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Symbiomix closes $41 million Series A financing and reports positive results from SYM-1219 Phase 2 trial

Symbiomix closes $41 million Series A financing and reports positive results from SYM-1219 Phase 2 trial

Symbiomix Therapeutics today announced multiple milestones, including the closing of the third and final tranche of a $41 million Series A financing and positive results from a multi-center, randomized Phase 2 trial testing a single oral dose of SYM-1219 for the treatment of bacterial vaginosis (BV). [More]
TAXIS Pharmaceuticals' TXA709 compound shows promise in combating antibiotic resistance

TAXIS Pharmaceuticals' TXA709 compound shows promise in combating antibiotic resistance

TAXIS Pharmaceuticals, a drug-discovery company focused on developing a new class of antibiotic agents to treat life-threatening, multidrug-resistant bacterial infections, today announced the presentation of data demonstrating the promise of its lead clinical candidate, TXA709, in combating antibiotic resistance. [More]
aTyr's Resolaris granted FDA Orphan Drug Designation for treatment of FSHD

aTyr's Resolaris granted FDA Orphan Drug Designation for treatment of FSHD

aTyr Pharma, a biotherapeutics company engaged in the discovery and development of Physiocrine-based therapeutics to address rare diseases, announced today that Resolaris has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of facioscapulohumeral muscular dystrophy (FSHD). [More]
Eisai, Arena complete two Phase 1 registrational trials for once-daily formulation of lorcaserin

Eisai, Arena complete two Phase 1 registrational trials for once-daily formulation of lorcaserin

Eisai Inc. and Arena Pharmaceuticals, Inc. today announced the completion of two Phase 1 registrational clinical trials that Eisai and Arena believe demonstrate bioequivalence of an investigational once-daily extended release formulation of lorcaserin, as compared to the twice-daily immediate release formulation approved by the US Food and Drug Administration and marketed as BELVIQ. [More]
Rhythm, Actavis announce initiation of relamorelin Phase 2b trial for treatment of diabetic gastroparesis

Rhythm, Actavis announce initiation of relamorelin Phase 2b trial for treatment of diabetic gastroparesis

Rhythm, a biopharmaceutical company, and Actavis plc, a leading global pharmaceutical company, announced today the initiation of a Phase 2b clinical trial assessing the efficacy and safety of relamorelin (RM-131), Rhythm's ghrelin agonist, for the treatment of gastroparesis in patients with type 1 and type 2 diabetes. [More]
Bilirubin levels raised in newly diagnosed Parkinson’s disease

Bilirubin levels raised in newly diagnosed Parkinson’s disease

Bilirubin levels are upregulated in patients with early Parkinson’s disease and are associated with disease progression at 2 years, a study shows. [More]
AMRI plans to close its API manufacturing facility in Holywell, U.K.

AMRI plans to close its API manufacturing facility in Holywell, U.K.

AMRI announced today that it has decided to close its Holywell, U.K. facility following a consultation process with employee representatives. [More]

DURECT initiates DUR-928 multi-dose Phase 1 clinical trial for NAFLD, NASH and AKI

DURECT Corporation today announced that it has initiated a multi-dose Phase 1 clinical trial of an oral formulation of DUR-928, the lead molecule in DURECT's Epigenomic Regulator Program. [More]
Transition announces positive results from ELND005 AME and renal clearance studies

Transition announces positive results from ELND005 AME and renal clearance studies

Transition Therapeutics Inc. today announced results from two phase 1 clinical studies of neuropsychiatric drug candidate ELND005. These studies, an absorption-metabolism-excretion ("AME") study and a renal clearance study, are specialized clinical pharmacology trials that are required by the United States Food and Drug Administration for the approval of most drugs in development. [More]
Isis Pharmaceuticals announces positive results from ISIS-ANGPTL3Rx Phase 1 study

Isis Pharmaceuticals announces positive results from ISIS-ANGPTL3Rx Phase 1 study

Isis Pharmaceuticals, Inc. announced today positive results from a Phase 1 study with ISIS-ANGPTL3Rx. In this study, healthy volunteers treated with ISIS-ANGPTL3Rx achieved dose-dependent, statistically significant reductions in angiopoietin-like 3 (ANGPTL3) of up to 93 percent with a mean reduction of up to 84 percent from baseline (p<0.001). [More]
UF pharmacy dean to be honored with 2015 SURA Distinguished Scientist Award

