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.
Vaxxinity Inc. priced its IPO below the targeted range, selling 6 million shares (NASDAQ:VAXX) at $13 each for proceeds of $78 million, but came out of the gate impressively, closing at $16.55, up $3.55, or 27%, after reaching $22.77 during the day.
The U.S. NIH said it will go to court if necessary to defend its role in developing Moderna Inc.’s COVID-19 vaccine. NIH spokeswoman Renate Myles told BioWorld that the agency “is not giving up on our claim that NIH is a co-inventor on the mRNA technology used in the Moderna’s COVID-19 vaccine but defers to legal authorities on how this might be resolved.”
The University of Oxford has begun recruiting for a phase I Ebola vaccine trial, with the first vaccinations based around the same technology as the university’s COVID-19 vaccine.
LONDON – Intensive monitoring of health care workers at two hospitals in London showed that despite having a blood biomarker of infection, 58 of them did not test positive for COVID-19 at any point, suggesting they may have been clearing subclinical infections before seroconversion.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascletis, Enlivex, Evofem, Iveena, Kalvista, Kyowa, Mei, Moderna, Modus, Pfizer, Promore, Sofie.
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