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Oeyama-Moto is in the hot seat yet again after the FDA accused the company of violating a clinical hold the agency had placed on a clinical trial. Read More
Clovis Oncology is stopping development of its lung cancer candidate rociletinib after the FDA warned the company of a potential complete response letter. Read More
Companies developing direct-acting antiviral hepatitis C drugs should factor in interferon treatment when designing clinical trials, the FDA said. Read More
Although it is easy for drugmakers to conflate the terms “biosimilars” and “generics,” it is important for them to realize that they are not one in the same, as the policies governing biosimilars are very different from those governing small molecule drugs, an expert stresses. Read More
As pharmacy benefit managers’ exclusion lists grow longer, drug developers hoping to avoid those lists must scramble to demonstrate clinical superiority and cost-effectiveness of their products, according to a new report. Read More
While three newer treatment options for multiple myeloma appear to improve patient survival and quality of life, their costs exceed their value, according to a new report. Read More