Healthcare Roundup – Pfizer (PFE), BioNTech (BNTX) vaccine is 95% effective in final analysis; FDA authorizes first at-home rapid COVID-19 test

医疗保健精选——辉瑞和BioNTech新冠疫苗最终有效率达95%;FDA批准首个在家使用的新冠病毒试剂
Published on: November 18, 2020
Author: Amy Liu

Pfizer (PFE), BioNTech (BNTX) vaccine is 95% effective in final analysis

The COVID-19 vaccine in development by Pfizer and BioNTech is 95% effective, according to the final clinical trial data.

And application for emergency authorization with be submitted “within days”.

In the trial with 44K participants, the vaccine protected patients and showed no significant safety problems.

It was 94% effective in those over 65 years old.

Pfizer (NYSE:PFE) is up 3.3% premarket. BioNTech (NASDAQ:BNTX) is up 7.7%.

S&P futures (SPX) saw a modest bump up as the headlines hit.

Moderna reported on Monday its vaccine candidate was 94.5% effective.

FDA authorizes first at-home rapid COVID-19 test

The FDA has issued an emergency use authorization (EUA) to the single-use COVID-19 diagnostic test kit from Lucira Health, a California manufacturer.

The Lucira COVID-19 All-In-One at home test kit provides rapid results. To date, the Agency has authorized nearly 300 tests for coronavirus.

The test allows users age 14 and older to swab themselves to collect a nasal sample. The sample is then swirled in a vial of laboratory solution that plugs into a portable device. Results are displayed in 30 minutes as lights labeled positive or negative.

The test is currently authorized for prescription use only.

Individuals with positive results should self-isolate and seek additional care from their health care provider.

Pfizer and Vivet on go with mid-stage VTX-801 study in liver disorder

Pfizer (NYSE:PFE) and privately held gene therapy biotech, Vivet Therapeutics announce that the FDA has cleared Vivet’s Investigational New Drug (IND) application for the GATEWAY study, a Phase 1/2 clinical trial evaluating Vivet’s gene therapy vector, VTX-801, for the potential treatment of Wilson disease (WD), a rare and life-threatening liver disorder. The trial is expected to commence in early 2021.

The GATEWAY trial will measure relevant biomarkers to evaluate physiological restoration of copper elimination and transport in patients.

The primary endpoint is to assess the safety and tolerability of VTX-801 at 52 weeks after a single infusion.

Vivet Therapeutics expects to enroll the first patient in early 2021.

In March 2019, Pfizer acquired 15% ownership stake in Vivet and secured an exclusive option to acquire all outstanding shares.

In September 2020, Vivet and Pfizer inked manufacturing agreement for the VTX-801.

Sinovac’s COVID-19 vaccine ‘successful’ in mid-stage trials

China’s Sinovac Biotech’s (NASDAQ:SVA) experimental COVID-19 vaccine, CoronaVac triggered a quick immune response but low levels of antibodies when compared to the people who had recovered from the disease, source Reuters.

While the early to mid-stage trials were not designed to assess the efficacy of CoronaVac, researchers said it could provide sufficient protection, based on their experience with other vaccines and data from preclinical studies with macaques.

The announcement comes after European and U.S. vaccines reported successful data from large late-stage trials. Three vaccines, developed in the U.S., Germany and Russia, have all released data suggesting efficiency of more than 90%.

Namaste to acquire 49% interest in CannMart Labs for full ownership

Namaste Technologies (OTCQB:NXTTF -0.3%) has agreed to acquire the remaining 49% interest in CannMart Labs from MKD and JLLS in exchange for $4.0M.

The company noted that CannMart Labs facility in Ontario has been completed for BHO (butane hash oil) extraction. The lab’s application is in the final phase for a processing license from Health Canada.

In May 2018, Namaste acquired a 51% interest in CannMart Labs and agreed to finance the construction of its facility in Etobicoke, a purpose-built oil extraction facility.

According to the proposed deal, the first tranche of purchase price will be $1.6M to paid in common shares of Namaste.

The remaining $2.4M is payable in equal tranches over the next nine fiscal quarters beginning on the fiscal quarter ending February 28, 2021.

The vendors are also entitled to earn-out payments in the form of Namaste shares, and maximum amount of each payment is capped at ~$1.94M Namaste shares.

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