Pharma News

Novartis  announced that the United States Food and Drug Administration (FDA) approved Afinitor® (everolimus) tablets for the treatment of adult patients with progressive, well-differentiated, nonfunctional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced or metastatic. Afinitor received a priority review designation providing a shortened review period for drugs that treat serious conditions and offer a significant improvement in safety or effectiveness.

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Teligent, Inc. a New Jersey-based specialty generic pharmaceutical company, announced it has received approval of the Company's abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) of Desoximetasone Ointment USP 0.25%, the generic equivalent of Topicort® Ointment, 0.25%, of Taro Pharmaceuticals U.S.A., Inc.

Gilead Sciences, Inc. announced that the company’s Marketing Authorization Application (MAA) for tenofovir alafenamide (as fumarate) (TAF) 25 mg an investigational, once-daily treatment for adults with chronic hepatitis B virus (HBV) infectionhas been fully validated and is now under assessment by the European Medicines Agency (EMA).

AstraZeneca and Acerta Pharma BV, a company in which AstraZeneca has a majority equity investment,  announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) adopted three positive opinions recommending acalabrutinib (ACP-196) for designation as an orphan medicinal product. The three positive opinions are for the treatment of chronic lymphocytic leukaemia (CLL) / small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL) and lymphoplasmacytic lymphoma (Waldenström’s macroglobulinaemia, WM).

Zoetis Inc. announced that the U.S. Food and Drug Administration (FDA) has approved SimparicaTM (sarolaner) Chewables to kill adult fleas and prevent flea infestations, as well as treat and control tick infestations due to the Lone Star tick, the Gulf Coast tick, the American dog tick, and the brown dog tick.

The Chinese are facing growing cancer risk from dioxin due to changes in their dietary patterns over the past three decades, a research has found.

An antidepressant can improve decision-making and reaction time, and suppress inflammation in people with HIV-associated cognitive impairment, new research has found.

Asterias Biotherapeutics, Inc. announced the successful completion of an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for AST-VAC1, its investigational therapy targeting acute myeloid leukemia (AML).

Luminex Corporation announced that it has received medical device licenses from Health Canada's Therapeutic Products Directorate, Medical Devices Bureau for the ARIES® System and ARIES® HSV 1&2 Assay. The ARIES® System and HSV 1&2 Assay previously received FDA clearance in October 2015 and were subsequently launched in the U.S. market.

In an important advancement towards an effective treatment against the deadly Ebola virus disease (EVD), researchers have found that a single monoclonal antibody isolated from a human survivor completely protects monkeys from lethal infection with the virus.