WESTCHESTER COUNTY LIFE SCIENCES UPDATE

Two of Regeneron's Novel Drugs Moving Forward

on the Path to Approval

Tarrytown’s Regeneron Pharmaceuticals, Inc. announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Libtayo® (cemiplimab) in combination with platinum-based chemotherapy. Specifically, the CHMP recommended the Libtayo combination be approved in the European Union (EU) for first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with ≥1% PD-L1 expression. This includes patients that have no EGFR, ALK or ROS1 aberrations and whose tumors are metastatic or locally advanced and not candidates for definitive chemoradiation.

The European Commission is expected to make a final decision on the application in the coming months. In November 2022, the Libtayo combination was approved by the U.S. Food and Drug Administration (FDA) for advanced NSCLC regardless of PD-L1 expression.

In addition, the US FDA has accepted for priority review Regeneron's high-dose version -- 8 mg -- of its best-selling macular degeneration and diabetic macular edema (DME) treatment Eylea (aflibercept). The company, which markets the drug with Bayer AG (OTCPK:BAYZF) (OTCPK:BAYRY) used a priority review voucher in the process. The action date is June 27. The application is supported by data from two trials, PULSAR in wet age-related macular degeneration and PHOTON in DME.

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New York I-Corps Hub x Gotham Innovation Gambit

Spring 2023 Bootcamp

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New York State Small Business Revolving Loan Fund Round 2

Did you know? New York State has a small business revolving loan fund that provides loans to small businesses, ranging from $500 to $2 million. Many different types of businesses are eligible and the loan can be used for many purposes. More information can be found here.

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UPCOMING EVENTS

NY Ventures - New Funding Programs

Empire State Development

Date: March 2, 2023

Time: 3:00 PM

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