Drug Discovery World

FEBRUARY 22, 2024

Lilly’s growth was further fuelled by Mounjaro’s FDA approval for the treatment of obesity received in Q3, with Mounjaro forecasted to reach global forecast sales of $4.7 in 2023, fuelled by the FDA approval of its CRISPR-based ex vivo cell therapy Casgevy. billion for 2023.

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Agency IQ

JANUARY 19, 2024

BY KIRSTEN MESSMER, PHD, RAC | JAN 17, 2024 9:16 PM CST Quick background: EMA annual new medicines reports At the beginning of each calendar year, the EMA publishes a New Medicines Highlights report, providing a high-level overview of new medicines reviewed by the EMA’s Committee for Medicinal Products of Human Use (CHMP). Based on the E.U.

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The Pharma Data

JUNE 24, 2021

“By combining enzalutamide, which has a proven clinical benefit in men with metastatic castration-sensitive prostate cancer, with talazoparib, our PARP inhibitor that is active in DDR-mutated cancer, we may be able to offer a new treatment option that targets the underlying genetic mechanisms associated with DDR-mutated mCSPC.”.

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. That did not happen.

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FDA Law Blog: Biosimilars

JANUARY 18, 2024

FDA found that marijuana continued to have a high potential for abuse, lacked accepted safety for use under medical supervision and had no currently accepted medical use in treatment in the United States. within the CSA’s definition of “marihuana” or “marijuana” based on FDA’s eight factor analysis.

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FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

156, a patent may be extended only once (even if it would be eligible for extension on more than one occasion because it applies to several FDA-approved products), and only one patent may be extended for each regulatory review period. In that case, the NDA sponsor applied for two PTEs based on these approvals—one for either U.S.

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Agency IQ

DECEMBER 1, 2023

and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S.

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