Newsletter | March 30, 2023

03.30.23 -- Biotech's Market Outlook In 2023 & Beyond

Featured Editorial

Biotech’s Market Outlook In 2023 And Beyond
		By Steve Kemler, life sciences senior analyst, RSM US LLP This article discusses three key themes in 2023 that are likely to have an outsized impact on biotech companies as well as the notable longer-term trends to watch over the next few years.

Resistance Or Defiance? The FDA And The 11th Circuit Spar Over Statute On Orphan Drug Statutory Exclusivity
		By C. Landmon and G. McIntyre, Axinn, Veltrop & Harkrider LLP Last September, the 11th Circuit Court of Appeals sided with a challenge to the FDA’s longstanding interpretation of the Orphan Drug Act by broadening the scope of orphan drug exclusivity under step one of the Chevron legal analysis. But the FDA has pushed back.

Industry Insights

Design Success Combined With Expertise In Testing And Raw Material Selection

Article | West Pharmaceutical Services, Inc.

Learn more about improvements and optimized benefits across the packaging attributes required for performance, quality, and safety of the packaging and delivery of lyophilized drug products.

News Headlines

• California Selects Civica Rx As Its Insulin Manufacturing Partner

• Sandoz Receives U.S. FDA Approval For Biosimilar Hyrimoz (adalimumab-adaz) High-Concentration Formulation

• Coya Therapeutics, Inc. Announces An Agreement With Dr. Reddy’s Laboratories, Ltd. To License Its Proposed Biosimilar Abatacept For The Development & Commercialization Of COYA 302

Solutions

Is Evaporation Important For Optical Biosensors?

Cytiva

Life Science Leader Magazine


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