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 The leading web portal for pharmacy resources, news, education and careers April 24, 2017
Pharmacy Choice - News - Pharmaceutical Development - April 24, 2017

Pharmacy News

 Pharmaceutical Development
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4/24/17 - Adamas Presents ADS-5102 Pooled Phase 3 Data Confirming Statistically Significant Reduction in Levodopa-Induced Dyskinesia and OFF Time in People with Parkinson's Disease
Adamas Pharmaceuticals, Inc. today announced the presentation of two separate analyses of pooled data from the placebo-controlled Phase 3 clinical trials of ADS-5102 extended-release capsules in oral platform and poster presentation sessions at the 69 th American Academy of Neurology Annual Meeting in Boston. Adamas is excited to present this.
4/24/17 - Addivant? Receives Formal Approval from the FDA for Use of Its Nonylphenol-Free Antioxidant WESTON 705 in Infant Food and Breast Milk Plastic Packaging
Addivant?, the world leading supplier of liquid phosphite antioxidants for plastics, announced today that its nonylphenol-free stabilizer, WESTON 705, has received formal approval from the US Food and Drug Administration for use in infant formula and human milk plastic packaging. This approval from the FDA for use in infant formula and human m
4/24/17 - Akari Therapeutics Demonstrates Positive Response with Coversin in Ongoing Phase 2 PNH Trial and in Additional Clinical Targets
Akari Therapeutics, an emerging growth, clinical-stage biopharmaceutical company, announced that it will present data from an interim analysis of its ongoing Phase 2 trial of Coversin in paroxysmal nocturnal hemoglobinuria, as well as preclinical data for additional indications and other opportunities, at today s Research and Development Day.
4/24/17 - Alder BioPharmaceuticals Presents Additional Data from Eptinezumab Development Program at 69th Annual American Academy of Neurology Meeting
Alder BioPharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing monoclonal antibody therapeutics, today presented additional data for eptinezumab, which is in Phase 3 clinical development for the prevention of migraine, at the 69 th Annual American Academy of Neurology meeting in Boston. "The data presented today at the AAN
4/24/17 - Alere Achieves FDA Clearance for Alere Reader Platform and Alere BinaxNOW Influenza A & B Card 2
By a News Reporter-Staff News Editor at Pharma Business Week- Alere Inc., a global leader in rapid diagnostics, announced that its Alere? Reader, a diagnostic analyzer that can be used in both point-of-care and laboratory settings, has received 510 marketing clearance from the US Food and Drug Administration. This reformulated test card is the
4/24/17 - American Regent Announces Enrollment of First Patient in Phase 3 Trial to Investigate Injectafer (Ferric Carboxymaltose) as Treatment for Heart Failure with Iron Deficiency
American Regent, a member of the Daiichi Sankyo Group, announced that the first patient has been enrolled into the phase 3 clinical trial, HEART-FID. "Iron deficiency affects up to half of all heart failure patients and is associated with impaired exercise tolerance, and mortality in patients with or without anemia, 2" said Adrian F. Hernandez,
4/24/17 - ArQule Receives Clearance of Investigational New Drug Application from the FDA for Proprietary Reversible BTK Inhibitor, ARQ 531
By a News Reporter-Staff News Editor at Clinical Trials Week ArQule, Inc. announced that it has received clearance from the U.S. Food and Drug Administration for the Investigational New Drug application to conduct a phase 1 clinical trial with ARQ 531 in patients with B-cell malignancies who are refractory to other therapeutic options.
4/24/17 - aTyr Pharma Announces Promising Top-Line Results from Resolaris? Phase 1b/2 Clinical Trial in Patients with Early Onset Facioscapulohumeral Muscular Dystrophy
aTyr Pharma, Inc., a biotherapeutics company engaged in the discovery and development of Physiocrine-based therapeutics to address severe, rare diseases, today announced promising clinical results from its Phase 1 b/2 003 trial assessing the safety and potential activity of Resolaris? in patients with early onset facioscapulohumeral muscular...
