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Gilead expands Arcellx cancer cell therapy deal

BioPharma Drive: Drug Pricing

The deal gives Gilead an estimated 13% ownership in Arcellx and extends the company’s cash runway into 2027.

Therapies 293
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Q BioMed’s Uttroside-B Receives U.S. FDA Orphan Drug Designation in the Treatment of Liver Cancer

The Pharma Data

. With very limited approved first-line pharmaceutical therapies for HCC available today, challenges include drug resistance, adverse side effects, and high costs. billion by 2027. An estimated 700,000 people are diagnosed with HCC each year, with the global market for liver cancer drugs expected to grow to $3.9

FDA 40
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No Sleep ‘Til District Court: Jazz Sues FDA Over Sodium Oxybate Clinical Superiority Determination

FDA Law Blog: Biosimilars

With that decision, Jazz lost its ODE, allowing Avadel’s sodium oxybate product to compete with Jazz’s long before the expiration of the ODE covering Jazz’s most recent product, Xywav, in 2027. Jazz argues, essentially, that the change in position was the product of a pressure campaign within the Agency.

FDA 52
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Breakthrough drug candidates and cancer treatment innovations

Drug Target Review

There is a high unmet medical need in this area because while other candidates have shown early signs of clinical activity, there is still a need for therapies with improved safety and efficacy profiles. How does Zymeworks plan to advance at least five novel medicines into clinical studies by 2027 under its ZYME 5×5 R&D objectives?

Treatment 100
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Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

We have tried to sort guidance documents by topic area.

FDA 40
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Improving Study Activation Time for Gene Therapy Research

Advarra

Research in gene therapies and genetically engineered drugs and vaccines are growing exponentially, and will only continue to become more popular. The accelerating gene therapy market is expected to grow globally by 16.6% between 2020-2027.

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Analysis Life Sciences Thank You BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions

Agency IQ

BSUFA III aimed to address biosimilar development challenges via a new regulatory science pilot program In the latest reauthorization of the Biosimilar User Fee Act (BSUFA III), FDA committed to a variety of activities for fiscal years 2023 through 2027.

Science 40