2nd Regencell study replicates results of earlier trial in eliminating COVID-19 symptoms.

 Founded in 2014, Hong Kong-based Regencell Bioscience (NASDAQ:RGC) is an early clinical stage bioscience company using Traditional Chinese Medicine (TCM) approach to develop standardized TCM formulas to holistically treat autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD) in children, and infectious diseases such as the coronavirus disease (COVID-19).

In March 2020, Regencell’s strategic partner and TCM practitioner, Mr. Sik-Kee Au, modified his proprietary cold and flu TCM formula for use in COVID-19 patients. The TCM practitioner subsequently treated 9 voluntary COVID-19 patients in the United States and patients showed improvements after an average of five days. Based on these promising results, Regencell formed a joint venture with Honor Epic Enterprises Limited in September 2021 to conduct further tests and commercialize Regencell’s COVID-19 treatment in ASEAN countries.

EARTH Efficacy Trials (EARTH-A Trial and EARTH-B Trial)

From March 2020 to August 2021, Regencell set up protocols and procedures to conduct the Evaluation and Assessment of RGC-COV19TM TCM through a Holistic approach (EARTH) efficacy trial in Malaysia and the United States. The first EARTH efficacy trial (EARTH-A Trial), was a non-blinded trial of 37 subjects to study the efficacy of Regencell’s TCM formula for COVID-19 (RCG-COV19TM) over a six-day treatment period. In the EARTH-A Trial, of the 37 subjects, 36 patients (97.3%) had all mild-to-moderate symptoms eliminated (except for Sensory Dysfunction or occasional cough) within six days.

An additional efficacy trial (EARTH-B Trial) was conducted from January 30 to March 31, 2022 to corroborate EARTH-A’s results. The EARTH-B Trial followed the same design as the EARTH-A Trial, on a larger group of subjects. During the EARTH-B Trial, the Omicron variant accounted for 80% of COVID-19 cases in Malaysia. The EARTH-A Trial was conducted when Delta was the dominant variant.

https://finance.yahoo.com/news/rgc-second-investigational-study-rgc-094600752.html

Outlook Therapeutics Confirms Biologics License Application (BLA) Submission

  Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, is providing an update on its Biologics License Application (BLA) submission for ONS-5010 / LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD).

As previously announced, Outlook Therapeutics submitted its BLA for ONS-5010 to the FDA in March 2022 and subsequently voluntarily withdrew its submission in May 2022 to provide additional information requested by the FDA. Following receipt of further correspondence from the FDA, Outlook Therapeutics has confirmed the additional information necessary to re-submit the BLA for ONS-5010.

https://finance.yahoo.com/news/outlook-therapeutics-confirms-status-biologics-120500862.html

Henry Schein cut to Neutral from Outperform by Baird

 Target to $88 from $103

https://finviz.com/quote.ashx?t=HSIC

Freeline Initiates Dosing of Second Cohort in Hemophilia B Trial

 Freeline Therapeutics Holdings plc (Nasdaq: FRLN) today announced that it has begun dosing the second cohort in its Phase 1/2 B-LIEVE dose confirmation trial of FLT180a in people with hemophilia B. Based on the strength of the data from cohort one and consistent with the advice of an Independent Data Monitoring Committee, patients in cohort two will receive the same low dose (7.7e11 vg/kg) of FLT180a and optimized prophylactic immune management regimen that were used in the first cohort. Dosing of the first cohort was completed in April and initial data from that cohort will be presented at the International Society on Thrombosis and Haemostasis (ISTH) Congress being held July 9-13, 2022 in London, UK.

https://finance.yahoo.com/news/freeline-initiates-dosing-second-cohort-110000879.html

Moderna COVID vaccine may pose higher heart inflammation risk - U.S. CDC

 Moderna's COVID-19 vaccine may pose a higher risk of heart inflammation in some age groups than Pfizer-BioNTech's shot, the U.S. Centers for Disease Control and Prevention said on Tuesday, citing recent data.

The agency, however, said the findings on myocarditis and pericarditis, types of heart inflammation linked to both the mRNA shots, were not consistent across all of the U.S. vaccine safety monitoring systems.

The CDC's analysis comes as the U.S. Food and Drug Administration's advisers meet on Tuesday to discuss the authorization of Moderna's vaccine for children and teens aged 6-17.

Based on data from the Vaccine Safety Datalink (VSD) system, the incidence of heart inflammation was 97.3 cases per million doses for males aged 18-39 following a second dose of Moderna's shot, versus 81.7 cases per million Pfizer vaccine doses.

Available information suggests that most people with myocarditis after mRNA COVID-19 vaccination recover over time, the CDC said. 

https://finance.yahoo.com/news/1-moderna-covid-vaccine-may-124910732.html

Oragenics: Positive Data for NT-CoV2-1 Intranasal COVID-19 Vaccine Candidate

 Oragenics, Inc. (NYSE American: OGEN) ("Oragenics" or the "Company"), a biotech company dedicated to fighting infectious diseases including coronavirus, announces the publication of an article co-authored by Oragenics and collaborators at Inspirevax and the National Research Council of Canada ("NRC") Human Health Therapeutics Research Centre in Scientific Reports, a Nature journal. The publication, available [https://rdcu.be/cPyZF] and titled "Intranasal Immunization with a Proteosome-Adjuvanted SARS-CoV2 Spike Protein-Based Vaccine is Immunogenic and Efficacious in Mice & Hamsters," concluded that Oragenics’ intranasal vaccine candidate, NT-CoV2-1, warrants further development as a novel SARS-CoV-2 vaccine.

https://finance.yahoo.com/news/oragenics-announces-publication-positive-data-113000879.html

Outset Medical Shipment Hold on New Tablo Systems for Home Use Pending FDA Review

 Outset Medical, Inc. (Nasdaq: OM) (“Outset” or the “company”) today announced it has implemented a shipment hold on the distribution of its Tablo Hemodialysis System for home use pending the Food and Drug Administration’s (FDA) review and clearance of a 510(k) the company submitted for changes made since the device’s original March 2020 clearance.

Outset has not identified any safety issues with Tablo. The company will continue to market and ship Tablo for use by healthcare professionals in chronic and acute care settings. Devices that are already distributed to home users have not been removed and current users can continue to work with their healthcare providers on appropriate treatment.

As a result of the shipment hold, Outset now expects second quarter 2022 revenue of at least $25 million. The company anticipates an update on the status of the regulatory review process in the third quarter and to provide an update to its 2022 revenue and other financial goals during its next quarterly update in early August. Until then, the company has suspended its prior guidance.

https://www.valdostadailytimes.com/news/business/outset-medical-announces-shipment-hold-on-new-tablo-systems-for-home-use-pending-fda-review/article_3e75f9d5-62c2-5f08-84b7-3091c478beb1.html