Pharma News

Cellceutix Corporation is pleased to announce that it has submitted a Special Protocol Assessment (SPA) request, along with a final protocol to FDA, for a phase 3 clinical trial of its novel single-dose antibiotic, Brilacidin, for the treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI) caused by Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). A SPA is a written agreement between the U.S. Food and Drug Administration (FDA) and a drug sponsor detailing the clinical trial design, endpoints and other clinical trial facets that can be used to support regulatory approval, thereby potentially reducing the risk of bringing a drug to market. The SPA submission is the next step in beginning a phase 3 program in ABSSSI after a successful End-of-Phase 2 Meeting with FDA last July (2015).   The title of the protocol submitted with the SPA request is:

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.

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.