After receiving feedback from the FDA, Lannett has announced that it is on track to submit an investigational new drug application for its insulin glargine candidate to the agency later in 2021. Following this, the company plans to file a biologics license application in 2022 and launch the product in 2023.
Lannett has announced that testing related to the production of a commercially scaled batch of its planned biosimilar to Sanofi’s Lantus(insulin glargine) is underway, as the company believes it remains on track to submit an investigational new drug application to the US Food and Drug Administration later in 2021.
Furthermore, the company revealed that after filing an acceptable IND, it anticipates commencing the pivotal trial early in 2022. After...
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.
Mounjaro, Eliquis, and Darzalex buck the Q1 trend to make gains
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.
