January 15th 2011 | Biologics, Psoriasis Research, Side-effects of treatment | 11 Comments
Abbott today announced in a securities filing that it has withdrawn its application with the U.S. Food and Drug Administration (FDA) and European regulators to market its much-anticipated, experimental psoriasis treatment briakinumab (ABT-874, Ozespa). The biologic, like Centocor Ortho Biotech’s Stelara (ustekinumab), targets two internal proteins linked to inflammation, IL-12 and IL-23. Briakinumab
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October 11th 2010 | Biologics, Psoriasis Research, Side-effects of treatment, Treatment | 10 Comments
[UPDATE 1/14/2011: Abbott today announced that it has withdrawn its application with the U.S. FDA to market briakinumab (ABT-874, Ozespa). Our full analysis of Abbott's pulling its briakinumab application is here. Our original, unedited post concerning the Phase Three trials is below.]
You know that buzz about Centocor Ortho Biotech’s biologic Stelara (ustekinumab),
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October 7th 2010 | Biologics, Psoriasis Research, Treatment | 0 Comments
New data on Stelara (ustekinumab) has been presented at a European scientific meeting, and it shows Stelara performing well for most patients in the clinical trial, even after 2 years and 10 months of use. The company’s press release is here.
Some background on the study the data came from: Patients who weighed less
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August 15th 2010 | Biologics, Psoriasis Research, Treatment | 2 Comments
Even before it received U.S. Food and Drug Administration (FDA) approval in September 2009, Stelara (ustekinumab) had considerable buzz in the psoriasis community. Imagine a treatment that (after two initial doses) you take just four times a year! But the early buzz was based on 12 week, and later 40 week, studies.
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September 25th 2009 | Biologics, Treatment | 0 Comments
Stelara (ustekinumab) was just approved by the US FDA for moderate to severe plaque psoriasis. Dosing will be just four times per year after an initial two doses in the first month. Read more here. The treatment will be administered by a health care provider (nurse, doctor, etc.), not by the patient at home.
May 26th 2009 | Biologics, Psoriasis Research | 0 Comments
The US Food and Drug Administration (FDA) has extended its time-frame for review of the promising new biologic Stelara (ustekinumab) for moderate to severe psoriasis by 90 days. That would mean we can expect a decision about Stelara by the fall of 2009. Stelara has already been approved for use in Canada.
December 19th 2008 | Biologics, Treatment | 0 Comments
Statement issued today from Centocor about Stelara (ustekinumab):
Centocor, Inc., announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response letter for its Biologics License Application (BLA) for ustekinumab. …
The Complete Response letter requests additional information, including a proposal by Centocor for a Risk Evaluation and Mitigation Strategy (REMS). … The ustekinumab
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