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Eisai and Biogen announced that Leqembi® intravenous infusion (lecanemab) will be launched in Japan on 20 December 2023, after it was scheduled on the Japan National Health Insurance (NHI) Drug Price List.  Leqembi® intravenous infusion was approved in Japan on 25 September...

Sandoz subsidiary Lek announced it has commenced construction of its US$400M biopharmaceutical production centre in Lendava, Slovenia.  The facility aims to be Europe’s most efficient producer of active pharmaceutical ingredients for biologics, and will have approximately 4...

Celltrion USA announced that large Medical Benefits Manager Ventegra® will add Vegzelma®, Celltrion’s biosimilar to Genentech’s Avastin® (bevacizumab) on its commercial formulary as a preferred brand. Vegzelma® (bevacizumab-adcd) was approved by the FDA to treat six types o...

Lotus Pharmaceutical announced that it has entered into a partnership with Intas Pharmaceuticals for the commercialisation of Intas’s Prolia® (denosumab) biosimilar in South Korea, Taiwan and certain markets in South East Asia.  According to the announcement, Intas will be ...

The FDA approved Vertex/CRISPR Therapeutics’ Casgevy® and Bluebird Bio’s Lyfgenia®, the first cell-based gene therapies to treat sickle cell disease in patients 12 years and older.  Casgevy® is the first FDA-approved treatment that uses CRISPR/Cas9 to genetically modify a p...

Bio-Thera announced that its Avzivi® (BAT1706), biosimilar to Genentech’s Avastin® (bevacizumab) is FDA approved with a full indication set (excluding hepatocellular carcinoma).  Bio-Thera is the only Chinese company to have received marketing approval for a biosimilar in t...

The National Institute for Health and Care Excellence (NICE) issued final draft guidance recommending AstraZeneca/MSD’s Lynparza® (olaparib) with bevacizumab be routinely used in the NHS in England and Wales for maintenance treatment of high-grade epithelial ovarian, ...

The US Patent Trial and Appeal Board (PTAB) has instituted Samsung Bioepis’ inter partes review (IPR) petition challenging Regeneron’s Eylea® (aflibercept) patent no. 10,464,992 in IPR proceeding IPR2023-01312.  The patent claims formulations of aflibercept suitable for int...

The US Patent Trial and Appeal Board (PTAB) has instituted three of Samsung Bioepis’ inter partes reviews (IPR) petitions challenging Alexion’s Soliris® (eculizumab) patent nos. 9,725,504, 9,718,880 and 9,732,149 in IPR proceedings IPR2023-00999, IPR2023-00998 and IPR2023-0...