OraSure COVID-19 Rapid Tests Receive U.S. FDA Authorization for Pediatric Use

 

With less than one minute of “hands-on time,” the InteliSwab test is as simple as “Swab, Swirl, and See.”

Data Demonstrates InteliSwab® is Accurate, Easy to Use, and Well Accepted by Children

 OraSure Technologies, Inc. (NASDAQ: OSUR), a global leader in point-of-care and home diagnostic testing and sample collection technologies, announced today that its InteliSwab® COVID-19 rapid tests have been authorized by the U.S. Food and Drug Administration (FDA) for use in children ages 2 to 14. InteliSwab® was previously authorized for use in adults and in children 15 to 17 when administered by an adult.

As part of its submission to the FDA for this label expansion, the Company conducted studies to evaluate the performance of the test in a pediatric population, as well as studies to evaluate usability and tolerability by children. From a combined performance perspective, InteliSwab® was shown to have 85 percent positive percent agreement (PPA) for individuals ages 2 and up and 98 percent negative percent agreement (NPA). The overall accuracy of the InteliSwab® test including a pediatric population is 93 percent, demonstrating similar accuracy when compared to the Company’s clinical studies in adults. OraSure also evaluated the usability and acceptability of the test in children. In the usability study, parents were able to use the test on children error free 96 percent of the time, demonstrating the exceptional ease of use of the test. The test was also well accepted by children across a broad age range.

https://finance.yahoo.com/news/inteliswab-covid-19-rapid-tests-120500584.html

Pfizer ends $3B drug dream despite phase 2b success, leaves Regeneron clear run at cardiovascular market

 A big chunk of Pfizer’s plan to add $15 billion to sales just went up in smoke. Having gone over phase 2b data on cardiovascular drug vupanorsen, Pfizer has decided to return the rights to Ionis Pharmaceuticals, leaving it without a candidate it tipped to deliver peak sales of more than $3 billion.

Pfizer paid Ionis $250 million upfront for vupanorsen in 2019 and put the drug at the heart of the growth plan it unveiled the following year. The belief vupanorsen could rack up big blockbuster sales was built on studies linking loss-of-function variants in the ANGPTL3 gene to low levels of plasma triglycerides and LDL and HDL cholesterol. A hit on the primary endpoint last year validated Ionis’ antisense approach. 

However, while the top-line results in patients with elevated non-HDL cholesterol and triglycerides were positive, a deeper dive into the phase 2b data has exposed weaknesses. All doses of vupanorsen reduced non-HDL cholesterol, but none were particularly impressive.

As Pfizer put it in a statement, “the magnitude of non-HDL-C and [triglycerides] reduction observed did not support” continued clinical research in cardiovascular risk reduction or severe hypertriglyceridemia. Pfizer also highlighted dose-dependent increases in liver fat and elevated liver enzymes at higher doses in its explanation of the decision to dump vupanorsen.

Ionis and Pfizer shared brief details of the liver toxicity issues when they released the top-line results late  last year. Those issues, coupled to muted comments by Pfizer about the next steps, had already pointed to potential problems for the program. Even so, Ionis’ stock fell 9% to $29 on news of the discontinuation.

Pfizer is returning the rights to Ionis. In theory, Ionis could take the drug forward, but the two companies  jointly announced its discontinuation; Richard Geary, chief development officer at the antisense firm, read the last rites.

“Although this is not the outcome we would have liked, we are grateful for this collaboration with Pfizer whose leadership in the development of vupanorsen has been instrumental in gaining important insights and learnings that will help us continue to deliver potentially life transforming treatments for people impacted by cardiovascular disease,” Geary said in a statement.

