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 grants pediatric exclusivity for UCB's Keppra

UCB has announced that the US Food and Drug Administration (FDA) has granted pediatric exclusivity for Keppra (levetiracetam). The decision was based on pediatric data submitted to the FDA following a written request in 2001.

8 Jun 2008

ThromboGenics and BioInvent report positive results for anti-PlGF cancer therapeutic TB-403

ThromboGenics NV and co-development partner BioInvent International AB today reported that the results from the first Phase l study of novel anti-cancer agent TB-403 showed that it is safe and well tolerated, with pharmacokinetic properties enabling it to be developed for the treatment of cancer

3 Jun 2008

Peregrine Pharmaceuticals updates on Bavituximab breast cancer study

Peregrine Pharmaceuticals, Inc. has announced that results from a Phase I clinical trial of its lead anti-phosphatidylserine (anti-PS) antibody bavituximab in combination with chemotherapy in patients with advanced cancer were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting.

2 Jun 2008

Medarex announces preliminary data for investigational anti-PD-1 antibody

Medarex, Inc. has announced preliminary data from an ongoing Phase 1 study of MDX-1106 (ONO-4538: development code of Ono Pharmaceutical Co., Ltd.), a fully human anti-PD-1 antibody.

2 Jun 2008

Genta announces initial trial results for novel drug for bone disease

Genta Incorporated has announced the release of final results from the Company's Phase 1 clinical trial of G4544, a proprietary small molecule that is intended as a treatment for diseases associated with accelerated bone loss. Results showed that the drug was very well-tolerated, and that blood levels were achieved in a range that is known to be clinically bioactive. The data were featured in a poster session at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago on Saturday, May 31, 2008.

2 Jun 2008

Novel approach to drug insolubility strengthens PolyTherics patent estate

Polytherics Ltd, a biopharmaceutical spin-out company from Imperial College London and the London School of Pharmacy that specialises in the targeted application of polymers to biopharmaceuticals, has announced the grant of a European patent on the application of polymer complexation technology to improve drug efficacy.

28 May 2008

Researchers highlight distinct subtypes of myalgic encephalomyelitis

Researchers have identified distinct subtypes of myalgic encephalomyelitis (ME/CFS - also referred to as chronic fatigue syndrome) and there is renewed hope that treatments are available for this debilitating neurological illness.

7 May 2008

MacroChem acquires Virium Pharmaceuticals

MacroChem Corporation announced today that on April 18, 2008 it acquired Virium Pharmaceuticals Inc., a non-public, development stage company developing and commercializing novel therapeutics, with a portfolio of clinical stage product candidates focused in oncology, including its next generation nucleoside analogue licensed from the Southern Research Institute.

23 Apr 2008

MedImmune advances clinical development of antibody targeting interleukin-9 in patients with asthma

MedImmune has announced that its clinical program studying an investigational treatment targeting interleukin-9 (IL-9) has advanced with the start of a new trial in patients with asthma.

19 Mar 2008

New nanotube findings give boost to potential biomedical applications

Carbon nanotubes have shown real promise as highly accurate vehicles for delivering antitumor agents into malignant cells, but a dearth of data about what happens to the tubes after they discharge their medical payloads has been a major stumbling block to progress.

3 Mar 2008

Fluorescent nanoparticles image tumor marker in animals

Since 2004 the U.S. Food and Drug Administration has approved three new-generation anticancer therapies that target epidermal growth factor receptor (EGFR), a protein that is greatly overexpressed on certain types of tumors, including some forms of colorectal and lung cancer.

3 Mar 2008

Hydroxyurea for sickle cell patients

An independent panel convened this week by the NIH concluded that the use of hydroxyurea for sickle cell patients should be increased in adolescents and adults.

28 Feb 2008

FDA approves Nexium for gastroesophageal reflux disease in children

The U.S. Food and Drug Administration approved Nexium (esomeprazole magnesium) for short-term use in children ages 1-11 years for the treatment of gastroesophageal reflux disease (GERD).

28 Feb 2008

Novel small molecule therapy shows benefit for anemic patients via hydration of red blood cells

Researchers are identifying innovative therapeutics for sickle cell anemia that focus on specific factors in the disease's progression, such as the important role of hydration of the red blood cells.

7 Feb 2008

Trius Therapeutics starts U.S. phase I trial for Oxazolidinone antibacterial drug

Trius Therapeutics, Inc. has announced that it initiated its first Phase 1 clinical trial of TR-701, an antibacterial drug candidate intended for treatment of patients with serious Gram-positive bacterial infections, including those caused by MRSA and other drug-resistant strains.

9 Jan 2008

BioMarin Pharmaceutical announces FDA approval for Kuvan

BioMarin Pharmaceutical Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Kuvan(TM) (sapropterin dihydrochloride) Tablets, the first specific drug therapy approved for the treatment of phenylketonuria (PKU).

14 Dec 2007

FDA and Pharsight continue to collaborate under CRADA

Pharsight Corporation has provided an update on its Cooperative Research and Development Agreement (CRADA) with the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER).

12 Dec 2007

Resverlogix receives FDA approval to start clinical trial for RVX-208

Resverlogix Corp. has announced that it has received approval by the US Food and Drug Administration (FDA) to initiate a Phase 1a clinical trial of oral RVX-208 in the USA. RVX-208 is a novel first-in-class small molecule that increases the production of ApoA-I and HDL.

10 Dec 2007

Study results from Zolinza (vorinostat) in combination with bortezomib for multiple myeloma trial

Results from two investigational Phase I trials of ZOLINZA (vorinostat) in combination with bortezomib provide preliminary anti-tumor activity in patients with relapsed and/or refractory multiple myeloma.

10 Dec 2007

BioMarin files investigational NDA for PEG-PAL for the treatment of phenylketonuria

BioMarin Pharmaceutical Inc. has announced that it has filed an investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) for PEG-PAL (Poly Ethylene Glycol-Phenylalanine Ammonia Lyase), formerly known as Phenylase, for the treatment of phenylketonuria (PKU).

27 Nov 2007