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.

Gentium second-quarter total revenues increase to EUR 7.55 million

Gentium S.p.A. today reported financial results for the first half of 2010 and for the quarter ended June 30, 2010. The Company reports its financial condition and operating results using U.S. Generally Accepted Accounting Principles (GAAP). The Company's financial statements are prepared using the Euro as its functional currency.

12 Aug 2010

Inhibitex reports net loss of $5.6 million for second-quarter 2010

Inhibitex, Inc. today announced its financial results for the second quarter ended June 30, 2010.

10 Aug 2010

Array BioPharma fiscal 2010 revenue increases to $53.9 million

Array BioPharma Inc. today reported financial results for the fourth quarter and full year of fiscal 2010.

10 Aug 2010

Elan and Transition Therapeutics report results of ELND005 Phase 2 study for Alzheimer's disease

Elan Corporation, plc and Transition Therapeutics, Inc today announced the results of a Phase 2 placebo-controlled study in 351 patients with mild to moderate Alzheimer's disease who received study drug for up to 18 months (Study AD201). Study subjects with MMSE scores between 16 and 26 received ELND005 oral doses of 250 mg, 1000 mg or 2000 mg twice daily or matching placebo. The study's cognitive (NTB) and functional (ADCS-ADL) co - primary endpoints did not achieve statistical significance.

10 Aug 2010

FDA approves Pfizer's Prefilled Dual-Chamber Syringe for XYNTHA administration in hemophilia A patients

Pfizer Inc. announced today that the U.S. Food and Drug Administration has granted approval of the use of a Prefilled Dual-Chamber Syringe for administration of XYNTHA® Antihemophilic Factor (Recombinant) Plasma/Albumin-Free to hemophilia A patients. XYNTHA is a recombinant factor VIII product indicated for both the control and prevention of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia) and for surgical prophylaxis in patients with hemophilia A.

9 Aug 2010

Aragon initiates dosing in ARN-509 Phase 1/2 clinical trial for castration-resistant prostate cancer

Aragon Pharmaceuticals today announced the dosing of the first patient in a Phase 1/2 clinical trial of the company's lead compound, ARN-509, in patients with castration-resistant prostate cancer (CRPC).

9 Aug 2010

New insights into development and applications of pharmacogenomics in psychiatry

In recent years, there have been major developments in the fields of pharmacogenetics and pharmacogenomics, with the potential to make drug treatments in psychiatric medicine more effective. However, improvements in drug efficacy and tolerability, as well as finding the optimal dosage, can only be realized if in vivo mechanisms of drug action and ADME (absorption, distribution, metabolism, excretion) processes (pharmacokinetics) of psychopharmacological agents are better understood.

5 Aug 2010

Merck's two pivotal boceprevir Phase III registration studies for chronic HCV meet primary endpoint

Merck reported that two pivotal Phase III registration studies for boceprevir, its investigational oral hepatitis C protease inhibitor, have been completed and met the primary endpoints: in both studies in patients with chronic hepatitis C virus (HCV) genotype 1 infection, the addition of boceprevir to treatment with PEGINTRON® and REBETOL® significantly increased the number of patients who achieved sustained virologic response, compared to control groups that received Peg/riba plus placebo.

5 Aug 2010

Alnylam second-quarter revenues increase to $26.6 million

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, today reported its consolidated financial results for the second quarter ended June 30, 2010, and company highlights.

5 Aug 2010

Acceleron's ACE-031 protein therapeutic for DMD receives FDA Fast Track designation

Acceleron Pharma, Inc., a biopharmaceutical company developing novel therapeutics that modulate the growth of cells and tissues including muscle, bone, fat, red blood cells and the vasculature, today announced it received FDA Fast Track designation for ACE-031 for the treatment of Duchenne Muscular Dystrophy (DMD), a fatal neuromuscular disease in which patients suffer from the progressive loss of muscle mass and strength. ACE-031 is an investigational protein therapeutic being developed to increase muscle mass and strength.

5 Aug 2010

MAP Pharmaceuticals reports net loss of $12.5M for second-quarter 2010

MAP Pharmaceuticals, Inc. today announced financial results for the second quarter ended June 30, 2010.

3 Aug 2010

Curis reports net loss of $2.1 million for second-quarter 2010

Curis, Inc., a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today reported its financial results for the second quarter ended June 30, 2010.

3 Aug 2010

First patient treated in Phase Ib expansion study of CUDC-101

Curis, Inc., a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that the first patient has been treated in a Phase Ib expansion study for CUDC-101 in patients with advanced head and neck, gastric, breast and liver cancers.

3 Aug 2010

FDA approves N30 Pharma's NDA for N6022 GSNOR

N30 Pharmaceuticals, LLC today announced the approval of its Investigational New Drug Application for N6022 by the U.S. Food and Drug Administration. N6022, a first-in-class inhibitor of s-nitrosoglutathione reductase (GSNOR), has the potential to be an important new treatment for acute exacerbations of asthma, chronic obstructive pulmonary disease (COPD) and inflammatory bowel disease (IBD).

