The US Food and Drug Administration has approved updates to the US labels for Tradjenta (linagliptin) and Jentadueto (linagliptin and metformin), treatments for Type 2 diabetes, in order to add pancreatitis to the warnings and precautions section of the labels, according to Boehringer Ingelheim Pharmaceuticals Inc and Eli Lilly and Company.
Basilea Pharmaceutica Ltd said its has signed a contract with the US Biomedical Advanced Research and Development Authority (BARDA) to co-develop a monosulfactam antibiotic for multidrug-resistant Gram negative bacteria.
The US Food and Drug Administration has approved the first test that identifies the genotype, or strain, of the hepatitis C virus which is present in individuals with chronic HCV infection. It has been manufactured by Abbott Molecular Inc.
For the second time in 12 months, H. Lundbeck A/S has announced plans to restructure its commercial operations in Europe in order to increase productivity and prepare for the launch of a number of new medicines.
Cardio3 BioSciences SA of Belgium said that its previously announced initial public offering of shares will commence on 21 June and end on 3 July. The indicative price range of the shares is between €16.65 per share and €19.00 per share.
A Phase 4 post-marketing trial of the Type 2 diabetes drug Onglyza (saxagliptin) in patients with a history of cardiovascular disease met the primary safety objective of non-inferiority, but did not show superiority versus placebo, the sponsors said.
A lawsuit has been filed in the US by a patient with Type 2 diabetes who was prescribed Byetta and Janumet and later developed pancreatic cancer. The suit was announced by Rheingold, Valet, Rheingold, McCartney & Giuffra LLP in New York.
Johnson & Johnson Inc is set to pay up to $1 billion to acquire privately-held Aragon Pharmaceuticals Inc of the US which has a product in Phase 2 development for castration resistant prostate cancer. The upfront payment is $650 million.
Index Ventures is launching a virtual, single-product company that is developing a monoclonal antibody with the potential, it says, to prevent heart attack and stroke without causing bleeding. The antibody targets the clotting enzyme thrombin. The funding was announced on 17 June.
Eli Lilly and Company has stopped a Phase 2 study of a beta secretase inhibitor being investigated in Alzheimer’s disease as a result of abnormal liver tests in patients. The decision doesn’t affect other compounds in development, the company said.