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 The leading web portal for pharmacy resources, news, education and careers August 22, 2017
Pharmacy Choice - News - Pharmaceutical Development - August 22, 2017

Pharmacy News

 Pharmaceutical Development
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
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8/22/17 - ALK to accelerate launches of ODACTRA in the USA / ACARIZAX in Canada [T-break Tech (Middle East)]
The FDA has today transferred the US product licences for the SLIT-tablet portfolio to ALK allowing the company to give full speed on the US activities. ALK plans to expand pivotal Phase III clinical trial on allergic asthma to include US patients based on discussions with the FDA. Full-year financial guidance for operating profit has been revised
8/22/17 - Alkermes Initiates Rolling Submission of ALKS 5461 New Drug Application for Major Depressive Disorder
Release date- 21082017- DUBLIN- Alkermes plc today announced the initiation of its rolling submission of a New Drug Application to the U.S. Food and Drug Administration, seeking marketing approval of ALKS 5461, a once daily, oral investigational medicine with a novel mechanism of action, for the adjunctive treatment of major depressive disorder.
8/22/17 - Alliance Foundation Trials Opens Global Trial Investigating First-in-Class Palbociclib in HR+, HER2+ Metastatic Breast Cancer
The Alliance Foundation Trials, LLC, in conjunction with Pfizer and six international cancer research groups, today announced the launch of PATINA a randomized, open-label, Phase 3 clinical study of the cyclin-dependent kinase 4/ 6 inhibitor palbociclib. The PATINA trial offers an exciting opportunity for a new global collaborative initiative
8/22/17 - ALTIMMUNE SUBMITS INVESTIGATIONAL NEW DRUG APPLICATION FOR NASOVAX IN PREPARATION FOR PHASE 2 TRIAL
Release date- 21082017- GAITHERSBURG, Md.- Altimmune, Inc., a clinical-stage immunotherapeutics company, today announced the Company has submitted an Investigational New Drug application to the U.S Food and Drug Administration for NasoVAX, the Company's intranasally administered recombinant flu vaccine. Sybil Tasker, Chief Medical Officer at Altimm
8/22/17 - Altimmune Submits Investigational New Drug Application for NasoVAX in Preparation for Phase 2 Trial [Syrian Arab News Agency]
Altimmune, Inc., a clinical-stage immunotherapeutics company, today announced the Company has submitted an Investigational New Drug application to the U.S Food and Drug Administration for NasoVAX, the Companys intranasally administered recombinant flu vaccine. Sybil Tasker, Chief Medical Officer at Altimmune. Current vaccines leave significant room
8/22/17 - Argos Therapeutics Announces Interim Analysis of Phase 3 ADAPT Trial to be Presented at ESMO 2017 Congress [T-break Tech (Middle East)]
-Argos Therapeutics Inc., an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis precision immunotherapy technology platform, today announced that an interim analysis of data from the ongoing Phase 3 ADAPT clinical trial evaluating Rocapuldencel-T for the treatment of...
8/22/17 - Astellas Pharma Inc. - First Patient Dosed in Phase 3 MORPHO Trial Evaluating Gilteritinib as Maintenance Therapy
Release date- 21082017- TOKYO- Astellas Pharma Inc. announced today that the first patient was dosed in the registrational Phase 3 MORPHO trial of gilteritinib, the fourth Phase 3 trial underway in the gilteritinib clinical development program. 'We know that FLT3+ AML patients face potentially worse outcomes than those with other mutations, and whi
8/22/17 - Aurobindo Pharma gets USFDA nod for anti-HIV drug [Arab News (Saudi Arabia)]
Aurobindo Pharma has received tentative approval from the USFDA for dolutegravir, lamivudine and tenofovir disoproxil fumarate tablets, used for the treatment of HIV, in the US market. In a BSE filing, Aurobindo Pharma said it has received "tentative approval from the US Food and Drug Administration under the US President`s Emergency Plan For AIDS
8/22/17 - BESPONSA (inotuzumab ozogamicin) Approved for Treatment of Adult Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia, Available for Order at Biologics, Inc.
Biologics, Inc., a McKesson Specialty Health oncology pharmacy services company, announced today it has been selected by Pfizer, Inc. to be a specialty pharmacy provider for BESPONSA , a promising new IV therapy for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Approved by the U.S. Food and Drug Adminis
8/22/17 - BioLineRx Announces Regulatory Submission of Phase 3 Registrational Study for BL-8040 in Stem Cell Mobilization
Release date- 21082017- Tel Aviv, Israel- BioLineRx Ltd., a clinical-stage biopharmaceutical company focused on oncology and immunology, announced today the filing of regulatory submissions required to commence a randomized, controlled Phase 3 registrational trial of BL8040 for the mobilization of hematopoietic stem cells for autologous...
8/22/17 - Cardiome Provides U.S. Regulatory Update for BRINAVESS
Release date- 21082017- Vancouver, Canada- Cardiome Pharma Corp. today announced that it has received a response from the U.S. Food and Drug Administration regarding the regulatory path for BRINAVESS, the Company's antiarrhythmic drug for the rapid conversion of recent onset atrial fibrillation. 'In our most recent communication with the FDA, we pr
8/22/17 - Cellectar Biosciences Announces Significant PDC Platform Advancement; Demonstrates Potential to Improve Therapeutic Window
Cellectar Biosciences, Inc., an oncology-focused, clinical stage biotechnology company, today announces that its Phospholipid Drug Conjugate research program has generated numerous PDC molecules that show significant improved pharmacologic activity versus the payload molecule alone.. Utilizing a selection of novel linkers to attach proprietary...
