December’s meeting of the Committee for Medicinal Products for Human Use within the European Medicines Agency has resulted in a trio of positive opinions recommending the granting of marketing authorizations for generic and hybrid medicines.
Krka, Accord And Xeris Pick Up European Nods
Rivals To Revlimid And Sutent Accompanied By GlucaGen Hybrid
The EMA’s CHMP has recommended granting pan-European marketing authorizations for Krka’s lenalidomide versions of Revlimid and Accord’s sunitinib rival to Sutent, as well as Xeris Pharmaceuticals’ glucagon hybrid rival to Glucagen.
More from Products
• By
Doubling down on previously shared data from the firm’s STELARIS trial, Teva has reported further findings from a survey featuring subjects and professionals involved in the Phase III study for its proposed long-acting olanzapine injectable.
• By
Amid ongoing generic drug supply problems, Japan's government is to set up a new fund to support corporate investments geared towards manufacturing and consolidation.
• By
Organon has swelled its immunology biosimilar portfolio after acquiring the US commercial rights to Bio-Thera’s tocilizumab biosimilar from Biogen, which last year decided to retain its interests in biosimilars following a lengthy strategic review.
• By
The US FDA has deemed certain CRO Raptim Research’s in vitro bioequivalence studies as “not acceptable” and raised concerns over its in vivo study methods. Will other agencies follow suit?
More from Generics Bulletin
• By
Organon has swelled its immunology biosimilar portfolio after acquiring the US commercial rights to Bio-Thera’s tocilizumab biosimilar from Biogen, which last year decided to retain its interests in biosimilars following a lengthy strategic review.
• By
The US FDA has deemed certain CRO Raptim Research’s in vitro bioequivalence studies as “not acceptable” and raised concerns over its in vivo study methods. Will other agencies follow suit?
• By
The EMA has accepted for review Henlius’ Perjeta biosimilar, which is to be commercialized by the Chinese company’s global partner Organon in the EU.