Blog
RSS FeedPosted by Michael Wonder on 26 Mar 2021
EMA validates marketing authorisation application for sacituzumab govitecan-hziy for the treatment of metastatic triple negative breast cancer
25 March 2021 - Agency grants accelerated assessment based on positive results of Phase 3 ASCENT trial. ...
Posted by Michael Wonder on 25 Mar 2021
FDA approves new indication for drug to treat neurogenic detrusor overactivity in paediatric patients
25 March 2021 - Today, the U.S. FDA approved a new indication for Myrbetriq (mirabegron extended-release tablets) and Myrbetriq Granules (mirabegron ...
Posted by Michael Wonder on 25 Mar 2021
Bright side of the moonshots
25 March 2021 - COVID-19 has brought together biomedical technologies that will transform human health. ...
Posted by Michael Wonder on 25 Mar 2021
Europe’s plans to restrict vaccine exports are dangerous
24 March 2021 - For itself—and for the world. ...
Posted by Michael Wonder on 25 Mar 2021
Statement on COVID-19 vaccine supply at Anagni plant in Italy
24 March 2021 - AstraZeneca would like to clarify a number of inaccurate statements relating to COVID-19 Vaccine AstraZeneca doses ...
Posted by Michael Wonder on 25 Mar 2021
COVID-19 Vaccine AstraZeneca – update on ongoing evaluation of blood clot cases
25 March 2021 - Last week, EMA’s safety committee, PRAC, concluded its preliminary review of cases of blood clots, including very ...
Posted by Michael Wonder on 25 Mar 2021
Taxpayers fund research and drug companies make a fortune
24 March 2021 - The pharmaceutical industry doesn’t want things to change, but Americans can have both lower prices and innovation. ...
Posted by Michael Wonder on 24 Mar 2021
Vertex receives Australian TGA approval for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to treat people with cystic fibrosis ages 12 years and older who have at least one F508del mutation
24 March 2021 - With this approval approximately 750 people living with cystic fibrosis in Australia will be newly eligible for ...
Posted by Michael Wonder on 24 Mar 2021
FDA grants two new breakthrough device designations for Natera’s Signatera MRD test
24 March 2021 - Natera today announced that the US FDA has granted two breakthrough device designations covering new intended ...
Posted by Michael Wonder on 24 Mar 2021
REN001 granted fast track designation by FDA for patients with primary mitochondrial myopathies
24 March 2021 - Reneo Pharmaceuticals today announced that the United States FDA granted fast track designation to REN001 for the ...
Posted by Michael Wonder on 24 Mar 2021
FDA grants breakthrough device designation to Tempus’ atrial fibrillation ECG analysis platform, developed in collaboration with Geisinger
24 March 2021 - Tempus today announced that the U.S. FDA has granted the company breakthrough device designation for its ECG ...
Posted by Michael Wonder on 24 Mar 2021
Biden’s choice and FDA’s loosening standards of evidence
23 March 2021 - The US Food and Drug Administration is widely considered the world’s premier regulator of drugs and devices, ...
Posted by Michael Wonder on 24 Mar 2021
FDA authorises LetsGetChecked’s home collection coronavirus (COVID-19) test for direct to consumer purchase
24 March 2021 - The direct to consumer test is now authorised by the FDA to sell directly to consumers online ...
Posted by Michael Wonder on 24 Mar 2021
Seqirus ready to reinforce Canada's influenza pandemic preparedness plans
23 March 2021 - Health Canada's approval of Foclivia (an adjuvanted, egg-based A strain H5N1 pandemic influenza vaccine) meets key requirement ...
Posted by Michael Wonder on 24 Mar 2021
Health Canada says AstraZeneca shot is safe as U.S. questions vaccine's clinical trial data
23 March 2021 - U.S. regulator says AstraZeneca may have included 'outdated' data when releasing clinical trial results. ...