UF pharmacy dean to be honored with 2015 SURA Distinguished Scientist Award

SURA today announced that Julie A. Johnson, Dean and Distinguished Professor at the University of Florida's College of Pharmacy, will receive its 2015 SURA Distinguished Scientist Award. [More]
Blunted cortisol response common in non-classic CAH

Blunted cortisol response common in non-classic CAH

Nearly two-thirds of children with non-classic congenital adrenal hyperplasia have an inadequate cortisol response, report researchers. [More]
Vrije University Brussels installs MILabs PET-SPECT-CT-MRI platform for nanobody research

Vrije University Brussels installs MILabs PET-SPECT-CT-MRI platform for nanobody research

The comprehensive MILabs PET-SPECT-CT-MR preclinical platform combines the best PET-SPECT functional imaging capabilities (sub-half-mm SPECT resolution and sub-mm PET resolution) with high resolution anatomical imaging from an integrated X-ray CT subsystem and/or a compact cryogen free 1.5 T MRI unit [More]
Bayer announces FDA acceptance of BAY 81-8973 BLA for treatment of hemophilia A

Bayer announces FDA acceptance of BAY 81-8973 BLA for treatment of hemophilia A

Bayer HealthCare today announced that the U.S. Food and Drug Administration has accepted the company's Biologics License Application for BAY 81-8973, a recombinant Factor VIII compound. Bayer is seeking FDA approval of the investigational compound, proposed trade name Kovaltry, for the treatment of hemophilia A in children and adults. [More]
Symbiomix Therapeutics announces positive results from SYM-1219 Phase 1 clinical program

Symbiomix Therapeutics announces positive results from SYM-1219 Phase 1 clinical program

Symbiomix Therapeutics, a late-stage, privately held biopharmaceutical company developing innovative medicines for serious women's health infections, today announced results from its Phase 1 clinical program demonstrating that its lead product candidate, SYM-1219, was safe and well tolerated and had predictable pharmacokinetics (PK), and that contraceptive efficacy for birth control pills would not be altered by SYM-1219 administration. [More]
Mundipharma launches Remsima® (infliximab), a new-generation value-based monoclonal antibody, in six European markets

Mundipharma launches Remsima® (infliximab), a new-generation value-based monoclonal antibody, in six European markets

Mundipharma International Limited’s network of independent associated companies are launching Remsima® (infliximab) this month in Germany, Italy, UK, Netherlands, Belgium and Luxembourg following expiry of the relevant patents and Supplementary Protection Certificates, having secured distribution rights from Celltrion Healthcare Hungary Kft for Remsima in these markets. [More]
Isis Pharmaceuticals announces positive results from Phase 1 study of ISIS-PKK Rx for HAE treatment

Isis Pharmaceuticals announces positive results from Phase 1 study of ISIS-PKK Rx for HAE treatment

Isis Pharmaceuticals, Inc. announced today positive results from a Phase 1 study with ISIS-PKKRx. In this study, healthy volunteers treated with ISIS-PKKRx achieved dose-dependent reductions of up to 95 percent in prekallikrein, or PKK. ISIS-PKKRx is a RNA-targeted antisense drug designed to inhibit the production of PKK for the prophylactic treatment of hereditary angioedema (HAE). [More]

Added benefit of simoctocog alfa not proven for haemophilia A

Simoctocog alfa (trade name Nuwiq) has been approved since July 2014 for people with type A haemophilia, an inherited disorder that impairs blood clotting. The German Institute for Quality and Efficiency in Health Care examined in a dossier assessment whether this new drug offers an added benefit over the appropriate comparator therapy. Such an added benefit cannot be derived from the dossier, however, because the drug manufacturer did not submit any suitable data. [More]
Clinical data demonstrates safety, efficacy of vedolizumab for treatment of adults with UC and CD

Clinical data demonstrates safety, efficacy of vedolizumab for treatment of adults with UC and CD

Takeda Pharmaceuticals International GmbH today announced the presentation of data further demonstrating the efficacy and safety of vedolizumab for the treatment of adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD). [More]
NIH-sponsored clinical trials examine safety, acceptability of HIV antiretroviral medicines

NIH-sponsored clinical trials examine safety, acceptability of HIV antiretroviral medicines

Two new clinical trials are examining the safety and acceptability of antiretroviral medicines administered via injection as a means of protecting against HIV infection. The studies are being funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and conducted by the NIAID-funded HIV Prevention Trials Network (HPTN). [More]
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