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.

Top-line results from Auxilium XIAFLEX palpable cord study in Dupuytren's contracture subjects

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced positive top-line results from a pilot clinical study to assess safety, tolerability, and multiple-dose pharmacokinetics of XIAFLEX (collagenase clostridium histolyticum) in adult Dupuytren's contracture subjects with multiple palpable cords.

7 Sep 2011

Positive results from BDSI's BEMA Buprenorphine/Naloxone formulation Phase 1 study on opioid dependence

BioDelivery Sciences International, Inc. announced positive preliminary results from its Phase 1 study assessing the pharmacokinetics of a BEMA Buprenorphine/Naloxone formulation.

6 Sep 2011

Enrollment complete in DURECT's POSIDUR Phase III study for post-surgical pain

DURECT Corporation announced today the dosing of the last patient in the U.S. pivotal Phase III clinical study for POSIDUR known as BESST.

6 Sep 2011

NOXXON to commence NOX-H94 Phase I trial in anemia of chronic disease

NOXXON Pharma today announced the initiation of a Phase I clinical trial for NOX-H94, the Company's third compound to enter the clinic. NOX-H94 is a Spiegelmer designed to treat anemia of chronic disease by targeting the peptide hormone hepcidin, the key regulator of iron metabolism.

6 Sep 2011

Bristol-Myers Squibb selects ICON as preferred provider for early phase clinical development

ICON plc, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced that it has been chosen by Bristol-Myers Squibb Company as a preferred provider for full-service clinical pharmacology and exploratory clinical studies.

30 Aug 2011

Results of darexaban phase II trial in recent acute coronary syndrome presented at ESC Congress

A phase II dose-finding study has found that the new oral Factor Xa inhibitor darexaban was associated with a two to four-fold increase in bleeding when added to dual antiplatelet therapy in patients following an acute coronary syndrome.

30 Aug 2011

BIPI to launch dabigatran etexilate Phase II trial in patients with mechanical heart valves

Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) today announced plans to launch RE-ALIGN, a global, Phase II trial evaluating the safety and pharmacokinetics of dabigatran etexilate in 400 patients who have mechanical heart valves.

26 Aug 2011

KFDA approves IND for DP-b99 Phase III MACSI stroke study in Korea

D-Pharm Ltd., announced today that the Korean Food & Drug Administration (KFDA) approved the Investigational New Drug application for the Phase III MACSI study of DP-b99 in Korea. The IND has been submitted by D-Pharm's co-development partner in South Korea, Yungjin Pharmaceutical Company Ltd..

24 Aug 2011

Spinifex secures AU$6.25 million in expanded Series B funding

Spinifex Pharmaceuticals, an Australian pain drug development company, today announced it has secured a further AU$6.25 million of venture capital investment from GBS Venture Partners Limited, Brandon Capital Partners Pty Limited, Uniseed Management Pty Limited and UniQuest Pty Limited to fund the development of its pain management drug, EMA401.

23 Aug 2011

Emergent commences TRU-016 Phase 1b/2 combination trial in relapsed indolent NHL

Emergent BioSolutions Inc. today announced the initiation of a Phase 1b/2 study (16011) of TRU-016 in combination with rituximab and bendamustine for patients with relapsed indolent non-Hodgkin's B-cell lymphomas, including follicular lymphoma, small lymphocytic lymphoma and marginal zone lymphoma.

17 Aug 2011

Curis initiates CUDC-101 Phase I combination trial in advanced head and neck cancer

Curis, Inc., a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that the first patient has been treated in a Phase I combination trial of CUDC-101.

17 Aug 2011

AVI BioPharma, MDA to initiate exon-51 Phase 2 trial in Duchenne muscular dystrophy

More than a decade of targeted Muscular Dystrophy Association-funded research, made possible as a result of generous public support of the MDA Labor Day Telethon and thousands of grass-roots special events, has today culminated in MDA providing financial assistance for the start of the first Phase 2 placebo-controlled, multiple dose efficacy, safety, tolerability and pharmacokinetics clinical trial of an exon-51 skipping drug, eteplirsen, as a potential therapy for Duchenne muscular dystrophy.

