Tipped to bring in sales of $500m or more by 2030, Arcutis Biotherapeutics’ Zoryve 0.3% cream has become the target of an ANDA filed by Padagis, a partner of Sol-Gel Technologies. The originator responded with an immediate suit to shut down any potential generic launch in the near term.
Padagis may have to defend itself against alleged patent infringement in the US after filing the first abbreviated new drug application for a generic version of Arcutis Biotherapeutics’ Zoryve (roflumilast) 0.3% cream – a rapidly growing treatment for plaque psoriasis that has been tipped to achieve peak sales exceeding $500m per year by 2030.
The Israeli firm has been sued by Arcturis in a US District Court for the District of New Jersey, with...
In an exclusive interview, Meitheal Pharmaceuticals CEO Tom Shea discusses the company’s oncology strategy following the recent launch of generic Abraxane, alongside discussion of complex injectables, the biosimilars pipeline, and how $300m in backing is fueling the company's next phase of growth.
As it prepares to complete its $6.7bn merger with Mallinckrodt, Endo has divested its International Pharmaceuticals business – consisting primarily of Canadian specialty firm Paladin Pharma – to Knight Therapeutics.
Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.