The discontinuation eliminates one of the most prominent riders in a blockbuster race. Regeneron is the other big beast of the ANGPTL3 space, and its antibody against the target, Evkeeza, is now approved and looks to be free from the liver toxicity issues that blighted vupanorsen. Other riders include Arrowhead Pharmaceuticals’ ARO-ANG3 and an early-stage program at Verve Therapeutics.

https://www.fiercebiotech.com/biotech/pfizer-ends-3b-drug-dream-despite-phase-2b-success-leaving-regeneron-a-clear-run-at

Bluejay: Pre-Submission Filing Package for Life-threatening Diseases Test is with FDA

 Bluejay Diagnostics, Inc. (NASDAQ: BJDX) (“Bluejay”, “the Company”) a late-stage, pre-revenue diagnostics company focused on developing cost-effective, rapid, near-patient products for triage and monitoring of disease progression, today announced that it has filed a Pre-Submission package for the Symphony IL-6 Test with the U.S. Food and Drug Administration (“FDA” or “the agency”). The purpose of this filing is to request feedback from the agency prior to submitting a medical device marketing application. The pre-submission package will allow the FDA to review and comment on the Company’s plans for clinical trials and analytical testing.

Neil Dey, Bluejay’s Chief Executive Officer commented, “I am very pleased to announce that Bluejay successfully met its goal of filing the pre-submission package with the FDA for the Symphony IL-6 Test by the end of January, 2022. Bluejay is developing the Symphony IL-6 Test to rapidly measure IL-6 in whole blood in a near-patient setting that is intended to help healthcare professionals make better treatment decisions for patients with life threatening diseases. The pre-submission filing an important milestone for Bluejay as we will receive important feedback from the FDA for our planned marketing submission for the Symphony IL-6 Test, planned for Q3:22.”

https://finance.yahoo.com/news/bluejay-diagnostics-inc-announces-pre-120000301.html

Viridian Cleared to Initiate Clinical Development of Thyroid Eye Disease Antibody

 Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology company advancing new treatments for patients suffering from serious diseases underserved by current therapies, today announced the United States Food and Drug Administration (FDA) clearance of its investigational new drug (IND) application of VRDN-002. The Company’s next generation IGF-1R antibody, VRDN-002, is a humanized monoclonal antibody that incorporates half-life extension technology and is designed to support administration as a convenient, low-volume, subcutaneous (SC) injection for the treatment of thyroid eye disease (TED).

The IND application clearance allows the Company to proceed with its planned first-in-human Phase 1 clinical trial of VRDN-002, which is a single ascending dose study to explore safety, tolerability, pharmacokinetics and pharmacodynamics of intravenously administered VRDN-002 in healthy volunteers. Data from this Phase 1 trial are expected to be announced in mid-2022 and will inform the feasibility of a low-volume and/or low-frequency SC dosing paradigm for TED patients.

https://finance.yahoo.com/news/viridian-therapeutics-announces-fda-clearance-120000270.html

Taysha: Positive Efficacy and Safety Data for High Dose Cohort and Long-term Durability Data in Neuropathy Trial

Efficacy data for high dose cohort demonstrated clinically meaningful and statistically significant improvement in MFM32 by Year 1 compared to natural history (n=3)

Long-term durability data across all therapeutic dose cohorts demonstrated a 10-point improvement in mean change in MFM32 by Year 3 compared to estimated natural history decline of 24 points (n=5)

Biopsy data in five of six patient samples analyzed to date confirmed active regeneration of nerve fibers following treatment with TSHA-120 (n=6)

TSHA-120 was safe and well-tolerated supported by 53 patient-years of clinical data

Conference call and live webcast today at 8:00 AM Eastern Time

Conference Call and Webcast Information

Taysha management will hold a conference call and webcast today at 8:00 am ET / 7:00 am CT to provide an update on the GAN program. The dial-in number for the conference call is 877-407-0792 (U.S./Canada) or 201-689-8263 (international). The conference ID for all callers is 13726815. The live webcast and replay may be accessed by visiting Taysha’s website at https://ir.tayshagtx.com/news-events/events-presentations. An archived version of the webcast will be available on the website for 30 days.

https://finance.yahoo.com/news/taysha-gene-therapies-reports-positive-120000818.html

Viracta Starts Phase 1b/2 of Epstein-Barr Virus-Positive Solid Tumor Trial

 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company targeting virus-associated malignancies, today announced that the first patient has been dosed in the multinational Phase 1b/2 trial of its all-oral combination product, Nana-val (nanatinostat and valganciclovir), in patients with Epstein-Barr virus-positive (EBV+) recurrent or metastatic nasopharyngeal carcinoma (R/M NPC) and other advanced EBV+ solid tumors. The trial is designed to evaluate the safety and preliminary efficacy of Nana-val alone and in combination with the PD-1 inhibitor pembrolizumab.

