Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Advanz, Alzinova, Arcadia, Arcutis, Avobis, Cellectar, Cosmo, EG 427, Kashiv, Lexeo, Neurizon, Orca Bio, Precision Neuromed, Spruce.
Bio Japan 2025 was abuzz with the news that Japan has once again snagged the Nobel Prize in Physiology or Medicine, with Shimon Sakaguchi winning for his discovery of a subtype of CD4-expressing T cells that affect the immune response. Earlier today, Susumu Kitagawa snatched the second Nobel Prize for Japan, this time in chemistry. Both Nobel Prize winners were professors at Kyoto University.
More than a decade after the last idiopathic pulmonary fibrosis (IPF) treatment gained U.S. FDA approval, Boehringer Ingelheim GmbH’s Jascayd (nerandomilast) is set to hit the market following the agency’s green light on Oct. 7. While expected to offer a modest benefit over existing therapies, Jascayd, an orally administered preferential inhibitor of phosphodiesterase 4B with breakthrough therapy status, is viewed by analysts as the first of several potential advancements in the IPF space over the next few years.
In a deal that could top $2 billion, China-based Innocare Pharma Ltd. licensed the exclusive worldwide development and commercialization rights to the BTK inhibitor orelabrutinib to Zenas Biopharma Inc. for multiple sclerosis and other indications aside from oncology.
As the many challenges facing cell therapies are being addressed, the CAR T field continues to evolve beyond its original design of T cells engineered to target hematological malignancies. During the 32nd Annual Congress of the European Society of Gene and Cell Therapy (ESGCT), held in Seville Oct. 7-10, several studies showed how this technology is being redefined as programmable and adaptable immune cells with expanded functional versatility.
The 2025 Nobel Prize in Chemistry “is a story full of holes, but with enormous capacity to absorb all your attention,” Heiner Linke told reporters. “And other things.” Linke is Chair of the Nobel Committee for Chemistry. On Oct. 8, 2025, the committee announced that it has awarded the 2025 Nobel Prize in Chemistry to Susumu Kitagawa, Richard Robson and Omar Yaghi “for the development of metal-organic frameworks” (MOFs).
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