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Off-label Use

RX Note

In fact, off-label drug uses can become widely entrenched in clinical practice and become predominant treatments for a given clinical condition. In a study published in JAMA Internal Medicine , off-label use lacking strong scientific evidence had a higher adverse drug event rate compared with on-label use.

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EMA panel probes heart inflammation with Pfizer/BioNTech COVID vaccine

pharmaphorum

At the moment, there’s no indication that the cases are linked to the vaccine itself, but the EMA has asked the companies to provide “further detailed data, including an analysis of the events according to age and gender,” as it looks into the signal.

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First patient dosed with HIV gene therapy

European Pharmaceutical Review

The removal of HIV DNA from the cellular genome is essential to effecting a cure; the virus takes up long-term residence in tissue reservoirs, where it hides, evading the immune system and escaping antiretroviral therapy. As a result, HIV can persist in tissue reservoirs for years.

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September 2023 Newsletter

Safe Biologics

FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars- Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. ASBM surveys of U.S. from 9:30 am – 2:00 pm ET.

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Electra Therapeutics secures FDA ODD status for HLH treatment

Pharmaceutical Business Review

“This designation underscores the high unmet medical need in sHLH and supports our continued efforts to evaluate the effectiveness of ELA026 in depleting the pathogenic immune cells responsible for the cytokine storm and addressing the high early mortality observed in this disease.”

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Developing a new treatment paradigm for chronic kidney disease

European Pharmaceutical Review

This leads to the formation of immune complexes that deposit in the glomerulus and result in haematuria, proteinuria, and decline in kidney function. The mechanism of action of atacicept targets the origin of IgAN pathology, acting upstream of the disease-causing events. IgAN is the most common primary glomerulonephritis worldwide.

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Developing a new treatment paradigm for IgAN

European Pharmaceutical Review

This leads to the formation of immune complexes that deposit in the glomerulus and result in haematuria, proteinuria, and decline in kidney function. The mechanism of action of atacicept targets the origin of IgAN pathology, acting upstream of the disease-causing events. IgAN is the most common primary glomerulonephritis worldwide.