Poxel SA has reported positive data from a Phase 2b study in Japan of imeglimin, its treatment for Type 2 diabetes. The primary endpoint of the trial was met, and was more pronounced in the Japanese patients than had been the case in similar Phase 2b trials in the US and the EU.
In a reversal of the usual sequence of events, the Food and Drug Administration has approved a new drug for amyotrophic lateral sclerosis (ALS) two years after the same treatment was authorised for marketing in Japan and South Korea.
The European Medicines Agency has issued guidance to companies with centralised marketing authorisations spelling out what they need to do to be in compliance with EU medicines law once Britain leaves the union.
A Phase 3 trial of an experimental drug for relapsing-remitting multiple sclerosis, laquinimod, has failed to meet its primary endpoint which was to show an improvement in the time to confirmed disease progression.
AstraZeneca Plc has taken steps to bolster its respiratory portfolio with a licensing deal for a preclinical drug candidate that is being developed for patients with moderate to severe asthma.
MorphoSys AG plans to substantially increase spending on research and development this year as more of its proprietary antibody therapeutics advance in the clinic. Speaking to analysts on 3 May the chief executive, Simon Moroney, predicted steady progress in developing the portfolio, financed by liquidity that stood at €349.9 million on 31 March.
An enzyme replacement therapy, Brineura (cerliponase alfa), has been approved in the US for children with a rare inherited disorder that primarily affects the nervous system. The disorder, tripeptidyl peptidase-1 (TPP1) deficiency, is a form of Batten disease.
AstraZeneca Plc has received an accelerated approval in the US for its checkpoint antibody Imfinzi (durvalumab), which is expected to be the cornerstone of a prospective portfolio of immune oncology products targeting a variety of cancers.
Shire Plc reported a doubling of product sales to $3.4 billion in the first quarter, a result that was shaped by the acquisition of Baxalta Inc in June of 2016. The Baxalta businesses contributed $1.6 billion of the total sales figure. On a pro forma basis, the rise in product sales was 9%.
Novartis has secured US approval for a new kinase inhibitor, Rydapt (midostaurin), to treat patients with FLT3-mutated acute myeloid leukaemia (AML) in combination with chemotherapy. The approval also covers a diagnostic designed to detect the mutation.