South Korea’s Ministry of Food and Drug Safety approved 18 biosimilar products in 2024, making it a record year for domestic biosimilar approvals since the agency’s first nod of Celltrion Inc.’s Remsima, a reference product of Remicade (infliximab), in 2012.
Research of the neuroimmune mechanisms involved in stress-related fear revealed how astrocytes interact with neurons in the amygdala. The study, led by Harvard scientists, also unveiled that this interaction recruited monocytes to the meninges during chronic stress and showed how psychedelic compounds reversed monocyte accumulation in the meninges and reduced fear behavior.
Granite Bio AG has emerged from stealth with $100 million in series A and B funding and a focus on developing first-in-class antibodies that target the root causes of a variety of inflammatory, autoimmune and fibrotic conditions.
Named after Swiss mountains, Granite Bio AG emerged from stealth with $70 million in funds through a series B to advance two immunology treatments incubated at Versant Ventures.
Aclaris Therapeutics Inc. has gained IND clearance from the FDA for ATI-052, a bispecific anti-thymic stromal lymphopoietin (TSLP)/interleukin-4 receptor (IL-4R) monoclonal antibody being developed to treat certain immuno-inflammatory diseases. A phase Ia/Ib trial, including a proof-of-concept portion in an undisclosed indication, will begin in the current quarter.
China’s National Medical Products Administration has given the thumbs up to Akeso Pharmaceuticals Inc.’s ebdarokimab for treating moderate to severe plaque psoriasis in adults. An interleukin (IL)-12/IL-23 dual-targeted monoclonal antibody, ebdarokimab (also known as AK-101) is the company's first class 1 new drug approved for autoimmune diseases.
The U.S. FDA issued a complete response letter in October 2023 for Dupixent (dupilumab) in treating chronic hives but has now approved the monoclonal antibody for the indication. The approval makes Dupixent the first targeted biologic the agency has approved in the past 11 years for chronic spontaneous urticaria.
Researchers have developed a new compound that can prevent long COVID symptoms in mice that could lead to a future drug for the debilitating condition in humans. Developed by researchers at the Walter and Eliza Hall Institute of Medical Research (WEHI) in Melbourne, the world-first study found mice treated with the antiviral compound were protected from long-term brain and lung dysfunction, which are key symptoms of long COVID.
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