The US Food and Drug Administration has approved a second indication for the Novartis immunosuppressant everolimus: to prevent organ rejection in adult liver transplant patients. The same indication was approved in Europe in late 2012.
Clavis Pharma ASA expects to report top-line Phase 3 results for its compound for acute myeloid leukaemia (AML) by the end of the first quarter. The compound, elacytarabine, is a derivative of cytarabine- the licensed AML chemotherapy.
The US Food and Drug Administration has granted priority review status to the prospective HIV/AIDS medicine, dolutegravir, which has been developed by ViiV Healthcare, a business venture among GSK, Pfizer Inc and Shionogi & Co.
With a new chief executive set to take charge this spring, Shire Plc has settled two outstanding lawsuits and started to broaden its specialist medicines portfolio. Flemming Ørnskov of Bayer AG will take over as CEO on 30 April, succeeding Angus Russell, who is retiring.
Ablynx NV has reported further efficacy data for its early-stage rheumatoid arthritis drug ALX-0061 which showed that up to 75% of patients achieved remission as defined by the DAS28 measure of disease activity at week 24 in a Phase 2 study.
The US Food and Drug Administration has granted ‘priority review’ status to the Algeta ASA investigational therapy for the treatment of castration-resistant prostate cancer patients with bone metastases. The product (radium-223) is an alpha-emitting nuclide.
MorphoSys AG and Heptares Therapeutics Ltd have entered into a collaboration to generate candidate antibody therapeutics targeting G protein-coupled receptors (GPCRs). The disease targets will be proposed by MorphoSys.
The US Food and Drug Administration has turned down Novo Nordisk A/S’s application to market the long-acting insulin drugs, Tresiba and Ryzodeg, pending the supply of more data on cardiovascular risk. It has also cited the Danish company for manufacturing violations.
e-Therapeutics Plc, which develops drugs that reach several optimized targets, has raised £40 million in a private placement with existing and new institutional investors. The placement is subject to existing shareholders waiving their preemption rights.
Up to £50 million is expected to be made available for British life science following the setting up of a new fund that will seek to identify early-stage technologies with global commercialistion potential.