The latest CHMP meeting has seen the EMA committee issue a positive opinion on two Accord hybrid medicines, Zolsketil (doxorubicin) and Camcevi (leuprorelin), at the same time as SERB’s generic amifampridine tablets were also endorsed.
Accord has received two endorsements for hybrid medicines from the Committee for Medicinal Products for Human Use within the European Medicines Agency, with the CHMP issuing positive opinions recommending the grant of pan-European marketing authorizations for the firm’s Zolsketil (doxorubicin) and Camcevi (leuprorelin) products.
The European Commission typically acts on the CHMP’s recommendations within 67 days.
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.
