A German court has granted Halozyme a preliminary injunction that halts the sale of the subcutaneous version of Keytruda in Germany, marking a significant legal win in the companies’ high stakes patent dispute. The decision could complicate Merck’s plans for the...
China’s life sciences sector is poised for a potential regulatory shake-up this week, as stakeholders await clarity on data exclusivity and intellectual property (IP) protection reforms. Earlier this year, the National Medical Products Administration (NMPA) released a...
For decades, the laboratory rat has been the quintessential symbol of biomedical research. Yet, as 2025 draws to a close, a profound shift is reshaping the life sciences landscape. Global regulatory bodies are no longer merely encouraging alternatives to animal...
A Coordinated Effort to Accelerate Approvals The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have launched a new initiative inviting early adopters to trial an accelerated and aligned...
A panel of independent experts convened by the U.S. Food and Drug Administration (FDA) has recommended against approving GSK’s (GSK.L) blood cancer treatment Blenrep, citing concerns over known ocular side effects. The decision prompted a nearly 5% drop in the British...
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