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First patient enrolled in CSL Behring's rVIIa-FP Phase II/III study to treat patients with hemophilia A or B with inhibitors

First patient enrolled in CSL Behring's rVIIa-FP Phase II/III study to treat patients with hemophilia A or B with inhibitors

CSL Behring announced today that the first patient has been enrolled in its Phase II/III clinical study evaluating the pharmacokinetics (PK), efficacy, and safety of the company's recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP) for on-demand treatment in patients with congenital hemophilia A or B who have developed an inhibitor to factor VIII or factor IX replacement therapy. [More]
Accutest makes strategic expansion into Latin America to support the growth of pharmaceutical sector

Accutest makes strategic expansion into Latin America to support the growth of pharmaceutical sector

Accutest Research Laboratories, a leading global Contract Research Organization (CRO), further pursues its strategic expansion into Latin America by opening offices and establishing operational presence in Brazil. [More]
AMRI’s total revenue increases $89.5 million to 31% in second quarter 2015

AMRI’s total revenue increases $89.5 million to 31% in second quarter 2015

AMRI today reported financial and operating results for the second quarter ended June 30, 2015. "We are very pleased to present another strong financial quarter, with all our divisions achieving excellent results," said William S. Marth, AMRI's president and chief executive officer. "Notably, recent acquisitions, combined with the cost reduction initiatives and efficiency efforts we've made to date, are contributing to continued strong contract margin performance. [More]
Oasmia announces topline results from head-to-head comparison study of Paclical and Abraxane

Oasmia announces topline results from head-to-head comparison study of Paclical and Abraxane

Oasmia Pharmaceutical AB, developer of a new generation of drugs within human and veterinary oncology, announced today the topline findings from a head-to-head comparison study of its lead human cancer product candidate Paclical and Celgene's Abraxane, which show similar pharmacokinetic (PK) profiles of the two products. The study was conducted in women with metastatic breast cancer. [More]
Research shows specific routes of administration can predict risk of drug addiction

Research shows specific routes of administration can predict risk of drug addiction

Abstinence is the best way to avoid drug addiction. But in many societies, drug use is the norm, not the exception, especially by youth. [More]
Daiichi Sankyo, Plexxikon’s Phase 1 trial shows PLX3397 induced prolonged tumor regression in TGCT patients

Daiichi Sankyo, Plexxikon’s Phase 1 trial shows PLX3397 induced prolonged tumor regression in TGCT patients

Daiichi Sankyo Europe and Plexxikon Inc., a member of the Daiichi Sankyo Group, announced today that The New England Journal of Medicine published clinical trial results demonstrating that the investigational drug, PLX3397, an oral targeted CSF-1R inhibitor, induced prolonged tumor regressions in most patients with tenosynovial giant cell tumor, a rare, locally aggressive neoplasm of the joint or tendon sheath. [More]
Research brief provides clinical validation of LOXO-101 Phase 1 trial for treatment of TRK fusion cancer

Research brief provides clinical validation of LOXO-101 Phase 1 trial for treatment of TRK fusion cancer

The University of Colorado Cancer Center and Loxo Oncology, Inc., a biopharmaceutical company focused on the discovery, development and commercialization of targeted cancer therapies, today announced the publication of a research brief in the online edition of the journal Cancer Discovery, describing the first patient with a tropomyosin receptor kinase fusion cancer enrolled in the Phase 1 dose escalation trial of LOXO-101, the only selective TRK inhibitor in clinical development. [More]
Research brief describes enrollment of first patient with TRK fusion cancer in LOXO-101 Phase 1 trial

Research brief describes enrollment of first patient with TRK fusion cancer in LOXO-101 Phase 1 trial

The University of Colorado Cancer Center and Loxo Oncology, Inc., a biopharmaceutical company focused on the discovery, development and commercialization of targeted cancer therapies, today announced the publication of a research brief in the online edition of the journal Cancer Discovery, describing the first patient with a tropomyosin receptor kinase (TRK) fusion cancer enrolled in the Phase 1 dose escalation trial of LOXO-101, the only selective TRK inhibitor in clinical development. [More]
MGB Biopharma begins MGB-BP-3 Phase I clinical trial for treatment of Clostridium difficile infections

MGB Biopharma begins MGB-BP-3 Phase I clinical trial for treatment of Clostridium difficile infections

MGB Biopharma, a biopharmaceutical company developing a truly novel class of anti-infectives, to address the major global problem of antibiotic resistance today announces that the first group of healthy male volunteers have been dosed in a Phase I clinical trial assessing the safety and tolerability of an oral formulation of MGB-BP-3, for use in the treatment of Clostridium difficile infections. [More]
C2N-8E12 (ABBV-8E12) gets orphan drug designation from FDA for PSP treatment

C2N-8E12 (ABBV-8E12) gets orphan drug designation from FDA for PSP treatment

C2N Diagnostics and AbbVie today announced that the U.S. Food and Drug Administration has granted their investigational recombinant humanized anti-tau antibody, C2N-8E12 (ABBV-8E12), an orphan drug designation for the treatment of progressive supranuclear palsy (PSP). [More]

