Pharma News

Array BioPharma announced the submission of a New Drug Application (NDA) for binimetinib in patients with advanced NRAS-mutant melanoma to the US Food and Drug Administration (FDA). The submission is based on results of the pivotal phase 3 NEMO (NRAS MELANOMA AND MEK INHBITOR) study, which found binimetinib significantly extended median progression-free survival (PFS), the study's primary endpoint, as compared with dacarbazine.

AstraZeneca announced that it has entered into agreements that support its strategic focus on three main therapy areas; Respiratory, Inflammation and Autoimmunity, Cardiovascular and Metabolic disease and Oncology. The agreements include two of AstraZeneca’s potential new medicines for dermatitis and psoriasis, allowing the Company to further simplify and sharpen focus on innovative new medicines in the main therapy areas. 

Kiadis Pharma N.V., a clinical stage biopharmaceutical company developing innovative T-cell immunotherapy treatments for blood cancers and inherited blood disorders, announced that its lead product, ATIR101, has been granted an expansion to its existing Orphan Drug designation (ODD) by the European Medicines Agency (EMA) to include treatment in a hematopoietic stem cell transplantation (HSCT).

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Diseased blood vessels in the brain may contribute more significantly to Alzheimer's disease dementia as per novel research by Rush Alzheimer's Disease Center.

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The study conducted at the UPV/EHU-University of the Basque Country describes for the first time how these receptors participate in spermatogenesisInfertility has become a major medical and social problem worldwide and many of the cases are due to male infertility. Yet the molecular mechanisms involved in spermatogenesis are only now beginning to emerge. A piece of research led by the UPV/EHU doctor Nerea Subirán has for the first time described the presence of opioids in the cells involved in the formation of spermatozoa. The work has been published in Plos One.

AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved HUMIRA® (adalimumab) for the treatment of non-infectious intermediate, posterior and panuveitis. HUMIRA is now the first and only FDA-approved non-corticosteroid therapy available for adults with non-infectious intermediate, posterior and panuveitis. This approval marks the 10th approved indication for HUMIRA in the United States for immune-mediated diseases.

Egalet Corporation  announced that a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA) has been scheduled for August 4, 2016, to review the new drug application (NDA) for ARYMO™ ER (morphine sulfate) extended-release tablets, an abuse-deterrent, oral morphine product candidate. ARYMO ER was developed for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Oncolytics Biotech Inc. announced that, following submission to the US Food and Drug Administration (FDA) for review, the Investigational New Drug (IND) application containing the protocol titled "Phase 2 study of Reolysin (pelareorep) in combination with Folfox6, bevacizumab and pembrolizumab in female patients with KRAS-mutant colorectal cancer metastatic to the liver" is now active.

Ritter Pharmaceuticals, Inc., a pharmaceutical company developing novel therapeutic products that modulate the human gut microbiome to treat gastrointestinal diseases, announced that it recently has been issued US patent number 9,370,532 by the US Patent & Trademark Office.