Biosimilars Drug Development Immunity 
Express Pharma
JULY 3, 2023
How is the industry’s approach to drug development transforming? How is Waters aiding advancements in drug development? A central aim in drug development is to create new molecular entities into commercially viable drugs useful in managing diseases. What are the imperatives that led to this change?
Safe Biologics
NOVEMBER 12, 2023
6 “The Biosimilar Red Tape Elimination Act”, which would prevent the HHS Secretary from requiring switching studies in order for a biosimilar to be deemed “interchangeable” Under U.S. state law, only biosimilars which are interchangeable may be substituted by a pharmacist without contacting the prescriber.
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Pharmaceutical Technology
FEBRUARY 28, 2023
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Pharmaceutical Technology
FEBRUARY 28, 2023
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Pharmaceutical Technology
FEBRUARY 28, 2023
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
FDA Law Blog: Biosimilars
MARCH 13, 2023
Bauer, Senior Regulatory Drug Expert & James E. Valentine — Incorporating patient and caregiver experiences into every phase of drug development has become increasingly prioritized during both development and review ( see, e.g. , previous coverage here ). By Larry J. His eczema cleared up completely.
Pharmaceutical Technology
FEBRUARY 28, 2023
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
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