Rite Aid partners with CDC on COVID-19 vaccine

 Rite Aid Corp. is partnering with the Centers for Disease Control and Prevention in helping administer COVID-19 vaccines.

"We have administered over one million COVID-19 tests and will be partnering with the CDC to help administer COVID-19 vaccines in our communities,” Rite Aid CEO Heyward Donigan said in a statement alongside the company’s quarterly results.

The Pfizer/BioNTech vaccine last week received emergency use authorization from the U.S. Food and Drug Administration and Moderna’s vaccine is expected to receive the same status later this week with distribution set to begin immediately. It is not clear when customers will be able to receive a vaccination at Rite Aid pharmacies.

Rite Aid on Thursday morning announced a third-quarter profit of $4.3 million, or an adjusted 40 cents per share, on $6.12 billion of revenue. Wall Street analysts surveyed by Refinitiv were anticipating a 5 cent per-share loss on revenue of $5.84 billion.

A 12% increase in revenue was driven by growth in the company’s retail pharmacy and pharmacy services segments.

Looking ahead, Rite Aid raised its fiscal year 2021 revenue guidance to between $23.9 billion and $24.2 billion, up from its previous range of $23.5 billion to $24 billion. The company expected to earn 45 cents to 85 cents per share after previously forecasting a loss of 67 cents to a profit of 9 cents.

https://www.foxbusiness.com/markets/rite-aid-cdc-coronavirus-vaccines

XpresSpa Takes Off After Securing COVID-19 Vaccine Services With United Airlines

 Shares of XpresSpa Group Inc 

XSPA 5.52% traded sharply higher Thursday morning after a subsidiary secured a national agreement with United Airlines Holdings Inc UAL 0.26% to provide COVID-19 testing services.

What Happened: XpresSpa is an airport retailer of spa services and related health and wellness products. The company pivoted during the pandemic by transforming its space to serve as a testing center.

The company said the new agreement between a subsidiary and United Airlines will start on Dec. 21 at the Newark Liberty Airport in New York and Denver International Airport.

XpresCheck will provide pre-travel testing with rapid testing kits to individuals. Anyone who tested positive must leave the airport along with their travel companions and self-isolate per government guidelines.

Why It's Important: XpresSpa is playing a key role in restoring travel confidence and safety.

"We are very pleased to support United's efforts to provide their customers with more testing options to meet their destination entry requirements with our easy rapid molecular testing protocol and convenient on-site testing facilities," said Doug Satzman, XpresSpa CEO.

What's Next: United was the first airliner to offer testing options at the airport and continues to examine how it can offer more testing options.

"Our partnership with XpresCheck represents another way we can continue to meet our customers' needs and contribute to creating the safest travel experience possible," said United Chief Customer Officer Toby Enqvist.

https://www.benzinga.com/news/20/12/18835872/xpresspas-stock-takes-flight-after-securing-covid-19-vaccine-services-with-united-airlines

Moderna wins panel backing for COVID-19 vaccine

 

• Vaccines and Related Biological Products Advisory Committee of the FDA has endorsed the COVID-19 vaccine candidate from Moderna (NASDAQ:MRNA), STAT News reports.
• The question of ‘based on the totality of scientific evidence available, do the benefits of the Moderna Covid-19 vaccine outweigh its risks for use in individuals 18 years of age and older?’ has received 20 votes in favor with one abstention.
• Though FDA is not bound by the endorsement, the regulator often follows the recommendation, which could potentially lead Moderna to win EUA as early as this week.
• Last week, Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) became the first vaccine candidate to win the EUA after the expert panel voted 17-4 with one abstention.
• https://seekingalpha.com/news/3645557-moderna-wins-adcom-backing-for-covidminus-19-vaccine

Amgen’s RIABNI wins FDA approval for multiple disorders

 

• Amgen (NASDAQ:AMGN) announces that FDA has approved its RIABNI™ (rituximab-arrx), a biosimilar to Rituxan® (rituximab) for the treatment of adults with Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Granulomatosis with Polyangiitis (Wegener's Granulomatosis), and Microscopic Polyangiitis.
• RIABNI, a CD20-directed cytolytic antibody, will be available in the U.S. from January 2021, with the Wholesale Acquisition Cost at 23.7% lower than Rituxan and comparable to Ruxience®, another Rituxan-biosimilar.
• The approval was based on data from a randomized, double-blind, comparative clinical study, conducted to evaluate the efficacy, pharmacokinetics, pharmacodynamics, safety, tolerability, and immunogenicity of RIABNI compared to Rituxan.
• https://seekingalpha.com/news/3645524-amgen-s-riabni-wins-fda-approval-for-multiple-disorders

