Healthcare Roundup – AstraZeneca to “follow the science” in development of COVID-19 vaccine, FDA OKs emergency use of T2 Biosystems COVID-19 test

医疗保健精选——阿斯利康将“遵循科学”开发COVID-19疫苗,FDA批准紧急使用T2 Biosystems的COVID-19试剂
Published on: August 31, 2020
Author: Amy Liu

AstraZeneca to “follow the science” in development of COVID-19 vaccine

In a statement, AstraZeneca (NYSE:AZN) reemphasizes its commitment to the highest safety standards and broad equitable global access to COVID-19 vaccine AZD1222, adding that its marketing applications will meet the stringent requirements by regulators around the world.

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 Its development plan aims to enroll more than 50K volunteers, including 30K in the U.S., Latin America, Asia, Europe, Russia and Africa.

AZD1221, co-invented by the University of Oxford and its spin-out company Vaccitech, is based on a weakened adenovirus vector containing genetic material of the SARS-CoV-2 virus spike protein.

The intense global race to commercialize a legitimate vaccine against the coronavirus has many observers worried that over-eager governments may sign off based on insufficient supporting data, exemplified by Russia’s approval of a vaccine, dubbed Sputnik V, based on results from less than 60 volunteers.

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FDA OKs emergency use of T2 Biosystems COVID-19 test

The FDA has signed off on emergency use of T2 Biosystems’ (NASDAQ:TTOO) T2SARS-CoV-2 Panel, a molecular test that detects the presence of the coronavirus in a nasopharyngeal sample in less than two hours.

The test is performed on the company’s fully automated T2Dx instrument.

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FDA OKs Exact Sciences’ COVID-19 sample collection kit

The FDA has approved the emergency use of Exact Sciences’ (EXAS +2.6%) COVID-19 nasal swab home collection kit.

It has been providing testing services for the respiratory infection since April.

Akari Therapeutics +7% on developmental plans of nomacopan for COVID-19

Akari Therapeutics (AKTX +6.5%) intends to develop nomacopan as a potential treatment for COVID-19 pneumonia through integrated clinical trial programs in U.S., U.K. and Brazil.

Nomacopan has been selected by the U.K.’s AGILE clinical program. An observational study relating to biomarkers that may identify COVID-19 patients is ongoing in the U.K. Data collected from ~50 patients are expected early in Q4.

In Brazil, patient recruitment completed for proof of principle (POP) clinical study; potential progression into follow-on randomized study expected in early Q4.

In U.S., Akari is collaborating on a proposed multi-center randomized study the commencement of which is subject to the FDA approval of a related IND. Initial POP treatment in patients with COVID-19 pneumonia via expanded access programs (EAPs) are ongoing in the US.

Nomacopan has been shown in clinical trials to inhibit both complement C5 activation and leukotriene B4 (LTB4), and has significant potential to simultaneously inhibit both microthrombi as well as block multiple cytokines (the cytokine storm) which together drive COVID-19 pneumonia and associated organ damage.

Novavax inks deal to supply 76M doses of COVID-19 vaccine to Canada

Novavax (NASDAQ:NVAX) has reached an agreement in principle with the Canadian government to supply up to 76M doses of COVID-19 vaccine, NVX-CoV2373, if approved.

Shipments may start as early as Q2 2021, subject to licensure.

The advance purchase agreement should be finalized shortly.

SA Contributor Terry Chrisomalis is Very Bullish on the stock.

Shares up 6% premarket on modest volume.

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