4/24/17 - aTyr Pharma Presents Analyses of Resolaris Phase 1b/2 Trial in Patients with Limb Girdle Muscular Dystrophy 2B and Facioscapulohumeral Muscular Dystrophy at the American Academy of Neurology 69th Annual Meeting
aTyr Pharma, Inc., a biotherapeutics company engaged in the discovery and development of Physiocrine-based therapeutics to address severe, rare diseases, today announced its participation as part of the Emerging Science Platform Session at the upcoming American Academy of Neurology 69 th Annual Meeting to be held April 22 28, 2017 in Boston, M
4/24/17 - Aurora Cancer Care Launches Precision Medicine Program to Bring Greater Cancer Treatment Options to Patients
The new multi-disciplinary Oncology Precision Medicine Clinic will be located inside the Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center and will leverage molecular profiling technology to help patients explore additional treatment options that take into consideration the genetic characteristics of their tumors.
4/24/17 - Basilea announces agreement with FDA on Special Protocol Assessments for antibiotic ceftobiprole phase 3 clinical studies in bloodstream and skin infections
Release date- 21042017- Basel, Switzerland- Basilea Pharmaceutica Ltd. announced today that it has reached agreement with the US Food and Drug Administration on Special Protocol Assessments for its two planned phase 3 clinical studies of Basilea's antibiotic ceftobiprole. Achim Kaufhold, Basilea's Chief Medical Officer, said:' With the agreement on
4/24/17 - Biologics, Inc. Selected by TESARO as a Specialty Pharmacy Provider for ZEJULATM (niraparib), Approved for the Treatment of Recurrent Ovarian Cancer
Biologics, Inc., a McKesson Specialty Health oncology pharmacy services company, has been selected by TESARO, Inc. to be a specialty pharmacy provider in the distribution network for ZEJULA TM. Approved by the U.S. Food and Drug Administration on March 27, 2017, ZEJULA is a poly ADP-ribose polymerase inhibitor, for the maintenance treatment of adul
4/24/17 - Bristol-Myers Squibb Co (NYSE:BMY) NASH Drug Next Big Thing on Liver Fat Fight
Bristol-Myers Squibb Co (NYSE:BMY) says its experimental drug BMS-986036 designed to fight liver fat has achieved yet another milestone in a mid-stage clinical trial. According to the biopharmaceutical company, the nonalcoholic steatohepatitis or NASH drug significantly reduced liver fats against placebo in a Phase IIstudy. NASH Phase IIStudy R
4/24/17 - Cara Therapeutics Announces Positive Data From Quantitative Phase 1 Trial Measuring Respiratory Safety of I.V. CR845
Cara Therapeutics, Inc., a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting peripheral kappa opioid receptors, today announced summary results from its Phase 1 safety trial showing that I.V. CR845 demonstrated no significant alteration in any
4/24/17 - CEL-SCI Corporation Releases Letter to Shareholders
The following letter is being released by CEL-SCI Corporation to its shareholders:. Approximately 2 months after the amendment was submitted, on September 26, 2016, the FDA put the study on partial clinical hold. The FDA stipulated that no further patients should be enrolled, while patients currently receiving study treatments in this Phase 3 trial
4/24/17 - CytoSorbents Awarded $1M Phase II SBIR Contract by U.S. Department of Defense to Advance Fungal Mycotoxin Blood Purification
CytoSorbents Corporation, a critical care immunotherapy leader using blood purification to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, announced that it was awarded a two-year $999,996 Small Business Innovation Research Phase II contract to continue development of CytoSorb for fungal mycotoxin...
4/24/17 - Denovo Biopharma Obtains Exclusive License To Liafensine From AMRI
Denovo Biopharma LLC, today announced that it has obtained an exclusive license to liafensine, a serotonin-norepinephrine-dopamine reuptake inhibitor, a late-stage CNS drug, from Albany Molecular Research, Inc.. The agreement between Denovo Biopharma and AMRI concludes AMRI's divesture of all its legacy intellectual property assets.
