In a Friday announcement, Novo Nordisk said it completed the first phase III trial of its drug N9-GP for hemophilia B patients.
The pivotal study for SAR302503 nailed the primary endpoint for the proportion of patients with a greater than 35% reduction in the volume of their spleens, which become enlarged as a result of abnormal blood cell production.
Gilead may be best known for its HIV drug franchise and a stellar late-stage effort on the hepatitis C front, but the big biotech is also making an ambitious bid to rapidly build a portfolio of cancer drugs. And last night Gilead captured a bit of the ASCO limelight with positive data from a small, early-stage study of the leukemia drug idelalisib (GS-1101).
Roche got a big boost for its bid to position the leukemia drug GA101 (obinutuzumab) as a next-gen successor to its blockbuster Rituxan, posting late-stage data last night that showed that a combination with chemotherapy performed much better than chemo alone or in combination with Rituxan.
Amid repeated pipeline struggles and an R&D re-think, Merck KGaA has signed an exclusive deal with the newly public Quintiles, launching a novel collaboration that will give the CRO a seat at the decisionmaking table.
In the pact, investigators at Merck Serono will join hands with experts at Quintiles to shape and guide the company's R&D strategy while the CRO manages trial planning and execution from Phase I through post-marketing studies.
Another team of researchers is tackling the task of developing a blood test designed to predict a patient's likelihood of suffering a heart attack. And they've zeroed on three promising biomarkers to help get the job done.
Despite a major backlash in the industry, GSK has agreed to open up the data vault to investigators who intend to publish their findings, accelerating a move in the industry to provide greater transparency to the public. But the pharma giant's "independent experts" selected to run the program include at least two people with close ties to GSK.
The long and frustrating search for something--anything--that can treat Alzheimer's or blunt its symptoms ran into yet another Phase III roadblock this morning as Baxter International reported that its Phase III study of the immune-bolstering treatment Gammagard ended in failure.
Celgene has put another brick in the wall of positive late-stage data for apremalist as a new therapy for psoriatic arthritis, building on its new drug application at the FDA.