R&D

Atox Bio’s Reltecimod Passes Futility Analysis in Phase 3 ACCUTE Study; Trial Continues as Planned

May 23, 2017

NESS ZIONA, Israel and CHAPEL HILL, North Carolina, May 23, 2017 /PRNewswire/ — Atox Bio today announced that the Phase 3 ACCUTE study, evaluating Reltecimod (previously AB103) in patients with Necrotizing Soft Tissue Infections, will continue as planned without modification based on the successful completion of a pre-specified futility analysis. The recommendation was made by […]

NeuroVive to Continue NeuroSTAT® Clinical Development After Positive Outcome in Preclinical and Clinical TBI Studies

May 23, 2017

LUND, Sweden,, May 23, 2017 /PRNewswire/ — NeuroVive Pharmaceutical AB(Nasdaq Stockholm: NVP, OTCQX: NEVPF) today announced positive results from clinical and preclinical studies with its drug NeuroSTAT® for the prevention of the sequelae of traumatic brain injury (TBI). The company is now preparing for the next clinical study with NeuroSTAT for TBI. The combined positive […]

CLJI Worldwide Trial Enrolls First Patient in Clinical Study Evaluating the Performance of VIBLOK as a Barrier for Herpes Simplex Virus Transmission in Men and Women

May 23, 2017

BAY HARBOR ISLANDS, Florida, May 23, 2017 /PRNewswire/ — CLJI Worldwide reports the start of the VIBLOK Safety And perFormancE Trial (SAFE Trial). The CLJI Worldwide SAFE Trial will evaluate the performance of VIBLOK for adults infected with herpes simplex virus-2 (HSV-2), the cause of genital herpes. VIBLOK is an investigational device developed to help […]

Phase III ZONDA Trial for Benralizumab Shows Ability to Reduce Oral Steroid Use in Severe Asthma Patients

May 23, 2017

MISSISSAUGA, ON, May 23, 2017 /CNW/ – Results from the Phase III ZONDA trial presented at the American Thoracic Society (ATS) 2017 International Congress on Monday, May 22, demonstrated that adding benralizumab to standard of care allowed patients dependent on OCS to significantly reduce or discontinue steroids while maintaining asthma control.4 Detailed results of the […]

Fractyl Announces Initiation of Multicenter Clinical Trial to Evaluate a Novel Medical Procedure for Poorly Controlled Type 2 Diabetes

May 23, 2017

LEXINGTON, Mass., May 23, 2017 /PRNewswire/ — Fractyl Laboratories Inc. (Fractyl) today announced that the first patient in Europe has been treated as part of a clinical trial called Revita-2. The trial is designed to evaluate the safety and efficacy of the Revita™ DMR System in orally-treated type 2 diabetes patients with poorly controlled disease. […]

New Analyses Show SPIRIVA® RESPIMAT® (tiotropium bromide) Inhalation Spray Improves Breathing for People with Asthma Regardless of BMI or Allergic Status

May 23, 2017

RIDGEFIELD, Conn., May 23, 2017 /PRNewswire/ — Boehringer Ingelheim today announced new analyses that provide further evidence that adding SPIRIVA RESPIMAT improved breathing across diverse patient populations who experience uncontrolled asthma symptoms despite the use of another daily maintenance therapy in the Phase III clinical development program. These data analyses will be presented today at […]

Daiichi Sankyo Cancer Enterprise Pipeline Data Showing Swift Progress in Precision Medicine for Breast Cancer to be Presented at 2017 American Society of Clinical Oncology (ASCO) Annual Meeting

May 23, 2017

PARSIPPANY, N.J., May 23, 2017 /PRNewswire/ — Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced new data on several investigational products in the Daiichi Sankyo Cancer Enterprise pipeline will be presented during the 2017 American Society for Clinical Oncology (ASCO) Annual Meeting from June 2-6 in Chicago.   Breast cancer precision medicine research on […]

ORYX reports positive clinical evidence with oncolytic virus ParvOryx in combination with immuno-oncology drugs

May 23, 2017

MUNICH–(BUSINESS WIRE)–ORYX, a translational medicine company focused on oncolytic virotherapy and cancer vaccines, today announced positive findings from 16 patients treated with the oncolytic virus, ParvOryx, in combination with Avastin(R) (bevacizumab) and with immune checkpoint inhibitors Keytruda(R) or Opdivo(R) under compassionate use programs. These promising results have encouraged ORYX to prepare a controlled clinical study, […]

United Neuroscience Reports Positive Phase 1 Results for Active Vaccine UB-311 in Alzheimer’s Disease

May 23, 2017

NEW YORK–(BUSINESS WIRE)–United Neuroscience (UNS), a clinical stage biotechnology company dedicated to developing best-in-class therapies for Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced positive Phase 1 data for UB-311, its novel synthetic peptide vaccine targeting beta amyloid (Aβ) in the treatment of AD. The Phase 1 data, which was published in the Alzheimer’s […]

FDA Grants Priority Review to Merck’s Supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab) for Treatment of Recurrent or Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

May 23, 2017

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, seeking approval for treatment of patients with recurrent or advanced gastric or gastroesophageal junction adenocarcinoma […]

BYDUREON EXSCEL Trial Meets Primary Safety Objective in Type-2 Diabetes Patients at Wide Range of Cardiovascular Risk

