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news.Samsung Bioepis initiates Byooviz commercialisation in Europe
The company has assumed commercial rights for Byooviz from Biogen, and the product will now be available as a Samsung Bioepis brand across several European countries as part
The company has assumed commercial rights for Byooviz from Biogen, and the product will now be available as a Samsung Bioepis brand across several European countries as part
The approval is based on the Phase I/II GO29781 clinical study, with full approval contingent upon further confirmatory trials. Lunsumio VELO’s SC injection requires around one minute, compared
The move will give Samsung Biologics its first manufacturing site in the country as part of its long-term commitment to the market. The Rockville, Maryland facility is located
In patients suffering with oHCM, myosin inhibition with MYQORZO, which is an allosteric and reversible inhibitor of cardiac myosin motor activity, lowers left ventricular outflow tract (LVOT) obstruction
The agreement covers the promotion license, sales, and distribution of CARTISTEM. MEDIPOST will supply the drug substance and retain manufacturing rights, while the exclusive rights for the Japanese
The initiative aims to shape future standards and safeguards for the way AI is used in healthcare settings. This call for evidence will inform the work of the
The approval covers all existing indications for Rybrevant. The SC formulation reduces administration time from several hours to five minutes, compared to intravenous (IV) delivery, offering increased patient
Formycon will complete the development of FYB206, prepare and file the regulatory dossier, and supply the biosimilar product. Zydus will manage its commercialisation. FYB206 is nearing the end
The once-daily oral therapy is administered as a 14-day course. Clinical trials demonstrated benefits from as early as day three, with significant symptom reduction by day 15, and
Lupus nephritis classifications indicate the severity and type of kidney damage, which is central to the disease. The EC’s decision is based on outcomes from the Phase II