Blog
RSS FeedPosted by Michael Wonder on 14 Jun 2022
FDA’s treatment of China developed drugs spurs demands for multiregional clinical trials
14 June 2022 - China’s ambition to become a leader in the biopharma industry has been clear in the last ...
Posted by Michael Wonder on 06 Jun 2022
COVID mRNA vaccines can be quickly updated for new variants. So, where's my Omicron booster?
6 June 2022 - Since Omicron was declared a variant of concern at the end of November, it quickly swept ...
Posted by Michael Wonder on 24 May 2022
EMA guidance supports development of new antibiotics
24 May 2022 - As part of its efforts to support a global approach to the development of new antimicrobial medicines, ...
Posted by Michael Wonder on 12 May 2022
Basket trials: review of current practice and innovations for future trials
10 May 2022 - Basket trials, one type of master protocol, emerged as a tool for evaluating biomarker-targeted therapies among multiple ...
Posted by Michael Wonder on 10 May 2022
FDA launches new Accelerating Rare disease Cures (ARC) program
10 May 2022 - FDA’s Center for Drug Evaluation and Research (CDER) is pleased to announce the launch of the new ...
Posted by Michael Wonder on 11 Apr 2022
The EQ-HWB: overview of the development of a measure of health and wellbeing and key results
8 April 2022 - This article presents an overview of the international development of a new generic measure, the EQ Health ...
Posted by Michael Wonder on 17 Mar 2022
Backing life-saving local cancer drug development
17 March 2022 - Joint media release with the Minister for Health and Aged Care the Hon Greg Hunt MP. ...
Posted by Michael Wonder on 03 Mar 2022
Medicines Australia welcomes reform efforts to speed up clinical trials
4 March 2022 - Australian patients will have improved access to clinical trials due to reforms to be introduced by ...
Posted by Michael Wonder on 09 Feb 2022
FDA raises concerns about China developed drugs
9 February 2022 - Agency could slow the plans of big Western drugmakers to sell Chinese tested medicines in U.S. ...
Posted by Michael Wonder on 02 Feb 2022
New order: European cancer coalition calls for cancer treatment overhaul
2 February 2022 - Coalition urges reformation of EU wide drug research and development to drive treatment optimisation ...
Posted by Michael Wonder on 21 Jan 2022
International regulators’ recommendations on COVID-19 vaccines and the Omicron variant
21 January 2022 - International regulators have published a report today highlighting their discussions on the effectiveness of current vaccines against ...
Posted by Michael Wonder on 16 Dec 2021
The wild west of checkpoint inhibitor development
15 December 2021 - Although immunotherapy development has improved overall survival among patients with common cancers and has led to important ...
Posted by Michael Wonder on 16 Dec 2021
Patient reported endpoints underrepresented in product information on new drugs
15 December 2021 - An IQWiG team analysed the extent to which patient reported outcomes, which were recorded as endpoints ...
Posted by Michael Wonder on 10 Dec 2021
International regulators stress continued need for COVID-19 therapeutics
11 December 2021 - EMA has endorsed a statement by the International Coalition of Medicines Regulatory Authorities that urges all ...
Posted by Michael Wonder on 09 Dec 2021
FDA issues draft guidance for industry, considerations for the use of real world data and real world evidence to support regulatory decision-making for drugs and biological products
9 December 2021 - The U.S. FDA issued a draft guidance for industry titled Considerations for the Use of Real-World Data ...