Facing an appeal on a favorable US district court decision, Mylan has opted to launch “at risk” the first generic Tecfidera in the US, after obtaining FDA approval and seeing the originator’s bid for injunctive relief shot down earlier this month.
Mylan has decided to introduce “at risk” the first generic version of Biogen’s $3.3bn Tecfidera (dimethyl fumarate) in the US following US Food and Drug Administration approval for its abbreviated new drug application, with litigation still pending over the last remaining Tecfidera patent listed in the agency’s Orange Book.
Market entry was confirmed by Mylan today, hours after the FDA’s database of approved drugs showed the company as holding...
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.
