There will be lessons learned aplenty when the COVID-19 pandemic finally breaks, including how serological and molecular testing can be used to maximum effect to corral a future pandemic.
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 – Chengdu, China-based Clover Biopharmaceuticals Inc. has teamed up with Emeryville, Calif.-based Dynavax Technologies Corp. on a research collaboration to develop a vaccine candidate to prevent COVID-19.
The past week has seen a lot of movement in terms of tests to detect SARS-CoV-2, the virus that causes COVID-19. “It is notable that the diagnostics community is coming together in a way we have not seen in our 20 years covering this industry,” wrote William Blair analyst Brian Weinstein in a March 14 note. “Regulators, lab professionals, and manufacturers are all in a frenetic fury to try and get testing up and running, and we generally see a sense of ‘in it together’ playing out.”
The latest mutation to the coronavirus, dubbed COVID-19, has sparked a reaction by many national governments, but the expense associated with development of vaccines and diagnostics is considerable.
A half-day open meeting intended to examine “how the public perceives and values pharmaceutical quality,” convened by the Robert J. Margolis Center for Health Policy at Duke University in cooperation with the FDA, included a rundown of the agency’s oversight program, results of surveys to measure viewpoints of patients and providers – and tart commentary from a two-member “reactant panel.”
The U.S. Department of Health and Human Services has declared a public health emergency in the U.S. over the coronavirus in part because a government diagnostic for the virus yields inconsistent results, a fact that may spur the life sciences to provide a solution.
Salt Lake City-based Co-Diagnostics Inc. has finished the principle design work for a polymerase chain reaction (PCR) screening test for the novel coronavirus that has sickened nearly 3,000 with an acute respiratory illness and killed more than 80 people in Wuhan, China.
Time will tell whether what the Trump administration is calling a “historic” and “landmark” trade agreement with China will better enable drug and device companies to more fairly compete in the Chinese market without having to sacrifice their intellectual property (IP) and technology.
A mere 26 months after the first patient was enrolled in its pivotal phase II study and about three months ahead of its PDUFA date, the FDA granted accelerated approval for Padcev (enfortumab vedotin-ejfv) to treat adults with locally advanced or metastatic urothelial cancer.
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