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Eli Lilly and Biogen Wednesday reported back-to-back positive clinical trial results for their investigational Alzheimer’s disease drugs, heating up the race for an effective cure. Read More
Exelixis’ Cometriq improved patient outcomes in a pivotal Phase 3 trial for metastatic kidney cancer — signaling new life for the drug, which failed another study last fall. Read More
Bristol-Myers Squibb cut short a Phase 3 study of Opdivo for the treatment of renal cell carcinoma after the immunotherapy drug met its primary endpoint versus everolimus, the current standard treatment. Read More
Amgen is reporting a “clinically meaningful number” of patients showed complete remission in a Phase 2 study of its pricey drug to treat a rare strain of leukemia. Read More
AstraZeneca and Eli Lilly have agreed to conduct a clinical trial to assess the safety and preliminary efficacy of AZ’s experimental anti-PD-L1 immune checkpoint inhibitor MEDI4736 in combination with Lilly’s Cyramza treatment for patients with advanced solid cancer tumors. Read More
Canadian drugmaker Tekmira has halted recruitment of patients for its Phase 2 clinical trial of TKM-Ebola-Guinea, citing lack of overall therapeutic benefit in Ebola virus patients. Read More
The FDA is adding plasma fibrinogen as a prognostic biomarker for patient selection in clinical trials involving chronic obstructive pulmonary disease and a high risk of death. Read More
Hoping to speed development of new treatments for children, the European Medicines Agency is offering drugmakers free meetings with members of its Paediatric Committee. Read More
Sponsors of new drugs to treat cardiovascular and metabolic diseases should use a composite of all major cardiovascular events as the primary endpoint in studies to establish CV risk, the European Medicines Agency says. Read More
The FDA wants drugmakers to assess the risks of active pharmaceutical ingredients taken by men on the development of embryos and fetuses of their female partners. Read More
Because cellular and gene therapy products can have more severe effects than other types of drug products, potentially leading to organ failure, tumors or death, sponsors should include these as primary safety objectives when designing early-phase clinical trials, the FDA says. Read More