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 The leading web portal for pharmacy resources, news, education and careers October 31, 2014
Pharmacy Choice - News - Pharmaceutical Development - October 31, 2014

Pharmacy News

 Pharmaceutical Development
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
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10/31/14 - FDA Approves Protein Sciences Flu Vaccine For Older Americans [The Hartford Courant]
Oct. 31 The Food and Drug Administration has extended its approval of the flu vaccine made by Meriden's Protein Sciences to adults age 50 and older. Making the drug available to older people is important for public health, said Protein Sciences Chief Medical Officer Dr. Protein Sciences makes its vaccines using a modern cell culture technology, w
10/31/14 - Immunomedics Provides Update On Phase 2 Study Of Isactuzumab Govitecan; Hemispherx Reports New Evidence of Ampligen(R)
{nfg} Immunomedics, Inc., announced isactuzumab govitecan, the Company's proprietary solid-tumor antibody-drug conjugate, continues to produce encouraging results in a Phase 2 clinical trial in heavily-pretreated patients with diverse, metastatic solid cancers. David M. Goldenberg, Chairman, Chief Scientific Officer, and Chief Medical Officer, at t
10/31/14 - Medivation and Astellas Announce Phase 3 Study of Enzalutamide in Men With High-Risk, Hormone-Sensitive, Non-Metastatic Prostate Cancer That Has Recurred Following Definitive Local Therapy
Medivation Inc. and Astellas today announced plans to initiate a global Phase 3 clinical trial that will evaluate the efficacy and safety of enzalutamide in patients with high-risk, hormone-sensitive, non-metastatic prostate cancer that has biochemically recurred following definitive local therapy with radical prostatectomy and/or radiation...
10/31/14 - New Toxicology and Pharmacology Study Findings Have Been Reported by Investigators at MHRA (Recommendations from a global cross-company data sharing...
New Toxicology and Pharmacology Study Findings Have Been Reported by Investigators at MHRA. By a News Reporter-Staff News Editor at Drug Week Research findings on Drugs and Therapies are discussed in a new report. According to news reporting from London, United Kingdom, by NewsRx journalists, research stated, "An international expert group which
10/31/14 - U.S. FDA Cardiovascular and Renal Drugs Advisory Committee Makes Recommendation on Daiichi Sankyo's Once-Daily SAVAYSA? (edoxaban) for the Reduction in Risk of Stroke and Systemic Embolic Events in Patients with Non-Valvular Atrial Fibrillation
"We are confident that the outcomes and robustness of the ENGAGE AF-TIMI 48 study fully support the approval in the U.S. of the 60 mg dosing regimen of SAVAYSA for patients with NVAF, with a dose reduction to 30 mg in selected patients," said Glenn Gormley, MD, PhD, Senior Executive Officer and Global Head of R&D, Daiichi Sankyo Company, Limited an
10/31/14 - United States : First vaccine approved by FDA to prevent serogroup B Meningococcal disease [TendersInfo (India)]
The U.S. Food and Drug Administration announced today the approval of Trumenba, the first vaccine licensed in the United States to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. According to the Centers for Disease Control and Prevention, about 500 total cases of mening
10/30/14 - ABIVAX Strengthens Executive Management Team With Senior Appointments
Daniel Kenny appointed Chief Commercial Officer& VP of Business Development. ABIVAX, the Paris- based clinical stage biopharmaceutical company specialised in the development and commercialisation of therapeutic vaccines and anti-viral compounds, today announced the appointments of Karl Birthistle, M.D., and Daniel Kenny to its Executive Management.
10/30/14 - Advaxis's ADXS-cHER2 Immunotherapy Demonstrates T-Cell Immune Response in Data Analysis From Canine Osteosarcoma Study
Advaxis, Inc., a clinical-stage biotechnology company developing cancer immunotherapies, today announced that a data analysis of its ongoing Phase 1 clinical study of ADXS-cHER2 in canine osteosarcoma indicates that the immunotherapy breaks peripheral tolerance to HER2/Neu and induces HER2-specific T cell responses in dogs. David J. Mauro, M.D.,
10/30/14 - Aegerion Pharmaceuticals Announces Third-Quarter 2014 Financial Results
Aegerion Pharmaceuticals, Inc., a biopharmaceutical company dedicated to the development and commercialization of innovative therapies for patients with debilitating rare diseases, announced its financial results and business highlights for the third-quarter of 2014.. Aegerion recorded $43.7 million in net product sales of JUXTAPID capsules in
10/30/14 - Alnylam to Webcast Presentation at the Nomura Biotechnology Conference
Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, today announced that management will present a company overview at the Nomura Biotechnology Conference on Thursday, November 6, 2014 at 9:00 a.m. ET at the Mandarin Oriental in Boston. About Alnylam Pharmaceuticals Alnylam is a biopharmaceutical company developing novel therapeutic
10/30/14 - AnaMar AB Reports Top-Line Results from Exploratory Phase 2a Study of AMAP102 and Provides Corporate Update
In the reported exploratory Phase 2 a trial, AMAP102, a 5- HT 2 B receptor antagonist, was well tolerated with no reported serious adverse events, but fell short of demonstrating a statistically significant reduction in pain over a 28- day period compared to placebo, as measured using the Western Ontario and McMaster Universities Arthritis Index pa
10/30/14 - Astrazeneca Receives U.S FDA Approval For Type-2 Diabetes Medecine XIGDUO XR
LONDON- Astrazeneca plc Thursday said U.S. Food and Drug Administration approved its once-daily XIGDUO XR for type-2 diabetes in adults. XIGDUO XR, an extended release of XIGDUO, has already been approved in Australia for type-2 diabetes and XIGDUO is approved by European Union. XIGDUO XR combines dapagliflozin and metformin hydrochloride...
