Inspiration Biopharmaceuticals has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for the approval of IB1001, used for the treatment and prevention of bleeding in individuals with hemophilia B. ...
Tags: FDA, IB1001, intravenous recombinant factor IX protein
The US Food and Drug Administration (FDA) has granted fast track designation for Idenix Pharmaceuticals' IDX719 to treat chronic hepatitis C infection (HCV). IDX719 is an NS5A inhibitor that demonstrated pan-genotypic activity in a recent ...
Tags: IDX719, HCV, chronic hepatitis C infection
Jazz Pharmaceuticals has initiated patient dosing in a clinical trial intravenously (IV) administering Erwinaze in acute lymphoblastic leukemia (ALL) patients hypersensitive to asparaginase therapy derived from E. coli. The trial will ...
Tags: pharmeceuticals, clinical, trial intravenously, E.coli
Takeda Pharmaceutical Company and Millennium: The Takeda Oncology Company have won European conditional marketing authorization for Adcetris (brentuximab vedotin). Adcetris is indicated for use in adult patients with relapsed or ...
Tags: adcetris, antibody-drug conjugate, Brentuximab vedotin, sALCL
Ironwood Pharmaceuticals, Bionomics' licensee, has submitted an investigational new drug (IND) application to the FDA to begin IW-2143 clinical trial. The trial will further evaluate pharmacokinetic profile of the anti-anxiety drug ...
Epigenomics has announced results from a comparative study between its blood-based colorectal cancer(CRC)detection test Epi proColon and fecal immunochemical testing(FIT)to demonstrate the non-inferiority of Epi proColon in detection of ...
Tags: Epigenomics, CRC, FIT, Epi proColon
PRC Clinical, a contract research organization (CRO), has selected Trial By Fire Solutions' SimpleCTMS clinical trial management system. PRC Clinical will incorporate SimpleCTMS into their suite of eClinical services to carry out a full ...
Tags: PRC Clinical, Trial By Fire solutions, SimpleCTMS, eClinical systems
Luitpold Pharmaceuticals has selected BioClinica's express electronic data capture (EDC) system for multiple upcoming clinical trials. BioClinica's Express EDC solution leverages time-tested, stable technology to provide a central hub to ...
Tags: Luitpold Pharmaceuticals
Walmart pharmacies has announced the availability of Ecoslide-RX, an eco-friendly prescription pharmaceutical package which is said to be designed to improve patients' adherence to medications. The package, which is manufactured by ...
Tags: Walmart pharmacies, Ecoslide-RX
Worldwide Clinical Trials(WCT)has opted for TransPerfect's web-based electronic trial master file(eTMF)technology,Trial Interactive,to improve overall TMF documentation management process. The contract research organization will leverage ...
Tags: WCT, eTMF technology, TMF documentation management process, TransPerfect
Takeda Pharmaceutical has received a complete response letter from the US Food and Drug Administration (FDA) regarding its new drug applications (NDAs) for alogliptin and the fixed-dose combination therapy alogliptin and pioglitazone. ...
Tags: FDA, alogliptin, clinical trial program
Abaxis has entered into a definitive agreement with a medical supplies sourcing and support company to deliver its 300 Piccolo Xpress chemistry analyzers. The biotechnology company will use CLIA waived Piccolo Xpress instruments in the ...
SWOG (formerly the Southwest Oncology Group) has chosen Sequenta's LymphoSIGHT platform for the measurement of minimal residual disease (MRD) in 180-patient mantle cell lymphoma clinical trial. The patients in the SWOG S1106 mantle cell ...
Tags: SWOG, Sequenta's LymphoSIGHT platform, minimal residual disease, MRD
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended Astellas Pharma Europe's Betmigatm (mirabegron) for the symptomatic treatment of urgency, increased micturition frequency ...
Tags: symptomatic treatment of urgency, pharmaceutical product
Great Lakes Pharmaceuticals (GLPI) has selected OmniComm Systems' TrialMaster suite of applications to support clinical research needs for a multi-national pivotal device study involving up to 400 subjects across 20 sites. OmniComm will ...
Tags: Great Lakes Pharmaceuticals, GLPI, OmniComm systems, TrialMaster