Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new.

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Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) approved Ferring Pharmaceuticals’ Prior-Approval Supplement (PAS) to the Biologics License Application (BLA) for the bladder cancer gene-therapy Adstiladrin (nadofaragene firadenovec). Download the full report to understand what to expect and how to align your strategies for success.

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European Pharmaceutical Review

NOVEMBER 4, 2022

Despite advances with targeted and immuno-oncology therapies, chemotherapies remain a cornerstone of cancer treatment for many tumour types – a reflection of their significant anti?tumour While highly effective, taxanes also exhibit several of the typical limitations associated with systemic chemotherapies. tumour effects.

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Pharmaceutical Technology

JUNE 16, 2023

Synthetic biology biopharma Biostar Pharma announced is ready to advance its utidelone injectable (UTD1) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), following approval from the US Food and Drug Administration (FDA) for the study. Please check your email to download the Report. ORR, 81.0%

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Pharmaceutical Technology

MAY 31, 2023

In January 2021, the US Food and Drug Administration (FDA) granted SNIPR001 a fast track designation. Several CRISPR-based gene therapies are in development , with one for sickle cell disease and transfusion-dependent beta thalassemia (TDT), being examined by the FDA for an approval. Please check your email to download the Report.

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Pharmaceutical Technology

JUNE 16, 2023

In 2021, as part of the same Keynote-811 trial, the US Food and Drug Administration (FDA) granted accelerated approval to Keytruda for treating locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma, in combination with trastuzumab and chemotherapy containing fluoropyrimidin and platinum.

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Pharmaceutical Technology

FEBRUARY 27, 2023

The ADC is already approved in the metastatic setting after chemotherapy or in the case of disease recurrence during or in six months after adjuvant chemotherapy. Regulatory decisions by the US FDA for select therapies from late December to late January, and the CMOs contracted to manufacture them.

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