Avoiding the political overtones that seem to be more viral than COVID-19 these days, Anand Shah, deputy commissioner for medical and scientific affairs at the FDA, stressed that even though the agency is making decisions in real time in response to the urgency of the pandemic in the U.S., its decisions are being driven by scientific integrity, regulatory independence and the FDA’s historic commitment to ensuring the safety and efficacy of the products it regulates.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Annovis, Ascletis, Aquestive, CNS, Entera, Immunic, Matinas, Orgenesis, Puma, Regeneron, Revive, Viiv.
Thermo Fisher Scientific Inc. released updated software and new instructions for its Taqpath COVID-19 Combo Kit, a widely used COVID-19 test kit that is also the basis for several other coronavirus diagnostics, following issuance of a letter to clinical laboratory staff and health care providers by the U.S. FDA about the risk of false results with the test. Separately, the Waltham, Mass.-based company has released the first in a series of hematology-oncology assays designed to run on its Ion Torrent Genexus system.
Alcon AG released second-quarter results Aug. 18, reporting worldwide sales of $1.2 billion. That figure represented a decrease of 36%, or 34% on a constant currency basis, vs. the same period last year as COVID-19 hit all business categories. As Wells Fargo’s Larry Biegelsen noted, the Geneva-based company, which held its call Aug. 19, saw net loss per share coming in worse than expected due to higher selling, general and administrative expenses.
Shanghai-based nanobody specialist Novamab Biopharmaceuticals Co. Ltd. is developing a new neutralizing nanobody, Nb11-59, as a potential inhaled therapy for COVID-19 – a convenient treatment if developed successfully. Similar research is being conducted worldwide.
PERTH, Australia – As Victoria suffers through a second COVID-19 wave, bringing the death toll to 430 for Australia, Prime Minister Scott Morrison said that Australians could be among the first in the world to receive a COVID-19 vaccine through an agreement with Astrazeneca plc. Under the deal, every Australian would be able to receive AZD-1222, which is being developed with the University of Oxford.
Life science companies doing business during a pandemic may believe that patients, judges and juries will look kindly on products that don’t perform as promised, but that may be an empty wish.
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