Pharmacokinetics News and Research

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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.

OncoMed commences dosing in OMP-52M51 Phase 1 clinical trial for hematologic cancers

OncoMed Pharmaceuticals, Inc., a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced that patient dosing has begun in a Phase 1 clinical trial of OMP-52M51 in patients with hematologic cancers.

21 Dec 2012

Biotest receives FDA approval for BIVIGAM to treat primary humoral immunodeficiency

Biotest AG announced today that Biotest Pharmaceuticals Corporation received approval for BIVIGAM for the treatment of patients with Primary Humoral Immunodeficiency (PI) from the U.S. Food and Drug Administration (FDA).

20 Dec 2012

Riverside Methodist Hospital treats first PAD patient with Cook Medical's Zilver PTX device

Just weeks after the Food and Drug Administration (FDA) approved Cook Medical's Zilver PTX Drug-Eluting Peripheral Stent, Riverside Methodist Hospital in Columbus, Ohio, has treated the first patient with the device as part of Cook's U.S. commercial launch.

19 Dec 2012

e-Therapeutics’ ETS2101 cancer trials on track

e-Therapeutics plc today provides an update on the clinical trials of its cancer drug ETS2101. Two phase I studies, one in patients with primary or secondary brain cancer and the other in patients with various solid tumours, remain on track to report final data in Q4 2013 and Q1 2014, respectively. Interim data from the trials are expected in H1 2013.

18 Dec 2012

Concern over enoxaparin bleeding risk in patients with moderate renal impairment

The low molecular weight heparin enoxaparin is associated with an increased risk for major bleeding in patients who have moderate renal impairment, say US scientists in findings that have prompted calls for updates to dosing recommendations.

14 Dec 2012

Interim results from Inspiration’s OBI-1 and IB1001 hemophilia clinical study

Inspiration Biopharmaceuticals, Inc. (Inspiration) announced interim clinical results for the company's two lead product candidates, an intravenous recombinant porcine FVIII (OBI-1) in the treatment of serious bleeds in acquired hemophilia A (AHA) and an intravenous recombinant FIX (IB1001) for the treatment and prevention of bleeding in children less than 12 years of age with hemophilia B.

13 Dec 2012

Unigene announces results from oral PTH Phase 2 study on osteoporosis

Unigene Laboratories, Inc., a leader in the design, delivery, manufacture and development of peptide-based therapeutics, today announced that the results of its successful Phase 2 clinical trial evaluating an experimental oral parathyroid hormone (PTH) analog for the treatment of osteoporosis in postmenopausal women has been published online by Bone, the Official Journal of the International Bone and Mineral Society.

13 Dec 2012

Astellas, Ambit announce results from quizartinib Phase 2 study on acute myeloid leukemia

Astellas Pharma Inc. and Ambit Biosciences Corporation announced today that the results from a completed Phase 2 study with the investigational FLT3 inhibitor, quizartinib (AC220), as an oral monotherapy treatment regimen in patients with relapsed or refractory acute myeloid leukemia (AML) were presented at the 54th Annual Meeting of the American Society of Hematology (ASH).

11 Dec 2012

Janssen announces U.S. prescribing information update for EDURANT tablets

Janssen Therapeutics, Division of Janssen Products, LP, announced today that the U.S. Food and Drug Administration (FDA) has approved a prescribing information update for EDURANT (rilpivirine) tablets to include 96-week pooled data from the Phase 3 ECHO and THRIVE studies, which evaluated the efficacy and safety of EDURANT for the treatment of human immunodeficiency virus type 1 (HIV-1) in antiretroviral treatment-naive adults.

11 Dec 2012

uniQure commences acute intermittent porphyria Phase I clinical trial

uniQure B.V., a leader in the field of human gene therapy, today announced the start of its Phase I clinical trial in acute intermittent porphyria (AIP) with the treatment of the first patient.

11 Dec 2012

Infinity announces new data from IPI-145 Phase 1 trial on advanced hematologic malignancies

Infinity Pharmaceuticals, Inc. today announced new data from its ongoing Phase 1, open-label, dose-escalation trial of IPI-145, the company's potent, oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, in patients with advanced hematologic malignancies.

11 Dec 2012

Janssen receives FDA approval for ZYTIGA to treat metastatic castration-resistant prostate cancer

Janssen announced today that the U.S. Food and Drug Administration (FDA) has approved a broader indication for the oral, once-daily medication ZYTIGA (abiraterone acetate).

