"After many months of raising concerns with NICE, NHS England and the Department of Health, and offering to work constructively on alternative proposals, we have applied to formally challenge these proposals in court."
Mike Thompson, chief executive, Association of the British Pharmaceutical Industry, whose organization along with the Bioindustry Association, are turning to the courts to prevent a new "budget impact" test being used to bring down drug prices. The test, introduced on April 1, means that any drug determined by the health technology assessment body NICE as being cost-effective will nonetheless automatically be referred for "commercial discussions" to reduce the price if it will cost more than £20 million (US$25.7 million) per annum in any of the first three years

"I was really pleased with the level of engagement from the agency. They took this very seriously. They asked excellent questions. They asked for the right data. As we would provide new data, they asked follow-up questions, which is exactly how this should work. The process was grounded in science, medicine and data, which hopefully will bode well for the review."
John Crowley, chairman and CEO, Amicus Therapeutics Inc., on the FDA giving the green light for the submission of a new drug application for migalastat in Fabry disease

"One of the strengths of this technique is that it can be applied to existing coronary CT angiogram imaging datasets that have already been acquired using standard CT scanners that are now widespread in most hospitals around the world. It does not require specialized hardware, nor does it require specialized acquisition techniques."
Keith Channon co-author of a University of Oxford study on a new way of analyzing computerized tomography (CT) angiography, the standard method for imaging blood vessels to look for potential blockages, which could help find future trouble spots before they become a concern

"MK2 was previously known to function mainly as an inflammatory signal, but we have now shown that it also functions as an inhibitor of cell death in some contexts, such as after Smac mimetic treatment."
Najoua Lalaoui, a senior postdoctoral researcher at the Walter and Elizabeth Hall Institute in Melbourne, Australia, and co-author of a study that provided the rationale for combining MK2 inhibitors with Smac mimetics as a potentially powerful new combination therapy for cancers with few treatment options, particularly acute myeloid leukemia