 2021 - NICE has published draft guidance rejecting Janssen's Erleada (apalutamide) with androgen deprivation therapy for treating prostate ...
Posted by Michael Wonder on 20 May 2021
COVID-19 vaccine weekly safety report
20 May 2021 - Six additional cases of blood clots with low blood platelets have been assessed as thrombosis with thrombocytopenia ...
Posted by Michael Wonder on 20 May 2021
Canada's change to Pfizer vaccine storage temperature has major implications on rollout
19 May 2021 - Health Canada now recommends storing Pfizer vaccine at fridge temperatures for up to 1 month. ...
Posted by Michael Wonder on 19 May 2021
Leading real world data and analytics organisations form industry coalition to advance policies to support regulatory use of real world evidence
19 May 2021 - RWE Alliance Launched by Aetion, Flatiron Health, IQVIA, Syapse, and Tempus. ...
Posted by Michael Wonder on 19 May 2021
Roche launches mySugr Pump Control within the mySugr app to simplify insulin pump therapy via smartphone
19 May 2021 - mySugr now allows control of the Accu-Chek Insight insulin pump directly via smartphone, starting in Austria, bringing ...
Posted by Michael Wonder on 19 May 2021
TGA considering changing storage rules of Pfizer jab, could allow Aussies to get dose at GPs or pharmacists: Hunt
20 May 2021 - Australians could get access to the Pfizer jab through GPs or pharmacists, on top of state-run ...
Posted by Michael Wonder on 19 May 2021
BioXcel Therapeutics announces FDA acceptance for filing of NDA for BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II
19 May 2021 - FDA sets PDUFA action date for 5 January 2022. ...
Posted by Michael Wonder on 19 May 2021
BeiGene announces U.S. FDA acceptance and priority review of supplemental new drug application for Brukinsa (zanubrutinib) in marginal zone lymphoma
19 May 2021 - BeiGene today announced that the U.S. FDA has accepted a supplemental new drug application for Brukinsa ...
Posted by Michael Wonder on 19 May 2021
FDA launches crowdsourcing challenge to solicit input on research questions to be addressed through FDA's oncologic clinical trial data
18 May 2021 - Today, the U.S. FDA's Oncology Center of Excellence launched the “Send Your Oncology Research Questions to ...
Posted by Michael Wonder on 19 May 2021
FDA: flexibility okay for gaps in gene therapy trials
18 May 2021 - The US FDA is not amenable to changing study outcome measures or sample sizes for gene therapy ...
Posted by Michael Wonder on 19 May 2021
Top FDA official says fully vaccinated people could need Covid booster shots within a year
18 May 2021 - COVID-19 booster shots could be needed for fully vaccinated people within a year, the FDA’s top ...
Posted by Michael Wonder on 19 May 2021
COVID-19 vaccines: In the rush for regulatory approval, do we need more data?
18 May 2021 - After rollout under emergency authorisation, manufacturers of COVID-19 vaccines now have their sights on regulatory approval. ...
Posted by Michael Wonder on 18 May 2021
Essilor receives FDA breakthrough device designation for Essilor Stellest, its new generation of spectacle lens solutions in the fight against myopia
17 May 2021 - Essilor today announced that the U.S. FDA has granted breakthrough device designation to its Essilor Stellest spectacle ...