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STAT+: Experts critique flawed system for monitoring drugs’ side effects in wake of asthma drug report

STAT

and globally, for monitoring adverse reactions after a drug is on the market — one that will require extensive changes to address. Experts say that the Singulair incident highlights a flawed system, both in the U.S.

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ACMT Toxicology Visual Pearls: Mushroom Mishap

ALiEM - Pharm Pearls

What well-known adverse reaction results from ingestion of the pictured mushroom? Acute hepatitis Disulfiram-like reaction with ethanol consumption Pneumonitis from inhalation of spores Seizures from glutamate agonist activity [Image from Canstockphoto] Reveal the Answer 2. What is the mechanism of the adverse reaction? [2-5]

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FDA Accepts Pfizer’s sNDA for BRAFTOVI + MEKTOVI

LifeProNow

In 2020, BRAFTOVI was FDA-approved, in combination with cetuximab, for the treatment of adults with metastatic CRC with a BRAF V600E mutation, as detected by an FDA-approved test. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction. The approval was based on results from the BEACON CRC trial.

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Pharmacovigilance deep dive: risk minimisation measures

European Pharmaceutical Review

This can be achieved by reducing the burden of adverse reactions or by optimising benefits through patient selection (eg, contraindications, recommendations of use, warnings, concomitant medicine[s], or certain test parameters) and treatment management (eg, specific dosing regimen, relevant testing, patient follow-up).

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New Bill could enhance UK clinical trial regulation

European Pharmaceutical Review

He highlighted research by the Association of the British Pharmaceutical Industry (ABPI) from 2022, which found that between 2018 and 2020, “the median time between application for regulatory approval and delivery of a first dose to a participant in a trial increased by almost a month.”

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Unlocking the potential in rare disease research with decentralised trials

pharmaphorum

The report found that people’s willingness to take part in clinical trials in 2020 fell dramatically compared to previous years – however that survey was conducted with the wider public while the Raremark survey focused specifically on people with rare diseases. Research and development will always be important to rare disease patients.

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First chikungunya vaccine approved

European Pharmaceutical Review

The vaccine was granted PRIority MEdicine (PRIME) designation by the EMA in 2020. As part of the US FDA approval, the FDA stated that the company is required to conduct a postmarketing study to assess the serious risk of severe chikungunya-like adverse reactions following administration of IXCHIQ.