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FDA fast track designation

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4 04, 2013

Exciting Updates: daratumumab and duloxetine (Cymbalta)

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There were two exciting new legal and research developments earlier this week.  First, a company called Genmab, announced that the FDA has fast tracked their experimental immunotherapy drug, daratumumab.   Later, JAMA published results of a new Phase 3 study using duloxetine (Cymbalta) in patients with peripheral neuropathy (PN) caused by chemotherapy.  Here are the details:

21 07, 2012

How do I know the Kyprolis story is BIG NEWS? Mom called!

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Yes.  FDA approval of Onyx Pharmaceutical's new anti-myeloma drug,carfilzomib (trade name Kyprolis), is news.  Big news.  But let's remember why. Kyprolis is the first myeloma therapy approved by the FDA in six years. Surprised?  I was!  I learned about this while researching my new book, New Multiple Myeloma Therapies from a Patient's Perspective.  Considering all

23 05, 2012

Sign petition to help speed FDA approval of breakthrough treatments!

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I recently wrote a pair of posts about a new FDA policy which is being considered to fast-track the evaluation and approval of breakthrough technologies on my site: New FDA breakthrough drug policy may speed patient access to new chemo drugs Help petition FDA to fast-track breakthrough medical technologies Patients with a wide variety

14 02, 2011

What Is The FDA’s Fast Track Designation & How Does It Work?

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Last month I broke a story about the new, experimental anti-myeloma novel therapy agent, carfilzomib:This Just In: FDA Announces Fast Track Designation For Carfilzomib.I asked Nadia Hasan, a representative from the manufacturer of carfilzomib, Onyx Pharmaceuticals, to better explain the FDA's fast track designation process.  She responded by email: The Fast Track designation process was

30 08, 2010

Ouch! Could There Be A Delay With Fast-Track, FDA Approval For New Anti-Myeloma Drug Carfilzomib?

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I wanted to get this controversial Bloomberg article out to you right away. It's early, but this doesn't sound good: ImmunoGen Cancer Drug Setback May Signal Delays for Onyx, Seattle Genetics By Ellen Gibson and Catherine Larkin ImmunoGen Inc.’s failure to win an accelerated U.S. review for its cancer drug sent shares down the most