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.

Targacept announces top-line results from AZD1446 Phase 2 clinical trial for ADHD

Targacept, Inc. today announced top-line results from a Phase 2 clinical trial of AZD1446 conducted by AstraZeneca in adults with attention deficit/hyperactivity disorder (ADHD).

8 Oct 2010

NeuroDerm receives $1M grant for development of ND0611 dermal patch for Parkinson's disease

NeuroDerm, Ltd. was informed today that it was awarded a grant of $1M by The Michael J. Fox Foundation for Parkinson's Research. These funds will support the next clinical study with ND0611, a new dermal patch for the treatment of Parkinson's disease, as part of the Foundation's prestigious Clinical Intervention Awards 2010 program. This study will evaluate the safety, tolerability, levodopa pharmacokinetics, and possible clinical benefits of ND0611 in advanced Parkinson's disease patients.

6 Oct 2010

Biogen to present late-stage clinical therapies for MS at ECTRIMS Congress

Biogen Idec today announced that more than 45 company and partner-sponsored platform and poster presentations will be presented during the 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Gothenburg, Sweden, October 13 - 16, 2010.

6 Oct 2010

FDA grants orphan drug designation to hGH-CTP for treating growth hormone deficiency

PROLOR Biotech, Inc., a company developing next generation biobetter therapeutic proteins, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to hGH-CTP, PROLOR's longer-acting version of human growth hormone for the treatment of growth hormone deficiency.

5 Oct 2010

Merck to appeal against jury verdict in retrial of federal FOSAMAX case

Merck & Co., Inc. today said it will appeal a decision by the U.S. District Court for the Southern District of New York that reduced the jury verdict from $8 million to $1.5 million but denied Merck's request for judgment in its favor or a new trial in the case of Boles v. Merck, a retrial of a federal FOSAMAX case.

5 Oct 2010

Merck's boceprevir Phase III studies for HCV to be presented at 61st AASLD

Merck today announced that final results from two pivotal Phase III studies of boceprevir, its investigational oral hepatitis C protease inhibitor, will be presented in oral plenary sessions at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which is taking place from Oct. 29 through Nov. 2 in Boston. Results for boceprevir in response-guided therapy strategies, which evaluated treatment durations shorter than current standard therapy, will be presented during the meeting.

4 Oct 2010

Sanofi-aventis publishes Phase III TROPIC study data in The Lancet article

Sanofi-aventis announced today that data from the Phase III TROPIC study, which was the basis for the June 2010 U.S. Food and Drug Administration (FDA) approval of Jevtana (cabazitaxel) Injection, was published in the October 2, 2010 print edition of The Lancet in an article titled "Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial.

4 Oct 2010

Array BioPharma to present positive interim results of Phase 1 ARRY-380 trial at ASCO Symposium

Array BioPharma Inc. today announced positive interim results of its novel, oral HER2 (ErbB2) inhibitor, ARRY-380, in a Phase 1 trial in patients with advanced cancer.

4 Oct 2010

Celsion presents Phase I/II DIGNITY trial data at 2010 Breast Cancer Symposium

Celsion Corporation announced today that interim data from its Phase I/II DIGNITY trial of ThermoDox in Recurrent Chest Wall (RCW) Breast Cancer were presented at the poster session at the 2010 Breast Cancer Symposium.

3 Oct 2010

FDA grants Emergent Fast Track Designation for AVP-21D9 anthrax monoclonal antibody development program

Emergent BioSolutions Inc. announced today that its anthrax monoclonal antibody development program investigating AVP-21D9 for the treatment of inhalational anthrax has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). Emergent recently commenced a Phase I clinical trial for AVP-21D9, which is a fully human monoclonal antibody product candidate being developed as a parenteral post-exposure therapeutic to treat symptoms of inhalational anthrax disease.

1 Oct 2010

Access Pharmaceuticals reports significant progress in Cobalamin-targeted drug-delivery program for siRNA therapies

ACCESS PHARMACEUTICALS, INC., a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes, announced today that it has made significant progress with its proprietary Cobalamin-targeted drug-delivery program for siRNA therapies.

30 Sep 2010

XenoPort to present XP21279 clinical trial data at World Parkinson Congress meeting

XenoPort, Inc. announced today that new data from its first clinical trial of XP21279, a Transported Prodrug of L-Dopa, in Parkinson's disease patients will be presented at the upcoming World Parkinson Congress meeting in Glasgow, Scotland.

29 Sep 2010

KAI Pharmaceuticals enrolls patients in Phase 1b study of KAI-4169 for treatment of SHPT

KAI Pharmaceuticals, Inc., a privately held drug discovery and development company, today announced enrollment of the first patients in a Phase 1b study of KAI-4169, a novel pharmaceutical agent being tested for the treatment of secondary hyperparathyroidism, which is a frequent and serious complication of end-stage renal disease.

