Fresenius Kabi has been forced to wait to gain a Notice of Compliance, effectively a marketing authorization, for its Idacio (adalimumab) biosimilar to Humira in Canada, in light of the Minister of Health’s interpretation of regulatory language. However, a Federal Court has now found that earlier decisions by the Ministry barring approval were unreasonable.
Canada’s Minister of Health must grant a Notice of Compliance, effectively a marketing authorization, for Fresenius Kabi’s Idacio (adalimumab) biosimilar to AbbVie’s Humira, the Federal Court of Canada has ordered following legal action initiated by the German company.
Federal Court Judge Michael Manson found that the Minister of Health had acted unreasonably in holding previously that the Notice...
Mounjaro, Eliquis, and Darzalex buck the Q1 trend to make gains
We’ve all been told that walking 10,000 steps a day is the magic number for better health. But what if the real secret to walking more isn’t about counting steps at all? In this article, we explore how focusing on motivation, environment, and mindset can help you build a walking habit that lasts.
We’ve all been told that walking 10,000 steps a day is the magic number for better health. But what if the real secret to walking more isn’t about counting steps at all? In this article, we explore how focusing on motivation, environment, and mindset can help you build a walking habit that lasts.
We’ve all been told that walking 10,000 steps a day is the magic number for better health. But what if the real secret to walking more isn’t about counting steps at all? In this article, we explore how focusing on motivation, environment, and mindset can help you build a walking habit that lasts.
After US President Joe Biden launched a review of the country’s API supply chain, the task force has reported back with key vulnerabilities that contribute to drug shortages and supply risks during a global public health emergency. According to the report, the lack of geographic diversity and dependence on foreign nations and anti-competitive actions by foreign nations are key areas of concern.
Laboratorio Elea has struck a deal with Nichi-Iko Pharmaceutical to market the Japanese firm’s infliximab biosimilar in Argentina.
Biocon has made two key appointments to the management team of Biocon Biologics following a recent change in CEO for the biosimilars business.
