BURLINGTON, Mass.--(BUSINESS WIRE)-- Decision Resources, one of the worlds leading research and advisory firms for pharmaceutical and healthcare issues, finds that, in light of repeated clinical trial failures of investigational treatments, neurologists remain skeptical about the launch potential of pharmacotherapies in clinical-stage development for the acute or post-acute treatment of ischemic stroke. As a result, Decision Resources expects that the market for ischemic stroke therapies will continue to be a graveyard for new product development in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan. According to the Pharmacor advisory service entitled Acute Ischemic Stroke, interviewed neurologists continue to express uncertainty about the probability of success for Lundbecks thrombolytic desmoteplasecurrently the only novel drug in Phase III developmentin its redesigned pivotal clinical trial program. Although Decision Resources does not currently forecast approval of desmoteplase, its approval for use within three-to-nine hours post-stroke onset could represent one of the most important therapeutic achievements in stroke in more than a decade, while expanding the proportion of ischemic stroke patients with access to acute therapy. The findings also reveal that most interviewed experts convey limited optimism that neuroprotectants will prove effective in the treatment of ischemic stroke, given countless failures … Continue reading →

CHICAGO (Reuters) - Republican Senator Mark Kirk, who suffered a stroke last year, hopes to return to Washington in January, his spokesman said on Monday. Kirk, 53, won President Barack Obama's former seat in the U.S. Senate in 2010. He is not up for election this year. Kirk first made the comments on Sunday to a Chicago TV station at a fund-raiser for the clinic where he is receiving out-patient treatment. The event was Kirk's first public appearance since he suffered a stroke last January. According to the local NBC affiliate, Kirk, 53, told its reporter covering the stair-climbing fund-raiser that his next goal was to climb the stairs of Capitol Hill when the new Senate convenes in January. The station did not air nor post a clip of Kirk making the comments. But Erin Athas, Kirk's press secretary, confirmed to Reuters on Monday that his boss "was hoping to return in January." Kirk, who beat former Illinois Treasurer Alexi Giannoulias to win Obama's Senate seat in 2010, is one of two Illinois lawmakers sent to Washington who have been sidelined by illness this year. U.S. Representative Jesse Jackson Jr., a Democrat, has been on medical leave from the House … Continue reading →

- Health Technology Assessment (HTA) Bodies may need to review their requirements when assessing products that have been granted a PUMA - - Buccolam (Midazolam, Oromucosal Solution) was the first medicine to be granted a PUMA and has received positive recommendations by two HTA bodies in Europe - BRUSSELS, Nov. 5, 2012 /PRNewswire/ -- ViroPharma Incorporated today announced the presentation of a poster on cost effectiveness considerations in submissions for therapeutics targeting small patient populations, including those considered under the new Paediatric Use Marketing Authorisation (PUMA) process. These data were presented at the 15th Annual Congress of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), held November 3 - 7 in Berlin, Germany. The PUMA approval process differs from a traditional marketing authorisation, as it will often be based upon population subsets, as is often seen in orphan drug product development. In the case of Buccolam (Midazolam, Oromucosal Solution), in order to help inform the HTA, primary data gathering was required to gain information on cost effectiveness, the results and approach of which have been accepted by two HTA bodies (the Scottish Medicines Consortium and All Wales Medicines Strategy Group). These data included expert views on the treatment pathways … Continue reading →