Woodcock Urges Forward March Toward Personalized Medicine
May 29th 2013New approaches for conducting clinical trials and developing therapies that actually prevent and cure disease are key to the future of effective drug therapy, according to Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER).
The UK's New "Revolutionary" Medicines Optimization Plan
May 21st 2013The UK’s Royal Pharmaceutical Society has joined forces with a number of other organizations, including the Association of the British Pharmaceutical Industry (ABPI), to issue new guidance on medicines optimization. Sir Bruce Keogh, Medical Director of NHS England, says it could be revolutionary.
Into the Extrapolation Machine: How We Joined the Elite 58
May 16th 2013The problem we see with the polarity of views is that both sides seem to be cranking up the extrapolation machine and use single studies/data points to draw broad conclusions to gin up opinions about ACA’s success or lack thereof.
Medicines Patent Pool: Industry's Toe Still in the Water
May 13th 2013At a time when Big Pharma is struggling with new business models geared to the demands of a changing marketplace, the Medicines Patent Pool (MPP) is offering a way forward through voluntary licensing and patent deals that it insists will deliver what the drug majors say they want: more innovation; better market access; and the opportunity to demonstrate measurable improvements in public health. Is the MPP, as founding chair Phillipe Douste-Blazy claims, that “new business model for the future?”
Will Congress Provide Sequester "Flexibility" for User Fees?
April 30th 2013Just about every federal program and affected interest group is pressing for relief from the 8% across-the-board cuts in funding imposed by the budget sequestration mandate. Recent fast action on Capitol Hill to curb personnel furloughs of air traffic controllers by the Federal Aviation Administration, though, has spurred lobbying for similar treatment across many fronts.
PCORI Launches Clinical Research Network to Support Trials, Outcomes Research
April 30th 2013The new National Patient-Centered Clinical Research Network funded by the Patient-Centered Outcomes Research Institute (PCORI) aims to provide patients and clinicians with useful information on treatment options and outcomes
Tough Times Ahead for New Medicines under NHS England?
April 22nd 2013You’d be forgiven for missing it with the vast array of new agencies and the policy documents, guidance, consultations and ‘engagement’ activity they’re doing on in the ‘new’ NHS in England, but on the 4th April NHS England (formerly the NHS Commissioning Board) set out 15 commissioning policies in 250 pages.