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.
Sanofi SA has reported a 4.7% rise in net sales to €34.9 billion for 2012 despite losing an estimated €1.3 billion to generic competition. However, the near-term outlook is not favourable. Sales in the fourth quarter were barely changed at €8.5 billion and the French pharmaceutical company estimated that the loss of exclusivity of just two drugs (Plavix and Avapro) would impact sales by around €800 million in the first half of 2013.
Eli Lilly and Company has decided to stop development of the monoclonal antibody, tabalumab, in rheumatoid arthritis due to lack of efficacy. But it will continue to investigate the same drug as a possible treatment for systemic lupus erythematosus.