Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abivax, Akeso, Algernon, Alnylam, Aurinia, Cytrx, Expression, Hansa, Kala, Neurobo, Novaremed, Orphazyme, Qurient, Rockwell, Sino, Takeda, Zealand.
Wall Street has stabilized enough after the recent pandemic-induced volatility to offer enthusiastic support to a med tech generating significant revenue that already reached breakeven during the first quarter. Inari Medical Inc. priced its IPO at the top of an already upwardly revised range to raise $156 million. It sold 8.2 million shares at $19, above the prior range of $17 to $18. Shares of the Irvine, Calif.-based company (NASDAQ:NARI) then more than doubled to hit about $43 on its first day of trading.
The U.S. FDA reported that 28 serology tests for antibodies for the SARS-CoV-2 virus either have been withdrawn from the market by the sponsor or delisted by the agency for failure to comply with its notification process for emergency use authorization (EUA). The agency said the list of unavailable tests will be updated over time. For his part, Commissioner Stephen Hahn said the move was undertaken “to ensure that Americans have access to trustworthy tests.”
Of the 160 biopharma deals tracked by BioWorld during the month of April, 36% are for collaborations focusing on the development of therapeutics and vaccines for COVID-19.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Avra, Cls Laserthermia Systems, Infinite Mind, Kahala Biosciences, Orasure, Osang Healthcare, Ra Medical, Rymedi, SG Blocks, Tiziana.
LONDON – Human challenge specialist Open Orphan plc has raised £12 million (US$14.6 million) in a placing to accelerate development of COVID-19 challenge study models, to meet demand from vaccines and therapeutics developers worldwide.
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