8/22/17 - CHRISTUS Health Joins TriNetX Health Research Network to Accelerate Clinical Trial Efforts [Sudan Tribune]
CHRISTUS Health, one of the top ten largest Catholic health systems in the U. S., has signed on to the TriNetX global health research network, TriNetX announced today. CHRISTUS Health has decided to standardize on the TriNetX network as their conduit to sponsored clinical trials. "CHRISTUS Health`s partnership with TriNetX will enhance our clinica
8/22/17 - Clinical and Regulatory Progress Boosting Biotech Sector
Advancing biotechs this week include: Moleculin Biotech, Inc.,, Pfizer Inc., Merck& Co., AVEO Pharmaceuticals Inc., Sucampo Pharmaceuticals Inc.. Moleculin Biotech, Inc.,, a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System
8/22/17 - Contract Research Organizations (CROs) Services Global Market 2017 Share, Trend, Segmentation and Forecast to 2022
PUNE, INDIA, August 22, 2017/ EINPresswire.com/ Global Contract Research Organizations Services Market This report mainly introduces volume and value market share by players, by regions, by product type, by consumers and also their price change details. As a Detailed Analysis report, it covers all details inside analysis and opinion in Contract R
8/22/17 - CURE Pharmaceutical Subsidiary Completes Critical Milestone
CURE Pharmaceutical announced its subsidiary Oak Therapeutics completed a milestone as part of their research contract with the National Institutes of Health and National Institute of Allergy and Infectious Diseases to develop 300 mg of Isoniazid in a rapidly dissolving Oral Dissolvable Strip as an antituberculosis treatment. Under the Phase I...
8/22/17 - CURE Pharmaceutical Subsidiary, Oak Therapeutics, Completes Critical Milestone in Phase 1 of NIH Grant to Develop Oral Dissolvable Strip for Tuberculosis
CURE Pharmaceutical,, a leading disruptive drug delivery technology company, today announced that its subsidiary company, Oak Therapeutics, has completed a critical milestone of its Phase I Small Business Innovative Research Contract from the National Institutes of Health/National Institute of Allergy and Infectious Diseases to develop a formulat
8/22/17 - CytoDyn Provides Update on PRO 140 Pivotal Combination Therapy Trial in Patients with HIV
Release date- 21082017- VANCOUVER, Washington- CytoDyn Inc., a biotechnology company focused on the development of new antibody therapies for combating human immunodeficiency virus infection, announces that the Company has enrolled 34 patients in its pivotal Phase 2 b/3 trial of PRO 140 in combination with antiretroviral therapy in HIV-infected pat
8/22/17 - CytoDyn Provides Update on PRO 140 Pivotal Combination Therapy Trial in Patients with HIV [T-break Tech (Middle East)]
CytoDyn Inc., a biotechnology company focused on the development of new antibody therapies for combating human immunodeficiency virus infection, announces that the Company has enrolled 34 patients in its pivotal Phase 2 b/3 trial of PRO 140 in combination with antiretroviral therapy in HIV-infected patients. Thirty-three of the enrolled patients ha
8/22/17 - Edison Issues Update on GW Pharmaceuticals (GWPH)
LONDON, ENGLAND/ ACCESSWIRE/ August 22, 2017/ GW Pharmaceuticals recently announced that a rolling NDA filing for Epidiolex in both Dravet syndrome and Lennox-Gastaut syndrome is underway. GW anticipates the FDA will grant priority review status, which would enable a June 2018 PDUFA date. We have reduced our valuation from $3.43 bn, or $136.08 per
8/22/17 - FDA Approves IRWD's Gout Drug, It's A Thumbs Up For ALXN In EU, CRME Crushed
TOKYO- Today's Daily Dose brings you news about European approval of Alexion' s Soliris for an additional indication; Alkermes' New Drug Application for a major depressive disorder drug; Astellas' MORPHO trial progress; Axovant's move to NASDAQ from the Big Board; Cardiome's disappointing update related to its antiarrhythmic drug and FDA approval o
8/22/17 - FDA evaluates prescription opioid medications approved for children
The FDA has heard from professional groups, including the American Academy of Paediatrics about the use of opioid cough suppressants for children...
8/22/17 - Findings from National Taiwan University Hospital in Clinical Trials and Studies Reported (Right or left? Side selection for a totally implantable...
Findings from National Taiwan University Hospital in Clinical Trials and Studies Reported. By a News Reporter-Staff News Editor at Cancer Weekly Investigators publish new report on Clinical Research- Clinical Trials and Studies. Our news journalists obtained a quote from the research from National Taiwan University Hospital, "We enrolled patients
8/22/17 - GDC-0084 Progress Update: On Track for Phase II Commencement in 2017
Novogen Ltd, an Australian oncology drug development company, is pleased to provide an update to investors on progress with its clinical-stage drug development candidate, GDC-0084. Novogen CEO, Dr James Garner, commented on recent progress, "The GDC-0084 study is on track to commence this year, in line with our prior guidance to the market. Novog
8/22/17 - GeoVax to Present at Upcoming Immuno-Oncology Conference
GeoVax Labs, Inc., a biotechnology company developing human vaccines, announced today that its Chief Scientific Officer, Farshad Guirakhoo, PhD, will give two talks at the Immuno-Oncology Summit being held in Boston, MA on August 29 to September 1. Guirakhoo's first presentation, entitled "A Novel Alternative Approach to Develop a Safe Vaccine for
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