Clinical research
The fate of three cancer immunotherapies that had been authorized under the U.S. Food and Drug Administration’s Accelerated Approval pathway will be determined next week following failures in confirmatory trials.
It was a busy week for non-COVID-19-related clinical trial news, while fairly quiet on the COVID-19 arena. Here’s a look.
Molecular Partners announced yesterday it has filed for a $100 million initial public offering with the Securities and Exchange Commission in the U.S., funding which will go toward supporting the company’s work in the development of protein-based treatments for COVID-19 and various cancers.
Ocugen’s plan to bring a COVID-19 vaccine developed by India-based Bharat Biotech later this year remains on track following an interim analysis of Phase III data that shows the vaccine demonstrated a 78% efficacy against mild to moderate infection and 100% efficacy against severe COVID-19.
On the back of the two positive Phase III trials, Ortho said it will submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2022.
The American Academy of Neurology Virtual Annual Meeting 2021 is ongoing from April 17 through 22, with literally hundreds of presentations. Here’s a peek at just some of them.
The Swiss pharma giant quietly announced the cuts this morning in a breakdown of its first quarterly financial report.
Syndax Pharmaceuticals announced its treatment for mixed-lineage leukemia demonstrated robust clinical activity in a Phase I/II study.
Humanigen reported positive data from its Phase Ib ZUMA-19 trial of lenzilumab in patients treated with CAR-T in diffuse large B-cell lymphoma (DLBCL).
The agency is requesting additional information and analysis of preclinical studies regarding KVD824 before giving the go-ahead to the Phase II trial.
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