Pharma News

PharmaCyte Biotech, Inc. reported that the encapsulation facility located in Bangkok, Thailand, that will be used to encapsulate the live cells used for PharmaCyte’s pancreatic cancer therapy has recently been inspected by the Food and Drug Administration of Thailand (Thai FDA). In its report on that inspection, the Thai FDA stated that, “The facility is built according to the pre-approved floor plan and is now deemed suitable for the manufacture of pharmaceutical products.”

Bristol-Myers Squibb’s  company announced that the European Commission has approved Opdivo (nivolumab) monotherapy for an additional indication in advanced renal cell carcinoma (RCC) after prior therapy in adults. Opdivo is the first and only PD-1 immune checkpoint inhibitor approved in Europe to demonstrate an overall survival (OS) benefit versus a standard of care in this patient population. This approval allows for the expanded marketing of Opdivo in previously treated advanced RCC in all 28 Member States of the European Union.

Intercept Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA)'s Gastrointestinal Drugs Advisory Committee voted 17 to 0 to recommend accelerated approval of Ocaliva™ (obeticholic acid) for the treatment of patients with primary biliary cirrhosis, recently renamed primary biliary cholangitis (PBC). The target date for the FDA to take action under the Prescription Drug User Fee Act (PDUFA) is May 29, 2016. The FDA is not bound by the Advisory Committee's guidance, but takes its advice into consideration when reviewing investigational medicines. If approved, Ocaliva would be the first new treatment for PBC in nearly 20 years.

Hikma Pharmaceuticals PLC (Hikma) confirms that its abbreviated new drug application (ANDA) for fluticasone propionate and salmeterol inhalation powder has been accepted for filing by the U.S. Food and Drug Administration (FDA).

Anavex Life Sciences Corp. announced that the U.S. Food and Drug Administration (FDA) has granted that Orphan Drug Designation for ANAVEX 3-71 for the treatment of Frontotemporal dementia.

Researchers have identified a molecular marker that identifies proliferating cells in normal breast tissue and can predict a woman's risk of developing breast cancer, the leading cause of death in women with cancer worldwide.

Andhra Pradesh is all set to introduce rotavirus vaccine to combat diarrhoeal deaths among children, an official said on Thursday.The state has received 460,000 doses of rotavac, the country's first indigenous rotavirus vaccine.

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Scientists have developed a structure-based vaccine design that can jumpstart an effective immune response to HIV by rapidly offsetting antibodies against the virus, which so far have been unsuccessful.

Countries with higher male smoking rates such as India and Bangladesh can push up asthma and wheezing cases as a result of more exposure to second-hand smoke.This is what Jayadeep Patra, an epidemiologist at the Centre for Global Health Research at St. Michael's Hospital in Toronto, says.