European Pharmaceutical Review

European Pharmaceutical Review | January 03, 2017

The US Food and Drug Administration (FDA) cleared Glenmark Pharmaceutical’s investigational new drug (IND) application to initiate a phase I study of its lead candidate, GBR 1302-BEAT, in patients with HER2+ cancers....

European Pharmaceutical Review | January 11, 2017

The European Medicines Agency (EMA) Committee for Orphan Medicinal Products has granted orphan drug status to UK biotech firm F2G’s lead clinical candidate, F901318, for the treatment of invasive Aspergillosis and rare mould infections caused by Scedosporium species....

European Pharmaceutical Review | January 12, 2017

Now that it’s 2017, we are choosing to write this letter to provide recommendations for best practices to establish gender diversity as a priority for the biopharma industry. Last year’s open letter to the industry sparked a dialogue that led to changes in some company practices, new training programs, regional gender diversity initiatives and much more. But we believe this is just the start of the work to be done....

European Pharmaceutical Review | January 12, 2017

Everolimus is one of a series of drugs that has gone through a reappraisal process, where NICE assesses the cost and clinical effectiveness of drugs currently in the old CDF. In this case, the committee looked at new evidence and a price discount submitted by the drugs company, and was able to approve the drug for routine use on the NHS....