Articles tagged with: Kyprolis
News»
Onyx Pharmaceuticals this afternoon issued an announcement summarizing its full year and fourth quarter 2011 financial results.
Company management also discussed the firm's financial results and near-term plans in an analyst conference call later in the day.
Contrary to speculation by some analysts, today's announcement and management discussion did not provide any significant new information about the ongoing review by the U.S. Food and Drug Administration (FDA) of carfilzomib (Kyprolis).
Onyx (NASDAQ: ONXX) has submitted a new drug application to the FDA asking it to approve carfilzomib as …
Opinion»
I try to make a point about not talking in my column too much about whatever symptom, side effect, or malady is affecting me at any particular time.
But suffice it to say that lately there has been a lot going on with me, and it has brought to the forefront that inevitable discussion about what to do next should my current treatment regimen of Revlimid (lenalidomide) and dexamethasone (Decadron) start to fail.
I’ve discussed this prospect at various times over the past year with the handful of myeloma doctors …
News»
It has been ten days since the 2011 annual meeting of the American Society of Hematology (ASH) came to a close.
Since the meeting started, The Beacon has been providing detailed coverage in the form of discussion forum postings, daily updates, and in-depth articles about key research findings.
In this and The Beacon's next article about the meeting, however, the perspective changes a bit.
The focus shifts to the bigger picture -- to questions like: "What was the impact of the meeting?", and …
News»
The afternoon sessions of the third day of the American Society of Hematology (ASH) 2011 annual meeting in San Diego were just as awash with myeloma-related presentations as were the morning sessions.
Many of the afternoon sessions were devoted to two particular potential new myeloma treatments: carfilzomib and pomalidome.
Those presentations will be covered in this article, while presentation from the afternoon sessions that were about other new therapies will be summarized in the final daily update for the meeting's third day.
Carfilzomib
Carfilzomib (Kyprolis) is an investigational drug that belongs to the …
News»
Onyx Pharmaceuticals, the U.S. company developing carfilzomib as a potential new treatment for multiple myeloma, announced earlier today that the U.S. Food and Drug Administration (FDA) has granted "standard review designation" to the company's New Drug Application for carfilzomib.
This means that the FDA expects to make a decision by July 27, 2012, on Onyx's application to market carfilzomib (Kyprolis) in the United States.
The announcement is a disappointment for Onyx, which had hoped to receive a so-called "priority review" of the carfilzomib application.
The target FDA review time for applications granted …
News»
Yesterday was the first day of the American Society of Hematology (ASH) 2011 annual meeting, which is being held in San Diego.
Although the day featured no oral presentations of new myeloma-related research, it started with an interesting educational session focused on multiple myeloma.
There also were a number of poster presentations during the day summarizing important new research findings.
The educational session in the morning featured three presentations by leading myeloma specialists.
Induction Therapy And Maintenance Treatment
The first presentation was by Dr. Donna Reece of the Princess Margaret Hospital in …
News»
Onyx Pharmaceuticals, the U.S. company developing carfilzomib as a potential new treatment for multiple myeloma, announced this morning that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application for carfilzomib.
The announcement means that the FDA will now begin its full review of carfilzomib (Kyprolis).
The length of time required for that review depends on whether the FDA grants the drug what is known as "priority review."
If carfilzomib is granted priority review, the FDA will aim to make a decision on the application by the …

