LOS ANGELES--(BUSINESS WIRE)--A study by researchers at Children’s Hospital Los Angeles (CHLA), Brigham and Women’s Hospital and the California Department of Public Health suggests that all babies with a known mutation for cystic fibrosis (CF) and second mutation called the 5T allele should receive additional screening in order to better predict the risk of developing CF later in life.
Kite Pharma Licenses Enabling Technology for the Development of Off-the-Shelf Allogeneic T-Cell Therapies Platform for Renewable T-Cell Source Designed to Overcome Limitations of Current Allogeneic Approaches
SANTA MONICA, Calif.--(BUSINESS WIRE)--Kite Pharma, Inc. (Nasdaq:KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous T-cell therapy (eACT™) products for the treatment of cancer, today announced that it has entered into an exclusive, worldwide license agreement with The Regents of the University of California, on behalf of the University of California, Los Angeles (UCLA), for technology to advance the development of off-the-shelf allogeneic T-cell therapies from renewable pluripotent stem cells.
RTI Surgical® Continues to Advance Science Behind Allograft Implantation Peer-Reviewed, Pre-Clinical Study Published in Journal of Tissue Engineering
ALACHUA, Fla.--(BUSINESS WIRE)--RTI Surgical, Inc. (RTI) (Nasdaq: RTIX), a leading global surgical implant company, announced that a peer-reviewed, pre-clinical study titled Multipotent adult progenitor cells on an allograft scaffold facilitate the bone repair process has been published in the latest edition of the Journal of Tissue Engineering.
Celgene and LYSARC Provide Update on the Phase III ‘REMARC’ Study of REVLIMID® Maintenance Treatment in Patients with Diffuse Large B-Cell Lymphoma Responding to First-Line R-CHOP Therap
SUMMIT, N.J. & LYON, France--(BUSINESS WIRE)--Celgene Corporation (NASDAQ: CELG) and the Lymphoma Study Association (LYSA) today announced that the Lymphoma Academic Research Organisation (LYSARC) reported initial data from a phase III, randomized, double-blind, international clinical study (REMARC). This investigational study evaluated maintenance therapy with REVLIMID® (lenalidomide) compared with placebo in diffuse large B-cell lymphoma (DLBCL) patients responding to first-line rituximab plus CHOP chemotherapy (R-CHOP) induction therapy. LYSARC sponsored the study under a Clinical Trial Agreement with Celgene.
Enigma Biomedical Group Inc Signs Research Agreement with Biogen and Merck for Novel Tau Imaging Agent
TORONTO--(BUSINESS WIRE)--Enigma Biomedical Group Inc. today announced a research collaboration agreement with Biogen Inc. and Merck, known as MSD outside the US and Canada, for the validation and clinical qualification of an investigational imaging agent to be used in Positron Emission Tomography (PET) scans for assessing the status and progression of neurofibrillary tangles (NFTs) in the brain. NFTs made up of aggregated tau protein are a hallmark of several neurodegenerative diseases, including Alzheimer’s disease.
Enanta Announces the U.S. Food and Drug Administration has approved AbbVie’s New, Once-Daily VIEKIRA XR™ (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the Treatment of Genotype 1 Chronic Hepatitis C Virus
WATERTOWN, Mass.--(EON: Enhanced Online News)--Enanta Pharmaceuticals, Inc., (NASDAQ: ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved AbbVie’s New Drug Application (NDA) for VIEKIRA XR™ (dasabuvir, ombitasvir, paritaprevir and ritonavir) extended release tablets. VIEKIRA XR is a once-daily, extended-release co-formulation of the active ingredients in VIEKIRA PAK®(ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) and is for the treatment of patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated cirrhosis (Child-Pugh A). VIEKIRA XR is not for HCV patients with decompensated cirrhosis
Newron to Re-Submit US NDA for Xadago® (Safinamide) FDA agrees no additional evaluation of abuse liability or dependence/withdrawal effects in humans is required
MILAN--(BUSINESS WIRE)--Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system (CNS) and pain, and its partners Zambon S.p.A. and US WorldMeds announced today that the US Food and Drug Administration (FDA) and the Controlled Substance Staff (CSS) in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration no longer require Newron to perform any studies to clinically evaluate the potential abuse liability or dependence/withdrawal effects of Xadago®. The FDA decision was communicated during a meeting with Newron that was scheduled following the March 29, 2016 Complete Response Letter (CRL).
Poxel Announces Publication of Important New Mechanism Data for Imeglimin Relating to Insulin Secretion in the Treatment of Type 2 Diabetes
New study led by Yale School of Medicine demonstrates Imeglimin directly stimulates insulin secretion in a glucose-dependent mannerPreclinical results help to explain Imeglimin’s observed efficacy without causing hypoglycemia, as shown in more than 850 subjects in clinical trials to date
Allergan Receives Positive Opinion For Truberzi® (Eluxadoline) For Treatment Of Irritable Bowel Syndrome With Diarrhoea (IBS-D) In Adults
-- TRUBERZI® first-in-class medication offering sustained relief from multiple symptoms of IBS-D, such as pain, diarrhoea, urgency and bloating(1,2) -- -- Significant step towards bringing the only licensed prescription medication for IBS-D to patients in 28 countries of the European Union(2-4) -- -- Further demonstrates Allergan's commitment to addressing unmet medical needs in gastrointestinal disease by providing innovative medicines for patients and physicians -- DUBLIN , July 25, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a Positive Opinion for TRUBERZI® (eluxadoline) in the European Union .4 TRUBERZI® is an oral medication that relieves the main symptoms of irritable bowel syndrome with diarrhoea (IBS-D) in adults.1 In two pivotal trials, TRUBERZI® significantly reduced two of the most bothersome symptoms of IBS-D, abdominal pain and diarrhoea, with sustained relief demonstrated over six months1,2. TRUBERZI® was generally well tolerated with the most common side effects being nausea, constipation, and abdominal pain1,2.