4/24/17 - Devlin Brothers Go on a 3,000 Mile Run, 100-day Journey Across America to Stomp Out ALS
By a News Reporter-Staff News Editor at Clinical Trials Week- Brothers Mike and Joey Devlin announced their plans to travel across the U.S. to raise significant research funds for Project ALS in an effort to try one promising autophagy drug in people with ALS. Mike Devlin, 27, is an ultramarathon runner who will begin his quest in San Francisco o
4/24/17 - DGAP-News: MOLOGEN AG: Positive subgroup results of the exploratory phase II IMPULSE study of lefitolimod in extensive-disease small-cell lung cancer (SCLC) (english)
MOLOGEN AG: Positive subgroup results of the exploratory phase II IMPULSE study of lefitolimod in extensive-disease small-cell lung cancer ^ DGAP-News: MOLOGEN AG/ Key word: Study results MOLOGEN AG: Positive subgroup results of the exploratory phase II IMPULSE study of lefitolimod in extensive-disease small-cell lung cancer 24.04. 2017/ 07:26 The
4/24/17 - Dimension Therapeutics Announces Presentations at the Upcoming American Society for Gene and Cell Therapy (ASGCT) Annual Meeting
Title: Rapid characterization of transient transfection conditions for scalable production of adeno-associated virus using NanoSight NS300 Session Title: Vector and Cell Engineering and Manufacturing Session Date& Time: Friday, May 12, 2017, 5:45 PM- 7:45 PM Eastern Time Location: Exhibit Hall A& B South, Marriott Wardman Park Hotel, Washington, DC
4/24/17 - DURECT Announces Presentation of Data from a Phase 1b Study of DUR-928 in Nonalcoholic Steatohepatitis (NASH) at The International Liver Congress? 2017
DURECT Corporation, a biopharmaceutical company actively developing new therapeutics based on its Epigenetic Regulator Program and proprietary drug delivery platforms, announced that clinical data on DUR-928 were presented at The International Liver Congress TM 2017 on April 22 in Amsterdam. "DUR-928 was well tolerated in this study and plasma..
4/24/17 - Easton Pharmaceuticals Announces Signing NDA and Starts Negotiations For Acquisition
Easton Pharmaceuticals, Inc. is pleased to announce that it has signed a non-disclosure/ confidentiality agreement with a Producer of Crop Protection, Fertilizer and Plant Wash Products Company based in Israel. In other news, Easton expects a second purchase order to be received from Gedeon Richter for "Gynofit". Easton also expects to receive a pr
4/24/17 - Ebola: New trial launched in west Africa to evaluate three vaccination strategies
By a News Reporter-Staff News Editor at Clinical Trials Week The French National Institute of Health and Medical Research, the US National Institutes of Health and the London School of Hygiene& Tropical Medicine, in collaboration with health authorities in Guinea and Liberia, are launching a large clinical trial of candidate Ebola vaccines under
4/24/17 - Elbit Imaging Ltd. Announces FDA Approval Extension of Insightec's Exablate Neuro for Treatment of Essential Tremor
TEL AVIV, ISREAL/ ACCESSWIRE/ April 24, 2017/ Elbit Imaging Ltd. announced today, in furtherance to the announcements dated on October 22, 2015 and July 12, 2016, that it was informed by INSIGHTEC Ltd., that the FDA has extended its approval of Exablate Neuro system for a non-invasive treatment of essential tremor in patients who have not responded
4/24/17 - FDA Allows NuvOx Pharma to Run a Phase II Clinical Trial in Brain Cancer
By a News Reporter-Staff News Editor at Clinical Trials Week Nuvox Pharma announces that the FDA has allowed an Investigational New Drug application to initiate a Phase II clinical trial for its oxygen therapeutic, NVX-108, in patients with the hypoxic solid brain tumor, glioblastoma multiforme. The clinical trial's principal investigator, Baldas
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