Henlius has administered the first dose in its international Phase III trial into its denosumab biosimilar candidate, HLX14. The firm has also revealed that its new Songjiang plant has been granted GMP equivalence with EU practices.
The first subject has been dosed in Shanghai Henlius Biotech’s international multicenter Phase III clinical trial for HLX14, its proposed biosimilar to Amgen’s Prolia/Xgeva (denosumab), for the treatment of postmenopausal osteoporosis in women with high fracture risks.
The randomized, double-blind, international multicenter, parallel-controlled Phase III study aims to compare the efficacy, safety, tolerability and immunogenicity of HLX14...
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.
