In October 2012, the FDA cancelled the Oncologic Drugs Advisory Committee meeting scheduled for Nov. 8, which was to include a review of the new drug application for pomalidomide, Celgene Corp.'s immunomodulatory drug (IMiD) candidate in multiple myeloma (MM). Read More
A late-stage change in clinical direction and the use of a trial placebo that turned out also to be a treatment in chronic fatigue syndrome (CFS) may have hobbled Hemispherx Bioscience Inc.'s regulatory efforts with Ampligen (rintatolimod), the Toll-like receptor 3 modulator that was hit with a complete response letter (CRL) earlier this month. Read More
Although drugmakers will have to start tracking their payments to doctors and teaching hospitals in August under the Physician Payment Sunshine Act, the transactions will remain in the dark until late next year when the Centers for Medicare & Medicaid Services (CMS) opens the curtains and posts the data for all to see. Read More
The current thinking about mutations in cancer cells holds that there are two types – driver mutations that are behind cancer growth because they give tumor cells a growth advantage, and passenger mutations that are along for the ride. "Historically, passenger mutations have been largely ignored," Leonid Mirny told BioWorld Today, because cancer development is seen largely as "a series of unfortunate events" in the form of accumulating driver mutations. Read More
LONDON – Medgenics Inc. reached the higher end of its ambitions in an issue of stocks and warrants, raising $30 million to provide funding for further clinical development of its Biopump protein drug implant technology. Read More
Top-line data from a Phase I/II trial of Vaximm AG's oral cancer vaccine VXM01 in patients with advanced pancreatic cancer provide the first clinical indications that the vaccine can elicit an immune response. Read More
• OxOnc Development LP, of Princeton, N.J., said it entered a co-development agreement with Pfizer Inc., of New York, to conduct a pivotal trial of Pfizer's Xalkori (crizotinib) in patients with non-small-cell lung cancer harboring a ROS1 (c-ros) gene rearrangement). Read More
• RNL BIO Co. Ltd., of Seoul, South Korea, said it filed an investigational new drug application with Korean regulators to start Phase II and Phase III studies testing its RNL-Astrostem stem cell drug in patients with cerebral palsy. Read More
• Taro Pharmaceutical Industries Ltd., of Yakum, Israel, and Sun Pharmaceutical Industries Ltd., of Mumbai, India, agreed to terminate their merger agreement of August 2012, which would have given shareholders of Taro $39.50 per share upon closing. Read More
• Pozen Inc., of Chapel Hill, N.C., reported results from two Phase III studies of PA32540 in ischemic stroke showing that compared to EC-ASA (aspirin), treatment with PA32540 significantly reduced the rate of endoscopic gastroduodenal ulcers (2.0 percent vs. 12.4 percent; p = 0.005). Read More
Memories form faster than proteins can be synthesized, and researchers from the Scripps Research Institute have shown that microRNA expression changes are one mechanism by which the brain can rapidly respond to new experiences, and begin laying down memories about them. Read More
