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.

Second pivotal efficacy study not required for MAP Pharmaceuticals' LEVADEX NDA

MAP Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that a second pivotal efficacy study is not required for the Company's LEVADEX(TM) new drug application (NDA) submission for the acute treatment of migraine. The Company announced in May 2009 that the efficacy portion of its Phase 3 FREEDOM-301 clinical study of LEVADEX met all four primary endpoints. The Company had previously anticipated initiating a second pivotal efficacy study in the first quarter of 2010.

12 Jan 2010

Positive results from KemPharm's KP106 Phase 1 clinical trial for ADHD

KemPharm, Inc. today announced positive results from a Phase 1 clinical trial of KP106, its novel prodrug for attention-deficit hyperactivity disorder (ADHD). KP106, a new chemical entity (NCE) composed of the active pharmaceutical compound d-amphetamine and a ligand, was created using KemPharm’s proprietary Ligand Activated Therapy (LAT) prodrug approach.

12 Jan 2010

BioMarin Pharmaceutical commences BMN 195 Phase 1 clinical study for DMD

BioMarin Pharmaceutical Inc. announced today that the first subject has initiated treatment in the Phase 1 clinical study of BMN 195, a small molecule utrophin upregulator, for the treatment of Duchenne muscular dystrohpy (DMD). Initial top-line results are expected in the third quarter of 2010.

12 Jan 2010

New data from phase 3 study of avanafil for treatment of ED announced

VIVUS, Inc. today announced new data from an analysis of the recently completed phase 3 study (REVIVE TA-301) of avanafil, an investigational drug candidate for the treatment of erectile dysfunction (ED).

11 Jan 2010

Results from Phase 2a clinical trial of Raptor Pharmaceutical's cysteamine bitartrate published

Raptor Pharmaceutical Corp. ("Raptor" or the "Company"), today announced the publication of results from a Phase 2a clinical trial of a prototype formulation of its proprietary delayed-release cysteamine bitartrate ("DR Cysteamine") in patients with nephropathic cystinosis ("cystinosis").

11 Jan 2010

TetraLogic Pharmaceuticals commences its TL32711 SMAC mimetic Phase 1 clinical trial

TetraLogic Pharmaceuticals announced today that the Company has completed dosing of the first cohort in a Phase 1 clinical trial of its selective SMAC mimetic, TL32711. The Phase 1 trial is an open-label, dose-escalation study evaluating the safety and tolerability of TL32711 in adults with solid tumors or lymphoma refractory to standard therapies. The study will also assess the pharmacokinetics, pharmacodynamics and anti-tumor activity of TL32711.

8 Jan 2010

Phase 1 clinical trial of SIRT1 inhibitor for the treatment of Huntington’s Disease commenced

Elixir Pharmaceuticals, Inc. announced today that its partner, Siena Biotech S.p.A., has commenced Phase 1 clinical testing of Elixir’s potent, first-in-class SIRT1 (sirtuin-1) inhibitor for the treatment of Huntington’s Disease.

8 Jan 2010

Pharsight releases Phoenix NLME and Phoenix Connect

Pharsight, a market-leading provider of software and scientific services to improve productivity and decision-making in clinical drug development, today announced that it has released two new data analysis tools; Phoenix NLME and Phoenix Connect.

6 Jan 2010

Phase I clinical trial for Intellikine's INK128 inhibitor initiated

Intellikine, Inc. has initiated a Phase I clinical trial for its targeted anticancer drug INK128, a novel orally-available small molecule inhibitor of both the TORC1 and TORC2 complexes, key components of the PI3K/mTOR signaling pathway.

6 Jan 2010

EnVivo Pharmaceuticals announces initiation and dosing of patients in Phase 2b study of EVP-6124

EnVivo Pharmaceuticals today announced the initiation and dosing of patients in a Phase 2b study of its EVP-6124 compound, a selective alpha-7 nicotinic agonist in patients with schizophrenia. EnVivo is conducting the multi-center, dose ranging, placebo controlled, three-month study in the U.S. and Europe.

6 Jan 2010

ADVENTRX Pharmaceuticals submits a NDA for its vinorelbine injectable emulsion

ADVENTRX Pharmaceuticals, Inc. announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its product candidate ANX-530 (vinorelbine injectable emulsion).

4 Jan 2010

BioInvent International begins BI-505 drug study on patients with advanced multiple myeloma

BioInvent International AB announced today that the first patient has been treated in an open, dose-escalation phase I study of the company’s antibody BI-505 for patients with advanced multiple myeloma.

4 Jan 2010

Biodel submits NDA to FDA for clearance to market VIAject

Biodel, Inc. announced today that it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration for clearance to market VIAject® as a treatment for diabetes.

