Pharmacokinetics News and Research

RSS

The term pharmacokinetics is derived from the ancient Greek words “pharmakon” and “kinetikos”, meaning “drug” and “putting in motion” respectively. It is one of the main branches of pharmacology, and refers to the way that the body reacts on and affects a pharmaceutical substance in the body.

CytRx initiates aldoxorubicin Phase 2 trial in HIV-infected patients with Kaposi's sarcoma

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, today announced it has initiated a Phase 2 clinical trial to determine preliminary efficacy and safety of aldoxorubicin for HIV-infected patients with Kaposi's sarcoma.

23 Jan 2014

CytRx receives FDA approval to continue dosing aldoxorubicin for patients with soft tissue sarcomas

CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical research and development company specializing in oncology, today announced it has received approval from the U.S. Food and Drug Administration (FDA) to continue dosing patients with aldoxorubicin until disease progression in a planned pivotal, global Phase 3 clinical trial with aldoxorubicin as a second-line treatment for soft tissue sarcomas.

22 Jan 2014

Kolltan Pharmaceuticals announces treatment of first cancer patient with KTN3379

Kolltan Pharmaceuticals, a privately held biopharmaceutical company, today announced treatment of the first cancer patient with Kolltan's lead drug candidate, KTN3379, as part of a Phase 1 clinical study evaluating safety, preliminary evidence of antitumor activity, and pharmacokinetics. KTN3379 is a human monoclonal antibody that blocks the activity of ErbB3, a member of the ErbB family of receptor tyrosine kinases.

21 Jan 2014

European Commission approves ViiV Healthcare's Tivicay for treatment of HIV infected adults

ViiV Healthcare today announced that the European Commission has approved Tivicay (dolutegravir), an integrase inhibitor, for use in combination with other anti-retroviral medicinal products for the treatment of HIV infected adults and adolescents above 12 years of age.

21 Jan 2014

Daiichi Sankyo submits Marketing Authorization Application for edoxaban to EMA

Daiichi Sankyo, Company Limited (hereafter, Daiichi Sankyo) today announced that the Marketing Authorization Application for its investigational, oral, once-daily direct factor Xa-inhibitor edoxaban has been submitted to the European Medicines Agency.

7 Jan 2014

e-Therapeutics announces continuation of ETS2101 phase I trial in brain cancer

e-Therapeutics plc today announces that the investigator-led phase I trial of ETS2101 in brain cancer will continue into 2014. Five dose escalation steps have been completed without any drug-related serious adverse events and the investigator therefore intends to enrol further patients at higher dose levels.

7 Jan 2014

ANP reports positive interim results from ATL1103 Phase II clinical trial for acromegaly

Antisense Therapeutics Limited is pleased to advise that positive results have been achieved from the interim analysis of a subset of available data from its Phase II clinical trial of ATL1103 in patients with the growth disorder, acromegaly.

23 Dec 2013

MicuRx announces initiation of global clinical development program for MRX-I compound

MicuRx Pharmaceuticals, Inc., a privately-held biopharmaceutical company developing next-generation antibiotics, today announced the initiation of a global clinical development program for its lead compound MRX-I, a novel oxazolidinone antibiotic for treatment of Gram-positive infections including methicillin-resistant Staphylococcus aureus and vancomycin-resistant enterococci.

20 Dec 2013

BeiGene doses first patient in Phase 1 study of BGB-283

BeiGene (Beijing), Co., Ltd., today announced dose administration for the first patient in a Phase 1 study of BGB-283 in patients with B-RAF or K-RAS mutations. BGB-283 is an investigational, oral, selective, potent second generation inhibitor of B-RAF, making it a targeted therapeutic candidate to potentially treat and bring benefit to patients with cancers that harbor BRAF mutations and/or aberrations in the RAS-MAPK (mitogen-activated protein kinase) pathway.

20 Dec 2013

Blaze Bioscience to initiate first Phase 1 clinical study of BLZ-100 in patients with skin tumors

Blaze Bioscience, Inc. and its subsidiary, Blaze Bioscience Australia Pty Ltd, today announced the initiation of the first Phase 1 clinical study of the first Tumor Paint product candidate, BLZ-100. The study, titled "A Phase I Dose Escalation/Expansion Study of BLZ-100 Administered by Intravenous Injection in Adult Subjects with Skin Cancer," will enroll up to 30 patients with basal cell carcinoma, squamous cell carcinoma, or amelanotic melanoma.

