Tag Archive for: patient safety

India is testing samples of cough syrups produced by Maiden Pharmaceuticals after the World Health Organization said its products were linked to the deaths of dozens of children in Gambia, a government official said on Thursday.

The agency put the partial hold after a serious adverse event was seen in a patient during the study.

The company stated that it would start fresh late-stage studies of its HIV treatment, islatravir, months after the U.S. Food and Drug Administration put the trials on hold, citing safety concerns.

The report summarizes various measures of the pharmaceutical industry’s ability to deliver quality drugs to U.S. patients and consumers.

The agency said it received more than 48,000 reports of faulty Dutch medical equipment maker Philips’ ventilators and respiratory devices between May and July of this year.

Shares in GSK, Sanofi and Haleon fell sharply on Thursday, following declines earlier this week, amid growing concerns about U.S. litigation over a heartburn drug that was pulled from the market in 2020 for containing a probable carcinogen.

The European Medicines Agency (EMA) is recommending Novavax’s COVID-19 vaccine carry a warning of the possibility of two types of heart inflammation, an added burden for a shot that has so far failed to win wide uptake.

BioSpace sat down with Katy Powell, a psychiatric mental health nurse practitioner in Portland, Oregon, to discuss the relative risks and benefits associated with psychedelic-assisted therapy.

The agency will reconvene a meeting of its outside experts to review the company’s application seeking approval for its amyotrophic lateral sclerosis (ALS) treatment.

Pharmacovigilance, the industry term for drug safety, was unfamiliar to most of the general public before March 2020. But as the coronavirus pandemic unfolded, its rapid spread thrust drug safety into the spotlight. The public is more aware of drug safety and health regulators’ role than ever — and as the demand for pharmacovigilance information rises, the industry has had to find ways to keep up — according to Beena Wood, VP of safety at ArisGlobal.