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News For GMAB;AZN;RHHBY From the Last 2 Days
Dec 7, 2021 | 18:00 EST
Genentech, a unit of Roche, was granted orphan designation from the FDA for its recombinant humanized IgG1-based monoclonal antibody which binds to human latent myostatin in a pH dependent manner in the treatment of spinal muscular atrophy. Reference Link
Dec 7, 2021 | 10:24 EST
New data from the TROPION-PanTumor01 phase 1 trial of datopotamab deruxtecan, a TROP2 directed DXd antibody drug conjugate being developed by Daiichi Sankyo (DSNKY) and AstraZeneca (AZN), continue to show encouraging durable tumor response and disease control in patients with metastatic triple negative breast cancer with disease progression following standard treatment, the companies announced. Data were featured during an oral presentation at the 2021 San Antonio Breast Cancer Symposium, or SABCS21. An objective response rate, or ORR, of 34% was observed in 15 of 44 patients treated with datopotamab deruxtecan as assessed by blinded independent central review. Fourteen confirmed complete/partial responses, or CR/PRs, with one additional CR/PR awaiting confirmation and stable disease in 17 additional patients were reported after a median follow-up of 7.6 months. Median duration of response, or DOR, was not reached with the majority ongoing at the data cut-off of July 30, 2021. A disease control rate, or DCR, of 77% was observed. In a subgroup of 27 patients with measurable disease and previously untreated with a topoisomerase I inhibitor-based ADC, an ORR of 52% was reported with datopotamab deruxtecan. Thirteen confirmed CR/PRs with one additional CR/PR awaiting confirmation and stable disease were reported in nine additional patients after a median follow-up of 8.8 months. A DCR of 81% was observed in this subgroup of patients.
Dec 7, 2021 | 10:22 EST
San Antonio Breast Cancer Symposium: SABCS 2021 to be held on December 7-10. Webcast Link
Dec 6, 2021 | 08:10 EST
Roche announced its plans to launch the SARS-CoV-2 & Flu A/B Rapid Antigen Test for professional use in markets accepting the CE Mark by the beginning of January. Roche also intends to file for Emergency Use Authorization to the U.S. Food and Drug Administration in early 2022. Thomas Schinecker, CEO of Roche Diagnostics, stated, "It is critical that healthcare professionals have the ability to quickly know whether a patient has an infection with either SARS-CoV-2 or the flu, especially as the COVID-19 pandemic extends into our flu season. The combination rapid antigen test will help ensure the right decisions are taken by healthcare providers to treat patients and ultimately prevent community spread. The test adds a solution that will be critical to healthcare systems' long-term management of SARS-CoV-2 and seasonal flu, as we transition from today's global health emergency to the endemic phase of tomorrow."