Roche's Actemra Approved For RA After Year's Delay - To Craft A REMS?
Roche's novel interleukin-6 inhibitor Actemra won FDA approval Jan. 8 for second-line use in rheumatoid arthritis - after an FDA "complete response" letter set the product's regulatory process back more than a year
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UCB’s Cimzia wins ankylosing spondylitis claim, but axial spondyloarthritis is not looking good; GE’s Vizamyl joins Amyvid on list of underemployed amyloid imagers; Cubist stretches Entereg label a bit; Iroko builds a safer NSAID; and more.
Oral Dosing May Not Be Enough To Win Speedy Adoption Of Pfizer’s RA Pill Xeljanz
Pfizer’s newly approved oral RA therapy Xeljanz has an oral advantage over established immune modulators, which all are delivered by needle, but safety questions may slow its adoption.
Roche To Appeal NICE's Rejection Of Herceptin For HER2-positive Stomach Cancer
The latest appraisals from NICE include the rejection of Herceptin use in gastric cancer but give positive recommendations to RoActemra and TNF-inhibitors in rheumatoid arthritis.