Catalyst saw its share price jump by around 14% after striking what the market termed a favorable patent-litigation settlement agreement with ANDA sponsor Teva over its rare disease drug Firdapse.
Teva looks set to wait until early in 2035 to launch its proposed generic version of Catalyst Pharmaceuticals’ Firdapse (amifampridine) 10mg tablets in the US, after striking a settlement agreement with the originator that resolves all litigation previously pending in a district court in New Jersey.
“Pursuant to the terms of the agreement, Teva will not market its generic version of Firdapse in the US any...
Generic dapagliflozin rivals to AstraZeneca’s Forxiga are now free to hit the UK market after the country’s Supreme Court lifted the final barrier preventing launch, allowing off-patent firms access to a market worth hundreds of millions of pounds annually.
Germany’s Federal Patent Court has invalidated Bayer’s key patent covering once-daily use of Xarelto (rivaroxaban), paving the way for Sandoz to launch a generic version. Bayer is considering an appeal.
Dr Reddy’s CEO discusses the growth opportunity for semaglutide, including production capacity and ‘crazy’ demand indications, and a potential 20-plus product GLP-1 portfolio. All eyes are also on an upcoming hearing in India pertaining to Novo Nordisk’s semaglutide patent in the country.
Viatris’ Mylan has won a key patent case against Novo Nordisk over generic Wegovy, with a US federal district judge ruling Mylan’s label did not encourage use that infringed Novo’s method-of-treatment patent.
In our latest roundup of off-patent industry appointments, we see management changes at UK liquids specialist Rosemont, a push into biosimilars from Korea’s Daewoong, and fresh appointments at firms including Meitheal, Celltrion, Accord, Alvotech, Civica and Centrient.
Sandoz has revealed plans to streamline more biosimilar trials amid evolving regulatory moves towards minimizing the need for comparative efficacy studies. The disclosure was just one of many pipeline and portfolio updates provided as the firm delivered positive first-half results.
Amgen continues to advance its intravenous biosimilar programs for key immuno-oncology agents, including its ABP 234 biosimilar to Keytruda and ABP 206 biosimilar to Opdivo, despite growing interest in subcutaneous formulations enabled by hyaluronidase technology.
