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
March 13, 2018 The retail giant has stayed quiet about its pharma ambitions; however, a Goldman Sachs analyst in August 2017 outlined some potential pharmaceutical strategies the company might use. Now, Leerink Partners has published a report saying the category-killer is in talks with mid-size Pharmacy Benefits Managers (PBMs) “in an effort to get into various … Read more
March 08, 2018 Lymphatic vessels have the ability to wrap around tumors and weave through them, thereby allowing cancer cells to leave the primary site and spread throughout the body. However, in patients being treated with immune checkpoint inhibitors like Bristol-Myers Squibb’s Yervoy and Opdivo, those same vessels enhance the power of cancer-killing T cells, … Read more