Bangladesh’s Beximco has launched the world’s first molnupiravir generic, to be marketed as Emorivir, following an emergency use authorization by the local regulator. The company told Generics Bulletin it was able to manufacture and sell its version of the MSD oral COVID-19 treatment thanks to the WTO’s TRIPS waiver for less economically developed countries.
Bangladesh’s Beximco Pharmaceuticals has announced the launch of the world’s first generic version of MSD’s molnupiravir oral treatment for COVID-19, following an emergency use authorization by the local regulator.
“Beximco Pharma’s branded generic version of molnupiravir will be marketed as Emorivir,” the company stated, noting that the antiviral was...
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.
