’Selective approval’ would require follow up studies to identify most appropriate patients
One of the most promising new strategies for cancer treatment is the development of drugs that directly target molecular abnormalities that lead to the growth of tumors. Several such drugs have received Food and Drug Administration (FDA) approval in recent years, but some have been controversial because the data on which they were approved did not clearly define which patients will most benefit from the new medications.
Writing in the July 29 New England Journal of Medicine, two specialists from the Massachusetts General Hospital (MGH) Cancer Center propose an expansion of the FDA’s "fast-track" programs for drug approval. In their "Sounding Board" piece, Thomas Roberts Jr., MD, and Bruce Chabner, MD, call on the FDA to require pharmaceutical companies to carry out studies identifying the patients most likely to respond to a targeted-therapy drug, as a condition of the drug’s approval.
Sue McGreevey | EurekAlert!
Organ-on-a-chip mimics heart's biomechanical properties
23.02.2017 | Vanderbilt University
Researchers identify cause of hereditary skeletal muscle disorder
22.02.2017 | Klinikum der Universität München
On January 15, 2009, Chesley B. Sullenberger was celebrated world-wide: after the two engines had failed due to bird strike, he and his flight crew succeeded after a glide flight with an Airbus A320 in ditching on the Hudson River. All 155 people on board were saved.
On January 15, 2009, Chesley B. Sullenberger was celebrated world-wide: after the two engines had failed due to bird strike, he and his flight crew succeeded...
Cells need to repair damaged DNA in our genes to prevent the development of cancer and other diseases. Our cells therefore activate and send “repair-proteins”...
The Fraunhofer IWS Dresden and Technische Universität Dresden inaugurated their jointly operated Center for Additive Manufacturing Dresden (AMCD) with a festive ceremony on February 7, 2017. Scientists from various disciplines perform research on materials, additive manufacturing processes and innovative technologies, which build up components in a layer by layer process. This technology opens up new horizons for component design and combinations of functions. For example during fabrication, electrical conductors and sensors are already able to be additively manufactured into components. They provide information about stress conditions of a product during operation.
The 3D-printing technology, or additive manufacturing as it is often called, has long made the step out of scientific research laboratories into industrial...
Nature does amazing things with limited design materials. Grass, for example, can support its own weight, resist strong wind loads, and recover after being...
13.02.2017 | Event News
10.02.2017 | Event News
09.02.2017 | Event News
27.02.2017 | Materials Sciences
27.02.2017 | Interdisciplinary Research
27.02.2017 | Life Sciences