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.

Ortho-McNeil terminates collaboration agreement with Arena on APD597 trial program

Arena Pharmaceuticals, Inc. announced today that, following the completion of a Phase 1 clinical trial program for APD597 (JNJ-38431055) under its collaboration with Arena, Ortho-McNeil-Janssen Pharmaceuticals, Inc., has decided not to advance APD597 and has notified Arena that it is terminating the collaboration, effective December 28, 2010.

7 Nov 2010

New England Journal of Medicine publishes brentuximab vedotin Phase I clinical trial data

Seattle Genetics, Inc. and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, today announced that data from a phase I single-agent clinical trial of brentuximab vedotin (SGN-35) will be published in the November 4, 2010 issue of the New England Journal of Medicine.

4 Nov 2010

Gender-related disparity in outcomes of lower extremities peripheral arterial disease continues: Study

Researchers from the Mount Sinai School of Medicine report that despite overall improvement, there is still gender-related disparity in outcomes of lower extremities peripheral arterial disease (PAD). Details of their study appear in the November issue of the Journal of Vascular Surgery®, published by the Society for Vascular Surgery®.

4 Nov 2010

Alnylam third quarter revenue increases from $24.2 million to $27.7 million

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

4 Nov 2010

Researchers investigate Human-cl rhFVIII factor for severe hemophilia A treatment

Octapharma AG, one of the largest human protein products manufacturers in the world, and Octapharma USA today announced that patients diagnosed with severe hemophilia A have started treatment in a multi-center study that is researching the use of the first recombinant Factor VIII (rFVIII) derived from a human cell line (Human-cl rhFVIII).

2 Nov 2010

Inhibitex announces initiation of INX-189 Phase 1b clinical trial for HCV infection

Inhibitex, Inc. announced today that it has initiated a Phase 1b, multiple ascending dose (MAD) clinical trial of INX-189, its nucleotide polymerase inhibitor in development for the treatment of chronic infections caused by hepatitis C virus (HCV).

1 Nov 2010

Presidio to present PPI-461 data for HCV infection at AASLD meeting

Presidio Pharmaceuticals, Inc. announced today that Nathaniel Brown, M.D., Chief Medical Officer, will present a late-breaker poster, "Safety and Pharmacokinetics of PPI-461, a Potent New Hepatitis C virus (HCV) NS5A Inhibitor with Pan-Genotype Activity" at the 61st AASLD meeting in Boston, MA, on November 1, 2010.

30 Oct 2010

FDA approves Teflaro for treatment of community-acquired bacterial pneumonia

Forest Laboratories, Inc. announced today that Teflaro(ceftaroline fosamil), a broad-spectrum bactericidal cephalosporin with activity against both gram-positive and gram-negative microorganisms, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of community-acquired bacterial pneumonia (CABP), including cases caused by Streptococcus pneumoniae bacteremia, and acute bacterial skin and skin structure infection (ABSSSI), including cases caused by methicillin-resistant Staphylococcus aureus (MRSA).

30 Oct 2010

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

Pharmacokinetics News and Research

Further Reading

Ortho-McNeil terminates collaboration agreement with Arena on APD597 trial program

New England Journal of Medicine publishes brentuximab vedotin Phase I clinical trial data

Gender-related disparity in outcomes of lower extremities peripheral arterial disease continues: Study

Alnylam third quarter revenue increases from $24.2 million to $27.7 million

Researchers investigate Human-cl rhFVIII factor for severe hemophilia A treatment

Inhibitex announces initiation of INX-189 Phase 1b clinical trial for HCV infection

Presidio to present PPI-461 data for HCV infection at AASLD meeting

FDA approves Teflaro for treatment of community-acquired bacterial pneumonia

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

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