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 The leading web portal for pharmacy resources, news, education and careers December 20, 2014
Pharmacy Choice - News - Pharmaceutical Development - December 20, 2014

Pharmacy News

 Pharmaceutical Development
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
Articles(s): 1 - 25 of 250     Next >>     Go To Page:

12/20/14 - HeartFlow Secures De Novo Clearance from the U.S. Food and Drug Administration for Breakthrough FFRCT Technology
By a News Reporter-Staff News Editor at Obesity, Fitness& Wellness Week HeartFlow Inc., a pioneer in personalized medical technology for cardiovascular disease, announced that it received de novo clearance from the U.S. Food and Drug Administration for its FFRCT technology. HeartFlow FFRCT is the first and only non-invasive imaging technology for
12/20/14 - Jazz Pharmaceuticals Receives FDA Approval For Intravenous Administration Of Erwinaze (asparaginase Erwinia chrysanthemi)
Jazz Pharmaceuticals plc today announced that the U.S. Food and Drug Administration approved the intravenous administration of Erwinaze . "Administration of Erwinaze through an intravenous infusion provides physicians another option for patients, including those who cannot tolerate intramuscular injections," said Jeffrey Tobias, M.D., executiv
12/19/14 - AbbVie Receives U.S. FDA Approval of VIEKIRA PAK? (Ombitasvir/Paritaprevir/Ritonavir Tablets; Dasabuvir Tablets) for the Treatment of Chronic Genotype 1 Hepatitis C
The U.S. Food and Drug Administration has approved AbbVie's VIEKIRA PAK?, an all-oral, interferon-free treatment, with or without ribavirin, for the treatment of patients with chronic genotype 1 hepatitis C virus infection, including those with compensated cirrhosis. "We are proud of the work of our research and development organization to bri
12/19/14 - Agility-PSR Wins Second Consecutive "Best Contract Research Organization" in the 2014 ROAR Awards at the 5th Annual World Orphan Drug Congress in...
Agility-PSR Wins Second Consecutive "Best Contract Research Organization" in the 2014 ROAR Awards at the 5th Annual World Orphan Drug Congress in Brussels. By a News Reporter-Staff News Editor at Health& Medicine Week For its second consecutive year, Agility-PSR- the partnership between Agility Clinical, Inc., a Carlsbad-based specialty consultin
12/19/14 - Amarantus Submits Orphan Drug Designation Application to US FDA for Treatment of Retinal Artery Occlusion With Product Candidate MANF
Amarantus BioScience Holdings, Inc., a biotechnology company focused on the development of diagnostics in Alzheimer's disease and therapeutic products in the areas of neurology, psychiatry, ophthalmology and regenerative medicine, announced that it has applied to the U.S. Food& Drug Administration for Orphan Drug Designation for its investigation
12/19/14 - ANAVEX TO PRESENT AT BIOTECH SHOWCASE 2015 IN SAN FRANCISCO
Release date- 18122014- New York, NY- Anavex Life Sciences Corp., a clinical-stage biopharmaceutical company developing novel drug candidates to treat Alzheimer's disease, other diseases of the central nervous system and various types of cancer, will present at Biotech Showcase 2015 on Monday January 12, 2015 at 2:00pm PST. The investor and partner
12/19/14 - AstraZeneca cancer drug, companion test approved
TRENTON, N.J. U.S. regulators on Friday granted accelerated approval to the first in a new class of targeted drugs for ovarian cancer, Lynparza from British drugmaker AstraZeneca PLC. The Food and Drug Administration also approved a companion diagnostic test from Myriad Genetics Inc. of Salt Lake City called BRACAnalysis CDx. Richard Pazdur, dir
12/19/14 - AstraZeneca's Lynparza Gets US FDA Approval For Ovarian Cancer
LONDON- AstraZeneca PLC said Friday that the US Food and Drug Administration has approved Lynparza as a monotherapy for patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy. The FDA approval follows the approval of the drug in the EU as
12/19/14 - BIODEL INC - 10-K - MANAGEMENT DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and the related notes included elsewhere in this Annual Report on Form 10- K. Some of the information contained in this discussion and analysis or set forth elsewhere in this Form 10- K, including informa
12/19/14 - CHMP Recommends Approval of Xadago? (Safinamide) to Treat Parkinsons Disease in the EU
Newron Pharmaceuticals S.p.A., a research and development company focused on novel CNS and pain therapies, and its partner Zambon S.p.A., an international pharmaceutical company strongly committed to the CNS therapeutic area, announced today that the EU Committee for Medicinal Products for Human Use recommended that the European Commission approve
12/19/14 - CHMP recommends Approval of XadagoTM (safinamide) to treat Parkinsons disease in the EU
CHMP recommends Approval of XadagoTM. Milan, Italy, December 19, 2014- Newron Pharmaceuticals S.p.A., a research and development company focused on novel CNS and pain therapies, and its partner Zambon S.p.A., an international pharmaceutical company strongly committed to the CNS therapeutic area, announced today that the EU Committee for Medicinal P
12/19/14 - Cubist Announces FDA Approval of New Antibiotic ZERBAXA? (Ceftolozane/Tazobactam) for Complicated Urinary Tract and Complicated Intra-abdominal Infections
Cubist Pharmaceuticals, Inc. announced today the U.S. Food and Drug Administration approved ZERBAXA? for the treatment of adults with complicated urinary tract infections and complicated intra-abdominal infections caused by designated susceptible Gram-negative bacteria. Both trials met the pre-specified primary endpoints agreed upon with the FDA.
12/19/14 - CUMBERLAND PHARMACEUTICALS INC FILES (8-K) Disclosing Other Events
