Doing all it can to get quick COVID-19 tests into the field in the U.S., the FDA has signed off on Emergency Use Authorization for Bodysphere’s qualitative (yes or no answer) blood test that detects the presence of antibodies to SARS-Cov-2 in two minutes. The lateral flow chromatographic immunoassay should only be performed by medical professionals, however.
Abbott “held” the previous record of five minutes for its test launched on Friday, March 27.
One caveat is that current blood tests do not detect the presence of the actual virus (molecular tests on nasopharyngeal swabs do) so there is a small window of time between infection and the production of antibodies, typically a few days, where someone could be a coronavirus version of Typhoid Mary.
In an interview on CNBC’s Squawk Box, former FDA Commission Scott Gottlieb, M.D., stated that COVID-19 models indicate that the pandemic in the U.S. may peak in late April or early May, adding that the entire country is probably two or three weeks behind New York. Afterward, if the infection curve flattens then drops, authorities may consider a slow rollback of mitigation efforts.
Summer weather should be an effective backstop since coronaviruses typically don’t circulate then. April will be a tough month, May one of transition, then June onward life should (somewhat) return to normal, he says.
He also stated that health authorities will be much better prepared in the fall if the virus resurfaces than they were in January.
Neogen (NEOG +3.2%) has acquired the assets of Chile-based Magiar Chilena, a distributor of food, animal, and plant diagnostics, including Neogen products.
NEOG will incorporate the Magiar assets into its wholly owned subsidiary, Neogen Chile SpA.
John Adent, Neogen’s president and CEO: “The addition of operations in Chile gives us a direct presence in nearly all of the major agricultural and food industry markets in South America”.
CytoDyn (OTCQB:CYDY) announces that the FDA has provided clearance for initiation of a Phase 2 trial with leronlimab to treat Covid-19 patients with mild-to-moderate indications.
The Company’s IND, leronlimab, has been administered to 10 severely ill patients with Covid-19 in the New York City area under an emergency IND recently granted by the FDA.
The Phase 2 trial calls for 75 planned patients in up to 10 centers in the U.S. The treatment window is of approx. 6 weeks.
Eli Lilly (NYSE:LLY) inks an agreement with UK biopharmaceutical firm Sitryx aimed at developing up to four candidates to treat autoimmune disorders.
Under the terms of the deal, Lilly will pay Sitryx $50M upfront, up to $820M in milestones and mid- to high-single digit royalties on net sales. Lilly will also invest $10M in Stiryx equity. In return, it will receive exclusive global rights to develop and commercialize up to four novel immunometabolism-targeted therapeutics, including Sitryx’s two lead programs. Lilly will fund all clinical development and commercial activities. The parties will also establish a five-year research collaboration for drug discovery.
Lilly says the transaction will not affect its 2020 non-GAAP EPS guidance.
Shares up 1% premarket on light volume.
