LONDON – South Africa has decided against using the 1 million doses of Astrazeneca plc’s COVID-19 vaccine already in the country to start the rollout of its national vaccination program, in favor of opening a phase IIIb study of Johnson & Johnson’s single shot product. “Over the next few days, we expect to announce a plan to expedite vaccination using [J&J’s] investigational vaccine in health care professionals in South Africa,” said Glenda Gray, CEO of the South African Medical Research Council and chair of the country’s research committee on COVID-19.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anpac, Astrazeneca, Catapult, Elevar, Ellodi, Ideaya, Janssen, Passage, RDIF, Sinovac, Supernus, Viiv.
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.
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