Innovation That Matters - Drug Development

IMBRUVICA and Its Impact on Patients

This month’s Innovation That Matters featuresHeow Tan, Chief of Quality and Technical Operations at Pharmacyclics.  Tan joined Pharmacyclics in 2012 leading Global Quality, CMC Development, Global Manufacturing, Supply Chain, and Pharmacyclics International Operations.  Pharmacyclics lead product, Ibrutinib, with the trade name IMBRUVICA®, is one of the early molecules to receive US FDA Breakthrough Therapy Designation for Oncology.  It is also the only drug that received 3 Breakthrough Therapy Designations from the US FDA.
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Industry News

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Source: PBR

Clovis Oncology granted FDA Breakthrough Therapy designation for lung cancer treatment agent
Source: InnovatioNews

The FDA Has Granted First Breakthrough Therapy Designation in Bladder Cancer for MPDL3280A
Source: Genentech 

AngioChem's ANG1005 Received Fast Track and Orphan Drug Designation From FDA For The Treatment Of Glioblastoma Multiforme
Source: BioSpace

FDA Approves Ibalizumab Manufacturied by WuXi for Treatment of Patients on Expanded Access

WuXi's Analytical and Stability Testing Facilities Pass FDA Audit


WEBINAR: Breakthrough Drugs-The Story Behind the Story

Drugs Can Reach Patients Faster and Cheaper, FDA Chief Says
Source: Bloomberg

ASCO tackles a tough question: When is a cancer drug too pricey?
Source: FiercePharma

FDA Cancer Chief says "escalating" drug  prices can't continue
Source: Reuters

Breakthrough Therapy Designation vs. Fast Track Designation?  FDA Guidance for Expedited Programs For Serious Conditions
Source: Rare Disease REPORT

The FDA's new Breakthrough Therapy designation 
Source: Oxbridge Biotech Roundtable

Regulatory Renovation
Source: Scientific American
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