The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA sets up webpage, template for screening; Stryker’s STAR ankle exhibiting fracture risk.
LONDON – Exevir Bio NV added a further €15 million (US$17.9 million) to close its series A round at €42 million, providing the means to take its nanobody therapy for treating COVID-19 infection through to registration.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arbutus, Arch, Corat, Cytocom, Meissa, Merck & Co., Pep-Therapy, Sagimet, Spectrum, Visus.
Roche Holding AG will acquire Genmark Diagnostics Inc. for $24.05 per share in cash for a total of $1.8 billion on a fully diluted basis. The transaction will give Basel, Switzerland-based Roche access to Genmark’s molecular diagnostics portfolio. The deal is expected to close in the second quarter of 2021. The price represents a 43% premium on the Carlsbad, Calif.-headquartered diagnostics company’s share price as of Feb. 10, prior to media speculation about a potential acquisition.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Check-Cap, Fujifilm, Olympus Medical, Pelican Diagnostics.
While World Trade Organization members continue to debate a proposal to waive intellectual property rights for COVID-19 vaccines and therapies, Biolyse Pharma Corp. is threatening to apply for a compulsory license of Johnson & Johnson’s one-dose vaccine through the Canadian Access to Medicines Regime.
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