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AZ Snags Breakthrough Therapy Designation for Cancer Drug
Flexion’s Zilretta Flies High in Phase 3 Trial
FDA Seeks Feedback on Supply Chain Pilot Read More
An NHS England spokesperson has confirmed that the agency will investigate whether more than 130 NHS staff involved in assessing drugs were also paid as consultants by drugmakers. Read More
Merck Lands Complete Response Letter for Zetia, Vytorin sNDAs
Gilead’s Harvoni Snaps Up Additional Indications
FDA Grants Orphan Drug Designation for Remedy’s Cirara
Amgen’s Aranesp Shines in Phase 3 Read More
Two dietary supplement makers — Puerto Rico-based Majopa Industries and ATS Labs of Houston, Texas — were hit with FDA warning letters over the manufacture of adulterated products. Read More
Pfizer will pay $784.6 million to settle Justice Department allegations that a subsidiary overcharged Medicaid under a tentative agreement announced Tuesday. Read More
The FDA is providing additional information on trial designs for sponsors developing therapies to treat allergic and nonallergic rhinitis and anthrax exposure. Read More
The Pharmaceutical Research and Manufacturers Association singled out China and Canada as two of the 20 countries to watch for intellectual property transgressions in 2016. Read More