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.

FDA clears Lorus' LOR-253 IND application for treatment of hematologic malignancies

Lorus Therapeutics Inc. today announced that the Food and Drug Administration completed its review and cleared the company's Investigational New Drug (IND) application of LOR-253 for the treatment of hematologic malignancies including acute myeloid leukemia (AML), high-risk myelodysplastic syndromes (MDS), lymphomas and multiple myeloma.

28 Jul 2014

Phase 3 trial: NEXAVAR tablets fail to meet primary endpoint in HER2-negative breast cancer patients

Bayer HealthCare and Onyx Pharmaceuticals Inc., an Amgen subsidiary, today announced that an investigational Phase 3 trial of NEXAVAR (sorafenib) tablets in patients with advanced breast cancer did not meet its primary endpoint of improving progression-free survival (PFS).

25 Jul 2014

Kinex receives FDA approval to begin Phase I study of KX2-391 Ointment for actinic keratosis

Kinex Pharmaceuticals announced the receipt of an allowance by the US FDA for the Company's KX2-391 Ointment for the commencement of a Phase I clinical study in actinic keratosis. This is the Company's third IND to be allowed by the US FDA in the past 12 months.

25 Jul 2014

Glide Pharma announces successful completion of pre-clinical proof-of-concept study with novel solid formulation of octreotide acetate

Glide Pharma, the pharmaceutical development and device company focused on solid dose formulations of therapeutics and vaccines, today announced that its novel solid formulation of octreotide acetate achieved successful results in a pre-clinical proof-of-concept study comparing it with the currently marketed liquid product (Sandostatin®).

22 Jul 2014

Charles E. Daniels named recipient of 2014 John W. Webb Lecture Award

The American Society of Health-System Pharmacists has named Charles E. Daniels, PhD, FASHP, as the recipient of the 2014 John W. Webb Lecture Award.

10 Jul 2014

Genetic variants alter chance of sunitinib dose reduction

Scientists have identified genetic variants that reduce the likelihood of sunitinib dose reduction in patients with metastatic renal cell carcinoma.

30 Jun 2014

Merck reports results from global EMEND Phase 3 study for CINV prevention in pediatric cancer patients

Merck, known as MSD outside the United States and Canada, today announced results from a global, investigational Phase 3 study to evaluate the safety and efficacy of EMEND (aprepitant) in the prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric cancer patients, aged 6 months to 17 years.

30 Jun 2014

Afrezza gets FDA approval to improve glycemic control in adults with diabetes mellitus

The U.S. Food and Drug Administration today approved Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. Afrezza is a rapid-acting inhaled insulin that is administered at the beginning of each meal, or within 20 minutes after starting a meal.

28 Jun 2014

Trevena's Phase 1b data for TRV130 published in the journal Pain

Trevena, Inc., a clinical stage biopharmaceutical company and the leader in the discovery of G protein coupled receptor (GPCR) biased ligands, today announced the publication of its Phase 1b data for TRV130 in the journal Pain.

24 Jun 2014

Scientists turn to old class of antibiotics to fight superbugs resistant to modern medicine

Scientists at the University at Buffalo are turning to an old class of antibiotics to fight new superbugs resistant to modern medicine.

24 Jun 2014

Aradigm begins Pulmaquin Phase III study for treatment of non-CF BE

Aradigm Corporation ("Aradigm" or the "Company") today announced the dosing of the first patient in the ORBIT-4 (Once-daily Respiratory Bronchiectasis Inhalation Treatment) Phase III pivotal clinical trial of Aradigm's proprietary formulation of inhaled ciprofloxacin (Pulmaquin®) for the treatment of non-cystic fibrosis bronchiectasis (non-CF BE).

23 Jun 2014

Trevena reports positive results from TRV734 Phase 1 trial for treating acute/chronic pain

Trevena, Inc. (NASDAQ:TRVN) today announced positive results from its Phase 1 trial of TRV734, which Trevena is developing with the goal of providing improved analgesia while avoiding gastrointestinal and respiratory side effects typically associated with opioids.

23 Jun 2014

Debiopharm launches Phase 1 study of anti-infective agent Debio 1450

Debiopharm Group, a Swiss-based global biopharmaceutical company developing prescription drugs that target unmet medical needs as well as companion diagnostics, today announced the launch of a Phase 1 dose-escalation study of Debio 1450 (previously known as AFN-1720), a highly potent anti-infective agent that is selectively active against a large number of Staphylococcus species, including all known resistant strains such as methicillin-resistant S. aureus (MRSA) and vancomycin-intermediate S. aureus (VISA).

19 Jun 2014

Researchers examine effects of testosterone on women after menopause

Testosterone supplementation for women is a hot topic. A new pharmacokinetics study of a brand of testosterone cream for women approved in Western Australia has been published online in Menopause, the journal of The North American Menopause Society (NAMS).

11 Jun 2014

FDA grants orphan drug designation to EffRx Pharmaceuticals' EX404 for treatment of PCOS

EffRx Pharmaceuticals SA, a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration has granted orphan drug designation to its proprietary metformin-based product candidate, EX404, for the treatment of pediatric polycystic ovary syndrome (PCOS).

11 Jun 2014

Celsion signs definitive asset purchase agreement to acquire EGEN

Celsion Corporation (Celsion) (NASDAQ: CLSN), an oncology drug development company, and EGEN, Inc. (EGEN), a privately-held biopharmaceutical company focused on the development of nucleic acid-based therapeutics for the treatment of cancer and other difficult to treat diseases, today announced the signing of a definitive asset purchase agreement in which Celsion will acquire substantially all of the assets of EGEN, including its Phase Ib DNA-based immunotherapy product candidate EGEN-001 and its therapeutic platform technologies, TheraPlas™ for delivery of DNA and mRNA, TheraSilence™ for delivery of RNA, and RAST™ for Cell Enabled Expression and Secretion of RNA.

10 Jun 2014

Merck enrolls first patient in reformulated raltegravir Phase 3 trial for treatment of HIV-1 infection

Merck, known as MSD outside the United States and Canada, today announced that the first patient has been enrolled in the company's global Phase 3 clinical trial, ONCEMRK.

6 Jun 2014

Edge Therapeutics commences enrollment in second cohort of EG-1962 Phase 1/2 NEWTON study for aSAH

Edge Therapeutics, a clinical-stage biotechnology company that discovers, develops and seeks to commercialize novel, hospital-based therapies for acute, life-threatening neurological conditions, today announced that it has initiated patient enrollment in the second cohort of the NEWTON study, a multicenter, randomized, controlled, open-label, Phase 1/2 clinical trial of the company's lead product candidate, EG-1962.

5 Jun 2014

PsiOxus Therapeutics presents positive study results of anti-cancer vaccine Enadenotucirev at ASCO Annual Meeting

PsiOxus Therapeutics, Ltd. (PsiOxus), an award-winning biotechnology company developing innovative, novel treatments for cancer, announced that updates for its on-going international multicentre clinical program of the oncolytic vaccine enadenotucirev (previously known as ColoAd1) were presented at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.

4 Jun 2014

NeuroVive extends collaboration with Hospices Civils de Lyon

NeuroVive is extending its collaboration with Hospices Civils de Lyon (HCL) and Professor Ovize, which broadens the scope of NeuroVive's cardiovascular business area and creates the right conditions for the company to retain its leading position in mitochondrial medicine.