More Articles

EC expected to dish out more pay-for-delay fines Policies & Legislation | Posted 01/08/2014

The European Commission (EC) is planning to fine French drugmaker Les Laboratoires Servier (Servier) and generics giant Teva Pharmaceutical Industries (Teva) in its latest round of investigations o...

Healthcare providers concerned about FDA’s generics labelling rules Reports | Posted 01/08/2014

A survey by the Generic Pharmaceutical Association (GPhA) and the National Coalition on Healthcare (NCH) has revealed that healthcare providers have serious concerns about the US Food and Drug Admi...

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...