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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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)...
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...
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...
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...
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...
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...
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...
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...
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...