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 The leading web portal for pharmacy resources, news, education and careers July 29, 2014
Pharmacy Choice - News - Pharmaceutical Development - July 29, 2014

Pharmacy News

 Pharmaceutical Development
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
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7/28/14 - ACELRX PHARMACEUTICALS INC FILES (8-K) Disclosing Other Events, Financial Statements and Exhibits
On July 25, 2014, AcelRx Pharmaceuticals, Inc. issued a press release entitled "AcelRx Pharmaceuticals Receives Complete Response Letter from FDA for New Drug Application for Zalviso?," a copy of which is attached as Exhibit 99.1 to this Report.
7/28/14 - AG Gansler: Astellas Pharma US Inc. Pays $7.3 Million to Resolve False Claims Act Allegations Related to Marketing of Antifungal Agent Company promoted Mycamine to treat children without FDA approval
Baltimore, MD Attorney General Douglas F. Gansler announced today that Maryland, joined by multiple states and the federal government, has settled allegations that Astellas Pharma US, Inc. caused false claims to be submitted to federal and state health care programs in connection with its marketing and promotion of the drug Mycamine for pediatric
7/28/14 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Animal Generic Drug User Fee Cover Sheet
SUMMARY: The Food and Drug Administration is announcing that a collection of information entitled "Animal Generic Drug User Fee Cover Sheet" has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995.. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Col
7/28/14 - Alios BioPharma Presents Positive Results of Its Anti-RSV Nucleoside Analog AL-8176 in a Phase 2 Challenge Study in Adults Infected With Respiratory... [Health & Beauty Close - Up]
Alios BioPharma has reported positive results from a randomized, double-blind, placebo-controlled Phase 2 challenge study of its oral anti-RSV nucleoside analog AL-8176. In its release, Alios BioPharma noted:. The Alios study enrolled 62 healthy adults who received one of three dose regimens of AL-8176 or placebo over 5 days: 375 mg orally administ
7/28/14 - Anthera Pharmaceuticals Announces Acquisition of Sollpura liprotamase for Exocrine Pancreatic Insufficiency From Eli Lilly and Company
By a News Reporter-Staff News Editor at Clinical Trials Week Anthera Pharmaceuticals, Inc. announced that it has acquired Sollpura, a novel investigational Pancreatic Enzyme Replacement Therapy from Eli Lilly and Company. EPI is estimated to afflict more than 150,000 patients in the United States alone, with more than US $600 million spent on enz
7/28/14 - Aqua Pharmaceuticals, LLC Announces the U.S. Food and Drug Administration (FDA) Approval of ACTICLATE? (doxycycline hyclate USP) Tablets, 150 mg and 75 mg
West Chester- based Aqua Pharmaceuticals, an Almirall company, today announces the U.S. Food and Drug Administration approval of the NDA for ACTICLATE? Tablets, 150 mg and 75 mg, thereby continuing Aqua s leadership in medical dermatology and oral antibiotics for acne. We are pleased to bring ACTICLATE? to market, said Craig Ballaron,
7/28/14 - Arena Pharmaceuticals Issued Patent for APD371 by United States Patent and Trademark Office
By a News Reporter-Staff News Editor at Clinical Trials Week Arena Pharmaceuticals, Inc. announced that it was granted U.S. Patent applications for APD371 have been filed in 23 jurisdictions, including the United States, Europe, Japan and China. Keywords for this news article include: Arena Pharmaceuticals, Arena Pharmaceuticals Inc., Government
7/28/14 - Batu Biologics Strategy for FDA Approval of Lung Cancer Immunotherapy Featured in San Diego Business Journal
The article, which was published in the July 21 st edition, discussed the company s strategy in developing its immunotherapeutic lung cancer vaccine, ValloVax, for which FDA Investigational New Drug submission is planned in Q1 of 2015.. Alan Lewis and Thomas Ichim, subsequent to the $26 million purchase of Medistem by the NYSE- traded company In
7/28/14 - BiologicTx Announces Discovery 2 Life? Platform (D2L?) and Three-Year Transplant Clinical Outcomes at The World Transplant Congress
BiologicTx announced their Discovery 2 Life?, a leading digital health platform designed to guide and support hospitals, clinicians and patients throughout the organ transplant continuum. BiologicTx has partnered with 26 renal transplant programs in the United States. Since April 2011, when BiologicTx began clinical operations, transplant
7/28/14 - Boston Scientific Receives CE Mark For Ranger? Drug-Coated Balloon
By a News Reporter-Staff News Editor at Biotech Business Week Demonstrating its continued leadership in the development of innovative solutions for peripheral vascular disease, Boston Scientific Corporation has received CE Mark for the Ranger? Paclitaxel-Coated PTA Balloon Catheter. "The Ranger Drug-Coated Balloon offers tremendous promise and
7/28/14 - CANbridge Life Sciences And EUSA Pharma Form Agreement to Commercialize Caphosol in China
CANbridge Life Sciences, a biopharmaceutical company focused on developing Western drug candidates in China and North Asia, has entered into an exclusive partnership with EUSA Pharma, a Jazz Pharmaceuticals company, to commercialize Caphosol in China. Caphosol represents the second oncology product we will commercialize in China and will meet
7/28/14 - CANbridge Life Sciences And EUSA Pharma Form Agreement to Commericalize Caphosol in China
CANbridge Life Sciences, a biopharmaceutical company focused on developing Western drug candidates in China and North Asia, has entered into an exclusive partnership with EUSA Pharma, a Jazz Pharmaceuticals company, to commercialize Caphosol in China. Caphosol represents the second oncology product we will commercialize in China and will meet
