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Quality by design with a focus on biosimilars

Pharmaceutical Technology

Protein-based drugs are extremely expensive and so if you can create a biosimilar and potentially lower the cost, then this is an incentive for many companies to try to get into that marketplace, but also for regulators to encourage development.”. coli, where small amounts of contaminants could cause significant toxicity.

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The Utility of Liquid Biopsy in Oncology Clinical Trials

XTalks

However, Dr. Bahassi reported that the selection of CTCs using this method is often not very efficient and the CTC population is usually highly contaminated with leukocytes. Also, exosomes are mostly being used for the detection of circulating RNA and microRNA. “An Regulatory Approvals for Exosome-Based Liquid Biopsies.

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FDA approves twice-yearly resistant HIV therapy from Gilead

pharmaphorum

In trials, 81% of participants taking the regimen achieved HIV RNA suppression, where levels of HIV were low enough to be considered undetectable after six months, with 83% showing continued suppression in viral load after a year.

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Improving quality control for CAR T cell therapies

Drug Discovery World

For example, it is challenging to regulate transgene copy numbers in each T cell, posing safety risks. Although transgenes show a preference for certain sites, the CAR transgene could integrate into the T cell genome at any location, including within a sequence that regulates oncogene expression, thereby increasing cancer risk.

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COVID-19 Pandemic Coverage

XTalks

The company’s candidate vaccine, mRNA-1273, is a synthetic messenger RNA that encodes the stabilized SARS-CoV-2 spike protein. Meanwhile, N95 masks are in such short supply that regulators have told healthcare workers they can be used multiple times with little evidence that disinfecting them works.