Drugmaker Vivus said that a group of patients who participated in a late-stage clinical trial of its weight loss drug Qsymia were more than 70 percent less likely to develop type 2 diabetes compared to patients who took a placebo.
ASCB President Don W. Cleveland, PhD, from the Ludwig Cancer Institute at the University of California, San Diego, said that he can't get an answer from the NIH about a proposed clinical trial of a gene silencing therapy for a neurodegenerative disease. What other effects is the government shutdown having on biomedical research? Find out...
The FDA placed a partial clinical hold on all new patient enrollment in clinical trials of Iclusig, a kinase inhibitor designed to target BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). So what does this partial hold mean for the drug's development? Find out...
Harvard Stem Cell Institute (HSCI) researchers have published initial results of a Phase 1b human clinical trial of a therapeutic that has the potential to improve the success of blood stem cell transplantation. How did they respond to disappointing initial results? Find out...
In an article published today in the PLoS Medicine, researchers show that when all patient-relevant outcomes of the clinical trials are assessed, publicly available sources contained far less information than non-public CSRs prepared by pharmaceutical companies. So what should be done? Find out...
Medivir AB announced further results from the Phase 1 clinical study on the investigational cathepsin K inhibitor MIV-711 for the treatment of osteoarthritis and other bone related disorders.
Bayer HealthCare announced that the U.S. FDA has approved Adempas (riociguat) tablets for use in two forms of pulmonary hypertension, a group of life-threatening and progressive diseases.
Compugen Ltd. announced that CGEN-15001, an Fc fusion protein drug candidate derived from a novel immune checkpoint protein, has been shown to be highly efficient in preventing the development of disease in a well-accepted animal model of autoimmune Type 1 diabetes.
GT Biologics announced that the company's lead candidate, Thetanix (bacteroides thetaiotaomicron), has been granted Orphan Drug Designation by the U.S Food and Drug Administration (FDA) Office of Orphan Product Development for the treatment of pediatric Crohn’s disease.
Following the recent commercial introduction of five new drugs to address the medical needs of patients with various diseases, Bayer is now accelerating the development of further five promising drug candidates which are currently undergoing Phase 1 and 2 clinical studies.
Results from a large-scale Phase 3 trial show that the most clinically advanced malaria vaccine candidate, GlaxoSmithKline's RTS,S, continued to protect young children and infants from clinical malaria up to 18 months after vaccination.
Shares of Cell Therapeutics rose after the company said it had reached an agreement with regulators about the design of a key trial of an experimental drug. The agreement covers the design and goals of a late-stage trial of pacritinib as a treatment for myelofibrosis, a blood disorder.
Results of a recent Takeda Pharmaceutical Co. Ltd. study showed that the company's intramuscular bivalent (GI/GII) norovirus vaccine candidate significantly reduced mild, moderate or severe vomiting and/or diarrhea in vaccinated subjects, meeting the secondary endpoint of the study.
Isis Pharmaceuticals Inc. announced today that GlaxoSmithKline (GSK) has added development candidate ISIS-GSK3Rx to its collaboration with Isis. Isis earned $7 million in milestone payments associated with the advancement of this program. So what is ISIS-GSK3Rx design to do?
Delcath Systems Inc. announced today that as part of its efforts to increase operating efficiencies, the company has completed a strategic reorganization under which it has eliminated 21 positions, or approximately 33% of its global workforce. The company expects this reorganization, in conjunction with other cost saving measures, to significantly lower cash utilization.
Tarsa Therapeutics Inc. announced that it presented a new meta-analysis showing that salmon calcitonin does not appear to be associated with an increased risk of cancer in postmenopausal women. The meta-analysis was conducted using data derived from approximately 11,000 women in 24 randomized, controlled calcitonin trials that included reporting of adverse events.
Novartis announced new results from the Phase 3 ASTERIA I study showing omalizumab was effective and safe in the treatment of chronic spontaneous urticaria (CSU), known as chronic idiopathic urticaria (CIU) in the U.S., a chronic and debilitating form of hives.
U.S.-based biotechnology company X-Chem and UK-based pharmaceutical company AstraZeneca have entered into an expanded global drug discovery collaboration that covers all of AstraZeneca’s therapeutic areas and multiple target classes. So how long will the initial research collaboration between AstraZeneca and X-Chem be extended to? Find out...
StemCells Inc. said it received authorization to start a clinical trial of its purified stem cell therapy as a treatment for chronic spinal cord injury. The company said the Food and Drug Administration approved its investigational new drug application, meaning StemCells can start testing the treatment on humans in the U.S.
Teva announced that the District Court of the Hague (Netherlands) has issued a favorable ruling in a patent revocation action brought by Mylan B.V., a subsidiary of Mylan Laboratories Inc., seeking a court judgment that Teva’s European Patent for its relapsing-remitting multiple sclerosis product, Copaxone, is invalid.
Pfizer said the FDA approved its new hormone pill, Duavee, to treat hot flashes and osteoporosis associated with menopause. Regulators approved the drug for women who still have a uterus and are experiencing moderate to severe hot flashes.
Despite the current federal government shutdown, the U.S. Food and Drug Administration (FDA) has notified Amarin Corporation plc that ascheduled advisory committee meeting scheduled for later this month will still take place. Read more...
Eli Lilly and Co. told investors that foreign exchange rates and slower growth in some markets will make it challenging for the company to meet its 2014 revenue goal. So how is the Indianapolis company responding to plunging drug sales after losing U.S. patent protections? Find out...
Valeant Pharmaceuticals International Inc. announced that the New Drug Submission for Jublia has been approved from the Canadian regulatory authority, Health Canada, for the treatment of mild to moderate onychomycosis, a common and destructive nail infection caused predominantly by dermatophyte fungi.
Alnylam Pharmaceuticals Inc., an RNAi therapeutics company, announced the pubication of study results from a Phase 1 trial with ALN-PCS, a systemically administered RNAi therapeutic targeting PCSK9 for the treatment of hypercholesterolemia.