27 Sep 2010

Enobia announces positive results from ENB-0040 Phase II juvenile clinical trial for hypophosphatasia

Enobia Pharma today announced positive results for its Phase II juvenile clinical trial of ENB-0040 (asfotase alfa), an experimental bone-targeted enzyme replacement therapy intended for the treatment of hypophosphatasia (HPP). Hypophosphatasia is a rare, inherited, and sometimes fatal metabolic bone disease that affects individuals of all ages.

24 Sep 2010

Santaris Pharma paves way to conduct clinical trial of miravirsen in patients with HVC

Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, today announced that it has advanced miravirsen (SPC3649), the first microRNA-targeted drug to enter clinical trials, into Phase 2 studies to assess the safety and tolerability of the drug in treatment-naive patients infected with the Hepatitis C virus.

22 Sep 2010

Phase I/II DIGNITY trial abstract of ThermoDox accepted for poster session at 2010 Breast Cancer Symposium

Celsion Corporation announced today that an abstract on its Phase I/II DIGNITY trial of ThermoDox in Recurrent Chest Wall Breast Cancer has been accepted for a poster session at the 2010 Breast Cancer Symposium. The abstract will provide updated clinical results, as well as the rationale and design of the DIGNITY study, which is evaluating ThermoDox in combination with microwave hyperthermia in women with RCW Breast Cancer.

22 Sep 2010

Boston Scientific reports positive data from PLATINUM Element Stent quantitative coronary angiography study

Boston Scientific Corporation today announced data from its PLATINUM QCA study, which is designed to evaluate the Company's PROMUS Element™ Everolimus-Eluting Platinum Chromium Coronary Stent. The results provided 30-day and nine-month clinical outcomes and nine-month quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS) data supporting the safety and efficacy of the PROMUS Element Stent.

22 Sep 2010

NIDA awards 5-year, $3.7M research grant for development of drug to treat cocaine addiction

The University of Maryland School of Pharmacy has received a prestigious $3.7 million grant to develop a drug to treat cocaine addiction based on an active ingredient found in some Chinese prescription medicines.

21 Sep 2010

Cytheris commences enrollment in CYT107 recombinant human Interleukin-7 clinical trial for HIV

Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced that it has begun enrolling patients in INSPIRE 3, a Phase II clinical program evaluating the effect of repeated cycles of the company's investigative immune-modulator, recombinant human Interleukin-7 (CYT107), in the treatment of chronically HIV-1 infected patients classified as Immunological Non-Responders (INR) after at least 24 months of highly active anti-retroviral therapy (HAART).

21 Sep 2010

CEDRA is renamed as Worldwide Clinical Trials Drug Development Solutions

For over 20 years, CEDRA Corporation, a division of Worldwide Clinical Trials, has been an industry leader in providing Bioanalytical Sciences and Phase I-IIb Clinical Research Services. Operating as a division of Worldwide Clinical Trials over the past three years, today, CEDRA Corporation announces its new company name, Worldwide Clinical Trials Drug Development Solutions.

20 Sep 2010

Pharmacokinetics News and Research

Further Reading

Targacept announces top-line results from AZD1446 Phase 2 clinical trial for ADHD

NeuroDerm receives $1M grant for development of ND0611 dermal patch for Parkinson's disease

Biogen to present late-stage clinical therapies for MS at ECTRIMS Congress

FDA grants orphan drug designation to hGH-CTP for treating growth hormone deficiency

Merck to appeal against jury verdict in retrial of federal FOSAMAX case

Merck's boceprevir Phase III studies for HCV to be presented at 61st AASLD

Sanofi-aventis publishes Phase III TROPIC study data in The Lancet article

Array BioPharma to present positive interim results of Phase 1 ARRY-380 trial at ASCO Symposium

Celsion presents Phase I/II DIGNITY trial data at 2010 Breast Cancer Symposium

FDA grants Emergent Fast Track Designation for AVP-21D9 anthrax monoclonal antibody development program

Access Pharmaceuticals reports significant progress in Cobalamin-targeted drug-delivery program for siRNA therapies

XenoPort to present XP21279 clinical trial data at World Parkinson Congress meeting

KAI Pharmaceuticals enrolls patients in Phase 1b study of KAI-4169 for treatment of SHPT

Enobia announces positive results from ENB-0040 Phase II juvenile clinical trial for hypophosphatasia

Santaris Pharma paves way to conduct clinical trial of miravirsen in patients with HVC

Phase I/II DIGNITY trial abstract of ThermoDox accepted for poster session at 2010 Breast Cancer Symposium

Boston Scientific reports positive data from PLATINUM Element Stent quantitative coronary angiography study

NIDA awards 5-year, $3.7M research grant for development of drug to treat cocaine addiction

Cytheris commences enrollment in CYT107 recombinant human Interleukin-7 clinical trial for HIV

CEDRA is renamed as Worldwide Clinical Trials Drug Development Solutions

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