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.
Tag Archive for: side effects
The company’s CEO said its experimental multiple sclerosis drug can be a “blockbuster”, an industry term for annual sales that exceed $1 billion, even after concerns emerged that the drug may cause liver damage.
The Phase III STAND trial found no significant therapeutic benefit to Novartis’ Adakveo, pushing the European Commission to revoke its conditional authorization of the SCD treatment.
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.
BioNTech, a German company specializing in mRNA-based vaccines, is facing its first lawsuit in Germany related to alleged side effects of its COVID-19 vaccine, developed in partnership with Pfizer and authorized for emergency use in 158 countries, Reuters reported last week. But in the U.S., vaccine makers are protected from any such liability until October 2024, thanks to a provision the federal government put forth at the start of the pandemic.
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.
Blueprint Medicines Corp. said on Friday the U.S. drug regulator had put on partial hold an early-stage trial testing its experimental cancer drug due to safety concerns, sending its shares down nearly 6%.
Britain’s medicines regulator said on Tuesday that any new or worsening reactions in patients’ eyes arising from use of Sanofi’s best-selling asthma and eczema drug Dupixent should be promptly reviewed by healthcare professionals.
Reports of heavy periods – bleeding characterized by increased volume and/or duration that interferes with the quality of life – have been observed during clinical trials, from cases in the real world and in medical literature, according to the European Medicines Agency.
On Monday, Boston biopharma Karuna Therapeutics released results from the Phase III EMERGENT-2 trial showing that KarXT (xanomeline-trospium), its lead candidate, can strongly reduce symptom severity in schizophrenia patients.
