One part of a multi-pronged attack launched by AbbVie against Alvotech over the company’s proposed Humira (adalimumab) biosimilar has fallen, with a US district court stating that AbbVie’s US trade secrets lawsuit should be dismissed because it lacks a form of jurisdiction.
The litigation revolved around Humira trade secrets • Source: Alamy
A US lawsuit accusing Alvotech of illegally obtaining AbbVie’s trade secrets related to the originator’s Humira (adalimumab) brand for use in developing its own biosimilar rival has been dismissed by a US district court for lack of personal jurisdiction.
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The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
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.
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.