The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Cellex, Ipsum Diagnostics, Refocus Group.
Given the evolving COVID-19 situation, U.S. House committee chairs are asking the White House Office of Management and Budget (OMB) to direct federal agencies to immediately extend all public comment periods by at least 45 days beyond the end of the declared national emergency, whenever that may be.
In an uncertain time that’s dominated by COVID-19, Flagship Pioneering Inc. and Arch Venture Partners collectively raised a massive $2.56 billion to fund new company creation and growth.
COVID-19 has disrupted science in the way it has disrupted everything else. In the short term, universities have largely closed shop as a way to maximize social distancing, and lots of science – or at least, lots of bench work – is not getting done.
HONG KONG – China’s I-Mab Biopharma Co. Ltd. has entered a strategic partnership with Indonesia’s PT Kalbe Genexine Biologics (KG Bio). Through the deal, KG Bio will receive the right of first negotiation to commercialize two I-Mab-discovered candidates in the ASEAN and MENA regions as well as Sri Lanka.
DUBLIN – Ose Immunotherapeutics SA finds itself in the difficult place of hitting the primary endpoint of the first part of a phase III trial of Tedopi, a therapeutic vaccine, in non-small-cell lung cancer (NSCLC) while having to terminate the study without completing the crucial second part.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cytosorbents, Enlightenvue, Qiagen, Siemens Healthineers.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Affimed, Applied, Celularity, Fera, Nicox, Pfizer, Pharmamar, Seattle Genetics.
RSS
