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The Boston Globe - Synageva Drug Candidate Gets FDA’s ‘Breakthrough Therapy Designation’
Synageva Biotech Corp., a Lexington biopharmaceutical company developing therapies for rare diseases, said Monday that the Food and Drug Administration has granted breakthrough therapy designation to... Read more
FDA approves new drug for advanced prostate cancer
The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to... Read more
FierceBiotech - AbbVie gains inside 'breakthrough' track at FDA for hot hep C combo
While Novartis ($NVS) is beginning to test just how valuable the FDA's new "breakthrough" status is, AbbVie ($ABBV) has now joined the ranks of pharma companies that can lay claim to boasting rights... Read more
WSJ - Johnson & Johnson Myeloma Drug Gets FDA 'Breakthrough' Status
A Johnson & Johnson (JNJ) unit said that the U.S. Food and Drug Administration has designated its investigational myeloma treatment daratumumab a "breakthrough therapy," paving the way for its... Read more
Bloomberg - Cancer Therapy Cost Too High for Patients, Doctors Say
Cancer medicines that cost more than $100,000 a year aren’t morally justifiable and may keep patients from getting life-saving treatments, a group of more than 100 leukemia doctors said.Of the 12... Read more
Nature Medicine - Melanoma drug joins 'breakthrough' club
 Earlier this year, the US Food and Drug Administration (FDA) granted its first ‘breakthrough therapy designations’ to a pair of cystic fibrosis drugs (see Nat. Med. 19, 116–117, 2013). But since... Read more
NYT - Cancer Centers Racing to Map Patients’ Genes
Electric fans growl like airplanes taking off and banks of green lights wink in a basement at Mount Sinai’s medical school, where a new $3 million supercomputer makes quick work of huge amounts of... Read more
Senate Appropriations Committee, Subcommittee on Agriculture, Rural Development, the Food and Drug Administration, and Related Agencies Hearing – “FDA FY14 Budget Request”
 Date:     April 18, 2013Re:         Senate Appropriations Committee, Subcommittee on Agriculture, Rural Development, the Food and Drug Administration, and Related Agencies   Hearing – “FDA FY14... Read more
RPM Report - Landmark Trial for Personalized Medicine Coming Soon: NGS Approval May Be One Offshoot of Lung Cancer “Master Protocol”
 The primary goal of a proposed new trial for targeted therapies intended to treat squamous cell carcinoma of the lung is straightforward enough: to test several different therapies against a very... Read more
NYT - Nobel Laureates Urge No Cuts to Budgets for Research
More than 50 Nobel laureates are urging Congress to spare the federal science establishment from the looming budget cuts known as the sequester, saying that research has endured years of budget... Read more

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