Research Insight

Mylan N.V. announced the U.S. launch of Armodafinil Tablets, 50 mg, 150 mg, 250 mg, a generic version of Cephalon's Nuvigil®. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application...

Allergan plc announced that two pivotal trials of the Oculeve Intranasal Tear Neurostimulator, OCUN-009 and OCUN-010, each met their primary and secondary efficacy endpoints. With these new results, a premarket submission for the device is on-track to be submitted...

Chugai Pharmaceutical Co Ltd announced that "Actemra® Subcutaneous Injection" (Actemra), the humanized antihuman IL-6 receptor monoclonal antibody, successfully met the primary endpoint in a dose interval reduction study (MRA231JP study) conducted in patients with rheumatoid arthritis who inadequately respond...

FLAME study showed consistent superiority of Ultibro® Breezhaler® over Seretide® across exacerbation outcomes, lung function and health-related quality of life in COPD patients Ultibro Breezhaler also significantly reduced the rate and prolonged the time to the first...

Bayer announced that a Phase III trial evaluating its oncology compound regorafenib (Stivarga®) for the treatment of patients with unresectable hepatocellular carcinoma (HCC) has met its primary endpoint of a statistically significant improvement in overall survival. The study, called...

Designation based on results of Phase 3 study, CheckMate -141, in which Opdivo met its primary endpoint of overall survival, versus three standard of care options in this patient population. Designation signals the urgent need for new treatment approaches...

Novartis announced results from a Phase III study showing Afinitor®* (everolimus), when used as an adjunctive therapy, significantly reduced treatment-resistant seizures associated with tuberous sclerosis complex (TSC) compared to placebo. Patients in all treatment arms were also taking one...