Pharma News

• 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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Researchers have developed a promising titanium and gold based compound that destroys kidney cancer cells. The findings appeared in the journal Chemical Science.

A new study warns that if you often feel dizzy, faint or light-headed after getting up, these symptoms could indicate greater risk of developing brain disease such as Parkinson's or dementia, and even an increased risk of death. The findings appeared in the online issue of the journal Neurology.

Glioblastoma multiforme (GBM) is the most commonly occurring brain tumor in adults. A new research has now revealed that activating a specific family of proteins may stop the spread of this most lethal and aggressive brain cancer. The study appeared online in Molecular Biology of the Cell.