Heparin marks the start of Hikma’s pre-filled syringe portfolio in the US as the company looks to add value and differentiation to its injectables portfolio and pipeline, commercial and business development head Dan Motto told Generics Bulletin.
Hikma Pharmaceuticals has chosen heparin as its first injectable in the US to be made available in a pre-filled syringe presentation. The launch forms part of the company’s strategy to take its US Injectables operation into more differentiated, higher-value sectors of the parenterals market.
Speaking exclusively to Generics Bulletin as Hikma started the launch, the company’s executive vice-president of commercial and business development for...
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.
