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Experts describe role of quantitative systems pharmacology in first-in-human clinical trials

Certara, the global leader in model-informed drug development, regulatory science, market access and real-world evidence services, announced today that Clinical Pharmacology & Therapeutics has published its "Letter to the Editor" describing the important role that quantitative systems pharmacology can play in defining dosing criteria for first-in-human clinical trials, together with the European Medicines Agency's response.

26 Jul 2018

New drug offers hope to prevent attacks of hereditary angioedema

Hereditary angioedema is a chronic disorder that can sometimes be life-threatening. Now, a new drug therapy has been successfully tested in an international study headed by the University Hospital Frankfurt.

26 Jul 2018

Cutting-edge laboratory technique recapitulates brain development more accurately than ever

A cutting-edge laboratory technique that turns human stem cells into brain-like tissue now recapitulates human brain development more accurately than ever, according to a new study from Case Western Reserve University School of Medicine.

26 Jul 2018

Researchers find compounds that may pave way for new drugs against diabetes, obesity

A new study reveals that several drugs for treating hematological cancers are less effective than expected in inhibiting a special enzyme.

26 Jul 2018

Pivotal study of dasotraline in adults with binge eating disorder meets primary endpoint

Sunovion Pharmaceuticals Inc. today announced that a study evaluating the efficacy and safety of dasotraline in adults with moderate to severe binge eating disorder met its primary endpoint, demonstrating a statistically significant decrease in number of binge days per week from baseline to Week 12 in the group treated with dasotraline 6 mg/day versus the placebo-treated group.

25 Jul 2018

New data shows that simple blood test accurately diagnoses Peripheral Artery Disease

Prevencio, Inc., announces the publication of data that demonstrates a simple new blood test accurately diagnoses significant Peripheral Artery Disease, a circulatory problem in which plaque-narrowed arteries reduce blood flow to a patient's limbs and kidneys.

25 Jul 2018

Researchers study efficacy and safety of new treatment for OUD

Better delivery of medications to treat opioid use disorder is key to addressing the opioid crisis and helping the 2.6 million Americans affected by the disease.

20 Jul 2018

FDA approves first drug for treatment of adult AML patients with specific genetic mutation

The U.S. Food and Drug Administration today approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation.

20 Jul 2018

Exergaming can improve health in overweight and obese children, study shows

A new study from LSU's Pennington Biomedical Research Center showed for the first time that video games, in combination with fitness coaching and a step tracker, helped overweight children lose weight, lower their blood pressure and cholesterol and increase their physical activity.

20 Jul 2018

Using miniature drug-filled nanocarriers to target headaches and tumors

Scientists at the Mainz University Medical Center and the Max Planck Institute for Polymer Research have developed a new method to enable miniature drug-filled nanocarriers to dock on to immune cells, which in turn attack tumors.

20 Jul 2018

New discovery could save millions of lives from fatal fungal infections

Life-threatening fungal infections affect more than two million people worldwide. Effective antifungal medications are very limited.

20 Jul 2018

Research reveals long-term efficacy of drug used to treat common cause of kidney failure

New research provides support for the long-term efficacy of a drug used to treat in patients with autosomal dominant polycystic kidney disease, a common cause of kidney failure.

19 Jul 2018

Biophysicists use infrared sensor as new method for drug discovery

Using an infrared sensor, biophysicists at Ruhr-Universität Bochum have succeeded in analyzing quickly and easily which active agents affect the structure of proteins and how long that effect lasts.

19 Jul 2018

Scientists identify melanoma biomarkers that could help tailor immunotherapy treatments

Scientists at Dana-Farber/Brigham and Women's Cancer Center have identified biomarkers in melanoma that could help tailor immunotherapy treatments to maximize the benefits for patients while reducing the likelihood of severe side effects.

19 Jul 2018

FDA grants approval for first breast cancer drug through 'Real-Time Oncology Review'

The U.S. Food and Drug Administration today approved Kisqali (ribociclib) in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy.

19 Jul 2018

A simple pill for meth addicts on the cards

Researchers from Australia's Curtin University have developed a simple pill that could be used to treat methamphetamine addicts. It would soon be tried in a clinical trial to prove its efficacy and utility said the researchers.

18 Jul 2018

Study calls for new gold standard in research to treat non-alcoholic steatohepatitis

A new study by scientists from the Vrije Universiteit Brussel calls for a new gold standard in research to treat non-alcoholic steatohepatitis, an obesity-linked chronic liver disease impacting millions of people of all ages worldwide, which can progress to liver cancer if untreated, creating a massive strain on an already overburdened healthcare system.

18 Jul 2018

Homogenous BTK occupancy assay used in tirabrutinib clinical studies

In a new SLAS Discovery article, Helen Yu and a team of researchers at Gilead Sciences, Inc. present a time-resolved fluorescence resonance energy transfer-based Bruton's tyrosine kinase occupancy assay that can measure target engagement in peripheral blood mononuclear cells and in lymph-node and bone-marrow samples.

17 Jul 2018

NeuroTrauma Sciences and Henry Ford join hands to advance exosome technology

NeuroTrauma Sciences, LLC, a biopharmaceutical company, and Henry Ford Health System, a non-profit organization, today announce that a newly-formed subsidiary of NTS has entered into multi-year Sponsored Research and License Agreements.

16 Jul 2018

Pre-clinical pilot study shows promising results of 'concussion pill'

In 2016, funded by a $16 million grant from Scythian, the multidisciplinary Miller School team embarked on a five-year study to examine the effects of combining CBD (a cannabinoid derivative of hemp) with an NMDA antagonist (an anesthetic used in animals and humans) for the treatment of traumatic brain injury and concussion.

16 Jul 2018

Efficacy News and Research

Experts describe role of quantitative systems pharmacology in first-in-human clinical trials

New drug offers hope to prevent attacks of hereditary angioedema

Cutting-edge laboratory technique recapitulates brain development more accurately than ever

Researchers find compounds that may pave way for new drugs against diabetes, obesity

Pivotal study of dasotraline in adults with binge eating disorder meets primary endpoint

New data shows that simple blood test accurately diagnoses Peripheral Artery Disease

Researchers study efficacy and safety of new treatment for OUD

FDA approves first drug for treatment of adult AML patients with specific genetic mutation

Exergaming can improve health in overweight and obese children, study shows

Using miniature drug-filled nanocarriers to target headaches and tumors

New discovery could save millions of lives from fatal fungal infections

Research reveals long-term efficacy of drug used to treat common cause of kidney failure

Biophysicists use infrared sensor as new method for drug discovery

Scientists identify melanoma biomarkers that could help tailor immunotherapy treatments

FDA grants approval for first breast cancer drug through 'Real-Time Oncology Review'

A simple pill for meth addicts on the cards

Study calls for new gold standard in research to treat non-alcoholic steatohepatitis

Homogenous BTK occupancy assay used in tirabrutinib clinical studies

NeuroTrauma Sciences and Henry Ford join hands to advance exosome technology

Pre-clinical pilot study shows promising results of 'concussion pill'

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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