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Generic valsartan approved in US Generics/News | Posted 01/08/2014

India’s largest generics maker Ranbaxy Laboratories announced on 27 June 2014 that its subsidiary, US-based Ohm Laboratories (Ohm), had received approval from the US Food and Drug Administration (F...

India planning to extend pricing control to more drugs Generics/General | Posted 01/08/2014

India is thought likely to increase the number of drugs it considers ‘essential’ and therefore for which it controls the maximum retail price in the country.

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...