Phase III
Dengue fever affects as many as 400 million people annually and is caused by one of four related viruses transmitted by mosquitoes. The trial showed the vaccine was efficacious in preventing dengue fever by any of the four serotypes.
Under terms of the agreement, Neurocrine provided Voyager with $165 million in an upfront payment, along with funding for ongoing development of each program. If developmental, regulatory and commercial milestones are hit, Voyager could snag up to $1.7 billion.
Real-world evidence (RWE) or real-world data (RWD) relates to the collection of information about a drug’s safety and efficacy outside the structure of a clinical trial. Speaking yesterday, FDA Commissioner Scott Gottlieb laid out the FDA’s new framework for dealing with RWE and RWD.
Pfizer and Eli Lilly and Co. announced that their tanezumab hit two out of three co-primary endpoints in one dose and all three with a higher dose in patients with moderate-to-severe osteoarthritis (OA) pain in a Phase III trial.
Boston-based Alexion’s Ultomiris (ravulizumab-cwvz) hit its primary objective in its Phase III study of complement inhibitor-naïve patients with atypical hemolytic uremic syndrome (aHUS).
On Thursday, regulators with both the FDA and EMA announced that patients prescribed the drug should ask their doctors if it is wise to continue taking it. This comes after Lartruvo failed to hit endpoints in a Phase III study of advanced or metastatic soft tissue sarcoma.
Amgen and Allergan announced positive top-line results from a Phase I/Phase III trial of their biosimilar candidate, ABP 798, to Genentech and Biogen’s Rituxan (rituximab).
No safety issues were cited. Instead, it appears related to the company’s proposal to modify the trial’s analysis plan and various chemistry, manufacturing and controls (CMC) issues.
Nonalcoholic steatohepatitis (NASH) is prevalent in the U.S. and developing countries, but under that name, is largely unknown to the general public. NASH is a liver disease similar to cirrhosis, but which occurs in people who drink little or no alcohol.
The company provided an update on its Phase III trial of Imbruvica in combination with chemotherapy compared to placebo in metastatic pancreatic adenocarcinoma.
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