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Jun 25, 2024
On 25 June 2024, Novo Nordisk announced its plan to significantly boost its investment in manufacturing in 2024, allocating USD $6.8 billion towards production. This is up from USD $3.9 billion the previous year. The plan includes a USD $4.1 billion investment to...
Jun 25, 2024
Business Korea reports that Samsung Biologics has entered a contract manufacturing agreement with US based Kiniksa Pharmaceuticals. The deal, valued at approximately USD $156m (211b won) covers the period 21 June 2024 to 31 December 2031. This follows the...
Jun 25, 2024
On 25 June 2024, Celltrion announced that its Omlyclo (CT-P39), biosimilar to Genentech’s and Novartis’ Xolair® (omalizumab), was approved by the Korean Ministry of Food and Drug Safety for allergic asthma and chronic idiopathic urticaria. This is the first...
Jun 25, 2024
On 25 June 2024, Evotec announced that its subsidiary, Just – Evotec Biologics, Inc., has been selected by the U.S. Department of Defense to develop an accelerated monoclonal antibody development and manufacturing solution as part of the department’s Manufacturing...
Jun 24, 2024
On 24 June 2024, Biogen announced its IV tocilizumab, TOFIDENCE™, biosimilar to Roche’s ROACTEMRA®, has been approved by EC. Tofidence is authorised by the EC for treating moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis,...
Jun 24, 2024
On 24 June 2024, Teva Pharmaceuticals announced the US launch of its authorised generic liraglutide injection (1.8 mg) for type 2 diabetes. Originator Novo Nordisk supplies liraglutide as Victoza®, and Teva’s authorised generic Victoza is the first generic GLP-1...
Jun 24, 2024
On 24 June 2024, Biocon Biologics announced that it received approval from the European Medicines Agency to manufacture biosimilar bevacizumab from its multi-product mAbs facility at Bengaluru. Biocon received EC authorisation for its Abevmy® (biosimilar...
Jun 21, 2024
On 21 June 2025, Argenx announced that the FDA approved a new indication of its VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART Hytrulo is approved for CIDP, administered as a...
Jun 21, 2024
Results of phase 3 pertuzumab studies comparing Qilu’s QL1209 with Roche’s Perjeta® with trastuzumab and docetaxel were published in the British Journal of Cancer on 21 June 2024. The studies demonstrated that QL1209 is equivalent to Perjeta® in safety and efficacy...
Jun 21, 2024
On 14 and 21 June, respectively, the United States District Court for the Northern District of West Virginia granted Regeneron’s motions for preliminary injunctions against Samsung Bioepis and Formcyon (unpublished to date), preventing them from launching their US...
Jun 20, 2024
On 20 June 2024, Amgen’s WezenlaTM, biosimilar to Janssen’s Stelara® (ustekinumab) received marketing authorisation in Europe. This followed a positive CHMP recommendation in April 2024. Wezlana™ was approved in the US in October 2023, was launched in Canada in March...
Jun 20, 2024
On 20 June 2024, Korea Biomedical Review reported that Celltrion has successfully applied to be the exclusive supplier of Remsima® (biosimilar to Janssen’s Remicade® (infliximab)), Herzuma® (biosimilar to Roche’s Herceptin® (trastuzumab)) and Vegzelma® (biosimilar to...
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