Pharma News

Pixium Vision, a company developing innovative bionic vision systems to allow patients who have lost their sight to lead more independent lives, has received approval from the Medicines & Healthcare products Regulatory Agency (MHRA) in the UK to initiate a clinical trial for patients who have lost sight due to retinitis pigmentosa (RP) with the IRIS II bionic vision system. This system being evaluated includes a mini bio-inspired camera and a 150 electrode epi-retinal implant with an explantable design.

Vertex Pharmaceuticals Incorporated, a global biotechnology company, announced that the US Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for the use of Orkambi (lumacaftor/ivacaftor) in people with cystic fibrosis (CF) ages 6 to 11 who have two copies of the F508del mutation. The FDA granted Vertex's request for Priority Review of this sNDA, and a target review date of September 30, 2016 was set under the Prescription Drug User Fee Act (PDUFA).

Nektar Therapeutics has entered into an agreement with Daiichi Sankyo Europe for Nektar's investigational drug therapy, ONZEALD (etirinotecan pegol, NKTR-102), which has completed a Phase 3 clinical trial (the BEACON study) in patients with advanced breast cancer.  The agreement grants Daiichi Sankyo Europe exclusive rights to market ONZEALD in Europe (EEA), Switzerland and Turkey. Nektar Therapeutics will retain rights to ONZEALD in the United States and the rest of the world.

The lungs contain a thin layer of fluid known as the airway surface liquid (ASL), which helps protect against pathogens. The appropriate ASL volume, pH, and ionic composition are required for optimal airway defense.

Small cell lung cancer (SCLC) represents approximately 14 percent of all types of lung cancer. Many patients with SCLC respond to initial chemotherapy; however, they eventually relapse and develop progressive disease that has no effective treatment options. A new Moffitt Cancer Center study being presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago and published in The Lancet Oncology shows that utilizing the immunotherapeutic agents nivolumab and ipilimumab could lead to more effective treatment options for SCLC patients who fail initial therapy.

The results of an exploratory clinical trial indicate that a wearable artificial kidney could be developed as a viable, new dialysis technology. Some redesigns would be required to overcome device-related, technical problems observed during the testing.

Dentin is one of the most durable biological materials in the human body. Researchers from Charité - Universitätsmedizin Berlin were able to show that the reason for this can be traced to its nanostructures and specifically to the interactions between the organic and inorganic components. Measurements performed at BESSYII, the Helmholtz-Zentrum Berlin's synchrotron radiation source, showed that it is the mechanical coupling between the collagen protein fibers and mineral nanoparticles which renders dentin capable of withstanding extreme forces. Results from this research have been recently published in the journal Chemistry of Materials.

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Eating walnuts may change gut bacteria in a way that suppresses colon cancer, researchers led by UConn Health report in the journal Cancer Prevention Research.

Testing for metabolic changes in the blood could indicate whether a cancer drug is working as designed, a new study reports.Scientists have found that measuring how cancer treatment affects the levels of metabolites the building blocks of fats and proteins can be used to assess whether the drug is hitting its intended target.

Allergan plc, announced that the company has received approval from the U.S. Food and Drug Administration (FDA) to market JUVÉDERM VOLBELLA® XC, for use in the lips for lip augmentation and for correction of perioral rhytids, commonly referred to as perioral lines, in adults over the age of 21.