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.

Rifampin kinetics poor in children

Rifampin (RMP), a first-line antituberculosis drug, reaches serum concentrations well below suggested lower limits when a standard dose of 8-12mg/kg body weight is given to children.

22 Apr 2009

$Pharmacyclics starts clinical trial of novel oral Btk inhibitor for refractory B-cell non-Hodgkin's lymphoma$

Pharmacyclics starts clinical trial of novel oral Btk inhibitor for refractory B-cell non-Hodgkin's lymphoma

Pharmacyclics, Inc. has announced that it has begun treating patients in a Phase 1 dose-escalation study to evaluate the safety and tolerability of PCI-32765, an orally available, selective inhibitor of Bruton's tyrosine kinase, or Btk, as a potential treatment for patients with relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL).

13 Apr 2009

SARcode announces results of phase 1 trial of SAR 1118 ophthalmic solution in healthy adult subjects

SARcode Corporation announced today the results of its Phase 1 randomized, double-masked, placebo-controlled trial of the safety, tolerability, and pharmacokinetics of single- and multiple-escalating doses of SAR 1118 Ophthalmic Solution in healthy volunteers.

30 Mar 2009

SemBioSys Genetics announces clinical results with plant-produced insulin

SemBioSys Genetics Inc., specializing in the manufacture of high-value proteins and oils in plant seeds, today announced preliminary results of its first "in-man" clinical study of SBS-1000, a recombinant human insulin manufactured using its proprietary platform.

20 Mar 2009

MannKind Corporation submits NDA for Afresa for treatment of diabetes

MannKind Corporation has announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting approval of Afresa (insulin monomer human [rDNA origin]) Inhalation Powder and the Afresa Inhaler for the treatment of adults with type 1 or type 2 diabetes mellitus for the control of hyperglycemia.

16 Mar 2009

Helix BioPharma receives approval to start phase II study of topical interferon alpha-2b in low-grade cervical lesions

Helix BioPharma Corp. announced that it has received the necessary regulatory approvals in Germany to initiate its planned Phase II pharmacokinetic study of Topical Interferon Alpha-2b in patients with low-grade cervical lesions.

16 Mar 2009

BioCis Pharma starts trial of novel topical drug for dermatology

BioCis Pharma Ltd., a privately-held drug development company with its headquarters in Turku, Finland, announced that it has begun a new Phase IIa clinical testing of ProtoCure emulsion cream, the company's novel topical drug for dermatology.

12 Mar 2009

Azaya Therapeutics selected for Nanotechnology Characterization Lab by National Cancer Institute

Azaya Therapeutics, Inc. has announced that it has been selected by the National Cancer Institute (NCI) for a research collaboration to study Azaya's lead cancer therapy, ATI - 1123.

10 Mar 2009

New guidelines for prescribing opioid pain drugs

A prestigious panel of pain-management experts representing the American Pain Society (APS) www.ampainsoc.org and the American Academy of Pain Medicine (AAPM) has published the first comprehensive clinical practice guideline to assist clinicians in prescribing potent opioid pain medications for patients with chronic non-cancer pain.

10 Feb 2009

New guideline for prescribing opioid pain drugs published

A national panel of pain management experts representing the American Pain Society (APS) and the American Academy of Pain Medicine (AAPM) has published the first comprehensive, evidence-based clinical practice guideline to assist clinicians in prescribing potent opioid pain medications for patients with chronic non-cancer pain.

8 Feb 2009

Idenix Pharmaceuticals and GSK sign agreement for novel NNRTI for treatment of HIV

Idenix Pharmaceuticals, Inc. and GlaxoSmithKline (GSK) today announced the execution of a license agreement granting GSK exclusive worldwide rights to IDX899.

8 Feb 2009

Research finds more than 100 gene variations linked with response to leukemia treatment

Scientists from St. Jude Children's Research Hospital and the Children's Oncology Group (COG) have discovered in children with acute lymphoblastic leukemia (ALL) scores of inherited genetic variations that clinicians might be able to use as guideposts for designing more effective chemotherapy for this cancer.

29 Jan 2009

Medarex announces allowance of IND application for antibody-drug conjugate, MDX-1203

Medarex, Inc. has announced the allowance of an investigational new drug (IND) application filed with the U.S. Food & Drug Administration (FDA) for MDX-1203, the Company's first Antibody-Drug Conjugate (ADC) candidate generated from its proprietary technology.

29 Jan 2009

CSL Behring receives FDA approval of RiaSTAP

CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for RiaSTAP(TM), the first and only treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

19 Jan 2009

Savella - Fibromyalgia treatment approved by FDA

Forest Laboratories, Inc. and Cypress Bioscience, Inc. have announced that Savella (milnacipran HCl), a selective serotonin and norepinephrine dual reuptake inhibitor, was approved by the U.S. Food and Drug Administration (FDA) for the management of fibromyalgia.

19 Jan 2009

Polymer nanoparticle for oral anticancer drug delivery

One of the problems that cancer patients face is that many of the most potent anticancer therapies can be administered only by injection, which means that cancer patients must travel to receive their medication. But thanks to a new type of nanoparticle developed by researchers at the Johns Hopkins University School of Medicine, future cancer patients may be able to receive their medication in pill form.

18 Jan 2009

GSK and XenoPort resubmit NDA for Solzira in restless legs syndrome

GlaxoSmithKline and XenoPort, Inc. announced today that GSK has resubmitted the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting approval of Solzira(TM) (gabapentin enacarbil) Extended Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).

12 Jan 2009

Genta Incorporated issued two key U.S. patents for gallium products franchise

Genta Incorporated has announced that two new patents related to the Company's franchise in gallium-containing products have issued in the United States.

8 Jan 2009

Sequella, Inc. drug compound SQ109 selected for phase 1B clinical trial program

Sequella, Inc., a clinical-stage biopharmaceutical company focused on diseases of epidemic potential, announced today that SQ109, its lead drug candidate for the treatment of tuberculosis (TB), was the first drug approved for evaluation in a newly awarded clinical program contract to Dynport Vaccine Company LLC and Quintiles Transnational.

6 Jan 2009

Chimerix completes phase I study and starts phase II multi-dose trial for CMX001

Chimerix, Inc., a biotechnology company developing orally available antiviral therapeutics, has announced that the Company has completed a single and multi-dose Phase I study of CMX001 in healthy volunteers.