10/30/14 - Auspex Pharmaceuticals Initiates Second Pivotal Clinical Trial for SD-809 in Tardive Dyskinesia
Auspex Pharmaceuticals, Inc., a biopharmaceutical company dedicated to developing innovative medicines for people with movement disorders and other rare diseases, today announced the enrollment of the first patient in a multi-center Phase 3 clinical trial of its investigational drug SD-809 for the treatment of people with tardive dyskinesia.
10/30/14 - AUXILIUM PHARMACEUTICALS INC - 10-Q - Management's Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion is qualified in its entirety by, and should be read in conjunction with, the more detailed information set forth in the consolidated financial statements and the notes thereto appearing elsewhere in this Report. Special Note Regarding Forward-Looking Statements. You should read the following discussion and analysis of our..
10/30/14 - Avanir Pharmaceuticals Announces Publication of Pivotal Phase III Results from AVP-825 Acute Migraine Study in the Journal "Headache"
A New Drug Application for AVP-825 has been accepted and is currently under review by the U.S. Food and Drug Administration with a Prescription Drug User Fee Act goal date of November 26, 2014. We believe AVP-825 could provide a targeted, fast acting migraine treatment option by combining low-dose sumatriptan, the most widely used prescription migr
10/30/14 - BIND Therapeutics Announces Availability of Abstract with Preliminary Data from Phase 2 Study of BIND-014 in Non-small Cell Lung Cancer
BIND Therapeutics, Inc., a clinical-stage nanomedicine platform company developing targeted and programmable therapeutics called Accurins TM, announced the online availability of an abstract providing preliminary data from the Q3W arm of its ongoing Phase 2 study of BIND-014 in non-small cell lung cancer. Data included in the abstract were current
10/30/14 - Celator(R) Pharmaceuticals to Present on Liposome Delivery Systems at 2014 American Association of Pharmaceutical Scientists Annual Meeting
Celator Pharmaceuticals, Inc., a biopharmaceutical company that is transforming the science of combination therapy and developing products to improve patient outcomes in cancer, today announced that Dr. Lawrence Mayer, President, Founder and Chief Scientific Officer of Celator, will present at the 2014 American Association of Pharmaceutical Scien
10/30/14 - Cempra Reports Third Quarter 2014 Financial Results and Provides Corporate Update [Global Data Point]
?Completed enrollment of the global Solitaire-Oral Phase 3 clinical trial of oral solithromycin in adult patients with moderate to moderately severe community-acquired bacterial pneumonia? Received a $10 million milestone payment from Toyama Chemical Co., a subsidiary of FUJIFILM Holdings Corporation, triggered by Toyama's receipt of regulatory
10/30/14 - Chugai licenses ISPRI/OptiMatrix platform from EpiVax for de-risking biologics
Chugai Pharmaceutical Co., Ltd., signed an agreement with Rhode Island- based biotechnology company, EpiVax, Inc., to incorporate EpiVax's ISPRI immunogenicity screening and deimmunization technology into Chugai's drug development toolbox. Chugai is widely regarded as one of the most cutting edge biopharmaceutical companies in Japan.
10/30/14 - Conn. biotech company in process of developing Ebola vaccine [EMBIN (Emerging Markets Business Information News]
Protein Sciences, located in Meriden, is a month away from having vaccine material ready to be shipped to the National Institutes of Health, with human clinical testing in sight by the end of the year, said Manon Cox, president and CEO of the company. That protein has been shown to trigger antibodies ? agents of the body's defense system
10/30/14 - Critical Outcome Technologies Reports Successful Completion of Two-Species Toxicity Testing for COTI-2
Critical Outcome Technologies Inc., the biopharmaceutical company that uses machine learning to rapidly develop targeted therapies, announced today that its lead oncology drug candidate, COTI-2, successfully completed two-species repeated dose toxicity studies in anticipation of a United States Food and Drug Administration Investigational New...
10/30/14 - CytRx Announces Oral Presentation at 2014 Chemotherapy Foundation Symposium
The presentation, titled, "Drug Conjugates Bind Covalently to Albumin: A New Approach," will be given by Sant P. Chawla, M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center and principal investigator of the Company's ongoing global, pivotal Phase 3 aldoxorubicin clinical trial in second-line soft tissue sarcoma, at the 2014 Chemotherapy Found
10/30/14 - FDA Approves Protein Sciences Flu Vaccine For Older Americans [The Hartford Courant]
Oct. 30 The Food and Drug Administration has extended its approval the flu vaccine made by Meriden's Protein Sciences to adults 50 years old and above. The vaccine, Flublok, acquired its first stamp of approval from federal regulators in January 2013, but only for those aged 18 to 49. Making the drug available to older people is important for pub
10/30/14 - Findings on Clinical Trials and Studies Reported by Investigators at University of British Columbia [Transcranial direct current stimulation (tDCS)...
Findings on Clinical Trials and Studies Reported by Investigators at University of British Columbia. By a News Reporter-Staff News Editor at Women's Health Weekly Current study results on Clinical Research have been published. Our news journalists obtained a quote from the research from the University of British Columbia, "While antidepressant dr
10/30/14 - GeoVax CEO Interviewed on the Fox Business Network
ATLANTA, GA/ ACCESSWIRE/ October 30, 2014/ Robert T. McNally, PhD, President& CEO of GeoVax Labs, Inc., a biotechnology company developing innovative human vaccines using its novel DNA/MVA platform technology, was recently interviewed on the Fox Business Network's The Willis Report and on MONEY with Melissa Francis, discussing GeoVax's Ebola vaccin
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