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.

Baxter commences anti-MIF antibody Phase I trial in malignant solid tumors

Baxter International Inc. today announced that the company has begun dosing patients with malignant solid tumors in a Phase I clinical trial of a monoclonal antibody, representing the company's efforts to extend its oncology portfolio with advanced biological research and development.

From Baxter International Inc. 6 Sep 2012

Epizyme commences EPZ-5676 Phase 1 study for MLL-r leukemia

Epizyme, Inc., a company leading the creation of a new class of personalized therapeutics for patients with genetically defined cancers, announced today that it has initiated a Phase 1 Study of EPZ-5676. EPZ-5676 is a novel small molecule inhibitor of DOT1L, a histone methyltransferase (HMT) that is critical to the development of a specific type of acute leukemia defined by rearrangement of the MLL gene (MLL-r leukemia).

5 Sep 2012

Baxter seeks FDA BLA approval for BAX 326 rFIX protein to treat hemophilia B

Baxter International Inc. today announced that the company has submitted a biologics license application to the United States Food and Drug Administration for approval of BAX 326, a recombinant factor IX (rFIX) protein being investigated for the treatment and prophylaxis of bleeding episodes for patients over 12 years of age with hemophilia B.

From Baxter International Inc. 5 Sep 2012

ImmusanT commences Nexvax2 clinical trials for celiac disease in New Zealand, Australia and the U.S.

ImmusanT announced today that it has initiated clinical trials in New Zealand, Australia and the U.S. to evaluate Nexvax2, the first therapeutic vaccine for patients with celiac disease. Nexvax2 is designed to re-establish patients' tolerance to the toxic effects of gluten, a protein in wheat, barley and rye, and allow them to return to a normal diet.

5 Sep 2012

Data from ESTEVE’s S1RA E-52862 Phase I trial programme on pain

ESTEVE announces the recent publication of data from the Phase I clinical trial programme of a novel, highly potent and selective, once-daily, S1RA E-52862, developed by the ESTEVE R&D team, in the British Journal of Clinical Pharmacology.

4 Sep 2012

Positive results from Elevation Pharmaceuticals’ EP-101 Phase 2b study on COPD

Elevation Pharmaceuticals, Inc. today presented positive efficacy and safety results from the GOLDEN-1 study – a Phase 2b study evaluating EP-101 in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) – at the annual meeting of the European Respiratory Society in Vienna, Austria.

3 Sep 2012

VLST, Pfizer enter in-licensing agreement for anti-CD40 monoclonal antibody

VLST Corporation, a Seattle-based biotechnology company focused on the development of therapeutics for cancer and autoimmune and inflammatory disorders, today announced an in-licensing agreement with Pfizer Inc. for an anti-CD40 monoclonal antibody.

31 Aug 2012

Collegium commences enrollment in Oxycodone DETERx Phase 3 study in chronic lower back pain

Collegium Pharmaceutical, Inc., a specialty pharmaceutical company focused on the development of innovative treatments for chronic pain today announced that it has initiated enrollment in its Phase 3 clinical study for Oxycodone DETERx (COL-003).

30 Aug 2012

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