Blog
RSS FeedPosted by Michael Wonder on 19 Jan 2022
Beyond survival: the US FDA confirms surrogate end points for patients with newly diagnosed acute myeloid leukaemia treated with intensive chemotherapy
10 January 2022 - The treatment of acute myeloid leukaemia has rapidly evolved over the past decade. ...
Posted by Michael Wonder on 18 Jan 2022
TGA in review (2021)
19 January 2022 - Using a liberal definition of what constitutes a 'new medicine', we have determined the TGA approved ...
Posted by Michael Wonder on 18 Jan 2022
COVID-19: latest safety data provide reassurance about use of mRNA vaccines during pregnancy
18 January 2022 - Vaccination remains a major pillar of the response to COVID-19, particularly as variants of the virus continue ...
Posted by Michael Wonder on 17 Jan 2022
TGA approves ‘game changing’ ovarian cancer drug bringing new hope to patients
18 January 2022 - Federal health authorities have approved a breakthrough drug for ovarian cancer, bringing a game-changing treatment option ...
Posted by Michael Wonder on 17 Jan 2022
TGA recognises the Gamaleya Institute vaccine (Sputnik V, Russian Federation) for international travel to Australia
17 January 2022 - Today, the TGA determined that an additional COVID-19 vaccine, the two dose course of the Gamaleya ...
Posted by Michael Wonder on 16 Jan 2022
Accelerating clinical trials in the EU: for better clinical trials that address patients’ need
13 January 2022 - Today, the European Commission, the Heads of Medicines Agencies and the EMA have launched an initiative to ...
Posted by Michael Wonder on 16 Jan 2022
Global regulators discuss path towards regulatory alignment on response to Omicron variant
13 January 2022 - On 12 January, regulators from around the world discussed the global regulatory response to the COVID-19 Omicron ...
Posted by Michael Wonder on 14 Jan 2022
Advancing health through innovation: new drug therapy approvals 2021
13 January 2022 - The FDA’s Center for Drug Evaluation and Research has issued its report, Advancing Health Through Innovation: New ...
Posted by Michael Wonder on 14 Jan 2022
Senate panel advances Biden's FDA pick in 13-8 vote
13 January 2022 - Two senators on the panel who caucus with Democrats and six Republicans opposed the nomination. ...
Posted by Michael Wonder on 13 Jan 2022
Quebec to impose health tax on unvaccinated Canadians
12 January 2022 - The Canadian province of Quebec will charge a health tax to residents who are not vaccinated ...
Posted by Michael Wonder on 11 Jan 2022
FDA approved more first in class drugs, gave more accelerated approvals in 2021
7 January 2022 - The US Food and Drug Administration’s Center for Drug Evaluation and Research approved 50 new drug therapies ...
Posted by Michael Wonder on 11 Jan 2022
Preliminary data indicate COVID-19 vaccines remain effective against severe disease and hospitalisation caused by the Omicron variant
11 January 2022 - EMA continues to monitor emerging data on the effectiveness of vaccines against COVID-19, including disease caused ...
Posted by Michael Wonder on 08 Jan 2022
CMS takes action to lower out of pocket Medicare Part D prescription drug costs
6 January 2022 - Today, the Centers for Medicare & Medicaid Services issued a proposed rule that would make updates to ...
Posted by Michael Wonder on 04 Jan 2022
Will the Biden administration use ‘march-in’ to protect prostate cancer patients from excessive drug prices?
3 January 2022 - Astellas Pharma, a drug company headquartered in Japan, is charging U.S. patients $156,000 a year for ...
Posted by Michael Wonder on 26 Dec 2021
Japan’s First Committee on New Drugs of The Pharmaceutical Affairs and Food Sanitation Council seeks additional data; aducanumab remains under review
22 December 2021 - Biogen and Eisai today announced that the First Committee on New Drugs of the Pharmaceutical Affairs ...