Despite concerns about small size of safety database, Arthritis Advisory Committee endorses 2 mg dose; panel recommends against approval of 4 mg dose due to stronger thrombosis signal in clinical trials, brushing back Lilly's attempt to position the higher dose as having a positive benefit-risk profile in patients with more refractory disease.
A US FDA advisory committee handed Eli Lilly & Co. a mixed verdict on its rheumatoid arthritis drug Olumiant (baricitinib), endorsing a 2 mg dose but not a 4 mg version due to a thrombosis signal in clinical trials.
At an April 23 meeting, the Arthritis Advisory Committee voted 10-5 for approval of 2 mg baricitinib, a JAK1/2 inhibitor,...
Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.
Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.
The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.
Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.
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Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.
The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.
