Viatris and partner Kindeva Drug Delivery are celebrating a first tentative nod for a generic to one of the most significant respiratory opportunities in the US, but cannot launch at present with the firms having failed to navigate key pieces of intellectual property.
Viatris has received a first tentative approval from the US Food and Drug Administration for a generic to AstraZeneca’s blockbuster Symbicort (budesonide/formoterol fumarate dihydrate) pressurized metered dose inhaler, although an unfavorable patent-litigation court decision handed down shortly beforehand has left the generics and biosimilars giant on the back foot.
Days before the tentative approval was announced, a court in West Virginia held as valid asserted claims in three patents...
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.
