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April 24, 2017

Vol. 14 No. 78

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EMA Revises Guidance on Clinical Data Publication Policy

The agency added checklists for the validation stage and for redaction proposal documents. Read More

Shire Division Asks Court to Dismiss FTC Suit over Citizen Petitions

The agency claims the Shire division filed 46 meritless petitions. Read More

Teva Receives Second FDA Warning Letter in Six Months for International Facilities

Teva said it is undertaking corrective actions and is communicating with the agency. Read More

Enzyvant Gains Two FDA Therapy Designations for its Drug Candidate RVT-802

The therapy is being developed for complete DiGeorge syndrome. Read More

FDA Grants Breakthrough Therapy Designation to Novartis’s CAR-T Cell Therapy CTL019

T cells are drawn from a patient's blood and reprogrammed in the laboratory. Read More