Pharma News

World Pharmacists Day (SEPTEMBER 25, 2015)

The Indian Pharmaceutical Association (IPA) Anantapuramu Local Branch, with Head Office of Raghavendra Institute of Pharmaceutical Education & Research (RIPER), celebrated the World Pharmacist Day on September 15, 2015 (Friday).

U.S. Food and Drug Administration (FDA) has accepted BMS's filing and review a supplemental Biologics License Application (sBLA) for the Opdivo (nivolumab)+Yervoy (ipilimumab) regimen to include clinical data from CheckMate -067, a landmark trial in patients with previously untreated advanced melanoma. The FDA also granted Priority Review for this application with a target action date of January 23, 2016.

Bristol-Myers Squibb Company (BMS) and Moffitt Cancer Center today announced that they have entered into a collaboration agreement as part of Bristol-Myers Squibb’s Immuno-Oncology Rare Population Malignancy (I-O RPM) program in the U.S. The I-O RPM program is a multi-institutional initiative with academic-based cancer centers focused on the clinical investigation of immuno-oncology therapeutics as potential treatment options for patients with high risk, poor prognostic cancers, defined as a rare population malignancy.

• GBR 1302, a HER2xCD3 bi-specific antibody has successfully completed the  preclinical  evaluation phase
• Preclinically, GBR 1302 has demonstrated superiority over current antibody therapies against most HER2 positive cancers, including breast cancer
• The phase 1 trial application for this antibody has been submitted  to  German regulatory  authorities.
• GBR  1302  has the potential  to  be  used  in  the  treatment a  broad  array  of  cancers  in cluding breast cancer
• If  confirmed  in  clinical  trials,  GBR  1302  could  constitute an innovative treatment for HER2 positive cancers, potentially  superior  to the currently available  monoclonal  antibody treatments

GlaxoSmithKline and Theravance, Inc. joined to file a supplemental Japanese New Drug Application (sJNDA) for Relvar® Ellipta® (fluticasone furoate “FF”/vilanterol “VI” or “FF/VI”) for the treatment of chronic obstructive   (COPD) with the Japanese regulatory authority during the first quarter of 2016. This decision follows results from an additional global phase III efficacy and safety study.

Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for mepolizumab, which will be commercialised under the brand name Nucala, as an add-on treatment for severe refractory eosinophilic asthma in adult patients.

Novo Nordisk announced the headline results from the second phase 3a trial for semaglutide, SUSTAIN3. Semaglutide is a new GLP-1 analogue administered subcutaneously once weekly. The trial investigated the efficacy and safety of 1.0 mg semaglutide compared with 2.0 mg exenatide once-weekly after 56 weeks of treatment added on to 1-2 oral antidiabetic drugs in 813 people with type 2 diabetes.

US Food and Drug Administration (FDA) has approved Novonordisk's Tresiba® and Ryzodeg® 70/30 for the treatment of diabetes mellitus in adults after review of the class II resubmissions of the New Drug Applications (NDAs).

New research shows that taking blood pressure medications at bedtime whilst asleep halves the risk of developing type 2 diabetes. The study is published in Diabetologia.

Researchers have created smarter immune cells that produce and deliver a healing protein to the brain while also teaching neurons to begin making the protein for themselves. The study was published in PLOS One.

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