TRxADE Launches MedCheks Health Passport App for iOS

 TRxADE HEALTH, INC.(NASDAQ:MEDS), a health services IT company focused on digitizing the retail pharmacy experience by optimizing drug procurement, the prescription journey, and patient engagement in the U.S., today announced that the Company's MedCheks subsidiary has launched its Health Passport app, which is currently available for download on the iOS App store.

Once installed on an iOS device, the MedCheks app provides a QR code to securely show proof of a health record, i.e., vaccination or test results to gain entry to a country, establishment, event or mode of transportation where verification protocols are required. The app is a strategic addition to the TRxADE HEALTH next-gen technology portfolio, meeting the demand for advanced, cost-effective digital healthcare applications to accelerate reopening of the economy as COVID-19 subsides in certain markets.

MedCheks' app is designed to provide peace-of-mind to business owners and governments, transforming the verification process from a labor-intensive process bottleneck into a seamless, fast and credible transaction between business and end-user. MedCheks intuitive and easy-to-use app features include health records like proof of vaccination and testing tracking, as well as compatibility with no-touch, customizable verification kiosks.

Potential clients such as transportation providers, venue operators, corporate officers, eldercare facilities, hospitality and other locations can learn more by visiting the MedCheks website at www.medcheks.com.

"The Medcheks app maintains a safe and secure digital health record that can be used in real-time for entry to any location as long as the end-user is a partner in our network or is looking for proof of health Record i.e vaccination or a negative COVID test," said James Ram, President of MedCheks, a TRxADE HEALTH company. "We are working to rapidly build our future partner network of countries, and companies across all verticals, who value the security, ease and cost-effective measures afforded by a trusted app designed to securely reestablish day-to-day operations. We look forward to driving a successful launch with our initial partners in the months to come."

https://finance.yahoo.com/news/trxade-health-inc-announces-launch-123500830.html

Why Biogen Shares Are Trading Higher

 Biogen Inc (NASDAQ:BIIB) shares are trading higher by 3.2% at $419.81 after SVB Leerink maintained an Outperform on the stock and raised its price target from $380 to $475. The stock is also experiencing continued volatility following FDA accelerated approval of its Alzheimer's candidate.

Biogen and Idec merged in 2003, combining forces to market Biogen's multiple sclerosis drug Avonex and Idec's cancer drug Rituxan.

Biogen has several drug candidates in phase 3 trials in neurology and neurodegenerative diseases and has launched Spinraza with partner Ionis. Aduhelm was approved as the firm's first Alzheimer's disease therapy in June 2021.

https://www.benzinga.com/trading-ideas/long-ideas/21/06/21514169/why-biogen-shares-are-trading-higher-today

Moderna asks FDA to clear Covid vaccine for adolescents 12 to 17

 Moderna said it has asked the Food and Drug Administration to expand the emergency use of its Covid-19 vaccine in adolescents ages 12 to 17.

If approved by the FDA, it would likely dramatically expand the number of shots available to middle and high school students ahead of the next school year. Pfizer and German partner BioNTech were cleared last month to use their vaccine for 12-to-15-year-olds.

Moderna said on May 25 its Covid vaccine was 100% effective in a study of 12-to-17-year-olds, making it the second shot to demonstrate high efficacy in younger age groups. Moderna’s two-dose vaccine, which is given four weeks apart, is already authorized for adults.

The study the company cited included more than 3,700 adolescents. No cases of Covid were observed in participants who received two doses of the vaccine, while four cases were observed in the placebo group, according to the company.

No significant safety concerns have been identified, and side effects generally are consistent with those seen in an earlier trial of adults, the company said. The most common side effects after the second dose were headache, fatigue, muscle pain and chills, Moderna said.

U.S. regulators are expected to grant Moderna’s request for use in teens. The approval process could take about a month, just in time for fall classes. Pfizer and BioNTech requested expanded use of their shot in adolescents on April 9, for example, and were authorized by the FDA on May 10.

Vaccinating children is seen as crucial to ending the pandemic. The nation is unlikely to achieve herd immunity — when enough people in a given community have antibodies against a specific disease — until children can get vaccinated, scientists say.

Children make up around 20% of the total U.S. population, according to government data. Some 70% to 85% of the U.S. population needs to be vaccinated against Covid to achieve herd immunity, medical experts say, and some adults may refuse to get the shots. More experts say herd immunity is looking increasingly unlikely as coronavirus variants spread.

Vaccinating kids may also hasten the return of in-person learning and after-school extracurricular activities such as sports, art and music, health experts say.

