Dr Reddy’s Laboratories is set to reap the rewards of a significant US generic launch – albeit one with a limited volume caveat decreed by a patent-litigation settlement deal – after it began selling its generic of Bristol Myers Squibb’s multi-billion-dollar blockbuster Revlimid.
Dr Reddy’s has realized plans to introduce the two strengths of its generic version of Bristol Myers Squibb’s multi-billion-dollar blockbuster Revlimid (lenalidomide) in the US for which it holds 180-day generic exclusivity, as part of a complete six-strength offering.
The Indian firm’s launch, including lenalidomide 2.5mg and 20mg capsules with an exclusivity period, came as a glut of other...
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.
