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FDA drug dosage optimisation guidelines signal clinical trial reform

Pharmaceutical Technology

In 2021, the FDA granted Amgen’s (NASDAQ:AMGN) non-small cell lung cancer (NSCLC) drug Lumakras (sotorasib) an expedited approval, making it the first FDA-approved KRAS inhibitor. In 2021, Amgen agreed to conduct a Phase II study (NCT04933695), which is supposed to complete in May 2024, according to Clinicaltrials.gov.

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Why are my toes numb?

The Checkup by Singlecare

Causes of neuropathy can also include autoimmune diseases like rheumatoid arthritis, nutrient deficiencies, medication toxicity (such as chemotherapy), genetics, and age-related changes, says Dr. Machemehl. Multiple sclerosis is a nervous system disorder that often causes toe numbness.

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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. Chemotherapy used to treat blood cancer results in increased intestinal permeability, making E. 2021 was a year of continued innovation and change in the Biopharmaceutical industry.

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Lymphoma Action – championing the patient voice in cell therapy

pharmaphorum

Now, people living with particular types of lymphoma have individualised options beyond chemotherapy for the first time.”. We’ve learnt how best to communicate with people, their care partners and families, so they’re fully informed and able to take part in the conversation. Last accessed March 2021. Available at: [link].

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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.

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

Pharmaceutical Technology

Designated as BG01-2202, this latest trial will be an open-label, randomised, controlled clinical study of UTD1 versus chemotherapy drug docetaxel. A Phase III study to evaluate UTD1 versus docetaxel in patients that have failed chemotherapy with a platinum-containing regimen is also currently underway in China. ORR, 81.0%

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ASCO 2023: Summit Therapeutics plans to rise with bispecific NSCLC data

Pharmaceutical Technology

In results presented at the ongoing American Society of Clinical Oncology (ASCO) Annual Meeting , Summit reported an overall response rate (ORR) of 67% in NSCLC patients with squamous histology treated with its lead drug ivonescimab plus chemotherapy. The treatment had an acceptable safety profile in combination with chemotherapy.