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RSS FeedPosted by Michael Wonder on 26 Mar 2021
FDA authorises marketing of device to improve gait in multiple sclerosis patients
26 March 2021 - Today, the U.S. FDA authorised marketing of a new device indicated for use as a short-term treatment ...
Posted by Michael Wonder on 26 Mar 2021
FDA approves first in the world device to treat patients with congenital heart disease
26 March 2021 - New implant device provides less invasive option to treat pulmonary valve regurgitation for patients with a native ...
Posted by Michael Wonder on 26 Mar 2021
European Medicines Agency accepts marketing authorisation application for enfortumab vedotin
26 March 2021 - Enfortumab vedotin to be reviewed under accelerated assessment for the treatment of locally advanced or metastatic urothelial ...
Posted by Michael Wonder on 26 Mar 2021
Europe slams the brakes on vaccine exports until its needs are met
26 March 2021 - Europe has stepped back from its threat to seize AstraZeneca factories or enact a full vaccine ...
Posted by Michael Wonder on 26 Mar 2021
Takeda begins regulatory submissions for dengue vaccine candidate in EU and Dengue-endemic countries
26 March 2021 - EMA to conduct first-ever parallel assessment of a medicinal product, Takeda’s dengue vaccine candidate (TAK-003), for use ...
Posted by Michael Wonder on 26 Mar 2021
Attacks on AstraZeneca cast doubt over its vaccine pricing, says top scientist
26 March 2021 - The EU’s attacks on AstraZeneca call into question the company’s decision not to profit from its ...
Posted 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 ...