Articles tagged with: Kyprolis

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[ by | Feb 22, 2012 9:28 pm | One Comment ]
Onyx: No Real News To Report About Carfilzomib And The FDA

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 …

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Opinion»

[ by | Jan 31, 2012 1:16 pm | 46 Comments ]
Birds In Spring: Waiting On Carfilzomib

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 …

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[ by | Dec 23, 2011 7:09 pm | One Comment ]
ASH 2011 – Initial Thoughts On The Meeting's Key Myeloma-Related Findings

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 …

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[ by | Dec 19, 2011 11:00 am | 4 Comments ]
ASH 2011 Multiple Myeloma Update – Day Three Afternoon: Carfilzomib And Pomalidomide

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 …

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[ by | Dec 11, 2011 9:29 pm | Comments Off ]
Beacon Breaking News - Carfilzomib To Get Standard, Not Priority, FDA Review

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 …

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[ by | Dec 11, 2011 11:01 am | 2 Comments ]
ASH 2011 Multiple Myeloma Update – Day One

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 …

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[ by | Nov 29, 2011 8:55 am | Comments Off ]
Beacon Breaking News - FDA Accepts Carfilzomib New Drug Application

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 …

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