US FDA rejects Teva's petition to block generic Copaxone
This article was originally published in Scrip
The US FDA has rebuffed, for now, Teva Pharmaceutical Industries' bid to block approval of generic competition to its blockbuster multiple sclerosis drug Copaxone (glatiramer acetate).
You may also be interested in...
Heading into an advisory committee review, agency suggests belantamab’s risks of keratopathy and other ocular issues have not been fully characterized and questions whether the proposed mitigation measures, including dosing modifications, are adequate.
US FDA cardiovascular and renal drugs panel will weigh approvability of the vasopressin analog during a nine-hour, online meeting 15 July; terlipressin was the focus of a 2009 complete response letter but met its primary endpoint in the recent CONFIRM trial.
Under certain circumstances, potential clinical trial participants may be able to provide informed consent by writing on a blank piece of paper that they voluntarily agree to participate in a given protocol, and texting or emailing a photo of the signed document to the investigator, the US FDA says in its latest guidance update.