Pharma News

Flamel Technologies announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s New Drug Application (NDA) for Akovaz™ (ephedrine sulfate), a drug administered parenterally as a pressor agent to address clinically important hypotension in surgical settings.

Oncurious NV, an emerging oncology company focused on the development of innovative orphan drugs for the treatment of pediatric cancers, announces it has initiated a Phase I/IIa study that will evaluate the safety and tolerability and explore the preliminary efficacy of TB-403 for the treatment of relapsed or refractory medulloblastoma, a rare, life-threatening brain tumor that mainly affects children.

Teva Pharmaceutical Industries Ltd., announced that the U.S. Food and Drug Administration (FDA) has approved ProAir RespiClick^® (albuterol sulfate) Inhalation Powder for the treatment or prevention of bronchospasm in children 4 to 11 years of age with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm (EIB)

Researchers have learned new information about how different people respond to aspirin, a globally prescribed drug in cardioprotection. The research team, led by scientists at Cardiff University in the United Kingdom and including representatives from the University of Alabama at Birmingham and the University of Colorado, identified more than 5,600 lipids  or fats in blood platelets and gained new insights into how these cells respond to aspirin.

Vernakalant, a new drug for treating recent-onset atrial fibrillation, has proved to be considerably more effective than Ibutilide, an established drug in this indication. It was able to normalize patients’ heart rhythm more rapidly and with fewer side-effects ocurring. This was revealed by a study conducted at the Department of Emergency Medicine at Medical University of Vienna/General Hospital that has recently been published in "Europace", a journal of the European Society of Cardiology.

ACADIA Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has approved NUPLAZID (pimavanserin) for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. In 2014, the FDA designated NUPLAZID as a Breakthrough Therapy for this condition.

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The U.S. Food and Drug Administration today approved the first generic version of Crestor (rosuvastatin calcium) tablets for the following uses: in combination with diet for the treatment of high triglycerides (hypertriglyceridemia) in adults;  in combination with diet for treatment of patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia), a disorder associated with improper breakdown of cholesterol and triglycerides; either alone or in combination with other cholesterol treatment(s) for adult patients with homozygous familial hypercholesterolemia, a disorder associated with high low-density lipoprotein (LDL) cholesterol.

Janssen Pharmaceuticals, Inc., announced it has submitted to the U.S. Food and Drug Administration (FDA) a New Drug Application for a 500mg chewable tablet formulation of mebendazole. If approved, mebendazole chewable tablets will provide a treatment alternative for adults and children aged one year or older with single or mixed soil-transmitted helminthiasis (STH), and address an unmet need for children too young to swallow a solid tablet.

Janssen-Cilag International NV announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a Positive Opinion, recommending broadening the existing marketing authorisation for ibrutinib as a single agent for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).

The herbs peppermint, chamomile, rosemary and lavender have been proven to have an impact on mood and memory, with significant benefits displayed for older people, according to new research from Northumbria University.