The US Food and Drug Administration has approved Horizant (gabapentin enacarbil) for the management of postherpetic neuralgia in adults. This follows the drug’s approval in the US in 2011 for restless legs syndrome.
Ridaforolimus, an investigational treatment for metastatic soft tissue or bone sarcoma, has been turned down by the US Food and Drug Administration. The sponsor, Merck & Co Inc, announced receipt of a complete response letter on 5 June 2012.
Addex Therapeutics Ltd said that its partner, Janssen Pharmaceuticals Inc (Johnson & Johnson), is to start a Phase 2 study of an allosteric modulator for major depressive disorder, with anxiety symptoms. The same drug is being studied in schizophrenia.
A Phase 2 trial of gantenerumab, an experimental antibody treatment for early Alzheimer’s disease, is being expanded with a view to preparing for registration, MorphoSys AG announced. The trial is being conducted by Roche.
Thrombogenics NV and BioInvent International AB have decided to stop development of an early-stage anticoagulant after safety issues were identified. They have also regained a cancer asset from Roche, which has left the programme.
Erytech Pharma SA has received €6.95 million in grants and credits from the French innovation agency, OSEO, to lead a consortium that will investigate new therapies for the enzymatic treatment of chemotherapy or radiotherapy-resistant cancers.
Alize Pharma of France has raised €3.3 million from its existing shareholders to take an experimental product for metabolic disease into a first-in-human study. The study will be carried out in healthy volunteers in 2013.
New data from a Phase 2 study of the prostate cancer drug, tasquinimod, show longer median overall survival times than previously reported for this patient population, according to the sponsors, Active Biotech AB and Ipsen SA. The data were reported at Asco.
Boehringer Ingelheim Pharmaceuticals Inc said that a Phase 3 trial of its tyrosine kinase inhibitor, afatinib, in patients with non-small lung cancer reached its primary endpoint of progression free survival. Data are being presented at Asco on 4 June.
A Phase 3 trial of the Bayer compound, regorafenib, in patients with metastatic gastrointestinal stromal tumours (GIST) has met its primary endpoint of progression-free survival, according to the sponsors. Data are being presented at Asco on 4 June.