A busy regulatory environment globally throughout most of 2021 has translated into more than 15% of all actions taken relating to the COVID-19 pandemic, yet only one product has been approved in the U.S. for the SARS-CoV-2 virus.
A futility analysis of Molecular Partners AG’s ensovibep for treating hospitalized COVID-19 adults prompted an independent data safety monitoring board to recommend discontinuing recruitment of patients in the phase III ACTIV-3 study.
Patients and investors in Alung Technologies Inc. can breathe a little easier now that the company’s Hemolung respiratory assist system has won a de novo approval from the FDA. The FDA approval comes more than eight years after Hemolung received CE mark and Health Canada approval. Hemolung gained FDA emergency use authorization for patients with COVID-19 in April 2020.
The U.S. Department of Health and Human Services (HHS) has withdrawn its August 2020 rescission of the FDA’s authority to regulate lab-developed tests (LDTs), a reversal predicated on the need for additional testing capacity for the COVID-19 pandemic. However, the non-COVID implications are not clear as the FDA is not widely seen as having the capacity to regulate LDTs for non-pandemic purposes, while pending legislation would dramatically overhaul the agency’s approach to LDT regulation, making the current regulatory environment an unstable environment at best. The FDA accompanied the announcement with a statement that the emphasis at the agency is on tests that do not require that the patient sample be sent to a lab for processing.
My Life Technologies Corp. has raised $4 million from investors to fund production and clinical trials for its microneedle technology. Based in Leiden, Netherlands, the company is developing a ceramic patch that can deliver vaccines or drugs through the skin. The technology could prove to be an attractive alternative to standard vaccine injections due to what the company says is its simple and painless delivery.
LONDON – Cancer immunotherapy specialist Valo Therapeutics Oy has raised €11 million (US$12.6 million) in an oversubscribed round that will fund the final preparations to move the lead program into the clinic at the start of 2022, and to prepare for an IPO later next year. The phase I will be the first test in humans of Valo’s Pepticrad (peptide-coated conditionally replicating adenovirus technology), which combines two different approaches for which there is there is separate clinical proof: oncolytic adenoviruses and peptide cancer vaccines.