Archive: Company News
Company News: Curetis’ Partner Beijing Clear Biotech Submits Filing for Unyvero Approval in China
— Submission for Unyvero HPN Cartridge to Chinese regulatory authority NMPA includes U.S. and EU data
— Leverages recent changes in regulation allowing submission of foreign data
— Further collection of clinical data in China planned to support market access and adoption
Curetis N.V. (the “Company” and, together with its subsidiaries, “Curetis“), a developer of next-level molecular diagnostic solutions, today announced that Beijing Clear Biotech (BCB) has filed for regulatory approval of the Unyvero A50 HPN Application Cartridge for pneumonia with the Chinese National Medical Products Administration (NMPA; formerly Chinese Food and Drug Administration). Read more…
Company News: Curetis’ Unyvero Application Cartridges Receive Regulatory Approvals in Malaysia and Thailand
— HPN Cartridge approved in Malaysia; HPN, BCU Cartridges approved in Thailand
— Further commercial roll-out of Unyvero in ASEAN region by partner Acumen Research Laboratories facilitated
— Near-term Chinese NMPA submission of Unyvero HPN expected
Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis“), a developer of next-level molecular diagnostic solutions, today announced that its partner for the commercialization of Unyvero in the ASEAN region, Acumen Research Laboratories Pte Ltd. (Acumen), has received first approvals by the respective regulatory authorities to market the Unyvero HPN Hospitalized Pneumonia Application Cartridge in Malaysia and Thailand. Read more…
Company News: ISA Pharmaceuticals Announces Start of Phase 2 Combination Trial of ISA101b and Regeneron’s Cemiplimab in Oropharyngeal Cancer
– ISA101b and Cemiplimab studied in patients with platinum refractory HPV16-positive oropharyngeal cancer (OPC)
ISA Pharmaceuticals B.V., a clinical-stage company dedicated to the development of rationally designed immunotherapeutics, today announced randomization of the first patient in a Phase 2 combination trial of its lead compound ISA101b and Regeneron´s (NASDAQ: REGN) anti-PD-1 antibody cemiplimab (REGN2810). Read more…
Company News: ISA Pharmaceuticals´ Chief Scientific Officer Prof. Cornelis Melief to Present at Keystone Cancer Vaccines Conference
ISA Pharmaceuticals B.V., a clinical-stage immuno-oncology company, today announced that its Chief Scientific Officer Prof. Cornelis Melief will give a talk at the upcoming Keystone Cancer Vaccines Conference in Vancouver, BC, Canada, January 20-24, 2019. Read more…