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 ...

Read more →

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 ...

Read more →

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, ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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. ...

Read more →

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 ...

Read more →

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. ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →