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EMA/FDA

Eiger announces U.S. IND filing of pegylated interferon lambda for hepatitis delta virus infection

LIMT HDV: Lambda interferon monotherapy in HDV study enrolling PALO ALTO, Calif., May 3, 2017 — Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of targeted therapies for…

EMA and heads of national competent authorities discuss consequences of Brexit

Key principles and working methodology established The European Medicines Agency (EMA) organised an information meeting with members of its Management Board and heads of the National Competent Authorities (NCAs) of…

CHMP recommends extension of therapeutic indications for Celsentri

At its April meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended an extension of therapeutic indications for Celsentri (maraviroc) with marketing authorisation holder ViiV Healthcare…

FDA warns Mylan over quality concerns at India facility

The U.S. Food and Drug Administration (FDA) has raised concerns over quality controls at a Mylan NV manufacturing plant in India, according to a warning letter from the agency dated…

Orphan Drug Designation for CytoDyn’s PRO 140 declined by FDA

VANCOUVER, Washington, April 17, 2017 -- CytoDyn Inc. (OTC.QB:CYDY), a biotechnology company focused on the development of new antibody therapies for combating human immunodeficiency virus (HIV) infection, announces that its…

FDA approves two hepatitis C drugs for pediatric patients

April 7, 2017 - The U.S. Food and Drug Administration today approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children…

EMA: Reporting irregularities that may affect medicines

EMA Board adopts new policy on handling information on alleged improprieties from external sources The European Medicines Agency’s (EMA) Management Board has adopted a new policy on how EMA handles…

US drugs regulatory process faster than European agency’s

The US regulator, the Food and Drug Administration (FDA) reaches its decisions more quickly than its European counterpart, the European Medicines Agency (EMA), finds an analysis* published in a letter…

Optimising safety information for medicines in Europe throughout product lifecycle

New guidance and process improvement for periodic safety update reports Following two years of experience with safety monitoring of nationally authorised medicines via the single assessment of periodic safety update…

EU rapid drug approval plan worries some national agencies

A push by the European Medicines Agency to speed up the approval of new drugs that show promise is running into resistance from some of the national agencies that will…