Test developers and the U.S. FDA are scrambling to meet the testing needs of the American public, however, it's somewhat unclear what the agency's priorities are for the emergency use authorization (EUA) program. Jeffrey Shapiro, of Hyman Phelps & McNamara, made the case that the FDA’s Center for Devices and Radiological Health (CDRH) should be more transparent about its priorities for EUA review.
Adaptive Biotechnologies Corp. posted revenue of $30.2 million for the fourth quarter of 2020, up 25% from the corresponding prior year period. The tally beat consensus by $3.3 million. Clinical sequencing volume grew 41% to 4,539 clinical tests, compared with the fourth quarter of 2019. For the full year, revenue increased 16% year over year to $98.4 million, and clinical sequencing volume topped out at 15,216 clinical tests delivered, up 50%. The results coincided with the launch of the company’s T-Detect COVID, the first clinical T cell-based test to confirm recent or prior COVID-19 infection.
HONG KONG – Wuxi Diagnostic Investment (Cayman) Ltd. has raised $150 million in a series B financing round, while netting a number of new investors along the way. The new investors to come on board include Thermo Fisher Scientific Inc., Shiyu Capital, ABC International Holdings Ltd., Sunland Capital and CCBI Tech Venture.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: American Cryostem, Assure Holdings, Biotherapeutic Labs, Bird & Cronin, Caredx, Cerus, Charles River Laboratories, Clinical Reference Laboratory, Co-Diagnostics, Collplant Biotechnologies, Dynatronics, Grin, Henry Schein, Icon, Illumina, Imaging Endpoints, Intalere, Kibur Medical, Neovasc, New England Biolabs, Oxford Nanopore Technologies, Patientslikeme, PRA Health Sciences, Protembis, Puretech Health, Renalytix AI, Rubiconmd, Sentry Neuromonitoring, Shandong Zhongbaokang Medical Implements, Siren Care, Smiledirectclub, SQN Clinical, Transchart, TX Services, United Therapeutics, Veristat, Walgreens.
The EMA issued a guidance Feb. 25 outlining the requirements for manufacturers planning to modify COVID-19 vaccines to address emerging variants of the SARS-CoV-2 coronavirus.
Eight months after Beijing-based Yisheng Biopharma Co. Ltd. unveiled its recombinant protein vaccine candidate for COVID-19, YS-SC2-010, the company raised $130 million in a series B round to pave way for the vaccine to enter clinical trials in the second quarter of this year, the company’s CEO David Shao told BioWorld.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Aquestive, Bluebird, Cansino, Exelixis, Gannex, J&J, Retrotope, RDIF, Sinopharm, Viiv.
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