Newsletter | November 27, 2023

11.27.23 -- Understanding The FDA's Current Focus On REMS

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FEATURED ARTICLES

Understanding The FDA’s Current Focus On REMS

Our Life Science Connect sister publication, Bioprocess Online, asked Linda Pissott Reig, an attorney at Buchanan Ingersoll and Rooney, to explain more about why the FDA is focusing on safety programs for drugs with high-risk profiles and what it means for drug companies that have REMS products in their portfolios.

Patent Term In Peril

According to the United States Court of Appeals for the Federal Circuit’s recent ruling in In re Cellect, there are certain instances where the calculation of patent term may not include patent term adjustment (PTA).

Companies To Watch: Freya Biosciences

Freya Biosciences is enlivening the long-time lonely space of reproductive health, starting with a new focus on the vaginal microbiome.

INDUSTRY INSIGHTS

A Proven AAV Platform To Drive Down Program Costs And Maximize Speed

To ensure that your adeno-associated virus (AAV) therapy reaches patients as soon as possible, begin your relationship with an experienced AAV manufacturer early in the development journey.

mRNA: How To Build A Custom Program Using CDMO Services

Development of RNA-based therapies sits at the cutting edge of vaccine and oncology innovation, in addition to holding promise in dozens of other therapeutic areas.

Decades Of Breakthroughs: Learning From A Life Sciences Organization

Gain insights from the founder and CEO of Jaguar Health, Lisa Conte, on building a successful life sciences organization through innovation.

DIGITAL EDITION

November 2023 Digital Edition

Inside you will find more on:

  • Startup Stories
  • FDA Regulations
  • Leadership Tips
  • Biopharma Valuations

View the digital edition.

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