The head of the National Institutes of Health said Wednesday that although each of the 27 institutes and centers at NIH would have to cut 5.1 percent under sequester provisions of the budget control law, the directors of those entities could decide how to apportion the reduction within each institute. NIH faces a cut of…
Eleven scientists, most of them American, were scheduled to be named on Wednesday as the first winners of the world’s richest academic prize for medicine and biology — $3 million each, more than twice the amount of the Nobel Prize. The award, the Breakthrough Prize in Life Sciences, was established by four Internet titans led…
Two companies jointly developing a cancer drug that recently received FDA’s new breakthrough status said the implications of the designation are unclear and they are working with FDA to identify the pathway’s implications on development activities. The cancer therapy ibrutinib received two breakthrough designations to treat two types of lymphoma, representing the first oncology designations…
Friends of Cancer Research joined FasterCures to host a briefing on Capitol Hill yesterday on the “Blueprint of Medical Research-How Medicines Get from the Lab to a Patient.” It featured representative stakeholders across the long and challenging process of drug development from the National Institutes of Health which funds basic research to a university cancer…
FDA Commissioner Margaret Hamburg is working with industry to find a way for it to make “complete response” letters public. Aside from shining a light on application problems and failures, which have been tightly held sponsor secrets, the move also could be couched as a money-saving feature for government and industry at a time when…
Vertex Pharmaceuticals stepped forward this week and said it received FDA’s first two breakthrough drug designations, and will use the designations to expand uses for its landmark cystic fibrosis drug Kalydeco, ending widespread speculation about which company received the initial designations enacted by the FDA Safety and Innovation Act. The drug, although approved before the…
By SHARON BEGLEY As the United States enters the fifth decade of its “war on cancer,” deaths continue to decline, according to an exhaustive report based on official data released on Monday. But that doesn’t tell the whole story, say experts not involved in the report from the National Cancer Institute, the American Cancer Society…
By SHARON BEGLEY As the United States enters the fifth decade of its “war on cancer,” deaths continue to decline, according to an exhaustive report based on official data released on Monday. But that doesn’t tell the whole story, say experts not involved in the report from the National Cancer Institute, the American Cancer Society…
By BEN HIRSCHLER and CAROLINE HUMER U.S. regulators approved 39 new drugs in 2012, the most in 16 years, suggesting that pharmaceutical makers are poised for growth after losing billions of dollars in recent years to generic drug makers because of patent expirations. There were eight approvals in December alone, including a new treatment from…
By BEN HIRSCHLER and CAROLINE HUMER U.S. regulators approved 39 new drugs in 2012, the most in 16 years, suggesting that pharmaceutical makers are poised for growth after losing billions of dollars in recent years to generic drug makers because of patent expirations. There were eight approvals in December alone, including a new treatment from…
