Pharmacokinetics News and Research RSS Feed - Pharmacokinetics News and Research

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 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]
Alexza updates, amends ADASUVE (Staccato loxapine) commercial partnerships with Ferrer and Teva

Alexza updates, amends ADASUVE (Staccato loxapine) commercial partnerships with Ferrer and Teva

Alexza Pharmaceuticals, Inc. today announced that it has updated and amended its ADASUVE (Staccato loxapine) commercial partnerships with Grupo Ferrer Internacional, S.A. and Teva Pharmaceutical Industries Ltd. Ferrer is Alexza's commercial partner for ADASUVE in the European Union, Latin America, the Commonwealth of Independent States and other countries in Europe. [More]
Findings could lead to treatments for chronic pain caused by nerve damage

Findings could lead to treatments for chronic pain caused by nerve damage

Non-narcotic treatments for chronic pain that work well in people, not just mice, are sorely needed. Drawing from human pain genetics, an international team led by Boston Children's Hospital demonstrates a way to break the cycle of pain hypersensitivity without the development of addiction, tolerance or side effects. [More]
AMRI, PerkinElmer form strategic collaboration to accelerate drug discovery

AMRI, PerkinElmer form strategic collaboration to accelerate drug discovery

As further evidence of Governor Andrew M. Cuomo's successful establishment of a dynamic and growing bio-pharma sector in Buffalo, New York, Albany Molecular Research Inc. and PerkinElmer, Inc. today announced the formation of a strategic collaboration in connection with the opening of AMRI's drug discovery center as part of the new Buffalo Medical Innovation and Commercialization Hub. [More]
BerGenBio begins BGB324 Phase 1b trial in combination with erlotinib in NSCLC patients

BerGenBio begins BGB324 Phase 1b trial in combination with erlotinib in NSCLC patients

BerGenBio AS, an oncology biopharmaceutical company, today announces that its multi-centre open label Phase 1b trial (BGBC004) of BGB324, a selective inhibitor of Axl, in patients with Stage IIIb and Stage IV non-small cell lung cancer (NSCLC) in erlotinib-sensitive and refractory patients who have an activating EGFR mutation, is now underway at the University of Texas MD Anderson Cancer Center, Houston, Oncology Partners, Houston, and at UT Southwestern Medical Center, Dallas, Texas, USA. [More]
Regulus Therapeutics begins RG-012 Phase I clinical study for treatment of Alport syndrome

Regulus Therapeutics begins RG-012 Phase I clinical study for treatment of Alport syndrome

Regulus Therapeutics Inc., a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, announced today that dosing has begun in a first-in-human Phase I clinical study of RG-012, a single stranded, chemically modified oligonucleotide that binds to and inhibits the function of microRNA-21 ("miR-21"). [More]
Advertisement