A federal judge dismissed more than 40 states’ claims against the parent company that manufactures Suboxone in a suit accusing it of suppressing generics. Source: Drug Industry Daily
The European Medicines Agency’s pharmacovigilance committee recommended additional restrictions on Biogen’s Zinbryta (daclizumab), after reviewing its effects on the liver. Source: Drug Industry Daily
A UK court ruled for Mylan in its challenge to Teva’s patents on the long-acting version of Teva’s blockbuster multiple sclerosis drug. Source: Drug Industry Daily
Teva Pharmaceutical Industries accused Eli Lilly of infringing on patents for its migraine drug in a lawsuit filed Oct. 24. Source: Drug Industry Daily
The FDA published a draft guidance explaining the new GDUFA fee structure and the types of fees that took effect Oct. 1. The draft also covers how to submit payments…
An EU regulation meant to boost pediatric drug development has led to more medicines for children since it was adopted, although actual use of new products has not increased at…
The FDA issued a new draft guidance for sponsors developing treatments for gastroesophageal reflux disease in infants, children and adolescents — outlining clinical trial design considerations and the agency’s current…
John Kapoor, founder and majority owner of Insys Therapeutics, was arrested and charged with bribery and fraud in the illegal distribution of a fentanyl spray, an opioid intended to treat…
President Donald Trump officially declared the nationwide opioid crisis a public health emergency Thursday, directing agencies to use existing authority to the best of their ability to combat the epidemic.…
FDA Commissioner Scott Gottlieb told lawmakers the agency will work to break the stigma associated with medication-assisted treatments for opioid dependence and addiction. Source: Drug Industry Daily