Actavis confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Dronedarone Hydrochloride Tablets 400 mg. Actavis' ANDA product is a generic version of Sanofi's Multaq, which is an antiarrhythmic drug indicated to reduce the risk of hospitalization for atrial fibrillation (AF) in patients in sinus rhythm with a history of paroxysmal or persistent AF.
There have been great expectations regarding the production of a drug to block the enzyme LTA4 hydrolase, which plays a key role in the body's inflammatory response. However, in clinical trials, such molecules have proven to be only moderately effective. Now, researchers have successfully refined their understanding of why previous substances have been less effective—and in so doing have produced a molecule that gets around the problem.
ProBioGen AG and Merus B.V. signed a non-exclusive commercial option and license agreement on ProBioGen’s GlymaxX fucose-engineering technology. Under the terms of the agreement, ProBioGen is granting Merus the non-exclusive right to use the GlymaxX technology to enhance the ADCC (Antibody-Dependent Cell-Mediated Cytotoxicity) activity of one of its lead products, a bispecific anti-cancer antibody.
European Contract Research Organization (CRO), KCR, which is already operating across 18 countries in Europe as well as the U.S., has recently registered new entities in the UK and Germany. This move is part of the company’s strategy to bring the business closer to Western European customers and further deepen client relationships.
Dateline City: NEW YORK NEW YORK--( BUSINESS WIRE )--The Board of Directors of Bristol-Myers Squibb Company (NYSE:BMY) today declared a quarterly dividend of thirty-six cents ($0.36) per share on the $.10 par...
Takeda Pharmaceutical announced that the Ministry of Economy, Trade and Industry (METI) and the Tokyo Stock Exchange (TSE) have recognized Takeda as a Nadeshiko Brand, a listed enterprise that is “exceptional in encouraging women’s success in the workplace.”
Hamilton Storage Technologies launched the LabElite line of benchtop devices, offering laboratories a a way to automatically process and track samples while ensuring sample integrity. LabElite devices quickly process all common labware types, providing a flexible solution for optimizing workflows.
Boehringer Ingelheim announced new data from large scale, Phase 3 studies showing that once-daily tiotropium delivered via the Respimat inhaler was effective and well tolerated in patients across asthma severities. The study demonstrated that tiotropium Respimat improved lung function and was well tolerated in patients with asthma who remain symptomatic while receiving low-dose maintenance ICS treatment.
Roche announced that an independent data monitoring committee has recommended that the phase 3 METLung study be stopped due to a lack of clinically meaningful efficacy. The study evaluated if onartuzumab (MetMab) in combination with Tarceva (erlotinib) helped patients with previously treated, advanced non-small cell lung cancer (NSCLC) whose tumors were identified as MET-positive live longer compared to Tarceva alone.
Intra-Cellular Therapies announced the initiation of ITI-007-200, a Phase 1/2 clinical trial designed to evaluate the safety, tolerability, and pharmacokinetics of low doses of its lead drug candidate, ITI-007, in healthy geriatric subjects and in patients with dementia, including Alzheimer's disease.
AstraZeneca announced that the US Food and Drug Administration (FDA) has approved the BYDUREON Pen (exenatide extended-release for injectable suspension) 2 mg as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes. BYDUREON should not be used for treatment of patients with type 1 diabetes or diabetic ketoacidosis.
Naurex Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the investigation of GLYX-13, the company’s rapid-acting antidepressant in Phase 2 clinical development, as adjunctive therapy in major depressive disorder.
A University of Houston (UH) scientist and his team are working to develop the next generation of prostate cancer therapies, which are targeted at metabolism. Read more...
Two newer classes of drugs to treat adult-onset diabetes may be no more effective than the old standby, yet they cost significantly more over the course of a patient's disease. Read more...
Medivation Inc. tumbled in premarket trading Friday, a day after the drugmaker forecast 2014 revenue from its prostate cancer treatment Xtandi that fell short of analyst expectations. Read more...