Belgian biotech TiGenix claimed a rare Phase III win for a stem cell product last year when it reported that its lead program hit the primary endpoint among patients with Crohn's disease 24 weeks after therapy. And now it says the 52-week follow-up continued to reflect the treatment's success as it angles for a $57 million IPO on Nasdaq and a late-stage R&D; drive in the U.S.
Celldex's Rintega (rindopepimut) has proved to be a bust in glioblastoma. The biotech reported this morning that it is cutting a Phase III study short after independent monitors concluded that the drug failed the endpoint for improving overall survival.
The EMA has published new rules as it prepares for a watershed year that will see the life science industry in Europe make public more clinical trial data than ever before.
Five months after Verastem acknowledged the stock-crushing failure of its cancer drug VS-6063 (defactinib) against mesothelioma, the Cambridge, MA-based biotech will now try its chances in a combination study using a checkpoint inhibitor from Pfizer and Merck KGaA.
Houston CRO Pharm-Olam is on board to help Infinity Pharmaceuticals get its in-development lymphoma therapy through a Phase II trial, recruiting 230 patients in hopes of demonstrating an effect on survival.
MorphoSys has committed to a mushrooming of its proprietary product R&D; budget to support its growing program of clinical trials. The plan is to funnel up to €83 million ($90 million) into development of the products, giving MorphoSys the financial clout to move two drugs into the clinic and kick off a pair of Phase II trials of MOR202.
The Merck Group is pressing ahead with Phase III trials aimed at mimicking the world's biggest selling drug as it looks to create future growth with biosimilars.
Just days after AstraZeneca reported a success for a combination study of durvalumab and tremelimumab, the pharma giant has been forced to concede that the CTLA-4 drug tremelimumab flunked a solo challenge for mesothelioma.
With flu season in full swing, Mitsubishi Tanabe has its eyes on the horizon as it aims to get its quick-to-produce, tobacco-based flu vaccine on the market by 2018 or 2019. Nikkei Asian Review reported on Tuesday that the Osaka-based company has "all but finished" safety and efficacy trials of the vaccine in the U.S. and Canada and plans to run late-stage trials by the end of the year.
The Centers for Medicare & Medicaid Services (CMS) penalizes hospitals financially for high rates of patient readmissions--making it obviously in a healthcare group's interest to reduce patient readmissions, particularly in chronic conditions that are prone to them.