10 Dec 2012

NOXXON commences NOX-H94 Phase IIa trial to treat anemia of chronic disease

NOXXON Pharma today announced the treatment of the first patients in a Phase IIa clinical trial of its anti-hepcidin Spiegelmer NOX-H94 to treat anemia associated with chronic disease.

5 Dec 2012

Epizyme to present data from DOT1L and EZH2 inhibitor programs at 54th ASH annual meeting

Epizyme, Inc., a biopharmaceutical company leading the creation of personalized therapeutics to treat patients with genetically defined cancers, today announced the presentation of data evaluating the preclinical safety and efficacy of two of the Company's novel, potent and selective small molecule inhibitors. These inhibitors individually target DOT1L and EZH2, members of a class of epigenic enzymes called histone methyltransferases (HMTs).

30 Nov 2012

InSite Vision completes enrollment in BromSite Phase 3 trial for reduction of pain, inflammation

InSite Vision Incorporated today announced that patient enrollment has been completed in the first Phase 3 clinical trial of BromSite (ISV-303) for the reduction of pain and inflammation after cataract surgery.

29 Nov 2012

Bayer completes recruitment of first cohort for BAY 86-6150 Phase II/III study in hemophilia

Bayer's BAY 86-6150 is being investigated in a Phase II/III study called TRUST (TReatment with Unique recombinant rFVIIa STudy), and the recruitment of the first cohort is now complete.

28 Nov 2012

Diffusion Pharmaceuticals completes trans sodium crocetinate Phase I trial on glioblastoma

Diffusion Pharmaceuticals LLC, a biotechnology company developing innovative cancer treatments, today announced that it has successfully completed a Phase I clinical trial of its lead compound trans sodium crocetinate (TSC) in nine patients with newly diagnosed primary brain cancer (glioblastoma or GBM).

19 Nov 2012

Ligand Pharmaceuticals announces data from LG-7501 preclinical studies on HCV

Ligand Pharmaceuticals Incorporated announced that data from preclinical studies evaluating LG-7501 were featured in a poster presentation today at the 63rd Annual Meeting of the American Association for the Study of Liver Diseases in Boston.

14 Nov 2012

Positive results from Palatin’s bremelanotide Phase 2B trial on female sexual dysfunction

Palatin Technologies, Inc. today reported positive top-line results, including the successful achievement of statistical significance for the primary endpoint and key secondary endpoints in its Phase 2B clinical trial evaluating the efficacy and safety of bremelanotide for the treatment of female sexual dysfunction (FSD).

9 Nov 2012

Arisaph’s ARI-3037MO well tolerated in healthy male and female volunteers

Arisaph Pharmaceuticals, Inc. announced today during an oral presentation at the American Heart Association (AHA) meeting in Los Angeles, CA that its niacin analog, ARI-3037MO, was extremely well tolerated in a single-ascending dose (SAD) and a multiple-ascending dose (MAD) trial in healthy male and female volunteers.

7 Nov 2012

Pharmacokinetics News and Research

Further Reading

OncoMed commences dosing in OMP-52M51 Phase 1 clinical trial for hematologic cancers

Biotest receives FDA approval for BIVIGAM to treat primary humoral immunodeficiency

Riverside Methodist Hospital treats first PAD patient with Cook Medical's Zilver PTX device

e-Therapeutics’ ETS2101 cancer trials on track

Concern over enoxaparin bleeding risk in patients with moderate renal impairment

Interim results from Inspiration’s OBI-1 and IB1001 hemophilia clinical study

Unigene announces results from oral PTH Phase 2 study on osteoporosis

Astellas, Ambit announce results from quizartinib Phase 2 study on acute myeloid leukemia

Janssen announces U.S. prescribing information update for EDURANT tablets

uniQure commences acute intermittent porphyria Phase I clinical trial

Infinity announces new data from IPI-145 Phase 1 trial on advanced hematologic malignancies

Janssen receives FDA approval for ZYTIGA to treat metastatic castration-resistant prostate cancer

NOXXON commences NOX-H94 Phase IIa trial to treat anemia of chronic disease

Epizyme to present data from DOT1L and EZH2 inhibitor programs at 54th ASH annual meeting

InSite Vision completes enrollment in BromSite Phase 3 trial for reduction of pain, inflammation

Bayer completes recruitment of first cohort for BAY 86-6150 Phase II/III study in hemophilia

Diffusion Pharmaceuticals completes trans sodium crocetinate Phase I trial on glioblastoma

Ligand Pharmaceuticals announces data from LG-7501 preclinical studies on HCV

Positive results from Palatin’s bremelanotide Phase 2B trial on female sexual dysfunction

Arisaph’s ARI-3037MO well tolerated in healthy male and female volunteers

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