Healthcare Roundup – Moderna won’t seek FDA emergency use nod before November 25, AstraZeneca/Oxford COVID-19 vaccine nabs accelerated review in Europe

医疗保健精选——Moderna不会在11月25日之前申请紧急使用授权,阿斯利康/牛津COVID-19疫苗在欧洲加速审查
Published on: October 1, 2020
Author: Amy Liu

Moderna won’t seek FDA emergency use nod before November 25 – CEO

Commenting at a Financial Times conference, Moderna (MRNA -0.1%) chief Stéphane  Bancel stated that the company will not be able to apply for emergency use authorization (EUA) in the U.S. for COVID-19 vaccine mRNA-1273 before November 25 at the earliest reflecting the minimum amount of time needed to accumulate enough safety data.

He also said that the company does not expect full approval to distribute the vaccine to all sections of the U.S. population until next spring.

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AstraZeneca/Oxford COVID-19 vaccine nabs accelerated review in Europe

Bloomberg reports that the European Medicines Agency (EMA) has agreed to a rolling review of the marketing application for AstraZeneca (AZN -0.3%) and the University of Oxford’s COVID-19 vaccine (AZD1222/ChAdOx1).

The timing of the filing should be next year since topline data from two pivotal large-scale studies will not likely be available until then.

Sorrento teams up with ViralClear to explore COVID-19 combo treatment

Sorrento Therapeutics (NASDAQ:SRNE) inks an agreement with ViralClear Pharmaceuticals, subsidiary of BioSig Technologies (NASDAQ:BSGM), aimed at exploring the potential of small molecule and antibody combination therapies in COVID-19.

SRNE will initially contribute neutralizing antibody STI-1400 while ViralClear will contribute antiviral IMPDH inhibitor merimipodib (currently being tested in a mid-stage study with Gilead’s remdesivir).

The combo will be initially assessed in a Golden Syrian hamster model of COVID-19.

SRNE is up 1% premarket on robust volume while BSGM is up 5% on light volume.

Becton, Dickinson’s SARS-CoV-2 antigen test OK’d in Europe

Becton, Dickinson & Company (NYSE:BDX) announces its rapid, point-of-care, SARS-CoV-2 antigen test for use on the BD Veritor Plus System has been CE marked to the IVD Directive (98/79/EC).

The new test delivers results in 15 minutes on an easy-to-use, portable instrument. This new assay is expected to be commercial available at the end of October in Europe.

SA Authors and Wall Street sell-siders are Bullish with a price target of $281.75, while Quant Rating is Neutral.

Amwell expands partnership with Tyto Care

Amwell (AMWL +1.5%) expands its partnership with Tyto Care, introducing exclusive integrations and newly designed workflows and tools to enhance the ability for providers using the Amwell platform to examine and diagnose patients virtually.

Tyto Care is an all-in-one modular device and examination platform for AI-powered, on-demand, remote medical exams. Additionally, Amwell will become a reseller of Tyto Care’s integrated devices.

“With Google as AMWL’s go-to-market partner in the rapidly-expanding telehealth space, I can easily construct a “Very Bullish” outlook for the shares of American Well Corporation. The COVID-19 pandemic has increased the public’s familiarity and overall usage of telehealth solutions as a mechanism for healthcare delivery,” mentions SA Contributor Bill Gunderson with Very Bullish rating.

Biotechnology COVID-19 Life Science Pharmaceutical