Tag Archive for: patient safety

The Dutch medical devices maker started the recall process on Nov. 30 this year and has recalled 150 devices in the United States.

The World Health Organization on Thursday said several contaminated syrups and suspension medicines had been identified in countries in the WHO regions of the Americas, the Eastern Mediterranean, South-East Asia and the Western Pacific.

The regulator placed a partial clinical hold on Roche’s fenebrutinib—being developed for relapsing MS—after two patients experienced elevated hepatic transaminase and bilirubin levels indicative of liver injury.

The move follows a review that started in July and covered a range of drugs known as GLP-1 receptor agonists, also including Eli Lilly’s Trulicity, Sanofi’s Suliqua, AstraZeneca’s Bydureon and Novo’s Rybelsus and Saxenda.

Yesterday Novo Nordisk said it sued one compounding pharmacy and refiled a lawsuit against another after finding their products claiming to contain the active ingredient for its in-demand weight-loss drug Wegovy were impure, some by as much as 33%.

Philips shares fell more than 6% on Wednesday after the U.S. Food and Drug Administration said it is alerting patients of a new safety issue with machines made by the group that are used for the treatment of obstructive sleep apnea.

Texas Attorney General Ken Paxton accused Pfizer and its supplier Tris Pharma of providing children’s ADHD medicine that it knew might be ineffective to the state’s Medicaid insurance program for low-income people, in a lawsuit unsealed yesterday.

Yesterday the agency told healthcare providers and facilities not to use Cardinal Health’s Monoject syringes with patient-controlled pain management pumps and syringe pumps.

The U.S. health regulator’s staff flagged concerns that data on Merck’s chronic cough drug might not be enough to prove the treatment’s meaningful benefit, documents released ahead of a meeting of independent experts showed.

Whistleblowers allege that ZZ Biotech co-founder Berislav Zlokovic pressured his scientists to adjust data in favor of the investigational stroke therapy 3K3A-APC, according to a dossier obtained by Science.