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.

Simulations Plus launches new version of GastroPlus simulation software

Simulations Plus, Inc., a leading provider of simulation and modeling software and consulting services for pharmaceutical discovery and development, announced today the release of Version 8.0 of its flagship GastroPlus simulation software with significantly expanded functionality and user convenience.

27 Apr 2012

Positive results from Repligen's RG3039 Phase 1 study for spinal muscular atrophy

Repligen Corporation today announced positive results from a Phase 1 study to evaluate the pharmacokinetic (PK) and safety profile of RG3039, a novel small molecule drug candidate for the potential treatment of spinal muscular atrophy (SMA).

25 Apr 2012

R-Tech Ueno completes RK-023 phase I study on hypotrichosis of the eyelashes

R-Tech Ueno is pleased to announce the completion of a phase I clinical study of RK-023, a new compound that is being developed for the treatment of hypotrichosis of the eyelashes.

24 Apr 2012

MicuRx completes MRX-I Phase 1 trial on MRSA and VRE infection

MicuRx Pharmaceuticals, Inc., a privately-held biopharmaceutical company developing next-generation antibiotics, today announced the completion of its Phase 1 clinical trial for MRX-I, its first development-stage antibiotic drug candidate.

23 Apr 2012

Palatin, AstraZeneca initiate second AZD2820 phase I trial in obesity

Palatin Technologies, Inc. today announced that a second phase I clinical trial of AZD2820, a subcutaneously-administered peptide melanocortin receptor partial agonist under development for the treatment of obesity, has commenced.

20 Apr 2012

Final data from Santaris’ miravirsen Phase 2a trial on HCV to be presented at ILC 2012

Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, will present final data from a Phase 2a trial showing that miravirsen given as a four-week monotherapy treatment provided robust dose-dependent anti-viral activity with a mean reduction of 2 to 3 logs from baseline in HCV RNA (log10 IU/mL) that was sustained well beyond the end of therapy.

19 Apr 2012

Results from Presidio’s PPI-668 Phase 1a-1b trial on chronic HCV

Presidio Pharmaceuticals, Inc. announced results today from a Phase 1a-1b clinical trial of PPI-668, a potent, pan-genotypic HCV NS5A inhibitor being developed for the treatment of patients with chronic hepatitis C.

19 Apr 2012

Inspiration submits IB1001 BLA with FDA for treatment of hemophilia B

Ipsen today announced that its partner, Inspiration Biopharmaceuticals, Inc., has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the approval of IB1001, an intravenous recombinant factor IX (rFIX) for the treatment and prevention of bleeding in individuals with hemophilia B.

17 Apr 2012

USPTO issues two Notices of Allowance to AcelRx for NanoTab formulations

AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced that the U.S. Patent and Trademark Office (USPTO) has issued AcelRx two Notices of Allowance for the patent applications entitled "Small-Volume Oral Transmucosal Dosage Forms" and "Bioadhesive Drug Formulations for Oral Transmucosal Delivery."

12 Apr 2012

FDA clears Cerecor’s FP01 IND for treatment of cough

Cerecor Inc., a biopharmaceutical company focused on the discovery, development and commercialization of prescription pharmaceuticals whose primary activity is in the human nervous system, today announced that its Investigational New Drug (IND) Application for FP01 for the treatment of cough has cleared the 30 day deliberation period by the U.S. Food and Drug Administration.

12 Apr 2012

USPTO issues Notice of Allowance for Sunshine Biopharma's anti-tumor compound patent application

Sunshine Biopharma Inc. is pleased to announce that it has recently received notification that the United States Patent and Trademark Office has issued a "Notice of Allowance" for the patent application covering its lead anti-tumor compound, Adva-27a. The allowed claims protect Adva-27a and extensively cover various formulations, derivatives and cancer applications.

9 Apr 2012

Akebia completes AKB-6548 Phase 2 study for anemia in CKD patients

Akebia Therapeutics, Inc., a pharmaceutical discovery and development company focused on anemia and vascular disorders, today announced that it has successfully completed a randomized, double-blinded, placebo-controlled Phase 2 dose-ranging study of AKB-6548 in patients with stage 3 and 4 chronic kidney disease (CKD).

6 Apr 2012

Results from Abbott’s multiple interferon-free Phase 2 HCV studies to be presented at ILC 2012

Abbott will present clinical trial results from two different interferon-free, Phase 2 studies for the treatment of hepatitis C (HCV) at the International Liver Congress 2012 (ILC 2012), the annual meeting of the European Association for the Study of the Liver (EASL), April 18-22 in Barcelona, Spain.

5 Apr 2012

Novel tetracyclines with improved potency, efficacy against contemporary P. aeruginosa isolates

Tetraphase Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on next-generation antibiotics, announced today that it is presenting new results from studies that demonstrate the improved potency and pharmacokinetics of several of its newest discovery-stage tetracycline analogs.

2 Apr 2012

Nektar commences dosing in NKTR-192 Phase 1 clinical study for treatment of acute pain

Nektar Therapeutics announced today that the first subjects were dosed last week in a Phase 1 clinical study to evaluate the pharmacokinetics and safety of NKTR-192, the company's novel short-acting mu-opioid analgesic candidate.

2 Apr 2012

CSL Behring initiates rVIIa-FP Phase I study in hemophilia A and B

CSL Behring announced today the first in human dosing of recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP). The Phase I study will investigate in healthy volunteers the safety and pharmacokinetics of rVIIa-FP in comparison to placebo.

31 Mar 2012

AlphaCore Pharma commences ACP-501 Phase 1 study in coronary arterial disease

AlphaCore Pharma, a biopharmaceutical company developing ACP-501 (rhLCAT) for the treatment of high risk atherosclerosis and serious lipid metabolism disorders, today announced the initiation of a Phase 1 study of ACP-501 in patients with stable coronary arterial disease.

31 Mar 2012

Positive results from Nile's cenderitide Phase 1 trial on chronic heart failure

Nile Therapeutics, Inc., a biopharmaceutical company that develops novel therapeutics for heart failure patients, today announced results from its recently completed Phase 1 clinical trial evaluating the pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of subcutaneous bolus and subcutaneous infusion of cenderitide in patients with chronic heart failure.

29 Mar 2012

Top-line results from two Targacept TC-6987 Phase 2 studies on asthma, type 2 diabetes

Targacept, Inc., a clinical-stage biopharmaceutical company developing novel NNR Therapeutics, today announced top-line results from two separate exploratory Phase 2 studies of its product candidate TC-6987 conducted in the United States, one in asthma and one in type 2 diabetes.

28 Mar 2012

Positive data from Aerpio's AKB-9778 Phase 1 trial on DME

Aerpio Therapeutics, a clinical‐stage biopharmaceutical company focused on advancing innovative therapies for the treatment of diabetic eye disease and inflammatory bowel disease, today announced positive data from its Phase 1 trial of AKB-9778 for the treatment of diabetic macular edema.

21 Mar 2012