Featuring news, events and industry trends
Regeneron (REGN), Sanofi's Dupixent Gets EU Nod for Asthma in Kids

With the label expansion approval, Dupixent becomes the only biologic approved in the European Union as an add-on maintenance therapy to treat severe asthma with type 2 inflammation in individuals aged six years and older. The severe asthma in such patients should be characterized by raised blood eosinophils (EOS) and/or raised fractional exhaled nitric oxide (FeNO).
FDA Accepts Dupixent® (dupilumab) for Priority Review in Patients Aged 12 Years and Older with
Eosinophilic Esophagitis

Tarrytown headquartered, Regeneron Pharmaceuticals, Inc. and Sanofi announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) 300 mg weekly to treat adult and pediatric patients aged 12 years and older with eosinophilic esophagitis (EoE), a chronic and progressive type 2 inflammatory disease that damages the esophagus and impairs the ability to swallow. The target action date for the FDA decision on this investigational use is August 3, 2022.

If approved, Dupixent would be the first medicine available in the U.S. indicated to treat eosinophilic esophagitis. There are approximately 160,000 patients in the U.S. living with eosinophilic esophagitis who are currently treated, of whom approximately 48,000 have failed multiple treatments.
Cognition Therapeutics Announces Participation in 21st Annual Needham Virtual Healthcare Conference

Purchase headquartered Cognition Therapeutics, Inc., a clinical stage neuroscience company developing drugs to treat age-related degenerative diseases of the central nervous system and retina, announced that the company would be participating in Needham & Company’s 21st Annual Virtual Healthcare Conference being held April 11-14, 2022. The Company’s president and CEO, Lisa Ricciardi, will be providing a corporate update on Monday, April 11, 2022 from 3:00 – 3:40 p.m. ET.

A live and archived webcast will be available on the Investors section of the company’s website at https://ir.cogrx.com.
Ascensia Diabetes Care launches Eversense's
6-month CGM system in the US

Through a commercialization partnership with Ascensia Diabetes Care, with presence in Valhalla, which serves as the exclusive worldwide distributor of Senseonics’ Eversense implanted CGM sensors, the latest E3 system will be made available under an introductory payment program that aims to increase access to the device.

The Eversense Payment Assistance and Simple Savings program, or PASS, allows eligible users to pay $99 out-of-pocket for their first sensor and transmitter and then $100 per month for the six months of wear. 
Sapience Therapeutics Expands Executive Team with Appointment of Gina Capiaux, Ph.D.
as Vice President, Regulatory Affairs

Harrison headquartered, Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, announced the appointment of Gina Capiaux, Ph.D. as Vice President, Regulatory Affairs. 

Dr. Capiaux has a long-standing career in the biotechnology and pharmaceutical industry, holding several senior level positions at notable companies. Dr. Capiaux joined Sapience from Ultragenyx Pharmaceutical, where she served as a Senior Director and led multiple programs for rare genetic disorders including the enzyme replacement therapy Mepsevii™ for mucopolysaccharidosis 7 (MPS 7) and Dojolvi® for long-chain fatty acid oxidation disorders (LC-FAOD). Previously, she held positions of increasing responsibility at BioMarin Pharmaceutical, where she led the program for Vimizim® for (MPS 4A) and various other small molecule and biologic programs. Dr. Capiaux holds a B.A. in biochemistry from California State University Fresno and a Ph.D. in Pharmacology from the Weill Cornell Graduate School of Medical Sciences and Memorial Sloan-Kettering Cancer Center.
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. 

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