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Igenica Biotherapeutics doses first patient in Phase 1 clinical trial of IGN523 in patients with AML

Igenica Biotherapeutics doses first patient in Phase 1 clinical trial of IGN523 in patients with AML

Igenica Biotherapeutics, a company focused on the discovery and development of innovative antibodies and antibody-drug conjugates (ADCs) for the treatment of cancer, announced today that the first patient has been dosed in a Phase 1 clinical trial of IGN523 in patients with relapsed or refractory acute myeloid leukemia (AML). [More]
Merck's NOXAFIL injection gets FDA approval for intravenous use

Merck's NOXAFIL injection gets FDA approval for intravenous use

Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has approved NOXAFIL (posaconazole) injection (18 mg/ mL), a new formulation of NOXAFIL for intravenous (IV) use. [More]

N30 Pharma begins oral dosing in N91115 Phase 1 trial for treatment of cystic fibrosis

N30 Pharmaceuticals, Inc. announced today that it has begun oral dosing of N91115 in a Phase 1 clinical trial. N91115, a novel inhibitor of S-nitrosoglutathione reductase (GSNOR), is being developed for the treatment of cystic fibrosis (CF). [More]
Bayer and Onyx announce Phase 3 trial evaluating use of NEXAVAR for patients with HCC after local ablation

Bayer and Onyx announce Phase 3 trial evaluating use of NEXAVAR for patients with HCC after local ablation

Bayer HealthCare Pharmaceuticals Inc. and Onyx Pharmaceuticals, Inc., an Amgen subsidiary (Nasdaq: AMGN), today announced that a Phase 3 trial evaluating the investigational use of NEXAVAR® (sorafenib) tablets as an adjuvant treatment for patients with hepatocellular carcinoma (HCC), or liver cancer, who had no detectable disease after surgical resection or local ablation, did not meet its primary endpoint of improving recurrence-free survival. [More]
Fibrotech successfully completes Phase Ia trial of anti-fibrotic compound FT011

Fibrotech successfully completes Phase Ia trial of anti-fibrotic compound FT011

Fibrotech, an Australian biopharmaceutical company developing a new class of drugs to prevent a massive health burden associated with fibrosis, today announced that its lead anti-fibrotic compound FT011 has successfully completed a Phase Ia trial in healthy volunteers demonstrating safety and tolerability up to doses of 1000mg. [More]
Boehringer Ingelheim reports results from SVR12 Phase 3 trial in patients with HCV/HIV co-infection

Boehringer Ingelheim reports results from SVR12 Phase 3 trial in patients with HCV/HIV co-infection

Today Boehringer Ingelheim announced results from STARTVerso4 in patients with HCV/HIV co-infection. Hepatitis C viral cure 12 weeks after the conclusion of treatment (SVR12) was achieved by 72% of all patients in the trial. Patients were enrolled in either 120mg or 240mg faldaprevir dose groups. [More]
Verastem presents preliminary data from VS-6063 Phase 1 trial in Japanese patients with solid tumors

Verastem presents preliminary data from VS-6063 Phase 1 trial in Japanese patients with solid tumors

Verastem, Inc., focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells, today presented preliminary data from an ongoing First-in-Asia Phase 1 trial of VS-6063 in Japanese patients with advanced solid tumors, including one patient with mesothelioma. The Phase 1 study assessed the safety and pharmacokinetics of single agent VS-6063. [More]
Omeros submits investigational new drug to initiate OMS721 Phase 2 clinical program

Omeros submits investigational new drug to initiate OMS721 Phase 2 clinical program

Omeros Corporation today announced that it has submitted to the U.S. Food and Drug Administration (FDA) an investigational new drug (IND) application to initiate the Phase 2 clinical program for OMS721, the company's lead human monoclonal antibody targeting mannan-binding lectin‑associated serine protease-2 (MASP-2), the key regulator of the lectin pathway of the immune system. [More]

LFB SA initiates Phase 3 program for human Factor VIIa in patients with congenital hemophilia

LFB SA, through its rEVO Biologics subsidiary, announced today initiation of the global Phase 3 program for LR769, a novel recombinant form of human Factor VIIa, in patients with congenital hemophilia A or B with inhibitors. [More]
Intra-Cellular Therapies initiates Phase I/II clinical trial to evaluate pharmacokinetics in patients with dementia

Intra-Cellular Therapies initiates Phase I/II clinical trial to evaluate pharmacokinetics in patients with dementia