19 Dec 2013

Daiichi Sankyo submits LIXIANA supplemental NDA for review in Japan

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it has submitted a supplemental New Drug Application for its oral, once-daily direct factor Xa-inhibitor LIXIANA® (Edoxaban Tosilate Hydrate) for review by the Japanese Ministry of Health, Labour and Welfare. Daiichi Sankyo is seeking approval in Japan for edoxaban in new indications for non-valvular atrial fibrillation and symptomatic venous thromboembolism.

19 Dec 2013

Omeros' OMS721 receives FDA orphan drug designation for prevention of TMAs

Omeros Corporation today announced that OMS721, the company's lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the key regulator of the lectin pathway of the immune system, has received orphan drug designation from the U.S. Food and Drug Administration for prevention of complement-mediated thrombotic microangiopathies.

18 Dec 2013

arGEN-X reports that Phase Ib cancer study with ARGX-110 antibody meets translational development goals

arGEN-X announces that the dose-escalation part of a Phase Ib study with its lead antibody ARGX-110 has met its translational development goals: all pre-specified biological activity measures (e.g. target engagement, effector functions, immune-modulation) were met.

17 Dec 2013

Daiichi Sankyo presents subgroup analysis of Hokusai-VTE study at ASH annual meeting

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced results of a prespecified subgroup analysis of 771 cancer patients enrolled in the phase 3 Hokusai-VTE study.

11 Dec 2013

Pharmacyclics presents ibrutinib trial data for B-cell malignancies at ASH meeting

Pharmacyclics, Inc. today announced results of 40 clinical, non-clinical and pre-clinical presentations on ibrutinib (IMBRUVICA™) at the 55TH Annual meeting of the American Society of Hematology (ASH) held in New Orleans, Dec 7 - 10, 2013.

11 Dec 2013

ImmunoGen presents Phase I trial results of SAR650984 at ASH annual meeting

ImmunoGen, Inc., a biotechnology company that develops targeted, antibody-based anticancer therapeutics, today announced the first clinical findings with SAR650984 reported in an oral presentation at the ASH annual meeting. The data are from an ongoing Phase I trial assessing this CD38-targeting therapeutic antibody in patients with CD38-positive MM or other hematologic malignancy.

10 Dec 2013

Arrowhead reports Phase 1 study data on ARC-520 for treatment of chronic hepatitis B infection

Arrowhead Research Corporation, a biopharmaceutical company developing targeted RNAi therapeutics, today announced that COO and Head of R&D, Bruce Given, M.D., presented data on the Phase 1 clinical study of ARC-520, the company's clinical candidate for the treatment of chronic hepatitis B infection, at the HepDART 2013 conference being held on The Big Island, Hawaii.

9 Dec 2013

Heptares starts HTL9936 Phase 1 study for improving cognitive function in Alzheimer's patients

Heptares Therapeutics, the leading GPCR structure-guided drug discovery and development company, announces that it has initiated a Phase 1 clinical study of HTL9936, the first fully selective muscarinic M1 receptor agonist to enter clinical development. HTL9936 is an orally available, small molecule drug candidate discovered using the Heptares GPCR structure-based drug design platform.

9 Dec 2013

AtheroNova completes active treatment portion of Phase 1 clinical trial with AHRO-001

AtheroNova Inc., a biotech company focused on the research and development of compounds to safely regress atherosclerotic plaque and improve lipid profiles in humans, today announces achievement of a major milestone with the completion of the active treatment portion of its Phase 1 clinical trial with its lead compound, AHRO-001. The Phase 1 study objective is to evaluate the safety, tolerability and pharmacokinetics of AHRO-001 in healthy volunteers. The clinical study is being conducted in Russia with AtheroNova's licensing partner, OOO CardioNova.

5 Dec 2013

Merck announces approval of NOXAFIL delayed-release tablets by FDA

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved NOXAFIL® (posaconazole) 100 mg delayed-release tablets.

27 Nov 2013