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 The leading web portal for pharmacy resources, news, education and careers February 11, 2016
Pharmacy Choice - News - Pharmaceutical Development - February 11, 2016

Pharmacy News

 Pharmaceutical Development
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2/11/16 - "Method for Validation of Pharmaceutical Composition Formulations" in Patent Application Approval Process (USPTO 20160019366)
By a News Reporter-Staff News Editor at Politics& Government Week A patent application by the inventor Klomp, Paul P., filed on July 17, 2014, was made available online on January 28, 2016, according to news reporting originating from Washington, D.C., by VerticalNews correspondents. This patent application has not been assigned to a company or i
2/11/16 - Achillion Initiates Phase 1 Study of ACH-4471, First Orally-Administered Small Molecule Complement Factor D Inhibitor
Achillion Pharmaceuticals, Inc. today announced the initiation of a phase 1 study with ACH-4471, the Company s first orally-administered, highly potent and specific small molecule that has been shown to inhibit complement factor D. The phase 1 study is being conducted in healthy volunteers and is evaluating single ascending doses of ACH-4471 t
2/11/16 - Aegerion Pharmaceuticals Announces Reduction in Workforce as Part of Cost Reduction Plan
Aegerion Pharmaceuticals, Inc., a biopharmaceutical company dedicated to the development and commercialization of innovative therapies for patients with debilitating rare diseases, today announced that it is reducing approximately 25% percent of its global workforce. This reduction in force is part of a broad program taken by Aegerion to...
2/11/16 - Atlantic Healthcare starts pivotal Phase 3 trial of Alicaforsen to treat Inflammatory Bowel Disease Pouchitis
Atlantic Healthcare plc, an international specialty pharma company focusing on gastrointestinal disorders, is pleased to announce that patient recruitment has commenced for a Phase 3 trial of its wholly-owned product alicaforsen enema to treat Inflammatory Bowel Disease pouchitis. Atlantic is recruiting 138 patients at 40 trial centres across the..
2/11/16 - Bioethics International's Good Pharma Scorecard Publication Selected as BMJ Open Editors' Pick for 2015
"In our second editors' pick, Jennifer Miller and colleagues examined the levels of clinical trial registration, reporting and publication rates for new drugs approved by the Food and Drug Administration in 2012.". The study sought to evaluate clinical trial registration, reporting and publication rates for 15 new drugs approved by the FDA in 2012
2/11/16 - Chronic Cerebrospinal Venous Insufficiency (CCSVI) Global Clinical Trials Review, H2, 2015 - New Market Report
Fast Market Research announces the availability of the new GlobalData report, "Chronic Cerebrospinal Venous Insufficiency Global Clinical Trials Review, H2, 2015", on their comprehensive research portalBoston, MA 02/11/2016 GlobalData's clinical trial report, "Chronic Cerebrospinal Venous Insufficiency Global Clinical Trials Review, H2, 2015"
2/11/16 - Chugai's ALK Inhibitor 'Alecensa' Trial Stopped Early for Benefit - Demonstrates Statistically Significant Improvement in PFS in a Japanese Phase III Head to Head Study with Crizotinib
Release date- 10022016- TOKYO,- Chugai Pharmaceutical Co., Ltd. announced that it received a recommendation by an independent data monitoring committee that the J-ALEX Study, a phase III study targeting ALK fusion gene positive non-small cell lung cancer being conducted in Japan, should be stopped early as the study met its primary endpoint at a pr
2/11/16 - eClinical Solutions Market by Product, Delivery Mode, Clinical Trial Phases, End User - Global Forecast to 2020
Dublin- Research and Markets has announced the addition of the "eClinical Solutions Market by Product, Delivery Mode, Clinical Trial Phases, End User- Global Forecast to 2020" report to their offering. On the basis of geography, this market is classified into four regions, namely, North America, Europe, Asia-Pacific, and the Rest of the World. In 2
2/11/16 - eClinical Solutions Market by Product, Delivery Mode, Clinical Trial Phases, End User - Global Forecast to 2020 - Research and Markets
Research and Markets has announced the addition of the "eClinical Solutions Market by Product, Delivery Mode, Clinical Trial Phases, End User- Global Forecast to 2020" report to their offering. On the basis of geography, this market is classified into four regions, namely, North America, Europe, Asia-Pacific, and the Rest of the World. In 2015, the
2/11/16 - Endonovo Therapeutics Retains Holland & Knight to File for Orphan Drug Designation
LOS ANGELES, CA February 11, 2016- Endonovo Therapeutics, Inc., an innovative biotechnology company developing bioelectronics-based products and therapies for regenerative medicine, announced it has retained Holland& Knight to prepare and file the paperwork necessary to obtain an orphan drug designation for Endonovo's proprietary Cytotronics (TM)
2/11/16 - FDA Grants Priority Review to KemPharm for KP201/APAP NDA [Saudi Press Agency (Saudi Arabia)]
-KemPharm, Inc. today announced that the New Drug Application for KP201/APAP, its investigational drug candidate for the short-term management of acute pain, has been accepted and granted priority review by the U.S. Food and Drug Administration. In the NDA submission, KemPharm requested the FDA to recommend that KP201/APAP be classified as a Schedu
2/11/16 - FDA Lifts Heat Biologics Partial Clinical Hold [Arab News (Saudi Arabia)]
-Heat Biologics, Inc., an immuno-oncology company developing novel therapies that activate a patients immune system against cancer, announced that the U.S. Food and Drug Administration has lifted the partial clinical hold on the companys Phase 2 clinical trial evaluating HS-410 either alone or in combination with standard of care Bacillus Calmette-
