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Experimentation

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Men taking MDV3100 lived for a median of 18.4 months, compared with 13.6 months for men taking placebo (p < 0.0001; HR=0.631); MDV3100 also met all secondary endpoints, including radiographic progression-free survival (8.3...
Business Journal
This treatment regimen has been shown to improve recurrence-free survival, or RFS, and overall survival, or OS, for KIT+ GIST patients compared to 12 months of treatment. The US approval was based on...
Business Journal
Publication: LexisNexis | Filed In: Cystic Fibrosis and Genetic Diseases
KALYDECO is approved for people with CF ages 6 and older who have at least one copy of the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. KALYDECO was granted...
Business Journal
Publication: LexisNexis | Filed In: Statistical Method and Mathematics
Both pivotal Phase III studies are fully recruited, and all patients have been treated, reached the primary endpoint and are in long-term follow-up. The study met all primary, secondary and tertiary efficacy endpoints....
Business Journal
By Rabkin, April | Publication: Fast Company | Filed In: Corporate Culture and Management
HEADNOTE Three top Chinese tech companies-ALIBABA, BAIDU, and YOUKU-are remaking the country's moribund, hierarchical corporate culture with an injection of new ideas from the West. What is the sound of three hands clapping?...
Business Journal
Publication: LexisNexis | Filed In: Kidney Disease and Urogenital Disorders
In SHARP, VYTORIN 10/20 mg lowered LDL cholesterol in patients with moderate to severe chronic kidney disease, or CKD, and major vascular events were reduced in the treatment group compared to placebo. The...
Business Journal
Publication: LexisNexis | Filed In: Shareholders and Shareholders & Governance
The company has also announced the assignment of US co-promotion rights to AQUORAL, an FDA-cleared, prescription-only spray for the treatment of Xerostomia, or the medical term for dry mouth due to a lack...
Business Journal
The option agreement provides Navidea with exclusive rights for a period of up to six months to perform final due diligence and prepare the documentation necessary to enter into a definitive license agreement...
Business Journal
Publication: LexisNexis | Filed In: Epilepsy and Neurological Disorders
Keppra was previously approved in the US as adjunctive therapy for partial onset seizures in adults and children four years of age and older with epilepsy. The approval was based on data from...
Business Journal
Results from the trial, expected in 2014, could potentially impact atrial fibrillation treatment guidelines by providing further clinical evidence regarding the benefits of the Arctic Front system in treating a largely underserved patient...
Business Journal
Publication: LexisNexis | Filed In: Antivirals and Anti-Infectives
GS-7340 is a novel prodrug of tenofovir, the active agent in Viread, or tenofovir disoproxil fumarate. In previous studies, GS-7340 has demonstrated the ability to provide greater antiviral efficacy at a dose that...
Business Journal
Publication: LexisNexis | Filed In: Licensing Agreements and Contracts Law
NovaDel Pharma, Inc., a specialty pharmaceutical company, has terminated its license agreements with Talon Therapeutics, Inc. (formerly Hana Biosciences, Inc. ) and Par Pharmaceutical Companies, Inc., for Zensana. Talon is a biopharmaceutical company,...
Business Journal
By Quigley, Kelly | Publication: San Diego Business Journal | Filed In: FDA Approvals and Drug & Medical Devices Approval
Acne is the most common skin disorder in the United States, affecting up to 50 million people, according to the American Academy of Dermatology. It's so widespread that by their mid-teens, more than...
Business Journal
Publication: Business Wire | Filed In: Diabetes and Endocrine System Disorders
PRINCETON, N.J. & WILMINGTON, Del. -- Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the...
Press Release
By Solnik, Claude | Publication: Long Island Business News | Filed In: Tuberculosis and Infectious Disease
Stony Brook University has entered into a multiyear research partnership with the global pharmaceutical company Sanofi to develop a potential treatment for tuberculosis and other bacterial infections. The university didn't disclose the terms...
Business Journal
Publication: Business Wire | Filed In: Cancer and Diseases & Disorders
DUBLIN -- Research and Markets(http://www.researchandmarkets.com/research/ff135e/cervical_cancer_gl) has announced the addition of GlobalData 's new report "Cervical Cancer Global Clinical Trials Review, H2, 2011" to their offering. GlobalData's clinical trial report, Cervical Cancer Global Clinical...
Press Release
Publication: Business Wire | Filed In: Pharmacogenomics and Medical Science
Pharmacogenetic Patents Have the Potential to Extend Drug Candidate's Potential Commercial Exclusivity Period If Regulatory Approval Obtained BROOMFIELD, Colo. -- ARCA biopharma, Inc. (Nasdaq:ABIO), a biopharmaceutical company developing genetically targeted therapies for cardiovascular...
Press Release
Publication: Business Wire | Filed In: Cancer and Diseases & Disorders
DUBLIN -- Research and Markets(http://www.researchandmarkets.com/research/657030/brain_cancer_globa) has announced the addition of GlobalData's new report "Brain Cancer Global Clinical Trials Review, H2, 2011" to their offering. GlobalData's clinical trial report, Brain Cancer Global Clinical Trials...
Press Release
Publication: Business Wire | Filed In: Leukemia and Cancer
DUBLIN -- Research and Markets(http://www.researchandmarkets.com/research/966f32/chronic_myelocytic) has announced the addition of GlobalData's new report "Chronic Myelocytic Leukemia (CML) Global Clinical Trials Review, H2, 2011" to their offering. GlobalData's clinical trial report, Chronic Myelocytic Leukemia...
Press Release
Publication: Business Wire | Filed In: Clinical Trials and Medical Research
DUBLIN -- Research and Markets(http://www.researchandmarkets.com/research/5effb6/acute_myelocytic_l) has announced the addition of GlobalData 's new report "Acute Myelocytic Leukemia (AML) Global Clinical Trials Review, H2, 2011" to their offering. GlobalData's clinical trial report, Acute Myelocytic...
Press Release

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