Pharma News

An abortion drug, Mifepristone (MIF) can possibly have an anti-tumour effect in triple-negative breast cancer (TNBC), the media reported on Tuesday.

Opening a new window of opportunity for treating dementia, researchers have found that a drug compound created to treat cancer can restore memory in mice with Alzheimer's like disease.

Offering hope to millions of cancer patients around the world, the Scottish government has launched a new app that helps doctors diagnose the disease using information about symptoms, signs and images of what to look out for, a media report said.

US researchers have developed an inexpensive prototype of a biomedical device that can detect anaemia simply by running a blood sample from a finger prick under a smartphone.

Gum diseases are linked to many health problems. A type of bacterial species responsible for gum disease may also be a cause of esophageal cancer, finds a new study.

AstraZeneca  announced it has entered into a licensing agreement with China Medical System Holdings Ltd (CMS) for the commercialisation rights in China to its calcium channel blocker, Plendil (felodipine). Plendil was first approved in China in 1995 for the treatment of hypertension or high blood pressure and in 2015 achieved Product Sales of $189 million.

Baxalta Incorporated announced that it has submitted supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) seeking approval for the use of ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] to treat children under the age of 12 with hemophilia A and for use in surgical settings.

Egalet Corporation announced that the U.S. Food and Drug Administration (FDA) has accepted the new drug application (NDA) for ARYMO ER (morphine sulfate) extended-release tablets. ARYMO ER is being developed for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The FDA Prescription Drug User Fee Act (PDUFA) goal date for a decision is October 14, 2016.

AbbVie announced that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for the use of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) without ribavirin (RBV) in chronic hepatitis C virus (HCV) infected genotype 1b (GT1b) patients with compensated cirrhosis (Child-Pugh A).

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: