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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
Publication: LexisNexis | Filed In: Lymphoma and Cancer
In the Phase I trial, newly diagnosed patients are enrolled to one of two regimens evaluating ADCETRIS administered either sequentially with CHOP or concurrently with CH-P, which removes vincristine from the regimen: The...
Business Journal
XenoPort to Receive $10 Million Milestone Payment TOKYO & SANTA CLARA, Calif. -- Astellas Pharma Inc. (Tokyo:4503) and XenoPort, Inc. (NASDAQ:XNPT) announced today that Regnite([R] ) (gabapentin enacarbil) has received marketing approval in...
Press Release
Publication: Business Wire | Filed In: Animal Experiments and Experimentation
SHEFFIELD, England -- Simcyp Limited, the leader in modelling and simulation of drug-drug interactions in virtual human populations, today announces it has extended its animal models to include a virtual mouse. Laboratory mice...
Press Release
BRIDGEWATER, N.J. -- NovaDel Pharma Inc. (OTCBB: NVDL), a specialty pharmaceutical company that develops oral spray formulations of marketed pharmaceutical products, today announced that, as previously disclosed, it is continuing to explore various...
Press Release
WORCESTER, Mass. -- Agilux Laboratories, a provider of pharmaceutical and biotech services, today announced that it has completed the validation and implementation of the Thermo Watson Laboratory Information Management System (LIMS) for the...
Press Release
Publication: Business Wire | Filed In: Leukemia and Cancer
BOTHELL, Wash. -- Seattle Genetics, Inc. (Nasdaq: SGEN) today announced updates to the U.S. Prescribing Information (PI) for ADCETRIS[TM] (brentuximab vedotin). The revised PI will include the following updated information: * A boxed...
Press Release
The Montreal Heart Institute will work with GnuBIO to develop a genetic sudden cardiac death screening panel in order to predict risk in patients CAMBRIDGE, Mass. -- GnuBIO, Inc. (GnuBIO), www.gnubio.com a pioneer...
Press Release
Publication: LexisNexis | Filed In: AIDS & HIV and Immune System Disorders
This new indication is based on the evaluation of safety, tolerability, pharmacokinetic parameters and efficacy of ISENTRESS through at least 24-weeks, in a multicenter, open-label, non-comparative study, in HIV-1-infected children and adolescents two...
Business Journal
Publication: LexisNexis | Filed In: Cholesterol and Diet, Nutrition & Fitness
The Phase III study was a single-arm, open label trial, designed to evaluate the efficacy and long-term safety of lomitapide for the treatment of patients with homozygous familial hypercholesterolemia, or HoFH. The data...
Business Journal
Publication: LexisNexis | Filed In: Clinical Trials and Medical Research
ALN-TTR02 is a systemically delivered RNAi therapeutic, targeting the TTR gene that comprises a siRNA formulated in a second-generation lipid nanoparticle, or LNP. Following clearance of the CTA, Alnylam expects to initiate the...
Business Journal
Publication: LexisNexis | Filed In: Enzymes and Amino Acids, Peptides & Proteins
Amicus and GSK are developing migalastat HCl, an investigational oral pharmacological chaperone, as part of a global collaboration for Fabry disease. Migalastat HCl is in Phase III development (Study 011 and Study 012)...
Business Journal
Publication: Business Wire | Filed In: Arthritis and Musculoskeletal Diseases
Painless, drug-free, elevated pressure device brings affordable, portable relief for pain and inflammation MIRAMAR BEACH, Fla. -- Baro-Therapies, Inc. has announced the national launch of The Rejuvenator, a portable barometric therapy device that...
Press Release
Publication: Business Wire | Filed In: Appellate Decisions and Trial & Procedure
Federal Circuit affirms importance of investment in drug research and development BALTIMORE -- Celsis In Vitro, Inc. (Celsis IVT) announced today that the United States Court of Appeals for the Federal Circuit in...
Press Release
Publication: LexisNexis | Filed In: Product Recalls and Product Management
NCH is taking this action as a precautionary measure, because the products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets. This precautionary recall follows...
Business Journal
Publication: LexisNexis | Filed In: Clinical Trials and Medical Research
The company has also reported exploratory data on ACH-1625 for the treatment of HCV genotype 3, and initial proof-of-concept data for ACH-2684. Based upon these results, the company is planning further exploration of...
Business Journal
LEXINGTON, Mass. & CAMBRIDGE, Mass. -- Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) and Hydra Biosciences, Inc. today announced plans to begin a Phase 1 clinical trial for a small molecule antagonist of the human...
Press Release
SHEFFIELD, England -- With China poised to become the world's third largest market for pharmaceuticals, Simcyp Limited today announces the addition of a virtual Chinese patient population to the portfolio of virtual human...
Press Release
OMAHA, Neb. & THE WOODLANDS, Texas -- Transgenomic, Inc. (OTCBB: TBIO) and Power3 Medical Products, Inc. (OTCBB: PWRM) today announced that, following mediation through the offices of the United States District Court for...
Press Release
Publication: Business Wire | Filed In: Antivirals and Anti-Infectives
SAN FRANCISCO -- Presidio Pharmaceuticals, Inc. announced today the successful completion of a Phase 1a dose-ranging assessment of PPI-668, a potent, pan-genotypic second-generation hepatitis C virus (HCV) NS5A inhibitor, in healthy volunteers and...
Press Release

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