News & Analysis as of

Biotechnology Clinical Trials European Medicines Agency (EMA)

Goodwin

Alteogen’s Aflibercept Biosimilar Receives Positive CHMP Opinion

Goodwin on

​​​​​​​We previously reported that South Korean biopharmaceutical company Alteogen submitted its Marketing Authorization Application to the European Medicines Agency (“EMA”) for ALT-L9, what has since been named EYLUXVI. ...more

Hogan Lovells

EU Clinical Trials Regulation to apply from December 2021

Hogan Lovells on

On 12 June 2020, the management board of the European Medicines Agency (EMA) announced December 2021 as the date of entry into application of the EU Clinical Trials Information System (CTIS). ...more

Hogan Lovells

What the European Medicines Agency’s qualification opinion means for electronic clinical data capture

Hogan Lovells on

The European Medicines Agency (EMA) issued a qualification opinion following a request concerning proprietary eSource DDC (Direct Data Capture) technology. This technology allows the capture of clinical study source data...more

Wilson Sonsini Goodrich & Rosati

2018 Life Sciences Securities Litigation Roundup

2018 Filings - Companies in the life sciences industry, including biotechnology, medical devices, and pharmaceuticals, have long been favorite targets of securities class actions, and 2018 was no exception. According to a...more

Hogan Lovells

EMA launched improved version of EudraVigilance

Hogan Lovells on

The European Medicines Agency (“EMA”) has launched a new and improved version of EudraVigilance. EudraVigilance is the system for managing and analysing information concerning suspected adverse reactions to medicinal products...more

Hogan Lovells

New rules for expanded access in Italy

Hogan Lovells on

Fast track for orphan diseases and rare forms of cancers - By Ministerial Decree of 7 September 2017 (DM 7 September 2017), published in the Italian Official Journal on 2nd November2017, the Ministry of Health enacted new...more

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