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llllllllll dexamethasone / Generic mfg.EU watchdog assessing Dexamethasone Taw as possible COVID-19 drug (Reuters) - Sep 2, 2020 - "The European health regulator said on Wednesday it was evaluating Taw Pharma’s branded steroidal drug dexamethasone as a potential COVID-19 treatment for hospitalised adult patients after it received an application from the drug developer. The European Medicines Agency (EMA) said in a statement its human medicines committee (CHMP) would weigh-in on the application for Dexamethasone Taw within the shortest timeline possible....If approved, Dexamethasone Taw will be available as an injectable medicine for COVID-19, the EMA said." llllllllll CNM-Au8 / Clene NanomedicineClene Nanomedicine, Inc. to go Public through Merger with Tottenham Acquisition I Limited (PRNewswire) - Sep 2, 2020 - "Tottenham Acquisition I Limited...today announced that it has entered into a definitive merger agreement...for a business combination with Clene Nanomedicine, Inc. ('Clene')...for the treatment of neurodegenerative diseases in addition to a nanotechnology based-therapy with antiviral applications....Clene's lead asset, CNM-Au8, is an orally administered therapeutic...including multiple sclerosis, Parkinson's disease, and ALS, with one Phase 3 trial multiple Phase 2 clinical studies ongoing." llllllllll Inlyta (axitinib) / Pfizer; Bavencio (avelumab) / EMD Serono, PfizerNICE green light for immunotherapy Bavencio (PharmaTimes) - Sep 2, 2020 - "The National Institute for Health and Care Excellence (NICE) has now published final guidelines endorsing NHS use of Merck and Pfizer's immunotherapy Bavencio (avelumab) in combination with axitinib as a first-line treatment for kidney cancer....NICE concluded that clinical trial evidence shows that, for people with untreated advanced RCC, Bavencio plus axitinib increases how long people live without their disease getting worse compared with sunitinib, while early data also suggest the therapy increases survival." llllllllll disufenton sodium (OKN-007) / GtreeBNTBrain tumor drug receives rare disease designations from the FDA (PRNewswire) - Sep 2, 2020 - "The U.S. Food and Drug Administration has awarded Rare Pediatric Disease Designation (RPDD) for diffuse intrinsic pontine glioma (DIPG) and Orphan Drug Designation for treatment of malignant glioma to OKN-007, an investigational drug discovered at the Oklahoma Medical Research Foundation and being developed by Oblato, Inc." llllllllll polyinosinic:polycytidylic acid (BO-112) / Highlight Therap; Keytruda (pembrolizumab) / Merck (MSD)Highlight Therapeutics Announces Second Phase II Oncology Collaboration with Merck (GlobeNewswire) - Sep 2, 2020 - "Highlight Therapeutics...announces it has entered into a second Phase II trial collaboration with a subsidiary of Merck & Co., Inc...The collaboration will focus on the Phase II evaluation of the combination of BO-112, Highlight's lead program, and KEYTRUDA® (pembrolizumab), MSD's anti-PD-1 therapy, in patients that have progressed on anti-PD-1-based therapy in refractory advanced malignant melanoma...The trial, named Spotlight 203, will evaluate the combination of stimulation of the innate immune system by direct intra-tumoral administration of BO-112, combined with systemic administration of pembrolizumab..."
