Following the disappointment of a complete response letter and delayed trial proceedings, Eagle has secured FDA approval for the first generic version of Par’s Vasostrict, which is tipped to have branded sales approaching $1bn in the US in 2021.
Eagle Pharmaceuticals, Inc. is “implementing its launch plans” for the US firm’s generic to Par’s Vasostrict (vasopressin) 20 units/ml injectable in the US, after scooping a landmark first US Food and Drug Administration approval for its ANDA product referencing the complex antidiuretic hormone years ahead of patent expiry.
The New Jersey-based firm’s stock price climbed by around 10% on the back of the news, as Eagle confirmed it...
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.