May 23, 2017

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today announced top-line results from the Phase IIIb/IV EXSCEL (EXenatide Study of Cardiovascular Event Lowering) trial. The trial compared the effect of once-weekly Bydureon (exenatide extended-release) for injectable suspension versus placebo, when added to usual type-2 diabetes care, on the risk of MACE, a composite endpoint of CV death, non-fatal myocardial infarction […]

DNAnexus to Partner With AstraZeneca’s Centre for Genomics Research

May 23, 2017

MOUNTAIN VIEW, Calif.–(BUSINESS WIRE)–DNAnexus, Inc., the global leader in genome informatics and data management, today announced that its secure cloud-based platform has been selected as a partner for AstraZeneca’s Centre for Genomics Research (CGR), which will analyse over two million genomes in the next 10 years to inform drug discovery and development. Financial terms of […]

TG Therapeutics, Inc. Announces Successful Outcome from Pre-Planned Interim Analysis by Independent DSMB in the UNITY-CLL Phase 3 Trial

May 23, 2017

NEW YORK, May 23, 2017 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (NASDAQ:TGTX), today announced that the independent Data Safety Monitoring Board (DSMB) of the UNITY-CLL Phase 3 trial has successfully completed a pre-specified interim analysis to assess the contribution of TG-1101 (ublituximab) and TGR-1202 in the combination regimen of TG-1101 plus TGR-1202. In conducting the […]

Rev Up eCTD Production With Microsystems DocXtools™ at Drug Information Association Annual Meeting

May 23, 2017

Chicago, Ill., May 23, 2017 (Business Wire) — Microsystems, a leading provider of document authoring, editing, formatting and quality control solutions for the life science industry, is launching a new and improved version of DocXtools™ for Life Sciences at the Drug Information Association (DIA) Annual Meeting, June 18–22. DocXtools for Life Sciences dramatically cuts the […]

Clinical Ink and endpoint Announce Industry-First Alliance

May 23, 2017

San Francisco and Philadelphia; May 23, 2017 (Business Wire) –endpoint Clinical, the leading global interactive response technology (IRT®) company, and Clinical Ink, the pioneering provider of eSource and patient engagement technologies, have teamed up to integrate IRT and eSource in order to create a seamless user experience for investigator sites. “The workload on investigator sites […]

ChemoCentryx Granted EU Orphan Drug Designation for Avacopan in the Treatment of Debilitating Kidney Disease C3 Glomerulopathy (C3G)

May 23, 2017

MOUNTAIN VIEW, Calif., May 23, 2017 (GLOBE NEWSWIRE) — ChemoCentryx, Inc., (Nasdaq:CCXI), a biopharmaceutical company developing new medications targeted at inflammatory and autoimmune diseases and cancer, announced today that the European Medicines Agency (EMA) has granted orphan medicinal product designation for avacopan (formerly CCX168) in the treatment of patients with C3 glomerulopathy (C3G). In March, […]

Ammonett Pharma Receives Positive Opinion from European Orphan Medicinal Products Committee for MK-0677 for Treatment of Pediatric Growth Hormone Deficiency

May 23, 2017

MIDLOTHIAN, Va., May 23, 2017 (GLOBE NEWSWIRE) — Ammonett Pharma LLC (the Company or Ammonett), a privately-held biotechnology company developing a novel, daily, orally-administered mini-pill Growth Hormone (GH) secretagogue, today announced that the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) issued a positive opinion recommending the Company’s MK-0677 (Oratrope™) for designation as […]

Aeglea BioTherapeutics Provides AEB1102 Program and Corporate Update

May 23, 2017

AUSTIN, Texas, May 23, 2017 (GLOBE NEWSWIRE) — Aeglea BioTherapeutics, Inc., (NASDAQ:AGLE) a biotechnology company committed to developing enzyme-based therapeutics in the field of amino acid metabolism to treat rare genetic diseases and cancer, today provided an AEB1102 program and corporate update. AEB1102, the company’s lead investigational molecule, is an engineered human enzyme designed to […]

New Data from Emulate’s Asthma-on-Chip Presented at American Thoracic Society Annual Meeting

May 23, 2017

BOSTON, Mass., May 23, 2017 – Emulate Inc. presented data today that shows expanded functionality in modeling viral infection on the Small Airway Lung-Chip. This advancement opens new opportunities for studying viral-induced exacerbations of asthma using a human-relevant system. The data demonstrates the capability to model human airway tissue on the Small Airway Lung-Chip and […]

United Neuroscience Reports Positive Phase 1 Results for Active Vaccine UB-311 in Alzheimer’s Disease

May 23, 2017

NEW YORK, May 23, 2017—United Neuroscience (UNS), a clinical stage biotechnology company dedicated to developing best-in-class therapies for Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced positive Phase 1 data for UB-311, its novel synthetic peptide vaccine targeting beta amyloid (Ab) in the treatment of AD. The Phase 1 data, which was published in […]

Churchill Pharmaceuticals Announces Submission of NDA for Novel Oral Formulation of Prostate Cancer Treatment

May 23, 2017

King of Prussia, PA., May 23, 2017 – Churchill Pharmaceuticals, LLC (Churchill) today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for YONSA™ (abiraterone acetate), an improved ultramicrosize formulation of abiraterone acetate. YONSA is a CYP17 inhibitor for the treatment of metastatic castration-resistant prostate cancer in […]

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