Increasingly complex: EMA's take on new drug applications
This article was originally published in SRA
The European Medicines Agency says that while it has received a stable number of initial marketing authorization applications (MAAs) for human medicines, with a total of 96 applications received in 2012, it has observed an "increasing complexity" in the applications1.
You may also be interested in...
The UK's main reimbursement bodies made a series of decisions this week that were broadly favorable and largely focused on oncology medicines.
While troubled Valeant was divesting iNova to private equity investors, Novartis announced a pair of oncology-focused deals, out-licensing a brain cancer drug to Midatech and partnering with IBM Watson Health to optimize breast cancer treatment.
Astellas and Pfizer have amended the PROSPER trial protocol in a bid to position Xtandi ahead of Zytiga in the early stage prostate cancer market.