"The initiation of dosing in this clinical trial represents an important milestone for Viracta and is a critical step in potentially expanding the clinical applicability of the targeted all-oral Nana-val combination beyond lymphoma," said Lisa Rojkjaer, M.D., Chief Medical Officer of Viracta. "Advanced NPC patients have poor outcomes and are in urgent need of effective treatment options. We are looking forward to evaluating the clinical profile of this novel combination therapy and exploring potential synergies with a PD-1 inhibitor."

The Phase 1b/2 trial (NCT05166577) is an open-label, multinational trial evaluating Nana-val alone and in combination with pembrolizumab. The Phase 1b dose escalation portion is designed to evaluate safety and to determine the recommended Phase 2 dose (RP2D) of Nana-val in patients with EBV+ R/M NPC. In Phase 2, up to sixty patients with EBV+ R/M NPC will be randomized to receive Nana-val at the RP2D with or without pembrolizumab, to evaluate safety, overall response rate, and potential pharmacodynamic markers. Additionally, patients with other advanced EBV+ solid tumors will be enrolled to receive Nana-val at the RP2D in a Phase 1b dose expansion cohort.

https://finance.yahoo.com/news/viracta-therapeutics-announces-first-patient-133000881.html

New Consumer-Initiated Lab Test Solution Powered by QuestDirect™ Through Walmart.com

 Quest Diagnostics (NYSE: DGX) announced that they will now offer consumer-initiated laboratory testing powered by QuestDirect™ in collaboration with Walmart. The new solution allows people to take control of their health care and purchase the same high quality laboratory tests ordered by healthcare providers through a consumer-friendly website. This collaboration builds upon a long-standing relationship between Walmart and Quest Diagnostics to broaden access to high quality health services.

With this new testing solution, an individual can purchase among more than 50 different tests, including general health, digestive health, allergy, heart health, women's health, and infectious disease. Tests can be purchased at WalmartQuestdirect.QuestDiagnostics.com.

"Now more than ever, people seek healthcare that is convenient, individualized and meets them where they are," said Steve Rusckowski, Quest Diagnostics Chairman, President and CEO. "While many are too busy or face barriers to engage in in-person doctors' appointments, others choose to proactively arm themselves with diagnostic insights before engaging with one. Our close relationship with Walmart has allowed us to create a solution that is high quality and accessible. Powered by QuestDirect from Quest Diagnostics, this new solution can broaden access to laboratory testing and health insights, and support for a range of conditions for potentially better outcomes."

According to a recent Quest Diagnostics Health Trends™ report, the majority of U.S. adults (60%) admitted to skipping or delaying some in-person medical treatments or appointments during the COVID-19 pandemic. By allowing people to purchase their laboratory testing 24 hours a day from any connected computer or mobile device, they can access high quality healthcare at their convenience – putting the power to manage their healthcare back in their hands.

"Walmart is committed to providing its customers broad access to healthcare services," said Julie Barber, Senior Vice President of Health & Wellness Merchandising "This new testing solution, which is powered by QuestDirect, from Quest Diagnostics, allows us to build upon this commitment by empowering customers with a new way to take control of their own health and obtain high quality lab services with the click of the mouse."

https://www.news-journal.com/walmart-and-quest-diagnostics-empower-people-to-take-control-of-their-healthcare-through-new-consumer/article_821a5e27-47c8-5bf7-aa68-e98799afb064.html