Featuring news, events and industry trends
Regeneron Presents Encouraging Phase 2 Results for High-dose Aflibercept 8 mg in Wet Age-related Macular Degeneration at Angiogenesis Meeting

Tarrytown headquartered Regeneron Pharmaceuticals, Inc. announced results from its Phase 2 proof-of-concept trial evaluating an investigational 8 mg high dose of aflibercept compared to the currently-approved 2 mg dose of EYLEA® (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD). The results were presented at the Angiogenesis (Angiogenesis, Exudation, and Degeneration) 2022 annual meeting on Saturday, February 12. 

Wet AMD is the leading cause of vision loss among people 50 years and older in the U.S. Existing anti-VEGF treatments including EYLEA have helped change the course of disease for millions of patients worldwide, and efforts to develop new medicines are focused on further enhancing clinical effectiveness while extending the time between treatment doses.
Regeneron and Sanofi Provide Update on Ongoing Dupixent® (dupilumab) Chronic Spontaneous Urticaria Phase 3 Program

Regeneron Pharmaceuticals, Inc. and Sanofi announced a Phase 3 trial (CUPID STUDY B) evaluating Dupixent® (dupilumab) in patients with chronic spontaneous urticaria (CSU) will stop due to futility, based on a pre-specified interim analysis. The trial, which assessed Dupixent added to antihistamines in patients refractory to omalizumab at 24 weeks, showed positive numerical trends in reducing itch and hives (the primary endpoints) but did not meet statistical significance during an interim analysis conducted by an independent review committee. The safety data were generally consistent with the known safety profile of Dupixent in its approved indications.

The LIBERTY-CUPID pivotal program was initiated in 2020 with an accelerated direct-to-Phase 3 strategy. The previously reported Phase 3 trial, which evaluated a different group of patients who were biologic-naïve (i.e., not previously treated with omalizumab), met its primary and all key secondary endpoints at 24 weeks, showing that adding Dupixent to standard-of-care antihistamines significantly reduced itch and hives compared to antihistamines alone. The companies remain committed to advancing Dupixent for patients with CSU uncontrolled on antihistamines and are evaluating next steps.
Teladoc Health Launches Chronic Care Management Program to Ease Whole-Person Care

Virtual care giant Teladoc Health, located in Purchase, is diving into chronic condition management with the launch of its own program, Chronic Care Complete. The program offers whole-person care to individuals grappling with multiple chronic conditions.

The unique integrated program intends to offers patients with conditions such as diabetes, prediabetes and hypertension a complete continuum of chronic care management services ranging from providing convenient connected health monitoring devices to consultations with certified health coaches. The solution offers assistance from physicians and access to licensed therapists to address mental health needs.

The program will be available to members through their health plans or employers, and the company will work with clients to find eligible users. 
Celebrating Women and Girls in Science through cutting edge Neuroscience Research Programs

White Plains-headquartered Burke Neurological Institute (BNI) has established an environment that supports diversity and inclusion, with women comprising 43 percent of the BNI faculty of world-renowned neuroscientists, who have dedicated their lives to finding cures for neurological disorders.

In 2022, BNI unveiled their newest summer program, NeuroAcademy, which introduces high school students to fundamental biological based neuroscience at the molecular and cellular levels. Students have the chance to explore modern laboratory techniques while applying critical thinking to the scientific process and bioinformatics. With limited space for admission, NeuroAcademy aims to open doors for potential educational opportunities in the field of science both at the Burke Neurological Institute and other institutions in preparation for college-level science curriculum.

For more information on how to enroll at the NeuroAcademy.
BASF Launches RegXcellence for Plastic Additives

BASF, which has a presence in Tarrytown, launched a new service offering, RegXcellence, for its plastic additives customers which enables targeted access to a range of global regulatory support. RegXcellence provides digital solutions and simplifies regulatory issue management with advisory support to accelerate innovation opportunities. 

The regulatory landscape changes constantly. It is increasingly challenging for global businesses to navigate the complex regulatory frameworks whilst remaining compliant. As this service expands, plastic additives customers will have access to a convenient digital solution to access regulatory documents.

BASF already offers RegXcellence services to the customers of its fuel and lubricant solutions, plasticizers, pharma solutions and human nutrition businesses.
Ascensia Diabetes Care Announces FDA Approval of the Eversense E3 Continuous Glucose Monitoring System for Use for Up to 6-Months

With research headquarters in Valhalla, Ascensia Diabetes Care, a global diabetes care company, announces that its partner Senseonics Holdings, Inc. has received approval from the U.S. Food and Drug Administration (FDA) for the next-generation Eversense® E3 Continuous Glucose Monitoring (CGM) System. Ascensia plans to make the Eversense E3 sensor, which can be used for up to 6 months, available to patients in the U.S. during the second quarter of 2022.
Cognition Therapeutics to Participate in Panel during the BIO CEO & Investor Conference on the Development of Neurodegenerative Therapeutics

Purchase headquartered Cognition Therapeutics, Inc., a clinical-stage neuroscience company developing drugs that treat age-related degenerative diseases, announced that Anthony Caggiano, M.D., Ph.D., chief medical officer and head of R&D, will participate in a panel discussion during the annual BIO CEO & Investor Conference, entitled, “Exploring the Possibilities of Developing Neurodegenerative Therapeutics.” Joining Dr. Caggiano in the discussion will be representatives from companies, academic institutions and investment funds with stakes in neuroscience research and innovation.

The event will be webcast and available for replay by registered attendees. Registration details may be found here: www.bio.org/events/bio-ceo-investor-conference/registration.
Central New York Biotech Accelerator Now Accepting Applications for 2022 Medical Device Innovation Challenge

The CNYBAC Medical Device Innovation Challenge is a 6-month intensive mentorship / network expansion / resource rich program for early-stage innovators. This highly competitive program accepts 5-6 teams each year to participate. To date, 26 teams have graduated from the program and have amassed milestone achievements during and following their participation. The MDIC serves as a complement and a pipeline to other incubation/acceleration programs.
Applications are accepted January 1 through April 30 each year and are reviewed through a due diligence process performed by The Innovation Law Center, Syracuse University. Participants are selected by the MDIC Review Committee - interviews may be convened to assist in team selection. The program starts August 1 (some teams receive early commercialization research in advance of program start). You may participate virtually or on-site. If on-site, you receive 6-months of free work space in the CNYBC Creation Garage, 841 E. Fayette St., Syracuse, NY. All selected teams can utilize this facility at any point in time during the program. 
Invest NY: Health on March 3

Invest NY is an event series highlighting impactful innovations in important industry sectors. Each event features startups, VC & PE investors, and industry leaders from across New York and beyond. This event is dedicated to highlighting innovation in Health. Presented by Upstate Capital, the event will take place in-person and online.

March 3, 2022
12:00pm to 4:00pm
Biotech & Patient Engagement: More Important Than Ever
NewYorkBIO is holding its second annual Patient Engagement Summit on April 6th, bringing together industry, advocacy organizations, and - most importantly - the patient community for a dialogue on how innovation in healthcare can be more inclusive. This is a fully virtual, free event.

April 6, 2022
9:00am to 1:00pm

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