3 Aug 2010

BioMarin provides update on PEG-PAL Phase 2 clinical study for phenylketonuria

BioMarin Pharmaceutical Inc. announced today an update in the Phase 2 clinical study of PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase) for the treatment of phenylketonuria (PKU). Data reported in this announcement reflect preliminary results as of July 23, 2010. Complete top-line results are expected in the fourth quarter of 2010.

3 Aug 2010

Study: hGH linked to PROLOR's CTP technology increases half-life, bioactivity

PROLOR Biotech, Inc., a company developing next generation biobetter therapeutic proteins, today reported publication of a preclinical study in the current on-line edition of the journal Endocrinology showing that human growth hormone (hGH) linked to PROLOR's carboxyl terminal peptide (CTP) technology has significantly increased half-life and bioactivity compared to commercially available hGH. The publication, which is authored by PROLOR researchers, will also be included in the September print edition of Endocrinology.

2 Aug 2010

Bio-Path commences dosing in Liposomal Grb-2 Phase I cancer study

Bio-Path Holdings, Inc.,, a biotechnology company with drug development operations in Houston, Texas, announced today that the first patient has been dosed in a Phase I study of its cancer drug candidate, Liposomal Grb-2 (L-Grb-2 or BP-100-1.01), in patients with Acute Myeloid Leukemia (AML), Chronic Myelogenous Leukemia (CML), Acute Lymphoblastic Leukemia (ALL) or Myelodysplastic Syndrome (MDS).

30 Jul 2010

Teva Respiratory reports positive results from BDP HFA Nasal Aerosol Phase III trial in seasonal allergic rhinitis

Teva Respiratory today announced positive results from a Phase III trial evaluating the efficacy and safety of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) Nasal Aerosol in the treatment of seasonal allergic rhinitis (SAR). The study met all efficacy endpoints, demonstrating a statistically significant benefit as compared to placebo. Furthermore, the safety profile of BDP HFA Nasal Aerosol was similar to placebo.

29 Jul 2010

CMX157 shows potential to suppress replication of HIV in Phase 1 clinical trial

Chimerix, Inc., a biopharmaceutical company developing orally-available antiviral therapeutics, today announced the publication of research results demonstrating the potential of CMX157 (hexadecyloxypropyl tenofovir) to effectively suppress replication of human immunodeficiency virus (HIV) that cannot be treated with currently available nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), including tenofovir disoproxil fumarate (Viread), due to the development of multi-drug resistance. Earlier this year, Chimerix initiated a dose-escalating Phase 1 clinical trial of CMX-157 to evaluate drug safety, tolerability and pharmacokinetics.

29 Jul 2010

Limerick to announce new results from LIM-0705 human trials at 23rd Transplantation Society congress

Limerick BioPharma, Inc., a developer of innovative therapies that help cells pump out unwanted or toxic substances, will announce new results from human trials of its lead compound, LIM-0705, at the 23rd International Congress of the Transplantation Society in Vancouver, Canada, in an oral presentation on August 19, 2010.

29 Jul 2010

Pharmacokinetics News and Research

Further Reading

Gentium second-quarter total revenues increase to EUR 7.55 million

Inhibitex reports net loss of $5.6 million for second-quarter 2010

Array BioPharma fiscal 2010 revenue increases to $53.9 million

Elan and Transition Therapeutics report results of ELND005 Phase 2 study for Alzheimer's disease

FDA approves Pfizer's Prefilled Dual-Chamber Syringe for XYNTHA administration in hemophilia A patients

Aragon initiates dosing in ARN-509 Phase 1/2 clinical trial for castration-resistant prostate cancer

New insights into development and applications of pharmacogenomics in psychiatry

Merck's two pivotal boceprevir Phase III registration studies for chronic HCV meet primary endpoint

Alnylam second-quarter revenues increase to $26.6 million

Acceleron's ACE-031 protein therapeutic for DMD receives FDA Fast Track designation

MAP Pharmaceuticals reports net loss of $12.5M for second-quarter 2010

Curis reports net loss of $2.1 million for second-quarter 2010

First patient treated in Phase Ib expansion study of CUDC-101

FDA approves N30 Pharma's NDA for N6022 GSNOR

BioMarin provides update on PEG-PAL Phase 2 clinical study for phenylketonuria

Study: hGH linked to PROLOR's CTP technology increases half-life, bioactivity

Bio-Path commences dosing in Liposomal Grb-2 Phase I cancer study

Teva Respiratory reports positive results from BDP HFA Nasal Aerosol Phase III trial in seasonal allergic rhinitis

CMX157 shows potential to suppress replication of HIV in Phase 1 clinical trial

Limerick to announce new results from LIM-0705 human trials at 23rd Transplantation Society congress

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