The European Medicines Agency (EMA) is probing Novo Nordisk’s diabetes drug Ozempic and weight-loss treatment Saxenda after Iceland’s health regulator flagged three cases of patients on the drugs thinking about suicide or self-harm.
Tag Archive for: patient safety
The European Medicines Agency recently flagged a safety signal related to GLP-1 receptor agonists and sent a list of questions to manufacturers including Novo Nordisk, Eli Lilly, Sanofi and AstraZeneca.
The company’s “Albuterol Sulfate HFA Inhalation Aerosol” is a generic therapeutic equivalent version of an inhaler from Merck.
Citing insufficient safety evidence for one of the drug’s main ingredients, the regulator in a Complete Response Letter rejected the company’s application for Parkinson’s disease candidate IPX203.
The company said the trial site’s principal investigator, who enrolled 40% of the study participants at that site, was found to have fabricated email correspondence related to timing of the filing of a serious side-effect with the company’s vendor responsible for monitoring safety of the drug.
Merck now faces a raft of lawsuits alleging it knew from its early research that the drug could impact the brain and that it minimized the potential for psychiatric problems in statements to regulators.
The company and partner Seattle Children’s Therapeutics was studying its experimental therapy as a treatment for children with acute myeloid leukemia (AML), a cancer of the blood and bone marrow.
In Europe, where cost-conscious countries rigorously weigh new drugs before adopting their use, nine neurologists and researchers across six countries told Reuters lecanemab is unlikely to be widely used if approved. Their views underpin analyst estimates suggesting Europe will be a small market for the drug.
Shares of Biogen rose 4% in premarket trade on Monday as an unanimous backing of the company’s Alzheimer’s drug Leqembi by the U.S. regulator’s advisers eased concerns that a traditional approval for the treatment will not come with major new safety warnings.
The first hearing in a German court case against BioNTech over side effects allegedly caused by its COVID-19 vaccine was postponed on Monday after the plaintiff’s lawyer petitioned for the case to be heard by different judges.