Strength in clinical trials set to grow with funding boost

25 May 2017 - Australia’s world-class clinical trial capabilities are set to grow, with a $33 million funding boost announced ...

Read more →

How did Vertex win an FDA approval without running a clinical trial?

19 May 2017 - Vertex Pharmaceuticals scored a minor coup this week when the Food and Drug Administration signed off ...

Read more →

Clinical trial participants should have a say in new drug pricing

18 May 2017 - People who volunteer to participate in clinical trials of new drugs provide a valuable service to ...

Read more →

How patients are changing clinical trials

17 May 2017 - In September, the FDA approved a controversial drug to treat Duchenne muscular dystrophy, a rare but deadly ...

Read more →

Publication and reporting of the results of post-market studies for drugs required by the US FDA, 009 to 2013

15 May 2017 - Advancing scientific knowledge depends on the timely dissemination of research results, including those from medical product research ...

Read more →

Efficient trial design — FDA approval of valbenazine for tardive dyskinesia

10 May 2017 - A well-executed development program that addresses both regulatory and clinical requirements is critical for making novel therapeutics ...

Read more →

FDA and NIH release final template for clinical trial protocols

2 May 2017 - A little more than a year ago, FDA and NIH announced the availability of a draft template ...

Read more →

The failure of solanezumab — How the FDA saved taxpayers billions

3 May 2017 - The failure of solanezumab offers a window into the U.S. drug regulatory system, particularly in the context ...

Read more →

Disclosing the conflicts of interest of US Food and Drug Administration Advisory Committee members

2 May 2017 -  The agency excludes many individuals because of conflicts of interest; it may, however, determine that the ...

Read more →

Addressing bias and conflict of interest among biomedical researchers

2 May 2017 - Bias in research is ubiquitous and the goal of every researcher should be to reduce bias and ...

Read more →

Reevaluating eligibility criteria — balancing patient protection and participation in oncology trials

19 April 2017 - Specific patient populations are often excluded from oncology trials without clear reasons, which renders results less clearly ...

Read more →

Peak bodies unite against threat to commercialisation of Australian medical research

18 April 2017 - AusBiotech has joined fellow organisations - Research Australia, Medicines Australia, Medical Technologies Association of Australia and ...

Read more →

QUT, MTPConnect and industry partnership will help to ensure Australia stays globally competitive

10 April 2017 - Medicines Australia warmly welcomes the commencement of The Bridge Program – an initiative of a consortium ...

Read more →

CSIRO says red tape holding back Australia's medical technology, pharmaceutical industries

3 April 2017 - The CSIRO is warning that slow and outdated regulation is holding back Australia's medical technology and ...

Read more →

Differences in treatment effect size between overall survival and progression-free survival in immunotherapy trials: a meta-epidemiologic study of trials with results posted at ClinicalTrials.gov

4 April 2017 - Tan et al. compared treatment effect sizes between overall survival and progression-free survival in trials of ...

Read more →