The European Medicines Agency has announced the start of an in-depth safety review of Iclusig (ponatinib) in light of reports of cases of blood clots and blockages in the arteries or veins associated with the medicine’s use. ARIAD Pharmaceuticals is the manufacturer.
Biocartis NV has joined forces with the Flanders Institute for Biotechnology (VIB) to develop a new diagnostic test for cancer designed to detect biomarkers of microsatellite instability for several cancers, in particular colorectal cancer.
An experimental cancer therapy that is being developed by Apogenix GmbH has reportedly induced programmed cell death in different animal models of colon cancer, according to an article in the December issue of Molecular Cancer Therapeutics.
Eli Lilly and Company said that its experimental add-on therapy for depression, edivoxetine, failed to meet the primary endpoint of three Phase 3 studies and that it is ending development of the drug. This will result in a fourth quarter charge of $15 million.
Skyepharma Plc is on course to generate new product and technology platform revenue in the future following positive regulatory and reimbursement reviews for both its flutiform asthma drug and a GlaxoSmithKline Plc product that uses Skyepharma’s delivery technology.
BTG Plc has received the go-ahead from the Food and Drug Administration to market a non-surgical procedure for the treatment of patients with varicose veins, a condition that is estimated to affect more than 30 million adults in the US from the ages of 18 to 70 years.
Algeta ASA has confirmed receipt of a preliminary acquisition proposal from Bayer AG that values the company at NOK 336 (€40.5) per share. Bayer is Algeta’s partner for Xofigo, a new radiopharmaceutical for prostate cancer that has spread to the bone.
Novartis is to buy back $5 billion of its shares from the market as part of a broader strategy to increase productivity and improve the financial returns for its shareholders. The Switzerland-based multinational announced the share buyback on 22 November, saying the purchases would start immediately and be executed over a period of two years.
The Committee for Medicinal Products for Human Use has given positive opinions to seven new medicines including Gilead Sciences’ new treatment for chronic hepatitis C virus infection, sofosbuvir. The EMA issued the opinions on 22 November.
The US Food and Drug Administration has approved Olysio (simeprevir), a new therapy to treat hepatitis C virus infection developed by Janssen Research & Development LLC (Johnson & Johnson) and Medivir AB of Sweden.