AMRI purchases Gadea Pharmaceutical Group for $174 million

AMRI today announced that it has acquired all the outstanding shares of Gadea Pharmaceutical Group, a privately-held company located in Valladolid, Spain, specializing in technically complex active pharmaceutical ingredients (APIs) and finished drug product. [More]
Envarsus XR receives FDA approval for treatment of kidney transplant recipients

Envarsus XR receives FDA approval for treatment of kidney transplant recipients

Veloxis Pharmaceuticals A/S today announced U.S. Food and Drug Administration approval of Envarsus XR (tacrolimus extended-release tablets) for the prophylaxis of rejection in kidney transplant patients who require or desire conversion from other twice-daily tacrolimus products to once-daily Envarsus XR. [More]
Johns Hopkins, IOCB Prague sign drug discovery research agreement

Johns Hopkins, IOCB Prague sign drug discovery research agreement

The Johns Hopkins Drug Discovery (JHDD) program, created with the mission of identifying novel drug targets arising from Johns Hopkins faculty research and translating them into new therapeutics, and the Institute of Organic Chemistry and Biochemistry, The Czech Academy of Sciences (IOCB Prague) have entered into a five-year drug discovery research agreement to develop small-molecule and peptide drugs for a range of therapeutic areas including neurological diseases, cancer and gastrointestinal disorders. [More]
Aridis expands, accelerates current AR-301 Phase 2a study for treatment of acute pneumonia in the U.S.

Aridis expands, accelerates current AR-301 Phase 2a study for treatment of acute pneumonia in the U.S.

Aridis Pharmaceuticals, Inc., a biopharmaceutical company applying proprietary technologies to produce novel anti-infectives and immunotherapies for infectious diseases, announced today that the U.S. Food and Drug Administration has accepted its Investigational New Drug (IND) application for AR-301, also referred to as Salvecin, the company's fully human anti-Staphylococcal α-toxin IgG1 monoclonal antibody being developed for the treatment of hospital-acquired and ventilator-associated pneumonia (HAP and VAP) caused by Staphylococcus aureus, including multi-drug resistant 'MRSA' strains. [More]
Abide Therapeutics begins Phase 1a study of ABX-1431 investigational endocannabinoid system modulator

Abide Therapeutics begins Phase 1a study of ABX-1431 investigational endocannabinoid system modulator

Abide Therapeutics, a developer of innovative pharmaceuticals, announced today initiation of enrollment and dosing of the first subject in a Phase 1a clinical study of ABX-1431, a first-in-class, investigational endocannabinoid system modulator. [More]
European Nanomedicine Characterization Lab aims to bring safe, efficient nano-therapeutics to patients

European Nanomedicine Characterization Lab aims to bring safe, efficient nano-therapeutics to patients

Empa, the Swiss Federal Laboratories for Materials Science and Technology, is part of the European Nanomedicine Characterization Laboratory, a European project funded by the EU framework program «Horizon 2020. [More]
Aridis' Aerucin gets FDA Fast Track Designation for treatment of hospital-acquired and ventilator-associated pneumonia

Aridis' Aerucin gets FDA Fast Track Designation for treatment of hospital-acquired and ventilator-associated pneumonia

Aridis Pharmaceuticals, Inc., a biopharmaceutical company applying proprietary technologies to produce novel therapies for infectious diseases, announced today that the U.S. Food and Drug Administration granted Fast Track Designation to its fully human monoclonal antibody Aerucin for the treatment of hospital-acquired and ventilator-associated pneumonia caused by Pseudomonas aeruginosa. [More]
Can-Fite reports further progress in continuing preclinical program of CF602 sexual dysfunction drug

Can-Fite reports further progress in continuing preclinical program of CF602 sexual dysfunction drug

Can-Fite BioPharma Ltd., a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, today reported further progress in its continuing preclinical program of its CF602 drug candidate as the Company prepares to file an investigational new drug (IND) application with the U.S. Food and Drug Administration to allow the initiation of a Phase I clinical study. [More]
Potential new class of drugs lessen neurodegeneration in rat model of Parkinson's disease

Potential new class of drugs lessen neurodegeneration in rat model of Parkinson's disease

The first test in a mammalian model of a potential new class of drugs to treat Parkinson's disease shows abatement of neurodegeneration in the brains of test rats and no significant toxicities, University of Alabama at Birmingham and Pfizer Inc. researchers report online in The Journal of Biological Chemistry. [More]
CSL Behring presents Phase I/III rVIII-SingleChain hemophilia A data at 2015 ISTH Congress

CSL Behring presents Phase I/III rVIII-SingleChain hemophilia A data at 2015 ISTH Congress

CSL Behring today presented data from a Phase I/III study on the efficacy and safety of its novel investigational recombinant factor VIII single chain in adolescents and adults with hemophilia A during a late breaking abstract session at the 2015 International Society on Thrombosis and Haemostasis (ISTH) Congress. [More]
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