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RSS FeedPosted by Michael Wonder on 22 Mar 2021
EU has 'absolutely no need' of Russia's Sputnik V vaccine, commissioner says
21 March 2021 - The European Union does not need Russia's Sputnik V vaccine for Covid-19 and can achieve immunity ...
Posted by Michael Wonder on 21 Mar 2021
TGA approves CSL - Seqirus to manufacture AstraZeneca COVID-19 vaccine in Australia
21 March 2021 - Earlier today, the Therapeutic Goods Administration approved manufacture of the AstraZeneca COVID-19 Vaccine (ChAdOx1-S) in Australia. ...
Posted by Michael Wonder on 21 Mar 2021
AstraZeneca vaccine allowed by government regulators to be produced in Australia
21 March 2021 - Astra Zeneca vaccines will be produced in Australia from now on after the regulators approved doses being ...
Posted by Michael Wonder on 20 Mar 2021
FDA authorises first machine learning-based screening device to identify certain biomarkers that may indicate COVID-19 infection
19 March 2021 - Device may be used to identify biomarkers indicative of SARS-CoV-2 infection among certain asymptomatic individuals following a ...
Posted by Michael Wonder on 19 Mar 2021
Senate narrowly confirms Becerra as health secretary
18 March 2021 - Republican Sen. Susan Collins joined all of the Democrats present in the 50-49 vote. ...
Posted by Michael Wonder on 19 Mar 2021
Too fast or too slow: is the FDA moving at the right speed?
19 March 2021 - Regardless of President Joe Biden’s choice for the next commissioner of the FDA, the Senate Health, Education, ...
Posted by Michael Wonder on 19 Mar 2021
Janssen announces U.S. FDA approval of Ponvory (ponesimod), an oral treatment for adults with relapsing multiple sclerosis proven superior to Aubagio (teriflunomide) in reducing annual relapses and brain lesions
19 March 2021 - Ponvory is the first and only FDA approved oral disease modifying therapy studied against an established oral ...
Posted by Michael Wonder on 19 Mar 2021
U.S. FDA accepts Bristol Myers Squibb’s application for mavacamten in symptomatic obstructive hypertrophic cardiomyopathy
19 March 2021 - Application based on results from the Phase 3 EXPLORER-HCM trial. ...
Posted by Michael Wonder on 19 Mar 2021
Seqirus announces Health Canada approval of expanded age indication of its cell-based quadrivalent influenza vaccine for people two years of age and older
18 March 2021 - Seqirus announced that Health Canada has approved Flucelvax Quadrivalent (influenza vaccine), its cell-based quadrivalent influenza vaccine, for ...
Posted by Michael Wonder on 19 Mar 2021
Data on AstraZeneca vaccine insufficient for Swiss approval
18 March 2021 - The medicines regulator Swissmedic says it has not yet received enough robust data from clinical trials ...
Posted by Michael Wonder on 18 Mar 2021
Kiniksa announces FDA approval of Arcalyst (rilonacept) for recurrent pericarditis
18 March 2021 - Kiniksa launches Kiniksa One Connect patient support program. ...
Posted by Michael Wonder on 18 Mar 2021
Novartis' Kisqali (ribociclib) product monograph in Canada now includes MONALEESA-3 data demonstrating statistically significant improvement in overall survival in postmenopausal women with HR+/HER2- advanced breast cancer
18 March 2021 - Kisqali is currently the only CDK4/6 inhibitor that has demonstrated statistically significant improvement in overall survival (key ...
Posted by Michael Wonder on 18 Mar 2021
Stimdia Medical receives FDA breakthrough device designation for the pdSTIM system designed to facilitate weaning patients from mechanical ventilation
18 March 2021 - Stimdia Medical today announced the company’s pdSTIM system has received breakthrough device designation from the U.S. FDA. ...
Posted by Michael Wonder on 18 Mar 2021
Celularity announces fast track designation by the FDA for its natural killer cell therapy CYNK-001 in the treatment of recurrent glioblastoma multiforme
18 March 2021 - Celularity announced that the company has received fast track designation from the U.S. FDA for its non-genetically ...
Posted by Michael Wonder on 18 Mar 2021
COVID-19 Vaccine AstraZeneca: benefits still outweigh the risks despite possible link to rare blood clots with low blood platelets
18 March 2021 - EMA’s safety committee, PRAC, concluded its preliminary review of a signal of blood clots in people ...