Boehringer Ingelheim announced it has established a research collaboration with the Harvard Stem Cell Institute’s - Harvard Fibrosis Network to discover new ways of treating fibrotic diseases such as idiopathic pulmonary fibrosis (IPF), chronic kidney disease (CKD) and nonalcoholic steatohepatitis (NASH).
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 (ANDA) and was awarded 180 days of marketing exclusivity for these strengths.
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 to the currently approved bi-weekly dosage regimen.
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 RESORCE, evaluated the efficacy and safety of regorafenib in patients with HCC whose disease has progressed after treatment with sorafenib.
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 to the Food and Drug Administration (FDA) in the second half of 2016.
- 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 moderate or severe exacerbation, compared to Seretide
- Results published in the New England Journal of Medicine are anticipated to have important implications for the care of people living with COPD
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 to three anti-epileptic drugs (AEDs). The study, EXIST-3 (EXamining everolimus In a Study of TSC), is being presented during a plenary session at the 68th Annual Meeting of the American Academy of Neurology..