Pharmacyclics Cancer Drug Gets Priority FDA Review

Pharmacyclics (NASDAQ: PCYC  ) announced today that the Food & Drug Administration (FDA) has granted priority review for the company's oral cancer-treating Ibrutinib drug. With the filing review out of the way, Pharmacyclics' new drug application puts Ibrutinib one step closer to regulatory approval.

The drug was jointly developed with Johnson & Johnson's (NYSE: JNJ  ) Janssen Biotech division, and the FDA's most recent approval puts $75 million into Pharmacyclics' pocket per a collaboration agreement between the two corporations.

"We are very excited to have received the official FDA acceptance of our first NDA filing for ibrutinib," said Pharmacyclics Senior Vice President of Global Regulatory Affairs Dr. Urte Gayko in a statement today. "We look forward to continuing to work with the FDA as they complete their review of the ibrutinib application which includes the new Breakthrough Therapy Designation process."


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  • Report this Comment On August 29, 2013, at 9:13 PM, mridenhour wrote:

    All the big investors and stockholders better hope that no one ever exposes a real, real, real cure for cancer, you know, like prevention altogether or a simple, inexpensive cure if it does present. This will someday be exposed for the atrocity it is, and we've turned a deaf ear and blind eye for decades and millions of deaths. But we'll keep eating like they advertise to us, follow their plan, get sick and die while they're profiting off that. Most Eurpoean countries know that U.S. food is a disgrace and have banned many of the products that we inhale. Oh, well.....

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