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Gilead Sciences halts drug studies over side effects, death
2016-03-15 23:33:19| Biotech - Topix.net
Biologic drugmaker Gilead Sciences Inc. has halted several patient studies of its cancer drug, Zydelig, because of increased risk of death and serious side effects. The company told The Associated Press the "adverse events" were spotted during an ongoing review of late-stage testing in patients with chronic lymphocytic leukemia, a blood cancer, and patients with relapsed non-Hodgkin's lymphoma, a cancer of the infection-fighting lymphatic system.
Tags: side
death
effects
studies
Eli Lilly changes outcome goals in Alzheimer's drug study
2016-03-15 22:32:15| Biotech - Topix.net
" Eli Lilly says it's changed the outcome goals for a late-stage patient study of its closely watched experimental drug for Alzheimer's disease, solanezumab. The Expedition3 trial had two primary outcome measures: changes in participants' cognition and their daily function.
Tags: study
drug
goals
outcome
Indiana biotech firm's cancer drug analysis gets $200K boost
2016-03-15 05:50:54| Biotech - Topix.net
An Indiana biotechnology company has won $200,000 in federal funding to boost its technology that could help more quickly determine which drugs may help cancer patients. The National Cancer Institute awarded West Lafayette-based KinaSense the grant to refine technology that's based on Purdue University intellectual property.
Tags: analysis
drug
cancer
indiana
UPDATE 1-Infection worries prompt regulatory reviews of Gilead leukaemia drug
2016-03-12 05:33:35| Biotech - Topix.net
European and U.S. regulators are reviewing the safety of Gilead Sciences' leukaemia drug Zydelig due to concerns over serious adverse events, including deaths. The actions were prompted by an increased rate of harmful events, mostly due to infections, seen in three clinical trials that tested the drug in combination with other cancer medicines, the European Medicines Agency said on Friday.
Tags: reviews
update
drug
regulatory
FDA expands use of Pfizer drug for rare form of lung cancer
2016-03-11 21:25:28| Biotech - Topix.net
" The Food and Drug Administration expanded approval of a Pfizer drug to treat a small subset of lung cancer patients with a rare mutation. The agency said Friday that Xalkori capsules are now approved for patients with the ROS-1 gene mutation, who make up about 1 percent of U.S. patients with non-small cell lung cancer, the most common form of the disease.
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