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FDA recommens approval of Daiichi Sankyo's once-daily SAVAYSA for patients with NVAF

FDA recommens approval of Daiichi Sankyo's once-daily SAVAYSA for patients with NVAF

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the U.S. Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee voted 9 to 1 to recommend approval of once-daily SAVAYSA (edoxaban) 60 mg dosing regimen for the reduction in risk of stroke and systemic embolic events (SEE) in patients with non-valvular atrial fibrillation (NVAF). [More]
Osteros Biomedica initiates MBC-11 phase 1 study in patients with cancer-induced bone disease

Osteros Biomedica initiates MBC-11 phase 1 study in patients with cancer-induced bone disease

Osteros Biomedica Ltd., a joint venture company of Maxwell Biotech Group and MBC Pharma Inc., and formed with the participation of Russian Venture Company announced today that the first cohort of patients has been dosed in a phase 1 study of its drug MBC-11 in patients with cancer-induced bone disease. [More]
Population Council to present research on novel approaches to HIV prevention at HIV R4P 2014

Population Council to present research on novel approaches to HIV prevention at HIV R4P 2014

The Population Council will present new research on novel approaches to HIV, sexually transmitted infections (STIs), and unintended pregnancy prevention at the HIV Research for Prevention Conference, (HIV R4P) in Cape Town, South Africa. HIV R4P, which runs 28–31 October, is the first global scientific meeting dedicated exclusively to research on biomedical HIV prevention. [More]
Regulus Therapeutics demonstrates human proof-of-concept with microRNA therapeutic

Regulus Therapeutics demonstrates human proof-of-concept with microRNA therapeutic

Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced that it has demonstrated human proof-of-concept with a microRNA therapeutic from an ongoing clinical study evaluating RG-101, a wholly-owned, GalNac-conjugated anti-miR targeting microRNA-122 (“miR-122”), for the treatment of hepatitis C virus infection (“HCV”). [More]
CytRx begins Phase 1b trial of aldoxorubicin plus gemcitabine in patients with metastatic solid tumors

CytRx begins Phase 1b trial of aldoxorubicin plus gemcitabine in patients with metastatic solid tumors

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, today announced the initiation of enrollment in an open-label Phase 1b clinical trial designed to investigate the preliminary safety and activity of aldoxorubicin plus gemcitabine in subjects with metastatic solid tumors. [More]
CytRx begins aldoxorubicin Phase 2b clinical trial in patients with extensive-stage SCLC

CytRx begins aldoxorubicin Phase 2b clinical trial in patients with extensive-stage SCLC

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, today announced the initiation of a global Phase 2b clinical trial evaluating aldoxorubicin compared to topotecan in subjects with extensive-stage small cell lung cancer (SCLC) who have relapsed or were refractory to prior chemotherapy. [More]
Phase 3 COU-AA-302 results show ZYTIGA plus prednisone prolongs overall survival in men with chemotherapy-naive mCRPC

Phase 3 COU-AA-302 results show ZYTIGA plus prednisone prolongs overall survival in men with chemotherapy-naive mCRPC

A final analysis of the Phase 3 COU-AA-302 trial presented today at the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid, Spain showed that ZYTIGA® (abiraterone acetate) plus prednisone significantly prolonged overall survival (OS), compared to an active control of placebo plus prednisone, in men with chemotherapy-naive metastatic castration-resistant prostate cancer (mCRPC). [More]
Abbvie announces multiple study results of veliparib investigational compound in NSCLC patients

Abbvie announces multiple study results of veliparib investigational compound in NSCLC patients

AbbVie released interim results from an ongoing Phase 2 study of its investigational compound veliparib in combination with chemotherapy, which showed a 35 percent improvement (P-value=0.14) in progression-free survival (PFS) and a 30 percent improvement (P-value=0.21) in overall survival (OS) in patients with previously untreated metastatic or advanced non-small cell lung cancer (NSCLC). [More]
Dabrafenib shows significant anti-tumour activity in BRAF V600E mutant non-small cell lung cancer

Dabrafenib shows significant anti-tumour activity in BRAF V600E mutant non-small cell lung cancer

The BRAF inhibitor dabrafenib has significant anti-tumour activity in patients with advanced BRAF V600E mutant non-small cell lung cancer whose disease has progressed after chemotherapy, according to phase II data presented at the ESMO 2014 Congress in Madrid, Spain. [More]
FDA grants multiple Orphan Drug Designations for CytRx's aldoxorubicin

