Three months after publishing its draft guideline on biosimilars, China's Food and Drug Administration (CFDA) has just released the final official version, although it is still described as a pilot scheme. The new guideline may look similar to the draft on the surface, but a closer comparison reveals many differences.
Three months after publishing its draft guideline on biosimilars, China's Food and Drug Administration (CFDA) has just released the final official version, although it is still described as a pilot scheme. The new guideline may look similar to the draft on the surface, but a closer comparison reveals many differences.
The draft, released in November for public consultation (scripintelligence.com, 5 November 2014), was regarded as broadly similar to guidelines...
Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.
Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.
Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.
The US precision medicine company hopes its drug response predictor technology will enhance responses to the chemotherapy Ixempra on the basis of promising data from a handful of breast cancer patients in a Phase II trial, marking a positive turn in its journey to date.
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Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.
Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.
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