2/11/16 - Galmed Pharmaceuticals Announces Retirement of Chief Medical Officer
Galmed Pharmaceuticals Ltd., a clinical-stage biopharmaceutical company focused on the development of a once-daily, oral therapy for the treatment of liver diseases, announced today that its Chief Medical Officer, Dr. "Dr. Halpern has been an instrumental part of growing Galmed to the point where it is today," commented President and Chief Execu
2/11/16 - Genocea Reports Fourth Quarter and Year-End 2015 Financial Results
Genocea Biosciences, Inc., a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, today reported corporate highlights and financial results for the fourth quarter and year ended December 31, 2015. In October, we demonstrated significant and durable Phase 2 efficacy for GEN-003, potentially positioning it to become th
2/11/16 - Immune Design Enters into Clinical Trial Collaboration with Genentech
Deal Type: Partnership Deal Sub Type: Other Deal Country: United States of America Deal Status: Completed Deal Value: 0.0000 USD. Immune Design Corp., a clinical-stage immunotherapy company, has entered into a clinical trial collaboration with Genentech, Inc., a biotech company that undertakes discovery, development, manufacture and commercializati
2/11/16 - Incyte Announces Decision to Discontinue JANUS Studies of Ruxolitinib plus Capecitabine in Patients with Advanced or Metastatic Pancreatic Cancer
Incyte Corporation announced today its decision to discontinue the Phase 3 study of ruxolitinib or placebo in combination with capecitabine for the second-line treatment of patients with advanced or metastatic pancreatic cancer. Following these results, and the previously announced interim analysis of the Phase 2 sub-study of ruxolitinib or placebo
2/11/16 - Lancet Publishes First Trial To Show Overall Survival Benefit Of Halaven (eribulin) in People With Soft Tissue Sarcoma Sub-Types
Full results of study 309 published for the first time in The Lancet show Halaven improved median overall survival compared to dacarbazine for people with unresectable locally advanced liposarcomas and leiomyosarcomas, two of the most common forms of soft-tissue sarcoma. In addition to the full results, The Lancet has also published an editorial
2/11/16 - Lannett Receives FDA Approval For Temozolomide Capsules
Lannett Company, Inc. today announced that its wholly owned subsidiary, Kremers Urban Pharmaceuticals Inc., has received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application for Temozolomide Capsules 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg, the therapeutic equivalent to the reference listed drug Temod
2/11/16 - Meridian Lab Announces Positive Outcome from Pre-NDA Meeting with FDA for ML141
By a News Reporter-Staff News Editor at Politics& Government Week Buffalo Grove, Illinois- based specialty-oncology drug development company, Meridian Laboratories, Inc. announced the positive outcome of a pre-NDA meeting with the U.S. Food and Drug Administration. The FDA has agreed with the Company's proposal to use the 505 regulatory pathway f
2/11/16 - NAFDAC Approves Local Production of Life Saving Drugs
The National Agency for Food and Drug Administration and Control, NAFDAC, has approved the production of four United Nations life saving commodities for women and children. Paul Orhii, who spoke at a two-day Common Technical Document, CTD, workshop in Lagos, said, Nigerians now have improved access to locally produced safe, efficacious and affordab
2/11/16 - Neurotrope Doses First Patients in Phase 2b Study of Bryostatin for Treatment of Severe Alzheimer's Disease
Neurotrope, Inc. today announced that the first patients have been dosed in the Company s Phase 2 b clinical trial of its lead candidate, Bryostatin-1, for the treatment of advanced Alzheimer s disease.. This trial seeks to statistically verify preliminary results seen in compassionate use patients and patients treated in our completed Phas
2/11/16 - New Data From the Phase 1/2 NEWTON Study of Edge Therapeutics EG-1962 to be Presented at the International Stroke Conference 2016 [Emirates News Agency (WAM) (United Arab Emirates)]
-Edge Therapeutics, Inc., a clinical-stage biotechnology company developing novel hospital-based therapies in the management of acute, life-threatening conditions, today announced that the full dataset from its North American Phase 1/ 2 NEWTON study of EG-1962 has been accepted for an oral presentation at the International Stroke Conference 2016, t
2/11/16 - NEW ENGLAND JOURNAL OF MEDICINE PUBLISHES ABLYNX'S PHASE II TITAN STUDY OF CAPLACIZUMAB IN PATIENTS WITH ACQUIRED TTP
Ablynx today announced that the results of the Company's worldwide Phase II TITAN study with caplacizumab for patients with acquired thrombotic thrombocytopenic purpura have been published in today's issue of the New England Journal of Medicine. Dr Robert K. Zeldin, Chief Medical Officer of Ablynx, commented: "The publication of the TITAN data in
2/11/16 - ONL Therapeutics Receives Orphan Drug Designation for ONL1204 for Treatment of Retinal Detachment From FDA
ONL Therapeutics, Inc., a biopharmaceutical company developing novel therapies for preserving sight in a range of retinal diseases, today announced that the United States Food and Drug Administration has granted orphan drug designation to ONL1204 for the treatment of retinal detachment. ONL1204 is a novel, first-in-class small molecule peptide desi
2/11/16 - Puma Biotechnology's ExteNET Phase III Study Published Online in The Lancet Oncology
Puma Biotechnology, Inc., a biopharmaceutical company, announced that results from the ExteNET Phase III clinical trial of neratinib in patients with early stage HER2 positive breast cancer were published in the journal The Lancet Oncology. The article entitled Neratinib after trastuzumab-based adjuvant therapy in patients with HER2-positive bre
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