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EU probes low platelet safety issue with COVID-19 shots

pharmaphorum

The experts have also recommended a safety update on the label of Oxford University/AstraZeneca’s COVID-19 vaccine, which has been linked to anaphylactic reactions, in what has turned out to be a concerning week for vaccine safety. AZ vaccine safety update.

Vaccines 145
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Oral penicillin challenge deemed safe and effective in low-risk allergy patients

Hospital Pharmacy Europe

Removing the label of being allergic to penicillin involves intra-dermal skin testing followed by an oral penicillin challenge. The primary outcome of interest was a physician-verified positive immune-mediated oral penicillin challenge within one hour after the intervention. None of these were deemed to be serious.

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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.

Vaccines 122
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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.

Labelling 145
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FDA accepts to review ImmunityBio’s BLA for bladder cancer treatment

Pharmaceutical Technology

The open-label, three-cohort, multicentre trial analysed intravesical BCG, N-803 combination in BCG-unresponsive high-grade NMIBC patients. Furthermore, a 91% and 100% cystectomy avoidance rate and bladder cancer overall survival, respectively, were observed at 24 months without any serious adverse events (SAE).

FDA 105
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Tumour-infiltrating lymphocyte therapy in advanced melanoma superior to ipilimumab 

Hospital Pharmacy Europe

Tumour-infiltrating lymphocyte therapy (TILT) gave rise to superior progression-free survival in comparison to immune checkpoint inhibitor therapy with ipilimumab in a phase 3 trial of patients with advanced melanoma according to the results of a study presented at the European Society for medical Oncology (ESMO) Congress by Dutch researchers.

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Dupixent face rash and redness: Causes and treatment

The Checkup by Singlecare

How Dupixent works in the body It’s still unclear what causes atopic dermatitis , the most common form of adult and pediatric eczema, but it’s commonly regarded as an immune system and skin barrier condition. Those intruders trigger the immune system, which releases certain proteins that cause skin inflammation.