Johnson & Johnson and Vertex Pharmaceuticals, two companies whose drugs have received “breakthrough therapy” designation, have spoken out in support of the FDA’s new breakthrough program, which could shave years off of the approval process.
The ongoing battle for clinical trial transparency took an unexpected turn this past Sunday, 21st July, when the Guardian ran a story featuring details of a leaked memo, apparently containing a plan to conceal “secret documents on drugs trials” from the public and concerned medical practitioners.
This week the European Federation of Pharmaceutical Industries and Associations (EFPIA) and Pharmaceutical Research and Manufacturers of America (PhRMA) released a joint position paper for responsible clinical trial data sharing to benefit patients.
George Dagher, PhD, coordinator of the French infrastructure for biobanks and leader of funding and financing WP, Biobanking and Biomolecular Resources Research Infrastructure (BBMRI) shares some thoughts with Lina Genovesi on the opportunities of biobanks for pharma.
A recent report from The Academy of Medical Sciences makes recommendations to address barriers to the widespread development and adoption of stratified medicine in the UK, in areas such as clinical development and pricing and reimbursement.