Glaxo, Vir Biotech initiates of NIH-sponsored VIR-7831 study in COVID-19

 

• Vir Biotechnology (NASDAQ:VIR) and GlaxoSmithKline (NYSE:GSK) have announced dosing of the first patient in a new sub-trial of the National Institutes of Health’s (NIH) ACTIV Program Phase 3 trial, evaluating VIR-7831 (a.k.a GSK4182136) for the treatment of hospitalized adults with COVID-19.
• The study will assess safety and efficacy of the monoclonal antibody.
• ACTIV-3 is one of several ongoing trials in the NIH’s ACTIV program, a public-private partnership designed to accelerate development of COVID-19 treatments and vaccine candidates.
• In addition to the Phase 3 ACTIV-3 trial, VIR-7831 is also being evaluated in the global Phase 2/3 COMET-ICE trial for the early treatment of COVID-19 in adults at high risk of hospitalization.
• https://seekingalpha.com/news/3645499-gsk-vir-biotech-initiates-of-nih-sponsored-virminus-7831-study-in-covidminus-19

FDA authorizes first over-the-counter COVID-19 antigen test

  The U.S. Food and Drug administration on Tuesday authorized emergency use of the first over-the-counter COVID-19 antigen test, which can be used at home.

The test by Ellume offers a nasal swab analyzer that connects to a software application on users’ smartphone, and gives results in 20 minutes.

Anyone above two years of age, including those not showing symptoms, can take the test, the agency said.

The news follows authorization of the first prescription COVID-19 test for home use last month, and of a non-prescription test system allowing a lab to process nasal samples collected at home, last week.

The regulatory nods will help expand Americans’ access to testing, reduce the burden on laboratories and test supplies, and give more testing options, FDA Commissioner Stephen Hahn said in a statement.

The agency, however, cautioned that like other antigen tests, a small percentage of results from the test may be false.

Ellume said it will be shipping over 100,000 tests per day from next month, and plans to manufacture as well as deliver 20 million COVID-19 tests to the United States within the first half of 2021.

https://www.reuters.com/article/us-health-coronavirus-fda-testing/fda-authorizes-first-over-the-counter-covid-19-antigen-test-idUSKBN28P2EB

Early data show 2 doses of Oxford/AstraZeneca vaccine prompt good immune response

 Oxford University’s COVID-19 vaccine candidate has a better immune response when a two full-dose regime is used rather than a full-dose followed by a half-dose booster, the university said on Thursday, citing data from early trials.

The developers of the vaccine candidate, which has been licensed to pharmaceuticals company AstraZeneca, have already published later stage trial results showing higher efficacy when a half dose is followed by a full dose, compared to a two full-dose regime. However, more work needs to be done to affirm that result.

The latest details from the Phase I and 2 clinical trials released on Thursday made no reference to the half-dose/full-dose regime, which Oxford has said had been “unplanned” but approved by regulators.

Once seen as the frontrunner in the development of a coronavirus vaccine, the British team has been overtaken by U.S. drugmaker Pfizer, whose shots have been rolled out in Britain and the United States this month.

Data published earlier from the later Phase 3 trials showed efficacy was 62% for trial participants given two full doses, but a more robust 90% for a smaller sub-group given first a half, then a full dose.

In its statement on Thursday, the university said it had explored two dosing regimes in early stage trials, a full-dose/full-dose regime and a full-dose/half-dose regime, investigated as a possible “dose sparing” strategy.

“The booster doses of the vaccine are both shown to induce stronger antibody responses than a single dose, the standard dose/standard dose inducing the best response,” the university said in a statement.

The vaccine “stimulates broad antibody and T cell functions,” it said.

https://www.reuters.com/article/health-coronavirus-astrazeneca-oxford/early-data-show-two-doses-of-oxford-astrazeneca-vaccine-provoked-good-immune-response-idUSKBN28R2IU