As the FDA continues to shift its limited resources to the development and review of COVID-19 therapies and vaccines, other drugs in the pipeline may be delayed. In a question-and-answer guidance released late Tuesday, the agency acknowledged that, going forward, it may not be able to sustain its current performance level in meeting all its goal dates for new drugs and biologics.
Within a month of disclosing a CA$175.6 million (US$124.7 million) award from the Canadian government to use its antibody discovery platform for the analysis of patients who have recovered from COVID-19, Abcellera Biologics Inc. closed a $105 million series B financing aimed at expanding its capacity and investing in new technologies that complement its antibody discovery engine.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Amivas, Anivive, Astellas, Azitra, Beyond Air, BMS, Diffusion, Fresenius Kabi, GSK, Immunitybio, Intelgenx, Microbion, Protara, Radius, Regenerx, Regeneron, Relmada, Sanofi, Sorrento.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott Laboratories, Biotricity, Capsule Technologies, EKF Diagnostics, Indica Labs, Kings College London, Longhorn Vaccines and Diagnostics, Medisana, Meditemi, Octo, Oncimmune Holdings, Open Pathology, Opencell, Opentrons, Orthogenrx, Sherlock Biosciences, Sinai Health System, Somatix, Sunquest Information Systems, Temi, Transenterix, Varian, Vayyar.
The U.S. Department of Health and Human Services (HHS) has posted a national COVID-19 testing strategy in response to legislation passed in April, and the plan suggests that 300,000 tests per day should suffice to corral the pandemic. That calculation drew immediate fire from House and Senate Democrats, who characterized the plan as an attempt “to paint a rosy picture about testing,” but they also pushed the Senate to pass House legislation that would provide another $75 billion in funding for testing and contact tracing.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4DMedical, Bardy Diagnostics, Beyond Air, Merit Medical, Orteq Sports Medicine, Philips, Smart Medical Systems, United Imaging.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Activstyle, Adapthealth, Astrazeneca, Bio-Techne, Cerus, Echelon Diagnostics, Emed Technologies, Genscript Biotech Europe, Histoindex, IBM Watson Health, Koru Medical Systems, Leica Biosystems, Mauna Kea Technologies, Mesa Labs, Repro Med Systems, Seti, Siemens Healthineers, Skywater Solara Medical Supplies, St Robotics, Velano Vascular, Vizient.
The pandemic hasn't kept biotechs from going public. In fact, through the first five or so months of the year, the industry has raised more than $3.3 billion through IPOs, more capital than biotechs have raised during the first five months of any of the previous 20 years.