The Centers for Disease Control and Prevention on May 28 eased its public health guidance for summer camps, saying fully vaccinated teens don’t need to wear masks or stay 6 feet away from others.

https://www.cnbc.com/2021/06/10/covid-vaccine-moderna-asks-fda-to-ok-inoculations-for-kids-12-to-17.html

Bristol-Myers: Positive Results From Phase 3 Breyanzi Trial

 Bristol Myers Squibb (BMY) announced Thursday positive topline results from Phase 3 TRANSFORM trial evaluating Breyanzi (lisocabtagene maraleucel) versus chemotherapy followed by stem cell transplant in second-line relapsed or refractory large B-cell lymphoma or LBCL.

The trial met primary and key secondary endpoints, demonstrating a highly statistically significant improvement in event-free survival, complete response rate and progression-free survival compared to standard of care. Overall survival data were immature at the time of this interim analysis, the company noted.

TRANSFORM global, randomized, multicenter Phase 3 study evaluates Breyanzi (lisocabtagene maraleucel) as a second-line treatment in adults with relapsed or refractory LBCL compared to salvage therapy followed by high-dose chemotherapy and hematopoietic stem cell transplant, which is currently considered a gold standard treatment for these patients.

The trial's safety results were consistent with the known safety profile of Breyanzi for the treatment of LBCL in the third-line setting, and no new safety concerns were identified in this second-line setting.

Breyanzi safety results are consistent with data from pivotal TRANSCEND NHL 001 trial.

The company noted that the latest results represent the first time a therapy has shown a benefit over standard of care high-dose chemotherapy and stem cell transplant in relapsed or refractory LBCL. It is also the first time a CD19-directed CAR T cell therapy has demonstrated potential as a second-line therapy in this patient population.

https://www.nasdaq.com/articles/bmy-reports-positive-results-from-phase-3-breyanzi-trial-in-second-line-relapsed-or

Upward Health Announces Contract with Clover Health to Serve Patients In Four States

 -Upward Health, a leading in-home medical and behavioral primary care provider, today announced a new Preferred Provider relationship with Clover Health, an innovative technology company improving health outcomes for America’s seniors, to serve patients with complex medical, behavioral, and social challenges through Clover’s in-home primary care program, Clover Home Care. The effort was launched shortly after Clover was identified as a participant in CMS’ new Direct Contracting initiative, which is designed to improve healthcare quality and contain costs for beneficiaries with Original Medicare.

As Clover scales Clover Home Care through Direct Contracting, the company has contracted with Upward Health to provide integrated home-based medical and behavioral care for aligned beneficiaries with complex needs in the States of New York, Pennsylvania, Georgia, and Texas.

https://www.businesswire.com/news/home/20210610005563/en/Upward-Health-Announces-Contract-with-Clover-Health-to-Serve-Patients-In-Four-States-Under-New-Direct-Contracting-Initiative

Ocugen to file for full U.S. approval of COVID-19 shot instead of EUA

 Ocugen Inc said on Thursday it would no longer pursue an emergency use authorization for its COVID-19 vaccine candidate, Covaxin, and would instead aim to file for a full U.S. approval of the shot.

Ocugen said the decision was based on a recommendation from the U.S. Food and Drug Administration (FDA), which also requested more information and data for the full approval.

The company said it expects data from an additional clinical trial will be required to support the marketing application submission for Covaxin.

"While this will extend our timelines, we are committed to bringing COVAXIN to the U.S.," Ocugen Chief Executive Officer Dr Shankar Musunuri said.

The company is co-developing Covaxin with India-based Bharat Biotech for the U.S. market.

Ocugen recently secured exclusive rights to market the vaccine in Canada and has started discussions with Health Canada for regulatory approval, it said.

https://finance.yahoo.com/news/1-ocugen-file-full-u-120439454.html 

U.S. to issue COVID-19 rule for healthcare workers on Thursday

 The U.S. workplace regulator will publish a rule on Thursday requiring healthcare employers to take steps to protect workers from COVID-19, U.S. Secretary of Labor Marty Walsh told a congressional panel on Wednesday.

The Occupational Safety and Health Administration will also release non-binding guidance on how other businesses can protect workers, Walsh told a hearing of the U.S. House of Representatives Education and Labor Committee.

During the Trump administration, OSHA rejected calls by unions, Democrats and worker advocates for a rule that would apply to most employers. Instead, the agency issued a series of non-binding guidance documents tailored to different industries.

Walsh did not reveal other details of the rule. He said the guidance would apply to the treatment of workers who have not received COVID-19 vaccines.

Walsh's announcement immediately drew rebukes from Republicans on the House committee.

Rep. Tim Walberg, a Republican from Michigan, said that issuing a rule goes against recent U.S. Centers for Disease Control and Prevention guidance that said vaccinated people can largely go about their normal pre-pandemic lives.

"I think the answer should be, let's let people go back to work in a normal fashion," Walberg said during the hearing, held via Zoom.

"I like the signs of where we’re headed," Walsh responded. "However, people are still dying and are still getting infected."

https://www.yahoo.com/now/u-issue-covid-19-rule-181549360.html