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Endo to buy generics maker DAVA Pharma News | Posted 01/08/2014

Specialty pharmaceuticals maker Endo Health Solutions (Endo) announced on 24 June 2014 that it had reached a definitive agreement to acquire generics maker DAVA Pharmaceuticals for US$575 million i...

EMA issues revised version of biosimilars quality guideline Guidelines | Posted 04/07/2014

On 26 June 2014, the European Medicines Agency (EMA) published the new version of its biosimilars quality guideline, which will revise the agency’s 2005 overarching guideline on the quality of simi...

32 organizations agree biosimilars should have same names Biosimilars/General | Posted 04/07/2014

On 1 July 2014, 32 organizations signed a letter calling on the US Food and Drug Administration (FDA) to require biologicals and biosimilars to have the same International Nonproprietary Name (INN).

EMA approves biosimilar insulin Biosimilars/News | Posted 04/07/2014

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) announced on 27 June 2014 that it had recommended granting of marketing authorization for a biosimilar...

Abbott to buy Russian generics firm Pharma News | Posted 04/07/2014

US-based pharma company Abbott Laboratories (Abbott) announced on 23 June 2014 that it had signed a definitive agreement to acquire Russian generics maker Veropharm.

Patent term restoration provisions in CETA Generics/Research | Posted 04/07/2014

Some of the provisions included in the Comprehensive Economic and Trade Agreement (CETA) between the European Union (EU) and Canada are seen as having the potential to have a negative affect on the...

Biosimilar etanercept demonstrates equivalent efficacy Biosimilars/Research | Posted 04/07/2014

A phase III trial comparing Hanwha Chemical Corporation (Hanwha)’s biosimilar etanercept, HD203, with Enbrel (etanercept) has demonstrated equivalent efficacy [1].

Companies required to update information on drugs Policies & Legislation | Posted 04/07/2014

The European Medicines Agency (EMA) announced that as of 16 June 2014 marketing authorization holders would be required to update the information on medicines authorized in the European Union.