April 17, 2018 “Verzenio provides a new targeted treatment option for certain patients with breast cancer who are not responding to treatment, and unlike other drugs in the class, it can be given as a stand-alone treatment to patients who were previously treated with endocrine therapy and chemotherapy,” said Richard Pazdur, M.D., Director of the … Read more
April 12, 2018 Scientists at the Medical University of South Carolina have discovered genetic factors in the brain that they believe increase the risk of relapse in drug addicts. The culprit is actually epigenetics, or enzymes that change the behavior of genes but not the genes themselves. The team focused on the enzyme histone deacetylase … Read more
April 10, 2018 Face-to-face conversation When choosing the best CRO partner, of course the size, phase and therapeutic area of the study matter; however, Shannon Devens, Executive Director of Clinical Operations at Surface Oncology, a 2015 Fierce 15 winner, said her company also wants such relationships to be a match culturally. And to determine that, … Read more
April 05, 2018 During the FDA May inspection, Vianor Biotech management admitted to regulatory Investigators conducting an inspection that they falsified analytical test results used to release a lot of its products to the U.S. Additionally, the Agency said the company reported a batch of one of it’s products was within specification in its Certificate … Read more
April 03, 2018 More than 90% of EMA staff completed the survey and indicated how likely they are to relocate to each of the cities in the hat for the vote on its future home in November 2017. The survey found a sharp difference between the retention rates likely to be achieved by the cities, … Read more
March 29, 2018 The FDA approved Kymriah (tisagenlecleucel) for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL). “We’re entering a new frontier in medical innovation with the ability to reprogram a patient’s own cells to attack a deadly cancer,” said FDA Commissioner Scott Gottlieb, M.D. “New technologies such as … Read more
March 27, 2018 The researchers examined 50 patients with the condition for a median of two-and-one-half years following mitral surgery, according to an American College of Cardiology statement. All of them exhibited advanced heart failure symptoms and had received the maximum guideline-based therapy for more than 6 months. Of the 50 patients, 19 had died … Read more
March 22, 2018 In August 2017, for the first time we cleared an expanded indication for a home hemodialysis machine so it could be used without a care partner being present, a decision based in part on asking kidney patients about their tolerance for risk. Home dialysis may improve a patient’s quality of life, allowing … Read more
March 21, 2018 In MS, the immune system attacks myelin, the fatty substance that coats and protects nerve fibers in the brain and spinal cord. Its cause is still unknown, however, researchers think it stems from self-reactive effector T cells that target myelin. Current treatments for MS focus on reducing the number of relapses — … Read more
March 15, 2018 Now that same team has released a study that delves into the process by which the virus fights malignancy. It appears to do so by activating an inflammatory process, the researchers believe. That inflammation interferes with the ability of cancer cells to escape immune attack, according to a press release. The research … Read more