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FDA drug dosage optimisation guidelines signal clinical trial reform

Pharmaceutical Technology

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage.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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FDA pulls approval of COVID-19 antibody treatment due to inefficacy against variants

Pharmafile

The FDA has revoked its approval of AstraZeneca’s Evusheld due to the fact that it is not effective against more than 90% of COVID-19 variants currently in circulation in the US. read more

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Fennec’s hearing loss drug for cancer patients wins breakthrough FDA nod

Pharmaceutical Technology

The recent FDA approval of Fennec Pharmaceuticals’ drug PEDMARK (sodium thiosulfate injection) marks a significant advance for cancer treatment-associated hearing loss therapies, amidst a bid to improve quality of life for cancer patients. The current standard of care for many cancers is cisplatin chemotherapy or platinum therapy.

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International regulation: the importance of quality assurance in drug development

European Pharmaceutical Review

Since the first ADC was approved by the EMA in 2012, they have generated a great deal of interest in the oncology field because of their potential to address many of the challenges of traditional chemotherapy options. Teams must also accept the variety of analytical procedures these regulatory agencies prefer.

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FDA approves Biostar’s Phase II/III plans with utidelone injectable for NSCLC

Pharmaceutical Technology

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. Promising results were observed, with outcomes of 19.0% ORR, 81.0%

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SNIPR targets antibiotic resistance with CRISPR-based gene therapy trial

Pharmaceutical Technology

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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MSD’s Keytruda use in adenocarcinoma could be limited based on biomarker

Pharmaceutical Technology

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.