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.

Dabrafenib drug shrinks tumors in patients with melanoma brain metastases

An experimental drug targeting a common mutation in melanoma successfully shrank tumors that spread to the brain in nine out of 10 patients in part of an international phase I clinical trial report in the May 18 issue of The Lancet.

18 May 2012

Hitting the target: IntelliCap provides reliable and accurate regional drug delivery

Medimetrics, recently certified to ISO 13485, has successfully developed the IntelliCap system, specifically designed to target delivery of small molecule drugs and biologics to the gastrointestinal (GI) tract. The technology is capable of achieving controlled release of drugs to specific GI sites in a fast, cost-effective and convenient manner (Shimizu et al., 2008).

16 May 2012

Achaogen’s plazomicin and levofloxacin safe and effective in treating cUTI, acute pyelonephritis

Achaogen, Inc. announced today that all objectives were met in the company's multi-national Phase 2 study of plazomicin compared to levofloxacin for the treatment of complicated urinary tract infections (cUTI) and acute pyelonephritis in adults.

16 May 2012

Halozyme first quarter net loss increases to $15.1 million

Halozyme Therapeutics, Inc. today reported financial results for the quarter ended March 31, 2012.

8 May 2012

Flamel first quarter total revenues increase to $7.3 million

Flamel Technologies today announced its financial results for the first quarter of 2012.

7 May 2012

CSL Behring commences C1-INH phase I/II study in hereditary angioedema

CSL Behring announced today that it has initiated an international phase I/II study of a volume-reduced, subcutaneous formulation of C1-esterase inhibitor (C1-INH) concentrate in patients with hereditary angioedema.

4 May 2012

Generon commences F-627 Phase II trial in breast cancer

Generon Corporation Ltd. today announced the initiation of a Phase II clinical trial for F-627 after US FDA regulatory clearance. The current study is a Phase II, randomized, multicenter, open-label, active-controlled trial of F-627 in women with breast cancer receiving myelotoxic chemotherapy.

4 May 2012

SC formulation of Genentech’s ACTEMRA shows promise against RA

Genentech, a member of the Roche Group, today announced that the SUMMACTA study met its primary endpoint, showing comparable efficacy (non-inferiority) of the subcutaneous (SC) formulation of ACTEMRA (tocilizumab) 162mg weekly compared to 8 mg/kg ACTEMRA intravenous (IV) formulation every four weeks.

3 May 2012

XenoPort first quarter revenues increase to $10.4 million

XenoPort, Inc. announced today its financial results for the first quarter ended March 31, 2012. Revenues for the quarter were $10.4 million, compared to $0.4 million for the same period in 2011.

3 May 2012

Novo Nordisk granted exclusive rights to Caisson's heparosan-based drug delivery technology

Caisson Biotech, L.L.C., a biopharmaceutical company with a patented heparosan-based drug delivery technology, announced today that it has entered into a Development and License Agreement with Novo Nordisk A/S, a global healthcare company and leader in diabetes care.

From Novo Nordisk 2 May 2012

Topline, interim results from Celldex Phase 2b EMERGE study of CDX-011 for advanced breast cancer

Celldex Therapeutics, Inc. today announced that interim, topline results of the Phase 2b EMERGE study of CDX-011 in patients with advanced breast cancer will be presented in a webcast on May 23, 2012. Linda Vahdat, MD, Professor of Medicine, Chief of Solid Tumor Service and Director of the Breast Cancer Research Program at Weill Cornell Medical College and the lead investigator of the EMERGE study, will join Celldex on the webcast to discuss data from the study.

2 May 2012

Ultragenyx reports results from UX001 Phase 1 study on HIBM

Ultragenyx Pharmaceutical Inc., a biotechnology company focused on developing treatments for rare and ultra-rare genetic disorders, today announced results from a first-in-human, multi-center, Phase 1 study of UX001 in patients with hereditary inclusion body myopathy (HIBM) showing that UX001 was well-tolerated with an expected extended release profile on absorption after oral administration

2 May 2012

Simulations Plus launches new version of GastroPlus simulation software

Simulations Plus, Inc., a leading provider of simulation and modeling software and consulting services for pharmaceutical discovery and development, announced today the release of Version 8.0 of its flagship GastroPlus simulation software with significantly expanded functionality and user convenience.

27 Apr 2012

Positive results from Repligen's RG3039 Phase 1 study for spinal muscular atrophy

Repligen Corporation today announced positive results from a Phase 1 study to evaluate the pharmacokinetic (PK) and safety profile of RG3039, a novel small molecule drug candidate for the potential treatment of spinal muscular atrophy (SMA).

25 Apr 2012

R-Tech Ueno completes RK-023 phase I study on hypotrichosis of the eyelashes

R-Tech Ueno is pleased to announce the completion of a phase I clinical study of RK-023, a new compound that is being developed for the treatment of hypotrichosis of the eyelashes.

24 Apr 2012

MicuRx completes MRX-I Phase 1 trial on MRSA and VRE infection

MicuRx Pharmaceuticals, Inc., a privately-held biopharmaceutical company developing next-generation antibiotics, today announced the completion of its Phase 1 clinical trial for MRX-I, its first development-stage antibiotic drug candidate.

23 Apr 2012

Palatin, AstraZeneca initiate second AZD2820 phase I trial in obesity

Palatin Technologies, Inc. today announced that a second phase I clinical trial of AZD2820, a subcutaneously-administered peptide melanocortin receptor partial agonist under development for the treatment of obesity, has commenced.

20 Apr 2012

Final data from Santaris’ miravirsen Phase 2a trial on HCV to be presented at ILC 2012

Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, will present final data from a Phase 2a trial showing that miravirsen given as a four-week monotherapy treatment provided robust dose-dependent anti-viral activity with a mean reduction of 2 to 3 logs from baseline in HCV RNA (log10 IU/mL) that was sustained well beyond the end of therapy.

19 Apr 2012

Results from Presidio’s PPI-668 Phase 1a-1b trial on chronic HCV

Presidio Pharmaceuticals, Inc. announced results today from a Phase 1a-1b clinical trial of PPI-668, a potent, pan-genotypic HCV NS5A inhibitor being developed for the treatment of patients with chronic hepatitis C.

19 Apr 2012

Inspiration submits IB1001 BLA with FDA for treatment of hemophilia B

Ipsen today announced that its partner, Inspiration Biopharmaceuticals, Inc., has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the approval of IB1001, an intravenous recombinant factor IX (rFIX) for the treatment and prevention of bleeding in individuals with hemophilia B.

17 Apr 2012