Four years after the EMA first approved Novartis AG's Ilaris (canakinumab) for the treatment of adult-onset Still’s disease (AOSD), the FDA has followed suit, giving it a green light in the indication following a priority review. The rare rheumatic condition usually affects younger adults and can occur as infrequently as once, but also intermittently or chronically.
PERTH, Australia – CSL Ltd. said its subsidiary, CSL Behring, has agreed to exercise an option to acquire Canadian biotech Vitaeris Inc. for its lead phase III asset for rejection in solid organ kidney transplant patients.
San Diego-based Autobahn Therapeutics Inc.’s $76 million series B round will let the firm advance lead candidate ABX-002, a thyroid hormone receptor beta agonist therapy for multiple sclerosis and adrenomyeloneuropathy, a rare genetic disorder, plus a portfolio of central nervous system programs that leverage the company’s brain-targeting chemistry platform.
Novartis AG didn’t say why the FDA has put off action until September – a delay of three months – on the sBLA for multiple sclerosis (MS) prospect Arzerra (ofatumumab, OMB-157), first cleared in October 2009 for chronic lymphocytic leukemia, but the holdup brought renewed attention to the bustling space, and Immunic Inc. – which held its R&D Day on May 27 – is coming on strong.
Argenx SE’s later-stage effort with antibody fragment efgartigimod in generalized myasthenia gravis (gMG) was designed with guidance from the phase II trial that showed 75% of patients had a durable response of at least six weeks.
Navidea Biopharmaceuticals Inc. CEO Jed Latkin said positive findings from the second interim analysis of the phase IIb study called NAV3-31 “were certainly better than what we were looking for” and will “make our partnering discussions a lot more interesting.”
The $65 million that Hotspot Therapeutics Inc., of Boston, raised will help advance its lead programs to the clinic, including protein kinase C antagonists for Th2 and T-reg-driven autoimmune disease and S6 kinase antagonists for rare metabolic disease.
BEIJING – After being a health care investor for 21 years, Jonathan Wang decided to co-found biotech startup Inmagene Biopharmaceuticals Co. Ltd. in July 2019 to seek success in the China market using the experience and insights he had accumulated over the years. With $20 million in its war chest so far, the startup aims to excel in immunology-related therapeutic areas in China.
Vividion Therapeutics Inc. has continued to build its roster of partnerships with a multitarget collaboration deal with Roche Holding AG that could be worth billions.
DUBLIN – Affibody AB is getting $10 million up front and up to $215.5 million in regulatory and sales milestones from a licensing deal with Inmagene Biopharmaceuticals Co. Ltd., in which the latter firm gains commercial rights to its interleukin-17 inhibitor ABY-035 in China, Hong Kong, Taiwan, Macau and South Korea.
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