A full dossier is no guarantee of data exclusivity
This article was originally published in SRA
Raymond Meijer and Diederick Slijkerman contend that submitting a full dossier in the EU does not by default lead to data exclusivity.
You may also be interested in...
Company expects clinical trials to begin by September and says first batches could be available for emergency use authorization in early 2021; J&J pledges vaccine will be available to public on not-for-profit basis.
The US FDA wants to expand the availability of surgical apparel – including gowns, hoods and examination gloves – for health care professionals to use for the duration of the COVID-19 public health crisis. That means the agency will “not object” to the use of gowns and gloves providing low-to-minimal protection, as long as they do not create an undue risk to patients or users.
Efficacy seen in reducing hospitalization in high-risk heart failure patients, but not in reducing the risk of cardiovascular death. Analysts say this portends a more niche opportunity for vericiguat.