16 Aug 2011

China Pharma second quarter revenue increases 18% to $19.6 million

China Pharma Holdings, Inc., a specialty pharmaceuticals company in China, today announced financial results for the quarter ended June 30, 2011.

11 Aug 2011

Simcyp extends application in areas of PD modelling and drug distribution within CNS

Simcyp Limited is pleased to announce significant additions to its flagship simulator in line with priorities established by the Simcyp Consortium of global pharmaceutical companies.

6 Aug 2011

FDA accepts MAP Pharmaceuticals' LEVADEX NDA for filing

MAP Pharmaceuticals, Inc. today announced that its New Drug Application (NDA) for LEVADEX® orally inhaled migraine drug for the potential acute treatment of migraine in adults has been accepted for filing by the U.S. Food and Drug Administration (FDA), with a goal date of March 26, 2012 under the Prescription Drug User Fee Act (PDUFA).

2 Aug 2011

Positive results from Alnylam's ALN-VSP Phase I trial for liver cancer

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that it has completed its Phase I study with ALN-VSP, a systemically delivered RNAi therapeutic for the treatment of advanced solid tumors with liver involvement.

1 Aug 2011

ORENCIA SC formulation receives FDA approval for treatment of adults with RA

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration has approved a subcutaneous formulation of ORENCIA (abatacept) for the treatment of adults with moderate to severe rheumatoid arthritis.

30 Jul 2011

New preclinical data from Baxter's BAX 499 hemophilia study presented at ISTH

Baxter International Inc. announced today that new data from a series of studies on BAX 499, an investigational compound for potential subcutaneous hemophilia therapy, were presented this week during the 23rd annual congress of the International Society on Thrombosis and Haemostasis (ISTH) in Kyoto, Japan.

From Baxter International Inc. 27 Jul 2011

Lipid-based nanocarrier can improve cancer treatments

Scientists seeking to improve cancer treatments have created a tiny drug transporter that maximizes its ability to silence damaging genes by finding the equivalent of an expressway into a target cell.

27 Jul 2011

Ceridia completes CER006 Phase 1 Proof-of-Concept study in humans

Ceridia Pty Ltd., a biotechnology company focused on reformulating and developing therapeutic drugs, announce the successful completion of Phase 1 Proof-of-Concept study of its novel LipoCeramic ibuprofen formulation, CER006.

27 Jul 2011

Pharmacokinetics News and Research

Further Reading

Top-line results from Auxilium XIAFLEX palpable cord study in Dupuytren's contracture subjects

Positive results from BDSI's BEMA Buprenorphine/Naloxone formulation Phase 1 study on opioid dependence

Enrollment complete in DURECT's POSIDUR Phase III study for post-surgical pain

NOXXON to commence NOX-H94 Phase I trial in anemia of chronic disease

Bristol-Myers Squibb selects ICON as preferred provider for early phase clinical development

Results of darexaban phase II trial in recent acute coronary syndrome presented at ESC Congress

BIPI to launch dabigatran etexilate Phase II trial in patients with mechanical heart valves

KFDA approves IND for DP-b99 Phase III MACSI stroke study in Korea

Spinifex secures AU$6.25 million in expanded Series B funding

Emergent commences TRU-016 Phase 1b/2 combination trial in relapsed indolent NHL

Curis initiates CUDC-101 Phase I combination trial in advanced head and neck cancer

AVI BioPharma, MDA to initiate exon-51 Phase 2 trial in Duchenne muscular dystrophy

China Pharma second quarter revenue increases 18% to $19.6 million

Simcyp extends application in areas of PD modelling and drug distribution within CNS

FDA accepts MAP Pharmaceuticals' LEVADEX NDA for filing

Positive results from Alnylam's ALN-VSP Phase I trial for liver cancer

ORENCIA SC formulation receives FDA approval for treatment of adults with RA

New preclinical data from Baxter's BAX 499 hemophilia study presented at ISTH

Lipid-based nanocarrier can improve cancer treatments

Ceridia completes CER006 Phase 1 Proof-of-Concept study in humans

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