FDA grants multiple Orphan Drug Designations for CytRx's aldoxorubicin

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, today announced that the U.S. Food and Drug Administration has granted multiple Orphan Drug Designations for the Company's lead drug candidate, aldoxorubicin, in three indications: glioblastoma multiforme (GBM), small cell lung cancer and ovarian cancer. [More]
Elusys completes phase 3 clinical program of obiltoxaximab in healthy adult volunteers

Elusys completes phase 3 clinical program of obiltoxaximab in healthy adult volunteers

Elusys Therapeutics, Inc., a biopharmaceutical company developing antibody therapies to treat infectious disease, today announced it has completed three phase 3 healthy adult volunteer safety studies of obiltoxaximab (ETI-204). [More]
Novira completes Phase 1a clinical study of NVR-1221 for treatment of HBV infection

Novira completes Phase 1a clinical study of NVR-1221 for treatment of HBV infection

Novira Therapeutics, Inc., a privately held biopharmaceutical company developing novel therapies for curative treatment of chronic hepatitis B virus (HBV) infection, today announced successful completion of a Phase 1a clinical study of NVR-1221. [More]
ANP reports primary efficacy results from ATL1103 Phase II trial in patients with acromegaly

ANP reports primary efficacy results from ATL1103 Phase II trial in patients with acromegaly

Antisense Therapeutics Limited is pleased to report the primary efficacy results from its Phase II clinical trial of ATL1103 in patients with the potentially life threatening growth disorder, acromegaly. [More]
ChromaDex reports 42% increase in Q2 2014 net sales

ChromaDex reports 42% increase in Q2 2014 net sales

ChromaDex Corp., an innovative natural products company that provides proprietary, ingredients and science-based solutions to the dietary supplement, food and beverage, animal health, cosmetic and pharmaceutical industries, announced today the financial results for the quarter ended June 28, 2014. [More]
Bee, snake, scorpion venom could form basis of new generation of cancer-fighting drugs

Bee, snake, scorpion venom could form basis of new generation of cancer-fighting drugs

Bee, snake or scorpion venom could form the basis of a new generation of cancer-fighting drugs, scientists will report here today. [More]
Alexza Pharmaceuticals announces availability of ADASUVE inhalation powder in Guatemala

Alexza Pharmaceuticals announces availability of ADASUVE inhalation powder in Guatemala

Alexza Pharmaceuticals, Inc. today announced that ADASUVE inhalation powder, pre-dispensed (loxapine) is now available in Guatemala. This approval represents the first ADASUVE approval in Latin America for Ferrer and Alexza. [More]
AMRI total revenue increases 15% to $68.2 million in second quarter 2014

AMRI total revenue increases 15% to $68.2 million in second quarter 2014

AMRI today reported financial and operating results for the second quarter ended June 30, 2014. [More]
FDA grants orphan-drug designation to Genoa's pirfenidone for treatment of IPF disease

FDA grants orphan-drug designation to Genoa's pirfenidone for treatment of IPF disease

Genoa Pharmaceuticals, the leader in inhaled medicines for pulmonary fibrosis, today announced the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to Genoa for the use of pirfenidone in their lead program - inhaled GP-101 for the treatment of IPF. [More]
CardioNova initiates Phase 1b clinical trial with AtheroNova's AHRO-001

CardioNova initiates Phase 1b clinical trial with AtheroNova's AHRO-001

AtheroNova Inc., a biotech company focused on the research and development of compounds to safely regress atherosclerotic plaque and improve lipid profiles in humans, today announces that its partner, CardioNova, has accomplished first dosing of subjects for its Phase 1b clinical trial with AtheroNova's lead compound, AHRO-001. [More]
FDA clears Lorus' LOR-253 IND application for treatment of hematologic malignancies

FDA clears Lorus' LOR-253 IND application for treatment of hematologic malignancies

Lorus Therapeutics Inc. today announced that the Food and Drug Administration completed its review and cleared the company's Investigational New Drug (IND) application of LOR-253 for the treatment of hematologic malignancies including acute myeloid leukemia (AML), high-risk myelodysplastic syndromes (MDS), lymphomas and multiple myeloma. [More]