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.

Key findings from Phase I clinical trial of CPI-613 in AML to be presented at ASCO 2011

Cornerstone Pharmaceuticals and Wake Forest Baptist Medical Center today announced key findings from a Phase I clinical trial of Cornerstone's first-in-class cancer metabolism inhibitor drug, CPI-613 in Acute Myeloid Leukemia.

4 Jun 2011

Niiki Pharma to present NKP-1339 Phase I trial against metastatic cancer at ASCO 2011

Niiki Pharma announced today that it will present interim data from the ongoing Phase I clinical study for its lead product, NKP-1339, at the 2011 American Society for Clinical Oncology meeting in Chicago, IL.

2 Jun 2011

European Commission grants Orphan Drug Designation for CSL Behring's rVIIa-FP to treat hemophilia

CSL Behring announced today that it has been granted Orphan Drug Designations by the European Commission for the development of its recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP), a novel therapy to treat hemophilia A and hemophilia B patients with inhibitors.

1 Jun 2011

MAP Pharmaceuticals submits LEVADEX NDA to FDA for treatment of migraine in adults

MAP Pharmaceuticals, Inc. today announced that it has submitted a New Drug Application to the United States Food and Drug Administration for LEVADEX orally inhaled migraine drug for the potential acute treatment of migraine in adults.

27 May 2011

Merck's VICTRELIS receives European CHMP positive opinion for treatment of chronic HCV genotype 1 infection

Merck, today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion under accelerated assessment recommending approval of the investigational medicine VICTRELIS (boceprevir) for the treatment of chronic hepatitis C virus genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.

20 May 2011

Bayer, Onyx to present Nexavar-chemotherapy combination Phase 2b trial data in breast cancer at ASCO 2011

Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc. today announced results from a Phase 2b trial evaluating Nexavar® (sorafenib) tablets in patients with locally advanced or metastatic breast cancer previously treated with a bevacizumab-containing regimen, which showed that Nexavar was associated with statistically significant improvements in progression-free survival and time-to-progression.

20 May 2011

$Positive results from Onyx's carfilzomib Phase 2b 003-A1 study in relapsed and refractory multiple myeloma$

Positive results from Onyx's carfilzomib Phase 2b 003-A1 study in relapsed and refractory multiple myeloma

Onyx Pharmaceuticals, Inc. today announced updated results from the Phase 2b 003-A1 study of single-agent carfilzomib, a next generation proteasome inhibitor, in patients with relapsed and refractory multiple myeloma. Carfilzomib achieved a clinical benefit rate (CBR) (minimal response or greater) in the study population of 37 percent with a duration of response (DOR) of 8.3 months.

20 May 2011

Nektar to present new NKTR-102 Phase 2 clinical data in multiple cancers at ASCO annual meeting

Nektar Therapeutics today announced that new Phase 2 clinical data for NKTR-102, Nektar's lead oncology candidate being evaluated in multiple cancer indications, have been selected for presentation at the 47th Annual Meeting of the American Society of Clinical Oncology being held June 3-7, 2011 in Chicago, Illinois.

19 May 2011

Pharma Two B plans to initiate P2B001 Phase II study in Parkinson's disease

Pharma Two B announced today it is planning a Phase II study of its new combination therapy, P2B001, in development as a treatment for the early stages of Parkinson's disease. Assuming regulatory approval and the necessary financing, the company plans to commence the Phase II trial in Q4 2011.

18 May 2011

Clinical PET system for early stage breast cancer diagnosis

European researchers have developed a clinical PET system with the highest resolution and sensitivity in the market, specifically dedicated to breast cancer detection in early stages.

18 May 2011

Anavex comments on new Alzheimer’s disease diagnostic guidelines

Anavex Life Sciences Corp. (“Anavex”) (OTCBB: AVXL) today commented on new diagnostic criteria and guidelines for Alzheimer’s disease published recently by the National Institute on Aging (NIA) and the Alzheimer’s Association, which have been updated for the first time in more than 25 years. The new guidelines discuss the importance of new technologies, including brain imaging and biomarker analysis, in research and clinical diagnosis. They describe Alzheimer’s disease at a preclinical stage, Mild Cognitive Impairment (MCI) due to Alzheimer’s disease, and dementia due to Alzheimer’s pathology.

