Nearly 18% of clinical data reported in August were focused on the COVID-19 pandemic, representing the highest percentage for any single month this year. During the month, as the Delta variant took hold throughout the U.S., news of COVID-19 efforts spiked, doubling the amounts seen in both June and July, in which about 9% of the news was pandemic-related, and up significantly from 10% in May.
The European Society for Medical Oncology Congress 2021 has begun with a mix of education and multidisciplinary sessions in addition to symposia. Silverback Therapeutics Inc. was a presenter and took a hit on the market Sept. 16 with its interim phase I/Ib study results showing SBT-6050’s proof of mechanism was established with activated myeloid and T/natural killer cells when treating advanced or metastatic HER2-expressing solid tumors.
Aerie Pharmaceuticals Inc.’s wide-net endpoint approach with the phase IIb study called Comet-1 seemed less than appreciated by the stock market as the firm unveiled top-line data in dry eye disease with AR-15512.
DUBLIN – Allarity Therapeutics A/S plans to file an NDA with FDA for dovitinib in renal cell carcinoma (RCC) in the fourth quarter this year, after unveiling a new analysis at the European Society for Molecular Oncology’s virtual congress, which suggest that its companion diagnostic, DRP, can identify patients who obtain a survival benefit from the therapy.
Following two clinical trial disappointments, the newest being the phase III failure of ampreloxetine, Theravance Biopharma Inc. will restructure by laying off three-quarters of its staff and will stop developing all but two of its non-respiratory disease programs. The ampreloxetine study for treating symptomatic neurogenic orthostatic hypotension failed to meet its primary endpoint, the company announced Sept. 15. In late August, data from a phase IIb dose-finding study showed izencitinib, a gut-selective pan-JAK inhibitor for treating ulcerative colitis, failed to meet its primary endpoint.
Given the ethics and feasibility of placebo-controlled COVID-19 vaccine trials, Access Consortium members are recognizing appropriately designed immunobridging studies as an acceptable approach for authorizing the vaccines, including those being developed to protect against SARS-CoV-2 variants.
While privately held Calcimedica Inc. posted positive top-line results from a phase II study of its lead candidate in treating patients with severe COVID-19 pneumonia, Redhill Biopharma Inc. took a tumble as preliminary top-line data from a phase II/III study of opaganib in treating hospitalized COVID-19 patients showed the endpoints failed to achieve statistical significance.
RSS
