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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...
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...
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...
CGEN-15001, CGEN-15021 and CGEN-15091 are predicted B7/CD28-like proteins discovered using the company's Protein Family Members Discovery Platform. The company reported that in the collagen induced arthritis model of RA, treatments with either CGEN-15001...
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....
Peters brings more than 25 years of health care experience in marketing, market access and reimbursement, and business development positions. Most recently, Peters was vice president of US payers and national accounts, corporate...
HIGHLAND PARK, N.J., Feb. 1, 2012 (SEND2PRESS NEWSWIRE) -- 2012 marks an important milestone for Belvidere Pharmacy. It opened new doors in its new hometown of Highland Park. When owner and President Shara...
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...
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...
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...
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...
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...
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...
The study has enrolled 41 patients who progressed on at least one prior chemotherapy regimen that included a platinum compound, or cisplatin, oxaliplatin, or carboplatin, and a fluoropyrimidine compound, or 5-fluorouracil [5-FU] or...
NovaDel Pharma, Inc., a specialty pharmaceutical company, has terminated license agreement with Talon Therapeutics, Inc. (formerly Hana Biosciences, Inc. ) and Par Pharmaceutical Companies, Inc., for Zensana. Talon is a biopharmaceutical company, while...
The Medicines Company (MDCO) has settled the lawsuits filed in the US district court for the district of Delaware relating to the Abbreviated New Drug Application (ANDA) filed by APP Pharmaceuticals, LLC (APP)...
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,...
Eli Lilly and Co. is pouring more money than ever into its research and development pipeline, but Wall Street has been rewarding companies that cut such spending, according to a recent report by...
A key part of founding a company is knowing when to quit. Persistence is an admirable trait, says Michael Robertson, who has founded several companies. However, "there's a fine line between persistence and...