18 May 2011

Roche initiates TB-403 Phase Ib/II study in glioblastoma multiforme

ThromboGenics and co-development partner BioInvent International announce today that their partner Roche has dosed the first patient in a Phase Ib/II study with the novel antibody anti-cancer agent TB-403 (RG7334).

16 May 2011

Patients with sickle cell disease may require higher, frequent doses of morphine

Frequent episodes of severe pain occur in patients with sickle cell disease (SCD) and require treatment with potent opioid medications. A new study published in The Journal of Pain reports that SCD patients clear morphine from their blood stream quickly and, therefore, require high doses to achieve optimal analgesia.

13 May 2011

New clinical data affirms safety profile of PolyMedix's PMX-30063 in treatment of Staph infections

PolyMedix, Inc., an emerging biotechnology company focused on developing new therapeutic drugs to treat life-threatening infectious diseases and acute cardiovascular disorders, presented new clinical and pre-clinical data related to the safety and efficacy of its novel, lead defensin-mimetic antibiotic, PMX-30063.

12 May 2011

Aradigm first quarter total revenue decreases to $0.2 million

Aradigm Corporation today announced financial results for the first quarter and three months ended March 31, 2011.

12 May 2011

Atox Bio completes AB103 phase 1 study in severe bacterial infections and sepsis

Atox Bio Inc. today announced that it successfully completed a phase 1 clinical study of AB103, a novel therapy for the treatment of severe bacterial infections and sepsis.

12 May 2011

Santaris Pharma advances SPC4955 into Phase 1 trial for high cholesterol treatment

Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the research and development of mRNA and microRNA targeted therapies, today announced that it has advanced a second drug from its cardiometabolic program, SPC4955 into Phase 1 clinical trials, for the treatment of high cholesterol.

11 May 2011

China Pharma first quarter revenue increases 20% to $18.1 million

China Pharma Holdings, Inc., a fully-integrated specialty pharmaceuticals company in China, today announced financial results for the quarter ended March 31, 2011.

11 May 2011

EMA agrees to Swedish Orphan Biovitrum, Biogen Idec's pediatric rFIXFc trial in hemophilia

Biogen Idec and Swedish Orphan Biovitrum today announced that the European Medicines Agency's Pediatric Committee has adopted an opinion agreeing to the pediatric investigational plan for the companies' long-lasting, fully-recombinant Factor IX Fc fusion protein.

9 May 2011

Halozyme Therapeutics reports net loss of $9.6 million for first quarter 2011

Halozyme Therapeutics, Inc., a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the diabetes, cancer, dermatology and drug delivery markets, today reported financial results for the first quarter 2011.

7 May 2011

Pharmacokinetics News and Research

Further Reading

Key findings from Phase I clinical trial of CPI-613 in AML to be presented at ASCO 2011

Niiki Pharma to present NKP-1339 Phase I trial against metastatic cancer at ASCO 2011

European Commission grants Orphan Drug Designation for CSL Behring's rVIIa-FP to treat hemophilia

MAP Pharmaceuticals submits LEVADEX NDA to FDA for treatment of migraine in adults

Merck's VICTRELIS receives European CHMP positive opinion for treatment of chronic HCV genotype 1 infection

Bayer, Onyx to present Nexavar-chemotherapy combination Phase 2b trial data in breast cancer at ASCO 2011

Positive results from Onyx's carfilzomib Phase 2b 003-A1 study in relapsed and refractory multiple myeloma

Nektar to present new NKTR-102 Phase 2 clinical data in multiple cancers at ASCO annual meeting

Pharma Two B plans to initiate P2B001 Phase II study in Parkinson's disease

Clinical PET system for early stage breast cancer diagnosis

Anavex comments on new Alzheimer’s disease diagnostic guidelines

Roche initiates TB-403 Phase Ib/II study in glioblastoma multiforme

Patients with sickle cell disease may require higher, frequent doses of morphine

New clinical data affirms safety profile of PolyMedix's PMX-30063 in treatment of Staph infections

Aradigm first quarter total revenue decreases to $0.2 million

Atox Bio completes AB103 phase 1 study in severe bacterial infections and sepsis

Santaris Pharma advances SPC4955 into Phase 1 trial for high cholesterol treatment

China Pharma first quarter revenue increases 20% to $18.1 million

EMA agrees to Swedish Orphan Biovitrum, Biogen Idec's pediatric rFIXFc trial in hemophilia

Halozyme Therapeutics reports net loss of $9.6 million for first quarter 2011

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