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llllllllll Sirtex Medical and China Grand Pharmaceutical announce landmark drug registration milestone (Canada Newswire) - Aug 27, 2020 - "Sirtex Medical...announced...that Sirtex and its shareholders, China Grand Pharmaceutical and Healthcare Holdings Limited (CGP), have been issued a 'Notice of Drug Clinical Trial Approval' by the National Medical Products Administration (NMPA) of the People's Republic of China...The notice confirms that SIR-Spheres® Y-90 resin microspheres meet the relevant requirements for drug registration in China. With this confirmation, Sirtex is approved to file a New Drug Application (NDA) in the country....'This is a critical milestone toward allowing us to provide a valuable treatment option to people with liver cancer in China.'"llllllllll namodenoson (CF102) / Can-Fite, China Medical SystemCan-Fite Reports Second Quarter 2020 Financial Results & Provides Clinical Update (Businesswire) - Aug 27, 2020 - "Namodenoson Headed into Pivotal Phase III Liver Cancer Study in Europe and U.S. – Following a successful meeting with the European Medicines Agency (EMA) during the second quarter, and a prior End-of-Phase II Meeting with the U.S. Food and Drug Administration (FDA), Can-Fite completed its protocol for a pivotal Phase III study of Namodenoson in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. The study is designed to support a New Drug Application submission in the U.S. and a Marketing Authorization Application in Europe."llllllllll GB0139 / BMS, GalectoGalecto, Inc. Receives U.S. and EU Orphan Drug Designations for GB0139 in Idiopathic Pulmonary Fibrosis (GlobeNewswire) - Aug 27, 2020 - "Galecto, Inc.,...today announced it has received Orphan Drug Designation (ODD) from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for GB0139 in the treatment of Idiopathic Pulmonary Fibrosis (IPF). The EMA cited clinically relevant biomarker data in IPF patients as a justification for the ODD designation...'Our Phase 2b study in IPF is progressing well, and we look forward to bringing GB0139 further through clinical trials and potentially to market to address a significant unmet medical need.'"llllllllll Rizaport (rizatriptan oral film) / IntelGenx, Gensco LabIntelGenx and Exeltis Healthcare S.L. Expand RIZAPORT Commercialization Agreement to Include the European Union (GlobeNewswire) - Aug 27, 2020 - "IntelGenx Corp....today announced that it has granted Exeltis Healthcare, S.L. ('Exeltis') an exclusive license to manufacture and commercialize RIZAPORT®, a unique oral thin film for the treatment of acute migraines, in the European Union....Exeltis will pay IntelGenx prespecified royalties on net RIZAPORT® sales in the EU. In addition, IntelGenx has a right of first refusal to manufacture the Product for the EU market....'We are looking forward to continued collaboration with IntelGenx, and to launching RIZAPORT® in at least one major market early next year.'"llllllllll Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche; BI-1808 / BioInvent; BT-001 / BioInvent, Transgene; BI-1206 / BioInventBioInvent Interim Report January 1 - June 30, 2020 (PRNewswire) - Aug 27, 2020 - "BioInvent and Transgene presented preclinical data at AACR Virtual Session II, demonstrating high cure rates in solid tumors of BT-001, an anti-CTLA4 antibody-encoding oncolytic virus. Phase I clinical trial expected to start before the end of 2020...A clinical trial application was submitted to begin a Phase I/IIa, first-in-human study of BI-1808 for the treatment of solid tumors or cutaneous T-cell lymphoma. The trial is expected to start before the end of 2020....We are also progressing the Phase I/IIa trial of BI-1206 in combination with rituximab for the treatment of non-Hodgkin lymphoma (NHL) and are looking at the need to add additional sites to ensure good patient enrolment."
