Formulation Development Featured Articles
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FDA Seeks Comment On New Draft Guidance On Peptide Drug Product Pharmacology
10/3/2023
The FDA has announced a new draft guidance titled Clinical Pharmacology Considerations for Peptide Drug Products. This guidance describes recommendations related to hepatic impairment, drug–drug interactions, assessing QTc prolongation risk, and more. The public comment period ends December 11, 2023.
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Importance Of High-Performance Cell Culture Media And Feeds
9/13/2023
<p>Find out more about the benefits of high-performance cell culture media and feeds, as well as current development challenges and their potential solutions.</p>
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Comparing FDA And EMA Approaches To AI/ML In Drug Development & Manufacture
9/13/2023
Considering the feverish pace of innovation in the field of AI/ML and the inevitable impact on drug development, we outline the documents and guidances that the FDA and EMA have released thus far, comparing and contrasting their areas of focus and concern.
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Using Media And Feed Panels During Media Development
9/12/2023
Find out how a panel-based approach can help accelerate cell culture media and feed development and maximize the productivity of your biopharmaceutical manufacturing process.
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An Overview Of The 9 FDA Special Designations For Pipeline Drugs
9/8/2023
The FDA employs special designations to streamline and incentivize the advancement of drugs addressing medical gaps. Some designations can accelerate FDA timelines for NDAs and BLAs, others may abbreviate the duration of clinical trials. What scenarios or drugs/therapies are best suited for each?
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Respiratory Viral Infections: The Next Frontier For Antiviral Drug Development
8/29/2023
There is still no approved antiviral therapy for adults with RSV infections. As drug developers, we need to prioritize developing new antiviral therapies for immunocompromised patients.
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Navigating The Murky Waters Of Patent Claims Involving AI After Amgen v. Sanofi
8/24/2023
In May 2023, the Supreme Court issued a ruling on the Section 112 enablement requirement for patents in Amgen v. Sanofi. What does this mean for patent claims involving artificial intelligence (AI) going forward? These Haynes Boone attorneys explain.
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Are KRAS Inhibitors Poised To Cure Cancer?
8/21/2023
The KRAS gene, a crucial component of cell signaling pathways involved in cell growth and division, is frequently mutated in various cancers. By targeting the gene, KRAS inhibitors aim to block the aberrant signaling that promotes cancer cell proliferation. Amgen's sotorasib became the first approved KRAS inhibitor, opening up an exciting field.
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Diagnose Absorption Risks To Improve Preclinical And Clinical Outcomes
8/8/2023
Physiologically based pharmacokinetic modeling is a powerful tool for clinical trial design that can be leveraged alongside early development experiments to reduce costs and accelerate timelines.
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The ADC Market To Triple By 2030, Driven By Big Pharma Developments
8/8/2023
After two decades of trial and error in antibody–drug conjugates (ADC) development, the field is poised to deliver a plethora of targeted drugs to treat a wide range of tumor types. Let's take a look at new market research and some notable recent developments in the space.