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Jul 16, 2024
On 16 July 2024, Sandoz announced the Canadian launch of Wyost® (denosumab), biosimilar to Amgen’s Xgeva®. Wyost® is available as a 120 mg subcutaneous injection for use every four weeks. Wyost® was the first denosumab biosimilar approved in Canada in March 2024 for...
Jul 15, 2024
On 9 July 2024, Celltrion announced that it has received marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its omalizumab (Omlyclo®, CT-P39) as biosimilar to Genentech’s and Novartis’ Xolair® for allergic asthma and...
Jul 12, 2024
On 11 and 12 July 2024, respectively, Eisai and Biogen announced that Leqembi™ (lecanemab) has been approved in Hong Kong and Israel for treating Alzheimer's disease in patients with mild cognitive impairment or at the mild dementia stage of the disease. Leqembi® has...
Jul 11, 2024
On 11 July 2024, Fresenius Kabi announced that its Marketing Authorisation Applications (MAAs) for denosumab have been accepted for review by the European Medicines Agency (EMA) as biosimilars to, and for all indications of, Amgen’s Prolia® and Xgeva®. This comes...
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...
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