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XELJANZ-tofacitinib-JAK

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Mind-boggling! – Aftermath of Tofacitinib FDA Hearing Part 2

Kelly O'Neill 14 Comments , , ,
After the FDA Arthritis Advisory Committee (AAC) hearing earlier this month for Pfizer’s new oral treatment for RA,  tofacitinib, we looked at the four distinct votes of the AAC and some of the ways the media responded to them. They ranged from serious to pitiful to laughable. But there’s more.     3 news bytes that might...Continue reading      14 Comments » Read more

Aftermath of the FDA Vote on Pfizer’s RA JAK Inhibitor, Tofacitinib

Kelly O'Neill 44 Comments , , ,
After the tofacitinib FDA hearing, the votes are in, false perceptions persist, and patients still need relief. Some estimate that tofacitinib could be approved by the US FDA within a few months after mixed votes and mostly inaccurate press reports. It’s fitting this discussion takes place as rawarrior.com begins its fourth year of reporting the patient...Continue reading      44 Comments » Read more

FDA Arthritis Advisory Committee Hearing for Pfizer’s RA JAK: Tofacitinb

Kelly O'Neill 27 Comments ,
Advisory Committee hearing feed link My daughter Katie Beth and I are in Washington, DC for the final FDA Arthritis Advisory Committee (AAC) hearing about Pfizer’s JAK, tofacitinib. Early in the morning, Katie Beth and I will be en route to the meeting. The AAC meeting will be broadcast online with a live feed. We’ve been told...Continue reading      27 Comments » Read more

Attending an FDA Hearing for Pfizer’s JAK: Tofacitinib CP-690550

Kelly O'Neill 28 Comments ,
Three years ago, one of the first friends I made through my blog was Angie. She got into a Pfizer clinical trial for tofacitinib (then called tasocitinib). She sent me some info about the trial, but my rheum doc wasn’t interested and I didn’t pursue it. The current excitement about Pfizer’s tofacitinib Tofacitinib is an oral medication...Continue reading      28 Comments » Read more

Pfizer’s JAK inhibitor Tofacitinib EMA Application Validated

Kelly O'Neill 10 Comments ,
Pfizer JAK-3 press release “Pfizer Announces European Medicines Agency Acceptance Of Regulatory Submission For Tofacitinib For The Treatment Of Rheumatoid Arthritis: Pfizer Inc. (NYSE:PFE) announced today that its Market Authorisation Application for tofacitinib (development code CP-690,550), a novel, oral JAK inhibitor being studied for the treatment of moderate-to-severe active rheumatoid arthritis (RA), has been validated by...Continue reading      10 Comments » Read more

New Way to Report Response in RA Clinical Trials?

Kelly O'Neill 15 Comments , , ,
Untangling a possible replacement for the “familiar” ACR 20 describing treatment response in clinical trials for Rheumatoid Arthritis Special thanks to Jay Sprinkel for assistance with this post. Although he may be more known for the humor he provides to our Facebook group, Jay is a retired marine biologist who specializes in statistics. He is also...Continue reading      15 Comments » Read more

Tofacitinib / CP-690550 aka Tasocitinib Succeeds in Pfizer’s 2nd Phase 3 Trial

Kelly O'Neill 14 Comments , ,
A new name and new milestone for tofacitinib Pfizer announced Friday that CP-690550 tofacitinib (formerly tasocitinib) met its goals in its second phase three clinical trial for moderate to severe Rheumatoid Arthritis. Tofacitinib is a JAK 3 inhibitor, an oral treatment for RA with a different approach than current Biologic RA treatments. According to Pfizer, over 4,000...Continue reading      14 Comments » Read more
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