News

ABPI launches clinical-trial disclosure toolkit

As promised earlier this year, the Association of the British Pharmaceutical Industry (ABPI) has launched a clinical-trial disclosure toolkit to help its member companies comply with transparency requirements for information from or about clinical studies. 

NICE advises on tests for lung cancer mutation

The National Institute for Health and Care Excellence has endorsed a number of tests to help doctors better target treatment for patients with the most common form of lung cancer.

SkyePharma impresses with 58% sales hike

SkyePharma has posted an impressive set of results for the first half of 2013, with a huge sales hike largely driven by growing sales of asthma drug Flutiform across the globe.

Theorem allies with RadMD for imaging expertise

Theorem Clinical Research, the US-based provider of clinical research and development services, is tapping into the medical-imaging expertise increasingly required in clinical trials by adding imaging specialist RadMD to its roster of strategic alliances.

Quintiles to acquire Novella Clinical

Quintiles, the US-based provider of biopharmaceutical development and commercial outsourcing services, has agreed to acquire Novella Clinical, a full-service clinical research organisation (CRO) focused mainly on emerging oncology, medical devices and diagnostics customers.

MRC Technology’s joint call for Parkinson’s targets

MRC Technology, the technology-transfer arm of the UK’s Medical Research Council, has launched a joint call with research and support charity Parkinson’s UK for potential small-molecule or antibody targets to slow, arrest or reverse the progression of Parkinson’s disease.

US FDA hikes generic user fees 24%

The US Food and Drug Administration (FDA) has announced that user fees charged for Abbreviated New Drug Applications (ANDAs) in fiscal 2014 will rise 24%, from $51,520 to $63,860.

ViiV’s new HIV drug wins US approval

ViiV Healthcare, a joint venture between GlaxoSmithKline, Pfizer and Shionogi, will be thrilled with news that US regulators have issued a green light for its new once-daily HIV pill Tivicay.