FDA's Blood Products Advisory Committee meeting has been postponed until the fall. The panel had been scheduled to meet June 29 to consider the structural differences between Amgen's Epogen and Chugai-Upjohn's Marogen.
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Lotus Pharmaceuticals has expanded its biosimilar pipeline to five by bringing in rights in Taiwan and South East Asia markets to Chong Kun Dang Pharmaceutical’s biosimilar of Kyowa Kirin’s Nesp (darbepoetin alfa).
The pharmaceutical industry has given a muted welcome to proposals for building up the EU's resilience to medicine shortages, saying many of the ideas will not tackle the root causes of supply problems and could even serve to undermine innovation.
Accord Healthcare has garnered the first positive opinion recommending granting a pan-European marketing authorization for a generic version of rivaroxaban from the EMA’s CHMP. However, originator Bayer claims that no generic competition will be possible for another three years.