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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 - AbbVie Reports Third-Quarter 2014 Financial Results
PR Newswire/ Les Echos/ AbbVie Reports Third-Quarter 2014 Financial Results- Reports Third-Quarter Adjusted EPS of $0.89, Up 8.5 Percent and Well Above the Previous Guidance Range of $0.77 to $0.79; Reports GAAP EPS of $0.31- Significantly Raises 2014 Adjusted EPS Guidance Range to $3.25 to $3.27 from $3.06 to $3.16; 2014 Guidance Excludes Any Pote
10/31/14 - AtriCure Reports Third Quarter 2014 Financial Results [Global Data Point]
We continue to see increasing physician interest in managing the left atrial appendage and treating challenging Afib conditions, "said Mike Carrel, President and Chief Executive Officer of AtriCure. Secondly, we recently received approval from the FDA to begin our Dual Epicardial and Endocardial Procedure clinical trial. Revenue for the third quart
10/31/14 - BioLineRx Announces Publication of Results from Previous Phase 1/2 Trial o f BL-1040; Expecting Study Completion Mid '15
BioLineRx Ltd., a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today publication of the results of a previous Phase 1/ 2 study for IK-5001, currently named Bioabsorbable Cardiac Matrix, a novel resorbable polymer solution for the prevention of cardiac...
10/31/14 - BioLineRx Reports Publication in Peer Review Journal of Results from Previous Phase 1/2 Trial for BCM (BL-1040), a Novel Medical Device for Prevention of Cardiac Remodeling Following Acute Myocardial Infarction
BioLineRx Ltd., a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today publication of the results of a previous Phase 1/ 2 study for IK-5001, currently named Bioabsorbable Cardiac Matrix, a novel resorbable polymer solution for the prevention of cardiac...
10/31/14 - Clovis Oncology: First Patient Enrolled in Lucitanib Phase 2 Study [Professional Services Close - Up]
Clovis Oncology said that its global Phase 2 study of lucitanib in patients with FGFR1-amplified squamous non-small cell lung cancer has commenced and the first patient has been dosed at a U.S. study site. "Less than a year after acquiring lucitanib, we are commencing a broad clinical development program, which includes this study in FGFR1-amplifi
10/31/14 - Determination That TOPICORT (Desoximetasone) Cream and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. The 1984 amendments include what is now section 505 of
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 - FDA Clears Tensyn Band for AC/CC Joint Stabilization [Health & Beauty Close - Up]
Dallen Medical reported that the U.S. Food and Drug Administration has granted 510 clearance for its Tensyn Band for acromioclavicular joint and coracoacromial ligament repair in shoulder separation. According to a company release, the Tensyn Band technology, designed for orthopedic surgeons, offers proprietary, knotless banding for stabilized...
10/31/14 - Flamel Technologies Announces Third Quarter Results of Fiscal Year 2014
Flamel Technologies today announced its financial results for the third quarter of fiscal year 2014. Highlights from the quarter include:. Flamel is now the only drug manufacturer offering FDA- approved versions of all three product presentations of phenylephrine hydrochloride injection. Flamel announced data from a First-in-Man clinical study of i
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 - Impax Announces R%7ED Reorganization Designed to Yield Process Improvements and Efficiencies [Global Data Point]
As a result of the reorganization, the generic R %7 ED organization will be responsible for early stage product development and analytical functions for all Impax products, while the brand R %7 ED organization will focus on phase II, III and IV clinical activities, drug safety and pharmacovigilance for all Impax products. This realignment of the R
10/31/14 - La Jolla Pharmaceutical Updates on Data Presentation at the American Society of Nephrology Kidney Week Event [Professional Services Close - Up]
La Jolla Pharmaceutical Company reported that an abstract of the results for the Company's Phase 2 clinical trial of GCS-100 in chronic kidney disease has been selected by the American Society of Nephrology's Program Committee for poster presentation at the Kidney Week Annual Meeting. "We are delighted that results from our Phase 2 study of GCS-10
