Clinical updates, including trial initiations, enrollment status and data readouts and publications: AC Immune, Avrobio, Cassava, Covaxx, Cue, Dong-A, Eiger, Erytech, Freeline, Jasper, Magenta, Sinovac, Uniqure, Veru.
The latest global regulatory news, changes and updates affecting biopharma, including: CBO model touts savings of H.R. 3; FDA to ODAC: Are data ripe for 2nd TNBC Keytruda approval?; Fifth Circuit reiterates no liability remedy for generics; Consultant faces insider trading charges.
Novasignal Corp. has a launched a cloud-based app to provide alerts to clinicians directly from its cerebral ultrasound device. The new app allows physicians to get instant notifications from the company’s Novaguide device, a transcranial doppler ultrasound technology that allows for real-time assessment of blood flow in the brain by combining robotics and artificial intelligence (AI).
Infectious diseases diagnostics company Lucira Health Inc. launched an IPO of 9 million shares of common stock at $17 per share, for expected gross proceeds of $153 million. Friday’s Wall Street debut was a show of confidence, upsized from an original plan to offer 7.8 million shares at $15 to $17. The Emeryville, Calif.-based company has granted the underwriters a 30-day option to acquire up to an additional 1,350,000 shares of common stock at the initial public offering price, less underwriting discounts and commissions.
HONG KONG – Earlysense Ltd. has sold a contact-free continuous monitoring technology to global med-tech provider Hillrom Holdings Inc. Ramat Gan, Israel-based Earlysense will receive licensing for all intellectual property and technology sold to Chicago-based Hillrom for use outside the hospital along with $30 million in cash, commercial milestone payments and a portion of Hillrom's equity investment
LONDON – A follow-up study of participants in the phase II/III U.K. trial of Astrazeneca plc’s COVID-19 vaccine has shown it remains effective against the new B.1.1.7 variant of SARS-CoV-2.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: EMA initiates OPEN collaboration; NICE evaluating guidance processes; Florida researcher indicted.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Commonwealth Diagnostics International, Real Time Medical Systems, Seqwell, T2 Biosystems, Zimmer Biomet.
Covicept Therapeutics Inc., a young San Diego-based company focused on developing a small molecule to inhibit the replication and spread of SARS-CoV-2 and other RNA viruses, has launched with $2.3 million in seed funding from European VC firm Forbion. The company, spun out of research at the University of California, San Diego, aims to initiate its first clinical study in the middle of 2021.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Actinogen, BMS, Celltrion, Innocare, J&J, Novavax, RDIF, TG.
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