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.

Positive results from Spinifex’s EMA401 Phase 2 trial on postherpetic neuralgia

Spinifex Pharmaceuticals, an Australian pain drug development company, today announces positive headline results from the Phase 2 clinical trial of its lead product, EMA401, in postherpetic neuralgia (PHN), a painful condition that develops in some patients following herpes zoster (shingles) and where existing therapy does not relieve pain in all individuals.

28 Aug 2012

Debiopharm initiates enrollment in triptorelin phase III study for central precocious puberty

Debiopharm Group (Debiopharm), a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs and companion diagnostics, today announced that the first patient has been enrolled in an open-label phase III study to investigate the efficacy, safety, and pharmacokinetics of the sustained release triptorelin pamoate 22.5 mg 6-month-formulation in children with central precocious puberty (CPP), a rare disease.

27 Aug 2012

Kineta receives regulatory clearance to commence ShK-186 Phase I trial in autoimmune disease

Seattle-based biotech company Kineta, Inc. announced today it has received regulatory clearance in the Netherlands to initiate a first-in-human trial of ShK-186, an autoimmune drug candidate that specifically inhibits the Kv1.3 potassium ion channel.

21 Aug 2012

Medivir initiates MIV-711 phase Ib trial in healthy volunteers

Medivir AB, the research-based pharmaceutical company focused on the development of high-value treatments for infectious diseases, is reporting today that a clinical phase Ib trial of the company's candidate drug (CD) MIV-711 has commenced.

21 Aug 2012

Clinical trials to test safety of 3K3A-APC in patients with ischemic stroke

Clinical trials start this week for a stroke drug initially created by a team led by scientists at The Scripps Research Institute and the University of Southern California (USC), and further developed by biotech company ZZ Biotech.

9 Aug 2012

InSite Vision commences enrollment in BromSite Phase 3 clinical trial

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

31 Jul 2012

EC approves Vertex's KALYDECO for treatment of cystic fibrosis

Vertex Pharmaceuticals Incorporated announced today that the European Commission has approved KALYDECOTM (ivacaftor) for people with cystic fibrosis (CF) ages 6 and older who have at least one copy of the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

28 Jul 2012

FDA approves Horizon Pharma's RAYOS to treat key IL-6 mediated diseases

Horizon Pharma, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved RAYOS (prednisone) delayed-release tablets (1 mg, 2 mg and 5 mg) to treat a broad range of diseases including rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), ankylosing spondylitis (AS), asthma and chronic obstructive pulmonary disease (COPD).

26 Jul 2012

Alexion second quarter net product sales increase to $274.7 million

Alexion Pharmaceuticals, Inc. today announced financial results for the three and six months ended June 30, 2012.

25 Jul 2012

Vanderbilt researchers receives new $2.1M grant to develop microbrain bioreactor

Take a millionth of a human brain and squeeze it into a special chamber the size of a mustard seed. Link it to a second chamber filled with cerebral spinal fluid and thread both of them with artificial blood vessels in order to create a microenvironment that makes the neurons and other brain cells behave as if they were in a living brain. Then surround the chambers with a battery of sensors that monitor how the cells respond when exposed to minute quantities of dietary toxins, disease organisms or new drugs under development.

25 Jul 2012

Debiopharm initiates Debio 8206 Phase III study on advanced prostate cancer

Debiopharm Group (Debiopharm), a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs and companion diagnostics, today announced the treatment of its first patient in a multicentre, open, non-comparative Phase III study to investigate the efficacy, safety, and pharmacokinetics of two subcutaneous (SC) injections of Debio 8206 (triptorelin pamoate 22.5 mg 6-month formulation) in patients with advanced prostate cancer.

24 Jul 2012

XenoPort initiates XP23829 Phase 1 study in healthy adults

XenoPort, Inc. announced today that the first subjects have been dosed in a Phase 1, randomized, double-blind, two-period crossover, food effect comparison study of XP23829 in healthy adults. The trial is designed to assess the pharmacokinetics, safety and tolerability of a single dose of XP23829 administered in both fasted and fed conditions.

24 Jul 2012

Berg Pharma initiates BPM 31543 clinical trial for chemotherapy-induced alopecia

Berg Pharma, a Boston-based pharmaceutical company focused on discovery and development of new treatments in cancer and metabolic diseases, announced the initiation of a clinical trial entitled "Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a Topical Compound 31543 in Adult Patients Receiving Chemotherapy for the Treatment of Breast Cancer."

23 Jul 2012

Bayer, Onyx and Astellas announce results from Tarceva plus Nexavar Phase 3 trial on HCC

Bayer HealthCare Pharmaceuticals, Onyx Pharmaceuticals, Inc., and Astellas Pharma Inc. today announced that a Phase 3 trial evaluating the efficacy and safety of the addition of Tarceva (erlotinib) tablets to Nexavar (sorafenib) tablets did not improve overall survival for patients with unresectable hepatocellular carcinoma (HCC) vs. Nexavar alone.

23 Jul 2012

Angion Biomedica initiates BB3 Phase II trial in heart attack

Angion Biomedica Corp. announced today that the first patient was dosed in a Phase II multicenter clinical trial evaluating BB3 for the treatment of heart attack (acute myocardial infarction).

19 Jul 2012

Merck to present results from clinical studies on BACE inhibitors at AAIC 2012

Merck, known as MSD outside the United States and Canada, announced today presentations at the upcoming Alzheimer's Association International Conference (AAIC) being held in Vancouver, British Columbia, Canada on July 14-19, 2012.

16 Jul 2012

OncoMed commences dosing in OMP-54F28 Phase I clinical trial for advanced solid tumor cancers

OncoMed Pharmaceuticals, Inc., a clinical-stage company developing novel therapeutics that target cancer stem cells, or tumor-initiating cells, today announced that patient dosing has begun in a Phase I clinical trial of OMP-54F28 in patients with advanced solid tumor cancers.

13 Jul 2012

Arrowhead initiates Adipotide Phase 1 trial in obesity

Arrowhead Research Corporation, a targeted therapeutics company, today announced that the first patient has been dosed in a Phase 1 clinical trial with Adipotide, a new class of treatment for obesity.

11 Jul 2012

ImmunoGen announces start of IMGN853 Phase I trial for ovarian cancer, other solid tumors

ImmunoGen, Inc., a biotechnology company that develops anticancer therapeutics using its antibody expertise and Targeted Antibody Payload (TAP) technology, today announced the start of clinical testing with its IMGN853 product candidate.

11 Jul 2012

Anti-cancer activity of HuCAL antibody revealed by new data from OncoMed

MorphoSys AG's (FSE: MOR; Prime Standard Segment, TecDAX) partner OncoMed Pharmaceuticals today announced that Proceedings of the National Academy of Sciences of the United States of America (PNAS) has published online data demonstrating the potent anti-cancer activity of OMP-18R5, a HuCAL antibody targeting the Wnt pathway, in multiple preclinical human tumor models. OMP-18R5 is currently in Phase 1 clinical testing.

5 Jul 2012