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Second IL-23 nod in busy space

Sun Pharmaceutical Industries Ltd., the Mumbai, India-based pharma giant known more for its footprint in generics than in novel drug development, gained FDA approval of Ilumya (tildrakizumab-asmn) to treat adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

On the heels of last year's FDA nod for Privigen (immune globulin intravenous, human, 10 percent liquid), CSL Behring, a unit of Australia's CSL Ltd., gained the agency's green light for Hizentra (immune globulin subcutaneous [human] 20 percent liquid) as the first subcutaneous immunoglobulin (SCIg) therapy to treat chronic inflammatory demyelinating polyneuropathy (CIDP). The drug, approved by the FDA in 2010 to treat primary immunodeficiency (PI), is indicated as maintenance therapy in adults with CIDP to prevent relapse of neuromuscular disability and impairment.

The primary takeaway from Thursday's Senate Health, Education, Labor and Pensions (HELP) Committee hearing on the 340B program is that the committee leadership is serious about crafting legislation to bring more accountability to the prescription drug discount program that helps safety-net hospitals and community health centers provide charity care.

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