Hikma has begun 2023 with the long-awaited launch of a US authorized generic version of Xyrem (sodium oxybate). Meanwhile, the company has also struck a deal with Junshi Biosciences for toripalimab in the MENA region.
Hikma has kicked off 2023 by introducing an authorized generic version of Jazz Pharmaceuticals’ Xyrem (sodium oxybate) 0.5g/ml oral solution in the US, delivering on a launch that had previously been slated for mid-2022 and which took a chunk out of Hikma’s annual sales forecast when it slipped to the following calendar year.
Citing a $1.3bn sales figure in 2021 for the branded treatment for narcolepsy with sudden onset of weak or paralyzed...
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.
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.
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.
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.
