FDAnews Drug Daily Bulletin

The bill reauthorizing the Prescription Drug User Fee Act (PDUFA) for another five years is now headed to President Barack Obama’s desk to be signed into law after the Senate voted 92–4 to pass the FDA Safety and Innovation Act, S. 3187, Tuesday afternoon.

Experts are wondering whether Johnson & Johnson (J&J) made the right decision when it unblinded its pivotal trial for a supplemental indication for prostate cancer treatment Zytiga before the study met its overall survival endpoint.

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 11–0 with one abstention to recommend approval for Onyx Pharmaceuticals’ Kyprolis for patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapy.

Presidio Pharmaceuticals announced successful completion of Phase Ib clinical testing of its lead HCV NS5A inhibitor in patients with HCV genotype-1 infection, with positive efficacy and safety observations supporting advancement of PPI-668 to Phase II combination studies.

West Virginia Attorney General Darrell McGraw announced lawsuits against 14 pharmaceutical drug distributors, alleging their negligent practices have helped fuel the state’s pain pill abuse epidemic.

The head of Europe’s drug industry has written to EU leaders ahead of their summit tomorrow seeking concessions to ensure that the sector can continue to export pharmaceuticals to crisis-hit countries such as Ireland and Spain.

Daiichi Sankyo received regulatory approval yesterday to begin operating its first U.S.-based packaging plant in Bethlehem, Pa.

About 30 employees of Cherokee Pharmaceuticals will lose their jobs as the facility ceases its contract fermentation operations in September.

Pharmaceutical research firm Covance plans to add 465 jobs to its central Indiana site as part of a $150 million expansion, a development official said.