UCB’s Vimpat blockbuster has finally fallen to generic competition in the US, after its intellectual property was skewered by ANDA sponsors as part of a failed challenge before the US Supreme Court in 2018 and 2019.
Multiple generic versions of UCB’s €1.13bn ($1.25bn) Vimpat (lacosamide) tablets have been approved by the US Food and Drug Administration in all four strengths after the sole patent shielding the branded treatment of seizures expired.
The end of US reissued patent RE38,551’s term on 17 March has resulted in eight simultaneous ANDA approvals for lacosamide...
An abbreviated licensure pathway for biologics was created by the 2009 Biologics Price Competition and Innovation Act. Biologics demonstrated to be biosimilar to or interchangeable with FDA-approved products can use the 351(k) biologics license application pathway. Biosimilars BLAs submitted under the 351(k) pathway have a 12 month user fee goal for FDA action. Updated weekly.
Amneal has marked its entry into China after receiving its first product approval in the market. Meanwhile, the firm has also outlined US approvals for two generics currently suffering from shortages.
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.
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.