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 - Nicox Announces Third Quarter 2014 Financial Update [Global Data Point]
Michele Garufi, Chief Executive Officer of Nicox, commented: "In the third quarter of this year, we have achieved important progress in building our therapeutic ophthalmic pipeline, thanks to the positive pivotal phase 3 results for VESNEO and the recently completed acquisition of Aciex Therapeutics, Inc. Nicox now has two product candidates which
10/31/14 - OptiNose Announces Publication of Pivotal Phase III Results for Investigational Migraine Treatment Developed by OptiNose Using Bi-Directional? Breath Powered? Technology
OptiNose today announced that the TARGET study a pivotal phase III study evaluating the ef?cacy and safety of AVP-825, will be published in the January 2015 issue of Headache, The Journal of Head and Face Pain, the official journal of the American Headache Society. A New Drug Application for AVP-825 has been accepted by the FDA, and the Prescr
10/31/14 - Oramed to Report Key Top Line Results from U.S. Phase IIa Trial with Oral Insulin in Type 1 Diabetes
Oramed Pharmaceuticals Inc., a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announces that the company will host a conference call to discuss the clinical results from its Phase IIa clinical trial of ORMD-0801, the company's proprietary oral insulin capsules, to treat type 1 diabetes on Monday, Nov
10/31/14 - Seattle Genetics Reports Third Quarter 2014 Financial Results [Global Data Point]
"Our financial strength and clinical development progress in the third quarter were marked by record ADCETRIS net sales, up 32 percent from the third quarter of 2013, and positive topline results from the AETHERA phase 3 clinical trial," said Clay B. Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics. ?Reported positive top
10/31/14 - Sorin Group Completes Enrollment in the RESPOND CRT IDE Clinical Trial Using Innovative Heart Failure Management Technology
Sorin Group,, a global medical device company and a leader in the treatment of cardiovascular diseases, announced that it has reached the target enrollment for RESPOND CRT, an Investigational Device Exemption clinical trial. RESPOND CRT has enrolled a total of 1,039 patients in Europe, USA and Australia. Josep Brugada, Hospital Clinic, University o
10/31/14 - Specialised Therapeutics Australia Announces Breakthrough Cancer Drug Abraxane(R) to be PBS Listed for Metastatic Pancreatic Cancer
In Australia, pancreatic cancer is the 5 th most common cause of cancer mortality. Both the TGA approval and PBS listing were based on the pivotal randomised Phase III trial, MPACT, published in the New England Journal of Medicine in October 2013. "I believe it is the most effective therapy available on the PBS," Associate Professor Pavlakis comme
10/31/14 - SynteractHCR Joins the International Biopharma Community at the Thirteenth Annual Partnerships in Clinical Trials Congress in Europe [Global Data Point]
Massimo Ildebrando, Director of Project Management for SynteractHCR Italia, will present on Thursday, November 6 at 17:15 on best practices for exploring how a sponsor and CRO can "build quality in" to vendor engagements for optimal clinical trial execution. ?Using Quality by Design to properly assess and act on what's critical to quality? Crea
10/31/14 - Tenax Therapeutics Analyst Brief: Emerging Biopharmaceutical Player Back In the Clinical Trial Business Technical Exhaustion Setup Playing Out by Small Cap Traders
Analyst Brief by Small Cap Traders. Prior to the initiation of any human clinical studies using Oxycyte in the US, the company will need to develop an FDA approved protocol which will incorporate FDA input on the design and safety measures to be utilized in such studies. The study was recently enrolling patients in Israel for the second cohort of
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
10/31/14 - Vaxart Advancing with Ebola Tablet Vaccine Program [Professional Services Close - Up]
According to a release from the company, Vaxart anticipates commencing human clinical trials in the first quarter of 2015, following a recent meeting with the U.S. Food and Drug Administration. In a preclinical study conducted at the United States Army Medical Research Institute of Infectious Diseases, the company said its Ebola vaccine candidate..
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