Formulation Development Featured Editorial
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Peptides: Best Practices On Regulatory & Control Strategies, Analytical Methods, & More
6/18/2021
Industry, regulatory, and academic experts recently gathered at the United States Pharmacopeial Convention’s (USP’s) annual Peptides & Oligonucleotides Workshop virtually to share best practices on chemistry, manufacturing, and controls (CMC) for peptides. This article summarizes discussion highlights.
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FDA’s Longtime Approach To New Chemical Entity Designations Now Codified
6/14/2021
New chemical entity (NCE) designations are extremely important to small molecule pharmaceutical developers: they provide a five-year exclusivity period assuring no competition to a new drug product from generics, with or without patent protection. Recently, President Biden signed into law the Ensuring Innovation Act to clarify when a new drug may be granted NCE status.
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From Pharma To Biopharma — Education & Workforce Training Programs Converge To Meet Industry Needs
6/9/2021
The biopharmaceutical industry is poised for a new era of growth, particularly for manufacturing biologics. Workforce development remains a significant limitation, however. This article highlights how the industry workforce training model isn't enough, and what the Albany College of Pharmacy and Health Sciences is doing to address the need for the next-generation workforce.
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Patenting Antibodies: The 4 Tactics To Use In 2021
6/4/2021
With epitope claims less available post-Amgen v. Sanofi, this article examines four useful approaches that you and your antibody patent lawyer can implement in order to improve your chances of obtaining valid antibody claims with functional attributes.
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Outlook: Biotech In 2021 & Beyond
5/31/2021
Biopharma companies have responded in an astounding manner to the COVID-19 pandemic through vaccines, therapies, diagnostics, and variant tracking. For those efforts, the industry is seeing some amazing investor awareness, political support, and increased public perception. This article focuses on the U.S., but also includes some worldwide numbers.
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Synthetic Oligonucleotides: Regulatory, Analytical & Manufacturing Considerations
5/28/2021
In early March 2021, more than 300 professionals in regulatory, industry, and academic roles attended the USP's virtual Workshop on Therapeutic Peptides and Oligonucleotides. Building on regulatory considerations and control strategies, the workshop explored innovative techniques being used to analyze synthetic oligonucleotides, ensure quality, and reduce waste.
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The Next Decade In Gene Therapy Innovation — 6 Critical Questions (And Answers)
5/21/2021
What's ahead for gene therapy in the next decade? This article highlights six key questions and recommendations for the future of the industry. For example, what technologies should gene therapy companies evaluate beyond delivery vehicles, and how should a gene therapy be priced?
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Harnessing The Power Of AI In MS Diagnosis, Monitoring, And Treatment
5/17/2021
A prime example of the future potential of artificial intelligence (AI) is in revolutionizing the way we diagnose, monitor, and treat multiple sclerosis (MS), thereby advancing our understanding of the disease course. To maximize the utility of AI in MS, drug developers and medtech manufacturers must strategically incorporate AI solutions into their approach to MS drug development and commercialization.
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An Analysis Of The Gene Therapy Viral Vector Landscape
4/21/2021
Over the last five years, multiple gene therapies have been approved by regulatory agencies and a bolus of late-stage pipeline assets are approaching the market. However, as the first gene therapies began to post early wins, several challenges have emerged. This article discusses the landscape of the viral vector sector.
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What Role Will India Play In The Global COVID-19 Vaccine Narrative?
1/27/2021
While most Americans are focused on the incredible success of the COVID-19 vaccines developed and produced by Pfizer and Moderna under the $24 billion Operation Warp Speed, there is under-reported news from India that bears a closer look.