Pharmaceutical Technology

NOVEMBER 9, 2022

The US Food and Drug Administration (FDA) has approved Regeneron Pharmaceuticals ’ PD-1 inhibitor Libtayo (cemiplimab-rwlc) and chemotherapy combination as the first-line treatment for advanced non-small cell lung cancer (NSCLC). Patients may receive this therapy regardless of PD-L1 expression or tumour histology.

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Pharmaceutical Technology

MARCH 30, 2023

The European Commission (EC) has granted approval for Regeneron Pharmaceuticals’ Libtayo (cemiplimab), along with platinum-based chemotherapy, as the first-line treatment for PD-L1 expression positive advanced non-small cell lung cancer (NSCLC) in adult patients.

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Pharmaceutical Technology

JUNE 27, 2022

Ipsen has signed a definitive merger agreement to acquire all the outstanding shares of commercial-stage biopharmaceutical company Epizyme, for an initial total consideration of $247m. The transaction is focused on Epizyme’s lead asset, Tazverik (tazemetostat), a chemotherapy-free EZH2 a inhibitor. for each share. for each share.

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pharmaphorum

FEBRUARY 23, 2021

Sanofi’s cancer immunotherapy Libtayo (cemiplimab) has a third US indication after the FDA approved it for certain untreated lung cancer patients. In this patient population, Libtayo reduced the risk of death by 32% compared to chemotherapy.

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The FDA Law Blog

JANUARY 18, 2024

Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. By Larry K. 53,688 (Aug. 53,767 (Aug. 21 U.S.C. §

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pharmaphorum

DECEMBER 23, 2020

The FDA has gone on to grant a fast review of the results ahead of a regulatory decision on the new lung cancer indication next year. While Trodelvy is already conditionally approved in the US, the data showing the drug improved overall survival compared with chemotherapy could be enough for it to clinch a permanent licence in the US.

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ISPE

NOVEMBER 1, 2022

The first keynote speaker was Michael Kopcha, PhD, RPh, Director of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), US FDA. Quality is a foundation for the development and delivery of pharmaceuticals: per Kopcha’s definition, quality means consistently meeting the expectations of the user.

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