Zealand announces that the US Food and Drug Administration (FDA) has made briefing documents on lixisenatide and the lixisenatide/Lantus® combination available on its website. The documents relate to the upcoming meeting of the Endocrinologic and Metabolic Drugs Advisory Committee, scheduled by the FDA for 8:00 am to 5:00 pm ET on 25 May 2016 to discuss the New Drug Applications (NDAs) for the two drug products intended for the treatment of adults with Type 2 diabetes. The NDAs were submitted by Sanofi.
Astellas Pharma Inc., Daiichi Sankyo Company, Limited and Takeda Pharmaceutical Company Limited announced that they have entered into a joint research agreement. It is an agreement to comprehensively acquire and analyze fundamental biomarker data on healthy adult volunteers in order to optimize and accelerate the development of innovative medicines.
Horizon Pharma plc (Horizon Pharma), a biopharmaceutical company, announced that its affiliate has entered into a definitive agreement with Boehringer Ingelheim International GmbH (Boehringer Ingelheim) to acquire the rights to interferon gamma-1b, which Boehringer Ingelheim commercializes under the trade names Imukin, Imukine, Immukin and Immukine in an estimated 30 countries primarily in Europe and the Middle East.
Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) submitted by Samsung Bioepis Co., Ltd. for SB2 (infliximab), an investigational biosimilar candidate of Remicade.
ResMed announced primary results from a multicenter, randomized controlled phase II trial known as CAT-HF presented at the European Society of Cardiology's 2016 Annual Heart Failure Congress. CAT-HF assessed whether the treatment of moderate to severe sleep-disordered breathing (obstructive or central sleep apnea) with adaptive servo-ventilation (ASV) therapy could improve cardiovascular outcomes in patients who were hospitalized for a sudden worsening of their heart failure symptoms (acute decompensated heart failure) over six months.
Biocept, Inc. announces the launch of its test to detect RET oncogene fusions from a simple blood draw. Positive identification of patients with the RET gene provides important information in determining therapy options including targeted tyrosine kinase inhibitors.
Concert Pharmaceuticals, Inc. announced that it has initiated its Phase 1 clinical program for CTP-543, which is being developed for the treatment of alopecia areata, an autoimmune disease for which there are currently no approved treatments. CTP-543 was discovered by applying Concert's deuterium chemistry technology to modify ruxolitinib, which is commercially available under the name Jakafi® in the United States for the treatment of myelofibrosis and polycythemia vera. Ruxolitinib has been used to treat alopecia areata in academic settings, including an investigator-sponsored clinical trial, and has been shown to promote hair growth in individuals with moderate to severe disease. Concert's Phase 1 program will assess the safety, tolerability, pharmacokinetic and pharmacodynamic profile of single- and multiple-ascending doses of CTP-543 in healthy volunteers.
Genmab A/S announced that the first participants have been dosed in a clinical study of a DuoBody bispecific antibody under Genmab’s DuoBody technology platform collaboration with Janssen Biotech, Inc. (Janssen). The phase I study investigates the human bispecific antibody JNJ-61178104, which is directed to two inflammatory disease targets, for potential use in treating autoimmune disorders. Genmab will receive a $2 million milestone payment for the progress in the study.
Neurotrope, Inc., a clinical-stage company developing a disruptive therapy for the treatment of severe Alzheimer's disease (AD), has entered into a research collaboration with the International Rett Syndrome Foundation, DBA: Rettsyndrome.org, to explore the potential of Bryostatin for the treatment of Rett syndrome.
Boston Scientific Corporation announced the introduction of the Precision Montage MRI Spinal Cord Stimulator (SCS) System after receiving approval from the US Food and Drug Administration.