Clinical updates, including trial initiations, enrollment status and data readouts and publications: Intervenn, Istar, Ivantis, Life Science Biosensor Diagnostics, Masimo.
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.
The FDA categorized the recall of more than 2.2 million Ellume Pty Ltd. COVID-19 Home Tests that began Oct. 5 as a class I recall, “the most serious type of recall.” While the agency has received significant criticism lately about ambiguity in recalls that often leaves consumers uncertain about their seriousness, the FDA eliminated all doubt on this one saying, “use of these tests may cause serious adverse health consequences or death.” The FDA said it received 35 reports of false positives associated with the antigen test. No deaths have been reported.
A phase III trial testing the oral antiviral favipiravir for the treatment of mild to moderate COVID-19 failed to hit statistical significance on the primary endpoint of time to sustained clinical recovery, sponsor Appili Therapeutics Inc. said.
European regulators have put off a decision on Biogen Inc and Eisai, Co. Ltd.’s controversial Alzheimer’s drug, aducanumab, for likely another month, after the companies announced further supportive data from a follow-up under review by the FDA.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astrazeneca, Dicerna, Équilibre, Gain, Horizon, Humanigen, In8bio, Johnson & Johnson, Lantern, Lilly, Medicinova, Oncoheroes, Oncorus, Opus, Pharmacosmos, Pharmamar, Prokarium, Quoin, Seranovo, Sosei, Yamo, Vaxil.
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