30 Dec 2009

Compugen, Pfizer enter into multi-target collaboration

Compugen Ltd. announced today that it has signed a collaboration agreement with Pfizer for the predictive discovery by Compugen of therapeutic peptide product candidates for three drug targets of interest to Pfizer. The discovery process, which will be based on various Compugen discovery platforms and funded by Pfizer, is expected to take a few months, following which the predicted molecules will be synthesized and delivered to Pfizer.

23 Dec 2009

Neurocrine to advance its NBI-98854 VMAT2 Inhibitor into a multiple repeated dose Phase 1 study

Neurocrine Biosciences, Inc. today announced their highly selective vesicular monoamine transporter 2 (VMAT2) inhibitor, NBI-98854, will be advanced in clinical development.

21 Dec 2009

Durata Therapeutics acquires Vicuron Pharmaceuticals

Durata Therapeutics, Inc. announced today that it has acquired Vicuron Pharmaceuticals from Pfizer (PFE). Durata is a newly formed biopharmaceutical company that was created by a five-member venture capital syndicate to pursue late-stage clinical development of novel antibiotic programs. The acquisition was funded through a stock purchase by New Leaf Venture Partners, LLC, Domain Associates, LLC, Aisling Capital, Sofinnova Ventures Inc. and Canaan Partners.

21 Dec 2009

Arno Therapeutics announces dosing of first patient in Phase II clinical study of AR-67

Arno Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing oncology therapeutics, today announced the dosing of the first patient in a Phase II clinical study of its third-generation camptothecin compound, AR-67, in patients with Glioblastoma Multiforme (GBM), an aggressive form of brain cancer.

17 Dec 2009

Naurex commences dosing in its GLYX-13 Phase I clinical trial for treatment-resistant depression

Naurex Inc., a new clinical stage company developing innovative treatments for depression and other CNS disorders based on its novel GFPA NMDA receptor modulators, today announced that it has initiated a Phase I clinical trial of its lead compound GLYX-13 and has successfully dosed the first subjects in the study.

16 Dec 2009

Almac Discovery initiates Phase I clinical trial of intranasal Granisetron for CINV

Almac Discovery today announced the start of Phase I clinical trial of the novel intranasal Granisetron product. This product, which uses Archimedes' proprietary ChiSys® delivery technology, is being developed as a rapidly acting, well tolerated and convenient treatment for chemotherapy-induced nausea and vomiting (CINV).

15 Dec 2009

University of Wisconsin IRB approves GenSpera's G-202 Phase I study for cancer

GenSpera, Inc. announced today that the Institutional Review Board (IRB) at the University of Wisconsin, in Madison, WI, has approved a Phase I study of its target activated pro-drug, G-202, for the treatment of cancer. The FDA (US Food and Drug Administration) approved the study in September. GenSpera expects to enroll the first study patient early in the first quarter of 2010.

15 Dec 2009

Pharmacokinetics News and Research

Further Reading

Second pivotal efficacy study not required for MAP Pharmaceuticals' LEVADEX NDA

Positive results from KemPharm's KP106 Phase 1 clinical trial for ADHD

BioMarin Pharmaceutical commences BMN 195 Phase 1 clinical study for DMD

New data from phase 3 study of avanafil for treatment of ED announced

Results from Phase 2a clinical trial of Raptor Pharmaceutical's cysteamine bitartrate published

TetraLogic Pharmaceuticals commences its TL32711 SMAC mimetic Phase 1 clinical trial

Phase 1 clinical trial of SIRT1 inhibitor for the treatment of Huntington’s Disease commenced

Pharsight releases Phoenix NLME and Phoenix Connect

Phase I clinical trial for Intellikine's INK128 inhibitor initiated

EnVivo Pharmaceuticals announces initiation and dosing of patients in Phase 2b study of EVP-6124

ADVENTRX Pharmaceuticals submits a NDA for its vinorelbine injectable emulsion

BioInvent International begins BI-505 drug study on patients with advanced multiple myeloma

Biodel submits NDA to FDA for clearance to market VIAject

Compugen, Pfizer enter into multi-target collaboration

Neurocrine to advance its NBI-98854 VMAT2 Inhibitor into a multiple repeated dose Phase 1 study

Durata Therapeutics acquires Vicuron Pharmaceuticals

Arno Therapeutics announces dosing of first patient in Phase II clinical study of AR-67

Naurex commences dosing in its GLYX-13 Phase I clinical trial for treatment-resistant depression

Almac Discovery initiates Phase I clinical trial of intranasal Granisetron for CINV

University of Wisconsin IRB approves GenSpera's G-202 Phase I study for cancer

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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