PRNewswire/ -- Aptinyx Inc., a biopharmaceutical company developing novel modulators of the N-methyl-D-aspartate (NMDA) receptor for the treatment of challenging neurologic disorders, today announced the initiation of dosing in a Phase 1, first-in-human study for its lead therapeutic candidate, NYX-2925.The randomized, double-blind, placebo-controlled study will enroll approximately 70 healthy volunteers to evaluate the safety and tolerability of NYX-2925 at multiple doses. The study will include both single-dose and multiple-dose ascending cohorts, each with placebo controls. Aptinyx anticipates utilizing the results of the study to guide dose selection for Phase 2 efficacy studies in specific neurologic indications.
MRIGlobal To Lead International Research Collaboration For Tularemia Vaccine
MRIGlobal today announced that it has been awarded a .2 million, 5-year program from the Defense Threat Reduction Agency (DTRA) for the development of a vaccine for tularemia.The award continues a long-standing international co-operation to develop a tularemia vaccine.Tularemia is a disease of animals and humans caused by the bacterium Francisella tularensis. Rabbits, hares, and rodents are especially susceptible to tularemia and often die during outbreaks. Humans can become infected in several ways including tick and deer fly bites; skin contact with infected animals; ingestion of contaminated water; inhalation of contaminated dust or aerosols; and acts of bioterrorism.
Alcon launches Dailies Total1® Multifocal contact lenses, the first and only water gradient lenses designed for people with presbyopia
Basel, July 14, 2016 - Alcon, the global leader in eye care and a division of Novartis, introduces Dailies Total1 Multifocal contact lenses for people with presbyopia. This innovative multifocal lens provides both seamless distant, intermediate and near vision, and the outstanding comfort of the Dailies Total1 water gradient lens technology.,- Dailies Total1 Multifocal contact lenses use Alcon's Precision Profile(TM) lens design, a design also included in Alcon's Air Optix® Aqua and Dailies Aqual Comfort Plus® multifocal contact lenses.
Sandoz biosimilar etanercept recommended by FDA advisory committee for approval to treat multiple inflammatory diseases
Committee votes unanimously in favor of the Sandoz proposed biosimilar etanercept for all approved indications of the reference product Committee's recommendation based on totality of evidence from global development program showing biosimilar etanercept is highly similar to Enbrel®* Holzkirchen, 13 July, 2016. Sandoz, a Novartis division and leader in biosimilars, announced today that the US Food and Drug Administration (FDA) Arthritis Advisory Committee recommended approval of its proposed biosimilar etanercept. The committee voted unanimously (20-0), in support of biosimilar etanercept for all five indications of the reference product, including rheumatoid arthritis (RA), plaque psoriasis (PsO), psoriatic psoriasis (PsA), ankylosing spondylitis (AS) and polyarticular juvenile idiopathic arthritis (JIA).
Lilly and Boehringer Ingelheim Announce Clinical Trial Collaboration in Metastatic Breast Cancer
-- Study to evaluate potential of novel combination therapy for hormone-receptor-positive, human epidermal growth factor receptor 2-negative (HR+, HER2-) metastatic breast cancer (mBC) -- Lilly's CDK 4 and CDK 6 inhibitor abemaciclib and Boehringer Ingelheim's IGF mAB BI 836845 have shown promising early phase results in mBCINDIANAPOLIS, July 13, 2016 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Boehringer Ingelheim today announced a new collaboration on a Phase 1b study that will evaluate the safety and tolerability of abemaciclib (LY2835219), Lilly's cyclin-dependent kinase (CDK) 4 and CDK 6 inhibitor, in combination with BI 836845, Boehringer Ingelheim's insulin-like growth factor (IGF)-1/IGF-2 ligand neutralizing antibody, in patients diagnosed with HR+, HER2- mBC. Based on the Phase 1b trial results, the collaboration has the potential to expand to Phase 2 trials in patients with HR+, HER2- mBC and other solid tumors. Enrollment is scheduled to begin in late 2016, and Boehringer Ingelheim will be the sponsor of the study program."We are pleased to join with Boehringer Ingelheim to study the potential of their molecule in combination with Lilly's abemaciclib, for which we have an active Phase 3 development program underway," said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology. "For patients living with metastatic breast cancer, the limited treatment options available make this an important area of focus for our efforts to advance the most innovative treatments."
MD Anderson Laboratory Professional Named 2016 Cardinal Health urEssential Award Recipient
DUBLIN, Ohio, July 13, 2016 /PRNewswire/ -- Cardinal Health named Dr. Peter C. Hu, Ph.D., F.A.C.Sc, associate professor in the School of Health Professions at The University of Texas MD Anderson Cancer Center, the 2016 winner of the Cardinal Health urEssential Award, which recognizes the essential contributions medical laboratory professionals make to patient care. In addition to being nationally recognized for his outstanding contributions to the clinical lab and beyond, Cardinal Health will make a charitable contribution of ,000 to the institution of higher learning of Dr. Hu's selection. The contribution will be used as scholarship funding for MD Anderson's Molecular Genetic Technology Program and the Graduate Program in Diagnostic Genetics, both of which are academic programs for students seeking careers in laboratory medicine.
Medtronic Receives FDA Approval for IN.PACT Admiral DCB 150 mm Lengths
Medtronic plc (NYSE: MDT) has received U.S. Food and Drug Administration (FDA) approval for the IN.PACT(TM) Admiral(TM) drug-coated balloon (DCB) in longer, 150 mm lengths. The new 150 mm length balloon, available in four, five, and six mm diameters, will provide greater treatment options for long lesions in patients with peripheral artery disease (PAD). "The long lesion (10-18 cm) sub-group outcomes from the IN.PACT SFA Trial at one year demonstrated superiority over balloon angioplasty," said John Laird, M.D., interventional cardiologist at U.C. Davis Medical Center and co-principal investigator for the IN.PACT SFA Trial. "The availability of the 150 mm length sizes will expand proven treatment options to more patients."* The IN.PACT SFA Trial, a prospective, multi-center, randomized, controlled pivotal trial demonstrated, in a subgroup of patients with lesions >=10 cm and <18 cm, a clinically-driven target lesion revascularization (CD-TLR) rate of 5.3 percent for the IN.PACT Admiral DCB arm (n=79) and 32.4 percent for the PTA arm (n=36) (p<0.001). There were no device or procedure-related deaths, no occurrences of major target limb amputation, and a 3.9 percent thrombosis rate in the IN.PACT Admiral DCB arm versus 5.9 percent in the PTA arm through 12 months (p=0.326) in this subgroup.
Exclusive Agreement Includes Nine Biosimilars THOUSAND OAKS, Calif. and TOKYO , July 13, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo ; TSE: 4568) today announced the execution of an exclusive agreement to commercialize nine biosimilars in Japan . The deal includes several biosimilars in late-stage development, including biosimilars of adalimumab, bevacizumab and trastuzumab. Under the terms of the agreement, Amgen will remain responsible for the development and manufacturing of the biosimilars. Daiichi Sankyo will file for marketing approval and be responsible for distribution and commercialization in Japan , while Amgen will have a limited right to co-promote the products. " Amgen is excited to collaborate with Daiichi Sankyo as we seek to drive adoption and build confidence in biosimilars as a means of enhancing patient access to more affordable therapeutic options worldwide," said Scott Foraker , vice president and general manager of Biosimilars at Amgen . Amgen will retain all additional distribution and commercialization rights for the biosimilar programs outside of Japan . Specific financial terms of the agreement were not disclosed.