Sinocelltech Group Ltd. has received marketing approval for its recombinant chimeric anti-CD20 monoclonal antibody, ripertamab (SCT-400), from China’s NMPA to treat patients with CD20-positive diffuse large B-cell lymphoma. The country’s first homegrown anti-CD20 therapy, ripertamab has been shown to have similar efficacy to global blockbuster rituximab but with a superior safety profile.
Sinocelltech Group Ltd. has received marketing approval for its recombinant chimeric anti-CD20 monoclonal antibody, ripertamab (SCT-400), from China’s NMPA to treat patients with CD20-positive diffuse large B-cell lymphoma. The country’s first homegrown anti-CD20 therapy, ripertamab has been shown to have similar efficacy to global blockbuster rituximab but with a superior safety profile.
Ahead of U.S. President Joe Biden’s State of the Union address March 1 in which he gave a shoutout to his cancer moonshot initiative, the FDA released a trio of final guidances aimed at speeding the development of new cancer drugs. First launched in 2016 with the goal of doubling the rate of progress against cancer by making a decade worth of advances in five years, the moonshot was reignited last month with a new target following setbacks in cancer screenings and treatments during the COVID-19 pandemic. Now, Biden’s catch phrase is “ending cancer as we know it.”
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CMS tacks three years onto CJR, revises target price calculation; Connect for Health Act back in play; More bezel troubles for Alaris 8100; CMS announces two meetings for FY 2022 lab fee schedule.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Task force affirms hypertension screening recommendation; FDA adds to list of recognized standards; New Jersey DOJ office announces $93M fraud take-down.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: GAO denies Roche challenge of Air Force request; NICE updates atrial fibrillation guidelines.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: PTAB rejects 3Shape’s attempt to invalidate claims for Align patent.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Alivecor goes to ITC in patent scrum with Apple; Cordis carotid artery stent recalled; C-Rad snares court win for patent; Orthotics supplies subject of $65M in fraud.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: USPSTF sees no reason to recommend screening for AF; Two senators press for UDI data in Medicare claims; Medtronic blood pump console recalled; Federal Circuit affirms PTAB in Cerner/Clinicomp patent dispute.
The latest global regulatory news, changes and updates affecting biopharma in Asia, including: Central Drugs Standard Control Organization, World Health Organization.
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