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Industry poured $58.8 billion into pharmaceutical research and development in 2015, an increase of 10.3 percent from 2014, according to PhRMA. Read More
Within the next five years, clinical research organizations foresee specific technologies redefining trial design, but also posing data integrity risks due to minimal FDA guidance. Read More
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