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Jul 11, 2024
On 11 July 2024, Samsung Bioepis released its sixth US Biosimilar Market Report. The report, which has been published every quarter since April 2023, details average sales price information for US launched biosimilars and market share and price trends. The Q3 2024...
Jul 10, 2024
On 10 July 2024, the United States District Court for the Northern District of West Virginia made orders for a preliminary injunction restraining Celltrion from launching its CT-P42, biosimilar to Regeneron’s Eylea® (aflibercept), in the US without a licence from...
Jul 10, 2024
On 10 July 2024, Novo Nordisk announced that the FDA has issued a Complete Response Letter (CRL) regarding its BLA for once-weekly week insulin icodec for diabetes mellitus. The CRL is said to include "requests related to the manufacturing process and the type 1...
Jul 10, 2024
Novo Nordisk’s Wegovy® (semaglutide) known for treating diabetes, weight loss benefits, and reducing cardiovascular events and kidney disease risks, has been shown in a University of Oxford study, supported by the NIHR Oxford Health Biomedical Research Centre and the...
Jul 9, 2024
In a landmark injunction granted on 9 July 2024, the Delhi High Court has temporarily banned Zydus Lifesciences from selling its breast cancer drug SigrimaTM, biosimilar to Roche’s Perjeta® (pertuzumab). The injunction was ordered in proceedings commenced by Roche...
Jul 9, 2024
Novo Nordisk has reportedly struck a deal with Indonesia’s state-owned pharmaceutical company Bio Farma regarding the packaging of insulin in Indonesia. This is the first of Novo Nordisk's packaging deals in Indonesia for insulin, which is manufactured in Denmark and...
Jul 9, 2024
A Pfizer-sponsored literature review, published in Expert Opinion on Biological Medicine on 9 July 2024, concluded that there were no unexpected or serious adverse events after patients with IBD switched from Janssen's Remicade® (infliximab) to an infliximab...
Jul 9, 2024
On 9 July 2024, Regeneron, Mylan, Celltrion and Apotex agreed to the dismissal of Regeneron’s appeals in the US Court of Appeal for the Federal Circuit from PTAB decisions finding US Patent Nos. 9,254,338 and 9,669,069 invalid. The patents encompass Regeneron’s...
Jul 8, 2024
On 8 July 2024, Outlook Therapeutics announced that it received marketing authorisation from the UK’s MHRA for its ophthalmic formulation of bevacizumab (ONS-5010, Lytenava™) for the treatment of wet AMD. Bevacizumab has been used off label for ophthalmic conditions...
Jul 8, 2024
On 8 July 2024, Just – Evotec, a subsidiary of Evotec SE, announced that it has expanded its partnership with Sandoz to develop and manufacture multiple biosimilars. The deal was first entered into in May 2023 and is designed to utilise Just – Evotec's AI driven drug...
Jul 8, 2024
On 8 July 2024, Genentech announced that the FDA has approved the relaunch of Susvimo®, a refillable ocular implant containing a specialised formulation of ranibizumab, which is used for treating nAMD. The FDA first approved Susvimo® in October 2021. However, in...
Jul 8, 2024
On 8 July 2024, Eli Lilly and Morphic Holding announced that Eli Lilly has agreed to acquire Morphic for US $3.2b. Morphic Holding is a US biopharmaceutical company developing oral integrin therapies for treating chronic diseases. The acquisition has been approved...
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