This month, patent court trial proceedings are expected to get underway in the UK in Celltrion’s bid to secure a declaration that the local part of a key European patent shielding Novartis/Genentech’s Xolair (omalizumab) is invalid, or not infringed, by the Korean firm’s Omlyclo version.
What’s Next? Five Things To Look Out For In October
UK Xolair And US Abilify Maintena Patent Trials; Eleventh Generics Awards In Milan
Generics Bulletin previews the most notable and anticipated events for October 2024.
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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.
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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?
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Teva should not be able to overturn European fines imposed over a historical “pay-for-delay” arrangement covering Cephalon’s Provigil (modafinil), an advocate general of the CJEU has recommended.
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Alvotech has named two new key executives, while Biosimilars Canada has elected its 2025 leaders and the AAM has welcomed the new FDA commissioner in the US.
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Teva should not be able to overturn European fines imposed over a historical “pay-for-delay” arrangement covering Cephalon’s Provigil (modafinil), an advocate general of the CJEU has recommended.
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Alvotech has named two new key executives, while Biosimilars Canada has elected its 2025 leaders and the AAM has welcomed the new FDA commissioner in the US.
Gedeon Richter has filed its Mochida-partnered tocilizumab biosimilar rival to RoActemra with the European Medicines Agency. But with several biosimilars already having won approval, the market could be competitive.