Pharma News

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.

[adsense:336x280:8701650588]

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.

In a major move to combat rising incidence of diabetes in the country, the government on Wednesday inked an agreement with a Hyderabad-based firm to develop medicine to control diabetes and a software to keep tab on diabetics and those vulnerable to the lifestyle disease.

 Celltrion, a global biopharmaceutical company,  announced that the U.S. Food and Drug Administration (FDA) has approved INFLECTRA™ (biosimilar infliximab, sold in Europe as Remsima®) for all indications of the reference product, Janssen Biotech Inc.'s Remicade® (infliximab). INFLECTRA is the first biosimilar monoclonal antibody (mAb) medication to receive approval in the U.S., and is indicated for the treatment of patients with a number of serious autoimmune diseases, including Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.