Healthcare Roundup – Asymptomatic spread of COVID-19 rare, Gilead files remdesivir application in Europe

医疗保健精选——新冠无症状者传染性很小,吉利德提交瑞德西韦欧洲上市申请
Published on: Jun 8, 2020
Author: Amy Liu

Asymptomatic spread of COVID-19 rare – WHO

In an about-face, the World Health Organization (WHO) now says the spread of COVID-19 by asymptomatic people can occur, but is rare. Earlier in the pandemic, health authorities and researchers believed that the spread of the disease was driven, in a significant way, by infected people who experienced little or no symptoms from the viral infection.

On April 1, the U.S. Centers for Disease Control and Prevention (CDC) issued a report citing the “potential for presymptomatic transmission” as a reason backing social distancing.

The global health watchdog emphasizes that governments should focus on detecting and isolating infected people with symptoms.

Unsurprisingly, WHO says more research and data are needed to “truly answer” the asymptomatic transmission question.

Gilead files remdesivir application in Europe

The European Medicines Agency (EMA) reports that Gilead Sciences (GILD +0.6%) has submitted its marketing application seeking conditional approval of antiviral remdesivir for the treatment of COVID-19.

Considering that the regulator has already reviewed quality and manufacturing data, preliminary results from several clinical trial and supporting data from compassionate use programs, the review timeline will be shortened and the advisory group CHMP may issue an opinion “within weeks.” If positive, the EMA will work closely with the European Commission to fast track a final decision.

Remdesivir is currently approved for emergency use in the U.S. and Japan. The nod in Australia is imminent after a taskforce backed approval last week.

Arch Therapeutics announces capital raise of $1.4M

Arch Therapeutics (OTCQB:ARTH +4.6%) raises $1.4M from long-term shareholders, by issuing Series 1 Unsecured Convertible Note for principal amount of $0.55M; the note is convertible at $0.27/share

The Company may convert upon raising $5M of equity capital at the Conversion Price or greater or after the stock trades above $0.32 per share for at least 15 days.

The Company has also entered into an agreement with the holders of a majority of the outstanding Series D Warrants resulting in proceeds of ~$0.85M

Akcea’s Tegsedi nabs reimbursement in Italy

Ionis Pharmaceuticals (NASDAQ:IONS) affiliate Akcea Therapeutics (NASDAQ:AKCA) announces reimbursement approval in Italy for Tegsedi (inotersen) for stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin (hATTR) amyloidosis.

The med was approved in Europe in 2018.

Cresco Labs nabs processing license in Ohio

Cresco Labs (OTCQX:CRLBF) has been granted a provisional processing license by the state of Ohio, allowing the company to extract oils and manufacture products from cannabis thereby enabling the company to sell its entire House of Brands in Ohio.

Cresco has 25,000 square feet of cultivation, currently undergoing upgrades. On closing of the previous acquisitions and state approval, the company will have a total of five dispensaries in Ohio.

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