• Boehringer Ingelheim GmbH, of Ingelheim, Germany, said a retrospective subanalysis of the 18,113-patient RE-LY trial showed lower rates of intracranial hemorrhage (ICH), including both fatal and traumatic ICH, for Pradaxa (dabigatran etexilate mesylate) capsules 150 mg taken twice daily, compared to warfarin. Read More
• Caraco Pharmaceutical Laboratories Ltd., of Detroit, a subsidiary of Sun Pharmaceutical Industries Ltd., said the Supreme Court ruled in patent litigation against Bagsvaerd, Denmark-based Novo Nordisk A/S, regarding Caraco's generic version of Prandin (repaglinide) tablets. Read More
• Fibrocell Science Inc., of Exton, Pa., said pivotal clinical trial data demonstrated that Laviv (azficel-T) for nasolabial fold wrinkles is effective. The results came from two identical Phase III randomized, double-blind, placebo-controlled studies of 421 patients. Fibrocell is publishing the data in Dermatologic Surgery. Read More
• RegeneRx Biopharmaceuticals Inc., of Rockville, Md., said scientists at the Gladstone Institute of Cardiovascular Disease at the University of California, San Francisco, published animal data in Nature showing that the process of converting nonbeating heart muscle cells into functional beating-heart muscle cells can be enhanced using Thymosin beta 4 (Tbeta4). Read More
"I don't think any other sector of industry is more wasteful than health care," said Tomasz Sablinski, CEO of Transparency Life Sciences LLC. "Drug development is certainly very wasteful, and clinical trials are the champions of the world in wastefulness." Read More
Using nanostructures known as dendrimers to deliver anti-inflammatory drugs across the blood-brain barrier, scientists have been able to improve the symptoms of cerebral palsy in animals. Though still preclinical, that approach, which could also find applications in neurodegenerative diseases, adds cerebral palsy to the growing list of neurodevelopmental disorders that can be at least partially reversed. Read More
The first readily apparent conclusion from Wednesday's FDA workshop on the use of minimal residual disease (MRD) as a surrogate endpoint in acute lymphoblastic leukemia (ALL) is that technical implementation issues continue to lag and could stifle the obvious clinical interest in developing such efficacy biomarkers. Read More
