The US FDA has set a PDUFA date for Hyloris’ Maxigesic IV 505(b)(2) NDA that is earlier than expected, following two positive Phase III trials, spurring hopes that the product could also see earlier commercialization and registration than previously anticipated.
Belgian value-added medicines specialist Hyloris has announced that the US Food and Drug Administration has set an earlier than expected prescription drug user fee act date of 30 June 2022 for the firm’s 505(b)(2) new drug application for its Maxigesic IV (paracetamol/ibuprofen) 1,000mg/300mg intravenous analgesic for treating post-operative pain.
The 30 June 2022 date was “ahead of the August to September 2022 timeframe initially expected,” Hyloris indicated. CEO Stijn...
Neuraxpharm has expanded its footprint outside of Europe with the launch of its first product in Japan, in the form of the Buccolam value-added midazolam product gained through a deal with Takeda.
After partnering with companies like Purna Female Healthcare and AFT Pharmaceuticals, Belgian value-added medicines specialist Hyloris has announced plans to add three new products to its pipeline in the coming months with a goal of having 14 commercial products by 2024.
From 20 October, a free online platform will allow registrants attending the digital Global Generics & Biosimilars Awards 2020 to participate in two weeks of dedicated networking activities ahead of the ceremony on 3 November.
Value-added medicines specialist Hyloris has struck a deal worth up to €4.3m with Purna Female Healthcare to develop a treatment for vulvovaginal candidiasis that combines miconazole and domiphen bromide.
Avoiding disaster at the beginning of the pandemic and offering a pro-active supply chain blueprint should position the generics industry well for an onshoring debate in Congress, but a look back at March 2020 is a reminder that even small policy shifts can have a big impact.
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.
Teva and Biocon Biologics have become the latest firms to sign up to the Biosimilars Forum industry association in the US.
