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.

Flamel announces achievement of clinical development milestone with Merck Serono

Flamel Technologies announced today that it has achieved a clinical development milestone under the terms of its license agreement with Merck Serono, a division of Merck KGaA, Darmstadt, Germany, to develop an extended release formulation of interferon beta-1a using the Medusa platform.

19 Oct 2010

New data on Merck’s odanacatib for osteoporosis in postmenopausal women presented at 32nd ASBMR

New data on odanacatib, an investigational cathepsin-K (Cat-K) inhibitor in development for the treatment of osteoporosis in postmenopausal women, were presented at the 32nd Annual Meeting of the American Society for Bone and Mineral Research (ASBMR) in Toronto, Canada.

19 Oct 2010

14 global studies on osteoporosis medications FORTEO and EVISTA to be presented at ASBMR 2010

Eli Lilly and Company today announced that a total of 14 U.S. and global studies involving its osteoporosis medications, FORTEO® [teriparatide (rDNA origin) injection] and EVISTA® (raloxifene HCl tablets), will be presented at the American Society for Bone and Mineral Research (ASBMR) 2010 Annual Meeting from October 15-19 in Toronto, ON, Canada.

18 Oct 2010

Acceleron announces ACE-031 Phase 1b study results

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 preliminary results from a Phase 1b study to assess the safety, tolerability and pharmacodynamic (PD) activity of ACE-031 following multiple ascending doses in healthy postmenopausal volunteers.

14 Oct 2010

Threshold announces TH-302 Phase 1/2 clinical trial interim results

Threshold Pharmaceuticals, Inc. today announced interim results from an ongoing Phase 1/2 clinical trial in various solid tumors related to its hypoxia-activated prodrug, TH-302. The results were presented at the European Society for Medical Oncology (ESMO) Annual Meeting being held in Milan, Italy.

13 Oct 2010

Innate Therapeutics initiates MIS416 Phase 2a clinical study in patients with progressive multiple sclerosis

Innate Therapeutics today announced that the company has begun treating patients in a Phase 2a clinical study of its lead molecule, MIS416, in patients with progressive multiple sclerosis (MS).

11 Oct 2010

Infinity announces preliminary results of IPI-926 Phase 1 study in patients with solid tumors

Infinity Pharmaceuticals, Inc. today announced promising preliminary results from a Phase 1 study of IPI-926, its novel, oral small molecule that targets the Hedgehog pathway.

11 Oct 2010

IV ibuprofen effective in reducing fever in hospitalized patients

Cumberland Pharmaceuticals Inc. today announced the publication of data affirming the safety and efficacy of Caldolor (ibuprofen) Injection in treating fever in critically ill and non-critically ill adults. Published in the peer-reviewed journal Critical Care, the study showed that IV ibuprofen was significantly more effective at reducing fever in hospitalized patients than placebo.

8 Oct 2010

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

Pharmacokinetics News and Research

Further Reading

Flamel announces achievement of clinical development milestone with Merck Serono

New data on Merck’s odanacatib for osteoporosis in postmenopausal women presented at 32nd ASBMR

14 global studies on osteoporosis medications FORTEO and EVISTA to be presented at ASBMR 2010

Acceleron announces ACE-031 Phase 1b study results

Threshold announces TH-302 Phase 1/2 clinical trial interim results

Innate Therapeutics initiates MIS416 Phase 2a clinical study in patients with progressive multiple sclerosis

Infinity announces preliminary results of IPI-926 Phase 1 study in patients with solid tumors

IV ibuprofen effective in reducing fever in hospitalized patients

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

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