The Indian health ministry has announced that certain drugs approved for use in...
FDA accepts BLA from AstraZeneca and Daiichi for targeted chemotherapy
AstraZeneca and Daiichi Sankyo have announced that the US Food and Drug Administration (FDA) has accepted their biologics license application (BLA) for targeted cytotoxic chemotherapy trastuzumab deruxtecan.
WHO introduces human genome editing global registry
The World Health Organisation has approved the first phase of a new global registry to record the research conducted on human genome editing.
FDA encourages drugmakers to enrol men in breast cancer trials
The US Food and Drug Administration (FDA) has released new draft guidance encouraging drugmakers to enrol male patients in breast cancer clinical trials.
Nestle-sponsored trial violates India’s Infant Milk Substitutes Act
A clinical trial sponsored by infant milk substitutes and infant foods maker Nestle has violated Indian law under the Infant Milk Substitutes (IMS) Act.
April’s top news stories
Chinese clinical-stage biopharmaceutical company I-Mab Biopharma and German biotech company MorphoSys have begun the first dosed Phase III clinical study to assess investigational human CD38 antibody TJ202/MOR202 in combination with lenalidomide in patients suffering from relapsed or refractory multiple myeloma; and A small clinical trial by researchers at the University of Edinburgh in the UK has showed that cilostazol and isosorbide mononitrate could prevent recurrence of stroke and vascular dementia. Drugdevelopment-technology.com wraps up the key headlines from April 2019.
Timothy McGrath Appointed Chief Operating Officer of Newly Merged NEOMED-LABS / Pacific Biomarkers
The newly merged NEOMED-LABS / Pacific Biomarkers, an immunology centric service provider specialized in assay development and clinical laboratory testing for vaccines and soluble large molecules, announced today the appointment of Tim McGrath to the role of Chief Operating Officer.
Indian health ministry fast-tracks drug approvals with new clinical trial legislation
The Indian health ministry has announced that certain drugs approved for use in territories such as the EU and US will be automatically approved in India without a further native clinical trial taking place, in a bid to give patients faster access to new medicines.