Intra-Cellular Therapies, Inc., a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced the initiation of ITI-007-200, a Phase I/II clinical trial designed to evaluate the safety, tolerability and pharmacokinetics of low doses of its lead drug candidate, ITI-007, in healthy geriatric subjects and in patients with dementia, including Alzheimer's disease. [More]

Exposure to very low concentrations of BPA by pregnant females can cause fetal abnormalities in primates

Bisphenol A (BPA) is a chemical that is used in a wide variety of consumer products, such as resins used to line metal food and beverage containers, thermal paper store receipts, and dental composites. [More]

Omeros doses first patient in second Phase 2 clinical trial of OMS824

Omeros Corporation today announced dosing of the first patient in a second Phase 2 clinical trial of OMS824, the company's phosphodiesterase 10 (PDE10) inhibitor being developed for the treatment of schizophrenia, Huntington's disease (HD) and other cognitive disorders. The Phase 2 trial will evaluate the tolerability, safety, pharmacokinetics and performance on a battery of tests in patients with symptomatic HD. [More]

Viamet announces positive interim results from VT-1161 Phase 2 study in patients with AVVC

Viamet Pharmaceuticals Inc. today reported positive interim results from an ongoing Phase 2 study of VT-1161, the Company's novel oral antifungal compound, in patients with moderate to severe acute vulvovaginal candidiasis (AVVC). This study is intended as a precursor to a Phase 2b study in patients with recurrent vulvovaginal candidiasis (RVVC). [More]
FDA grants accelerated approval to NORTHERA (droxidopa) for patients with symptomatic NOH

FDA grants accelerated approval to NORTHERA (droxidopa) for patients with symptomatic NOH

Chelsea Therapeutics International, Ltd. today announced that the U.S. Food and Drug Administration granted accelerated approval of NORTHERA (droxidopa) for the treatment of symptomatic neurogenic orthostatic hypotension (NOH). NORTHERA is the first and only therapy approved by the FDA which demonstrates symptomatic benefit in patients with NOH. [More]
Ario Pharma begins XEN-0501 Phase IIa study for treatment persistent cough in COPD patients

Ario Pharma begins XEN-0501 Phase IIa study for treatment persistent cough in COPD patients

Ario Pharma Ltd, the Cambridge biopharmaceutical company developing innovative new approaches to treat respiratory disease, announced today that it has commenced a Phase IIa study of its TRPV1 antagonist, XEN-0501, for the treatment and prevention of cough in patients with chronic obstructive pulmonary disease (COPD). Persistent cough in COPD and other respiratory conditions present as a huge unmet medical need, with novel therapies urgently needed to improve the quality of life of patients. [More]
Sarepta Therapeutics reports positive safety results from AVI-7288 Phase I study

Sarepta Therapeutics reports positive safety results from AVI-7288 Phase I study

Sarepta Therapeutics, Inc., a developer of innovative RNA-based therapeutics, today announced positive safety results from a Phase I multiple ascending dose study of AVI-7288 in healthy volunteers. [More]

e-Therapeutics initiates Phase I clinical trial with oral formulation of ETS2101 anti-cancer compound

e-Therapeutics plc (AIM:ETX) announced today that it has dosed the first healthy volunteer in a newly initiated Phase I clinical trial with an oral formulation of its anti-cancer compound, ETS2101. [More]

Spinifex announces results of Phase 2 clinical trial of EMA401 in postherpetic neuralgia

Spinifex Pharmaceuticals, an Australian pain drug development company, today announces that The Lancet has published the results of its Phase 2 clinical trial of its lead candidate, EMA401, in postherpetic neuralgia (PHN). [More]
Addressing antibiotic resistance: an interview with Professor Otto Cars, Uppsala University, Sweden

Addressing antibiotic resistance: an interview with Professor Otto Cars, Uppsala University, Sweden

Antibiotic resistance is a consequence of antibiotic use. Bacteria adapt to the threat of antibiotics using mechanisms to overcome the drug. These bacteria, which we call resistant bacteria, then survive. [More]
Omeros announces positive results from Phase 2a trial of OMS824 in patients with schizophrenia

Omeros announces positive results from Phase 2a trial of OMS824 in patients with schizophrenia

Omeros Corporation today announced positive results from a Phase 2a clinical trial of OMS824, the company's phosphodiesterase 10 (PDE10) inhibitor, in which the drug was well tolerated and demonstrated comparable systemic pharmacokinetics when administered alone and concomitantly with approved antipsychotic agents in patients with schizophrenia. OMS824 selectively inhibits PDE10, an enzyme expressed in areas of the brain linked to a wide range of diseases that affect cognition, including schizophrenia and Huntington's disease. [More]