A new formulation of Acetadote Injection was developed by Cumberland Pharmaceuticals Inc. as part of a Phase IV commitment by the Company in response to a request by the Food and Drug Administration to evaluate the reduction of ethylene diamine tetraacetic acid from the product's formulation. The new formulation was listed in the FDA Orange Book
12/19/14 - Curis Reports Dosing of First Patient in Phase 1 Trial of CUDC-907; FUJIFILM Completes Acquisition of Kalon Biotherapeutics
Below is a look at some of the headlines for companies that made news in the healthcare sector on December 18, 2014.{ nfg} Curis, Inc., a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that the first patient has been treated in a Phase I clinical study of CUD
12/19/14 - Enanta Announces U.S. Food and Drug Administration Approves AbbVie's VIEKIRA PAK? (Ombitasvir/Paritaprevir/Ritonavir Tablets; Dasabuvir Tablets) for the Treatment of Chronic Genotype 1 Hepatitis C Virus
Enanta Pharmaceuticals, Inc., a research and development-focused biotechnology company dedicated to creating small molecule drugs primarily in the infectious disease field, today announced the U.S. Food and Drug Administration has approved AbbVie s VIEKIRA PAK? with or without ribavirin for the treatment of genotype 1 patients with chronic hep
12/19/14 - FDA Accepts IND Application for Radius Health's Investigational Drug RAD1901 Being Developed for Potential Use in Metastatic Breast Cancer
Radius Health, Inc. announced today that the U.S. Food and Drug Administration has accepted the Company's Investigational New Drug application for its investigational drug RAD1901, a tissue-selective estrogen receptor degrader being developed for potential use in metastatic breast cancer. We also are continuing discussions with the European...
12/19/14 - FDA approves AbbVie combo hepatitis C treatment
TRENTON, N.J. Patients with chronic hepatitis C have a new option for treating the liver-damaging virus, with the approval of a combination treatment developed by AbbVie. The Food and Drug Administration on Friday approved the sale of a packaged treatment called Viekira Pak made by AbbVie Inc. of North Chicago, Illinois. It includes a combinatio
12/19/14 - FDA Approves AstraZeneca's Lynparza To Treat Advanced Ovarian Cancer
LONDON- British drugmaker AstraZeneca PLC said Friday that the US Food and Drug Administration has approved Lynparza capsules, 400 mg twice daily, as the first monotherapy for patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy.
12/19/14 - FDA Approves Somatuline Depot (lanreotide) Injection [Health & Beauty Close - Up]
Ipsen Biopharmaceuticals reported that Somatuline Depot Injection 120 mg was approved by the U.S. Food and Drug Administration for the treatment of gastroenteropancreatic neuroendocrine tumors in adult patients with unresectable, well or moderately differentiated, locally advanced or metastatic disease to improve progression-free survival.
12/19/14 - FDAnews Announces: Reporting Failed Trial Data: New Rules for ClinicalTrials.gov Webinar, Jan. 28, 2015
FDA's new proposed rules will make drug manufacturers revamp the way they register data on ClinicalTrials.gov. Take 90 minutes and hear from one of the industry's ClinicalTrials.gov experts on what is needed to do to update trial data registration procedures. Under sweeping new changes drug and biologic makers would have to submit all clinical tria
12/19/14 - Genentech Provides Update on Phase III MARIANNE Study in People with Previously Untreated Advanced HER2-Positive Breast Cancer
Genentech, a member of the Roche Group, announced today top-line results of the Phase III MARIANNE study. The study evaluated three HER2-targeted regimens Kadcyla plus Perjeta , Kadcyla alone, and Herceptin plus taxane chemotherapy in people with previously untreated advanced HER2-positive breast cancer. In this study, we had hoped to
12/19/14 - Georgia Bio Deals of the Year Spotlight Financings, Acquisitions and Collaboration
Deals of the Year are awarded to one or more companies or institutions for the most significant financial or commercial transactions closed from November 1, 2013- October 31, 2014. The recipients will receive their awards at the Georgia Bio Annual Awards Dinner January 22, 6 pm to 9 pm, at Atlanta s Fox Theatre. Jude Medical/ CardioMEMS, Varian
12/19/14 - Halozyme Receives European Orphan Drug Designation For PEGylated Recombinant Human Hyaluronidase PH20 For Pancreatic Cancer
Halozyme Therapeutics, Inc. today announced that the European Commission, acting on the recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency, has designated PEGylated recombinant human hyaluronidase an orphan medicinal product for the treatment of pancreatic cancer. In October 2014, the Company disclose
12/19/14 - Hong Kong Pharmaceutical Company Pioneers World's First Ever High-performance Anti-pruritus Nanopatch
Comprehensive Drug Enterprises Ltd., which specializes in the research and development of advanced drugs and medical devices, and is an incubatee graduate of Hong Kong Science Park's Incubation Programme, today announced it has successfully developed and registered the world's first ever high-performance anti-pruritus nanopatch MJ Antipruritic.
12/19/14 - iGrow hair growth helmet from Boca cleared for women [Sun Sentinel]
Dec. 19 Apira Science, which makes a laser helmet system to grow hair, has received FDA marketing clearance for sales to women. Apira, based in Boca Raton, received FDA clearance for sales to men in 2012. Clearance by the FDA doesn't mean a product works, only that it's not harmful. The iGrow system, which retails for $695, is sold online at igro
Articles(s): 1 - 25 of 250     Next >>     Go To Page:


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