7/28/14 - Cannabis Capital Corp. CBCA Changes Name to Crown Baus Capital Corp., Better Reflecting Corporate Initiatives and Long-term Projects
By a News Reporter-Staff News Editor at Clinical Trials Week Cannabis Capital Corp. is a global acquisition-based conglomerate targeting five primary industries: High-Tech Incubation, Drug Development, Entertainment/Media, Education, and Financial Services. The Company is pleased to announce that its Board of Directors has selected the name Crown
7/28/14 - Celsion Corporation to Ring the NASDAQ Stock Market Closing Bell on July 16, 2014
By a News Reporter-Staff News Editor at Cancer Vaccine Week Celsion Corporation, a leading oncology drug development company, announced that the Company will ring the NASDAQ Stock Market closing bell on Wednesday, July 16, 2014 in Times Square, New York, NY. President and CEO Michael H. Tardugno and members of the Celsion and EGEN management team
7/28/14 - Cerus Submits Final Module in Premarket Approval PMA Application Process for INTERCEPT Platelets
By a News Reporter-Staff News Editor at Biotech Business Week Cerus Corporation announced today that it has submitted the third and final module for its Premarket Approval application to the U.S. Food and Drug Administration, for review of the INTERCEPT Blood System for platelets. The INTERCEPT platelet submission was completed at the end of the
7/28/14 - Coherus Announces Initiation Of Phase 3 Trial Of CHS-0214 Investigational Etanercept Biosimilar In Chronic Plaque Psoriasis RaPsOdy
By a News Reporter-Staff News Editor at Biotech Business Week Coherus BioSciences http://www.coherus.com/>, Inc. announced the start of its Phase 3 trial of CHS-0214, a proposed biosimilar of etanercept, in chronic plaque psoriasis. "It represents a pivotal study in the global clinical development for CHS-0214 and, if positive, will provide supp
7/28/14 - Cytonics Gets FDA Approval of New Drug Application [Manufacturing Close - Up]
Cytonics Corp. has reported that an Investigational New Drug application for a phase I/II clinical trial of the company's APIC Cell-Free System has been approved by the FDA. According to a release from the company, the system is indicated for the rapid preparation of concentrated protease inhibitors in plasma, specifically Alpha-2-Macroglobulin, fo
7/28/14 - Data from Aarhus University Hospital Advance Knowledge in Clinical Trials and Studies (Acceptance and commitment group therapy for health...
The news correspondents obtained a quote from the research from Aarhus University Hospital, "Patients were followed up by questionnaires for 6 months. Our news journalists report that additional information may be obtained by contacting T. Eilenberg, The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, Barths
7/28/14 - Depressed men with prostate cancer are diagnosed later stage, get less effective therapies
By a News Reporter-Staff News Editor at Clinical Trials Week Depressed men with localized prostate cancer were more likely to be diagnosed with more aggressive prostate cancer, received less effective treatments and survived for shorter times than prostate cancer patients who were not depressed, a UCLA study has found. Jim Hu, UCLA's Henry E. Sin
7/28/14 - Dipexium Pharmaceuticals Announces Successful Completion of Phase 1 Skin Irritation Trial of Locilex
By a News Reporter-Staff News Editor at Clinical Trials Week Dipexium Pharmaceuticals, Inc. announced successful completion and initial results of DPX-110, a Phase 1 skin irritation clinical trial of Locilex , the company's novel, broad-spectrum topical antibiotic peptide. The Company's pivotal Phase 3 clinical program is subject to a Special P
7/28/14 - Dipexium Pharmaceuticals Initiates Pivotal Phase 3 Clinical Trial of Locilex in Patients with Mild Infections of Diabetic Foot Ulcers
By a News Reporter-Staff News Editor at Diabetes Week Dipexium Pharmaceuticals, Inc. announced it has initiated patient enrollment in the first of two pivotal Phase 3 clinical trials, known as OneStep-1 and OneStep-2, evaluating Locilex , the company's novel, broad-spectrum, topical antibiotic peptide, for the treatment of patients with mild in
7/28/14 - Envarsus Receives European Marketing Authorization for Treatment of Both Kidney and Liver Transplant Patients
HORSHOLM, Denmark, July 28, 2014/ PRNewswire/ Veloxis Pharmaceuticals A/S and Chiesi Farmaceutici S.p.A. today announced that the European Commission has granted marketing authorization for Envarsus for the prevention of organ rejection in adult kidney and liver transplant patients in the European Union. The Phase I pharmacokinetic and Phase I
7/28/14 - ERYTECH Announces Enrollment of First Patient in Phase II Study of ERY-ASP in Pancreatic Cancer
ERYTECH Pharma, the French biopharmaceutical company that develops innovative tumor starvation treatments for acute leukemia and other oncology indications with unmet medical needs, announces the enrollment of the first patient in its Phase II study with ERY-ASP in second line treatment of patients affected by pancreatic cancer..
7/28/14 - FDA Approves the Freedom Portable Driver That Powers The SynCardia Total Artificial Heart
By a News Reporter-Staff News Editor at Pharma Business Week The Freedom portable driver received FDA approval on June 26, 2014 for use with the SynCardia temporary Total Artificial Heart as a bridge to transplantation in cardiac transplant candidates who are clinically stable. "With the FDA approval letter for the Freedom portable driver, Sy
7/28/14 - FDA Designates Opioid Overdose Treatment for Fast Track Development Program
The Fast Track program of the FDA is designed to expedite the development and review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. AntiOp and the FDA may also be able to employ additional tools to expedite the FDA review process such as "rolling subm
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