Posts tagged with "12 and older"

GlaxoSmithKline requests emergency authorization from FDA for COVID monoclonal antibody drug

March 29, 2021

On Friday, March 26, GlaxoSmithKline and Vir Biotechnology  applied for an emergency use authorization from the Food and Drug Administration for their monoclonal antibody drug, CNBC reports.

The companies are requesting clearance for use by high-risk patients, age 12 and older.

The FDA submission is based on an interim analysis of a phase three trial that evaluated the drug for the early treatment of COVID-19 in adults at high risk of hospitalization. The drug reduced hospitalizations or death from COVID by 85% compared with a placebo. The trial results were based on 583 patients.

“As a result, the Independent Data Monitoring Committee recommended that the trial be stopped for enrolment due to evidence of profound efficacy,” the companies said in a statement.

The companies started testing the antibody on early-stage COVID patients in August, CNBC notes—hoping to keep symptoms from progressing. Antibody drugs gained attention after they were used to treat former President Donald Trump last year.

U.S. health officials say antibody drugs already authorized for use—from Regeneron and Eli Lilly—are being underutilized.

GSK said the companies will also continue discussions with the European Medicines Agency and other global regulators to make the drug available to COVID patients as soon as possible.

Research contact: @CNBC

CVS Health and SmileDirectClub team up to provide in-store ‘SmileShops’ nationwide

April 26, 2019

Now, you can give more than “lip service” to dental health—even if you cannot afford expensive orthodontics. CVS Health and SmileDirectClub announced plans on April 25 to expand access to affordable, convenient orthodontic clear aligner therapy through the addition of in-store SmileShops to hundreds of CVS locations nationwide this year.

After a successful pilot, CVS Pharmacy is more than doubling the SmileShops’ current physical footprint and consumer access to this teledentistry innovation. The two companies say that the collaboration reinforces SmileDirectClub’s mission to democratize access to a straighter smile through an affordable and convenient direct-to-consumer platform.

Additionally, by early summer, SmileDirectClub will be added as an in-network health care option for Aetna Dental members.

“CVS Health and SmileDirectClub are aligned in the mission to put the customer at the center of their care by providing easier access to more affordable, more convenient health solutions with proven outcomes,” said Kevin Hourican, president of CVS Pharmacy and executive vice president of CVS Health. “SmileShops at CVS Pharmacy support our dedication to enhancing the customer experience with innovative and convenient health and beauty solutions.”

Today SmileDirectClub SmileShops already are open in 13 CVS Pharmacy locations in eight states, with planned expansion to over a thousand locations over the next several years. SmileDirectClub SmileShops at CVS Pharmacy feature SmileGuides to assist with getting customers started on their new smile journey, including a free 3D digital image of their teeth, teeth whitening kits, and information on the convenience and affordability of clear aligner therapy.

A member of SmileDirectClub’s digital network of 240+ state licensed dentists and orthodontists will approve and manage a custom clear aligner treatment plan. Upon the treating doctor’s and the customer’s approval of the treatment plan, aligners are sent directly to the customer’s door. Through SmileDirectClub’s proprietary teledentistry platform, customers are able to check in with their doctor every 90 days and more frequently if necessary.

SmileDirectClub’s clear aligner therapy works best for people 12 or older with all adult teeth and mild to moderate crowding or spacing issues. Customers can simply walk-in to a SmileDirectClub SmileShop at CVS Pharmacy or they can schedule a visit at https://retail.smiledirectclub.com/cvs.

Research contact: @CVSHealth