Gilead expands Arcellx cancer cell therapy deal
BioPharma Drive: Drug Pricing
NOVEMBER 15, 2023
The deal gives Gilead an estimated 13% ownership in Arcellx and extends the company’s cash runway into 2027.
BioPharma Drive: Drug Pricing
NOVEMBER 15, 2023
The deal gives Gilead an estimated 13% ownership in Arcellx and extends the company’s cash runway into 2027.
The Pharma Data
JANUARY 26, 2021
. 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
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FDA Law Blog: Biosimilars
JULY 24, 2023
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.
Drug Target Review
JUNE 5, 2023
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?
Agency IQ
FEBRUARY 15, 2024
We have tried to sort guidance documents by topic area.
Advarra
JUNE 13, 2023
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.
Agency IQ
OCTOBER 20, 2023
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.
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