Tag: EMA

Biocon Malaysia received EU GMP compliance certificate

biocon
Biopharmaceutical firm Biocon today said its Malaysian arm Biocon Sdn Bhd has received EU GMP compliance certificate

EMA started a survey to understand the awareness about side effects of medicines

european medicines agency
The European Medicines Agency (EMA) launches survey to assess whether patients and doctors are aware of the arrangements for reporting of side effects.

EC, EMA and FDA signed a new milestone commitment

EMA
The European Commission, the United States Food and Drug Administration and the European Medicines Agency have signed a new confidentiality commitment that allows the US regulator to share non-public and commercially confidential information

EU issued new report on antibiotic resistance

EU flag
A new report from the three agencies presents new data on antibiotic consumption and antibiotic resistance and reflects improved surveillance across Europe

Rydapt by Novartis received positive CHMP opinion

EMA
Last Friday Novartis announced that the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of Rydapt

French regulator ANSM found flaws at Biocon plant during its inspection

biocon
French health regulator ANSM found lapses in quality compliance at Indian biopharmaceutical company

Victoza by Novo Nordisk got positive opinion from CHMP

Novo Nordisk
Novo Nordisk announced that the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on update of the EU label for Victoza

Sanofi and Regeneron received European approval for Kevzara

sanofi
Sanofi and Regeneron Pharmaceuticals, Inc. announced today that the European Commission (EC) has granted marketing authorization for Kevzara

Novartis breast cancer drug received positive CHMP opinion

novartis
Novartis today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Kisqali

Russian medicine for hepatitis B included in the European PRIME program

myrcludex
Hepatera announced that MYRCLUDEX B is included in the PRIME program implemented by the European Medicines Agency

EC provided marketing authorization for spinal muscular atrophy drug

European-Commission
Ionis Pharmaceuticals announced that the European Commission (EC) has granted marketing authorization for SPINRAZA®

GSK put submissions for HIV treatment to EMA and FDA

gsk
GlaxoSmithKline (GSK) and ViiV Healthcare, the global specialist HIV company majority-owned by GSK yesterday announced regulatory submissions to the European Medicines Agency (EMA) and US Food and Drug Administration (FDA)

EMA published an information guide on biosimilars

EMA
The European Medicines Agency (EMA) and the European Commission have published an information guide for healthcare professionals on biosimilar medicines.

Gedeon Richter drug received positive opinion from CHMP

gedeon-richter
Gedeon Richter Plc announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on the company's application for cariprazine

European Medicines Agency issued its 2016 annual report

EMA
The European Medicines Agency (EMA) published 2016 annual report. It focuses on the Agency’s key achievements in the areas of medicine evaluation, support to research and development of new and innova...

EMA informed about GMP non-compliance statements in India

EMA
Authorities in the European Economic Area (EEA) issued non-compliance statements to 11% of the Indian drug manufacturing plants they inspected in 2016. The rate of non-compliance is far higher tha...