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RSS FeedPosted 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 ...
Posted by Michael Wonder on 18 Mar 2021
AstraZeneca ChAdOx1-S COVID-19
18 March 2021 - The TGA is closely reviewing reports of anaphylaxis after four cases were reported following the AstraZeneca ChAdOx1-S ...
Posted by Michael Wonder on 17 Mar 2021
FDA permits marketing of first SARS-CoV-2 diagnostic test using traditional premarket review process
17 March 2021 - BioFire Respiratory Panel 2.1 is the first COVID-19 diagnostic test granted marketing authorisation using the de novo ...
Posted by Michael Wonder on 17 Mar 2021
Sagimet Biosciences receives fast track designation from U.S. FDA for FASN inhibitor TVB-2640 in NASH
16 March 2021 - Sagimet Biosciences announced today that the U.S. FDA has granted fast track designation to TVB-2640 for ...
Posted by Michael Wonder on 17 Mar 2021
European Commission approves expanded indication for Merck’s Keytruda (pembrolizumab) in adult and paediatric patients with relapsed or refractory classical Hodgkin lymphoma
17 March 2021 - First Pediatric Indication for KEYTRUDA in the European Union. ...
Posted by Michael Wonder on 17 Mar 2021
U.S. plans to use real world and trial data to determine when vaccines need to be updated
17 March 2021 - U.S. officials plan to use data gathered from people who have already been vaccinated against COVID-19 as ...
Posted by Michael Wonder on 17 Mar 2021
Health Canada approves new indication for lung cancer treatment option Alunbrig
17 March 2021 - First-line indication offers Canadians with advanced lung cancer new treatment options. ...
Posted by Michael Wonder on 17 Mar 2021
Europe’s vaccine suspension may be driven as much by politics as science
16 March 2021 - Once it became clear Germany was pausing, the pressure mounted on other governments to hold off as ...
Posted by Michael Wonder on 17 Mar 2021
We are in the crisis of the century’: Europe threatens to seize AstraZeneca factories
18 March 2021 - Europe has threatened to seize AstraZeneca factories and strip the pharmaceutical giant of its intellectual property ...
Posted by Michael Wonder on 17 Mar 2021
AbbVie announces extension of review for supplemental new drug application of upadacitinib for the treatment of adults with active psoriatic arthritis
17 March 2021 - AbbVie announced that the U.S. FDA has extended the review period for the supplemental new drug application ...