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.

Pharmasset's PSI-938 phase I monotherapy trial shows positive result for HCV treatment

Pharmasset, Inc. reported positive preliminary results today from its phase I monotherapy trial of PSI-352938 for the treatment of chronic hepatitis C (HCV). PSI-938 is a guanosine nucleotide analog polymerase inhibitor in development for the treatment of chronic HCV infection.

28 Oct 2010

Octapharma initiates Human-cl rhFVIII clinical study for severe hemophilia A

Octapharma, one of the largest human protein products manufacturers in the world, today announced that patients diagnosed with severe hemophilia A have started treatment with the first recombinant Factor VIII derived from a human cell line (Human-cl rhFVIII). Researchers are investigating pharmacokinetics, efficacy, safety and immunogenicity of Human-cl rhFVIII for previously treated patients with severe hemophilia A.

28 Oct 2010

Lotus receives Chinese SFDA approval for R-Bambuterol Hydrochloride Phase I human clinical trials

Lotus Pharmaceuticals, Inc., a fast-growing, profitable developer, manufacturer and seller of medicine and drugs in the People's Republic of China ("PRC"), announced today that it received approval from the State Food and Drug Administration ("SFDA") Ethics Committee to commence Phase I human clinical trials of R-Bambuterol Hydrochloride, the Company's proprietary drug candidate for the treatment of asthma.

28 Oct 2010

Purdue and Mundipharma assume worldwide development for Infinity's fatty acid amide hydrolase program

Infinity Pharmaceuticals, Inc. today announced that Purdue Pharmaceutical Products L.P. and its independent associated company, Mundipharma International Corporation Ltd., have exercised their right to assume worldwide development and commercialization activities for Infinity's fatty acid amide hydrolase, or FAAH, program. The decision reflects progress made in the development of Infinity's oral FAAH inhibitor, IPI-940.

26 Oct 2010

TransPharma announces positive results of ViaDerm-hPTH Phase 1 trial for osteoporosis treatment

TransPharma Medical Ltd., a specialty pharmaceutical company focused on the development and commercialization of drug products utilizing a proprietary active transdermal drug delivery technology, announced today successful results of a 4 week Phase 1 trial of its new self-applied ViaDerm-hPTH(1-34) for the treatment of osteoporosis.

26 Oct 2010

Vertex initiates OPTIMIZE Phase 3b study in patients infected with genotype 1 HCV

Vertex Pharmaceuticals Incorporated today announced the initiation of a Phase 3b study called OPTIMIZE that will evaluate twice-daily (BID) dosing of a telaprevir-based combination regimen in people chronically infected with genotype 1 hepatitis C virus (HCV) who have not been treated previously. This is the first Phase 3 study to evaluate twice-daily dosing of a protease inhibitor for the treatment of hepatitis C. OPTIMIZE will not include a control arm of pegylated-interferon and ribavirin alone.

26 Oct 2010

Enrollment complete in ViroPharma's Phase 2 study evaluating subcutaneous delivery of Cinryze

ViroPharma Incorporated today announced that it has completed enrollment in its Phase 2 study evaluating subcutaneous delivery of Cinryze™ (C1esterase inhibitor [human]). This multi-center, open-label, multi-dose Phase 2 study is designed to evaluate the safety, pharmacokinetics and pharmacodynamics of subcutaneous versus intravenous administration of Cinryze in adolescent and adult subjects with hereditary angioedema (HAE).

25 Oct 2010

Astellas suspends patient enrollment from ACT 5 study of KYNAPID

Cardiome Pharma Corp. today announced that its co-development partner, Astellas Pharma US., Inc., has suspended patient enrollment in the ACT 5 study of KYNAPIDTM (vernakalant hydrochloride) Injection following a single unexpected serious adverse event of cardiogenic shock experienced by a patient with atrial fibrillation who received KYNAPID.

22 Oct 2010

Inspire presents data on denufosol therapy for cystic fibrosis at NACFC conference

Inspire Pharmaceuticals, Inc. announced today that data will be presented on denufosol tetrasodium, an investigational therapy for cystic fibrosis (CF), during oral and poster presentations at the 24th Annual North American Cystic Fibrosis Conference (NACFC) October 21-23, 2010 in Baltimore, Maryland.

22 Oct 2010

Idera announces IMO-3100 Phase 1 clinical trial results for autoimmune disease

Idera Pharmaceuticals, Inc. today announced results from its single-dose, dose-escalation Phase 1 clinical trial evaluating the safety and mechanism of action of IMO-3100, its lead Toll-like Receptor (TLR) 7 and TLR9 antagonist drug candidate for the treatment of autoimmune and inflammatory diseases.

22 Oct 2010

Astellas suspends enrollment in ACT 5 study of KYNAPID in atrial fibrillation patients

21 Oct 2010

Arena reports results of APD916 Phase 1 clinical trial for narcolepsy with cataplexy

Arena Pharmaceuticals, Inc. announced today results from a Phase 1 clinical trial of APD916, a novel drug candidate discovered by Arena that targets the histamine H3 receptor for the treatment of narcolepsy with cataplexy.

20 Oct 2010

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

Pharmacokinetics News and Research

Further Reading

Pharmasset's PSI-938 phase I monotherapy trial shows positive result for HCV treatment

Octapharma initiates Human-cl rhFVIII clinical study for severe hemophilia A

Lotus receives Chinese SFDA approval for R-Bambuterol Hydrochloride Phase I human clinical trials

Purdue and Mundipharma assume worldwide development for Infinity's fatty acid amide hydrolase program

TransPharma announces positive results of ViaDerm-hPTH Phase 1 trial for osteoporosis treatment

Vertex initiates OPTIMIZE Phase 3b study in patients infected with genotype 1 HCV

Enrollment complete in ViroPharma's Phase 2 study evaluating subcutaneous delivery of Cinryze

Astellas suspends patient enrollment from ACT 5 study of KYNAPID

Inspire presents data on denufosol therapy for cystic fibrosis at NACFC conference

Idera announces IMO-3100 Phase 1 clinical trial results for autoimmune disease

Astellas suspends enrollment in ACT 5 study of KYNAPID in atrial fibrillation patients

Arena reports results of APD916 Phase 1 clinical trial for narcolepsy with cataplexy

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

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