More Articles

Results of clinical trials in Europe to be made publicly available Generics/General | Posted 18/04/2014

It will soon be the law in Europe for all clinical drug trials to be registered and the results reported on a publicly-accessible database. Members of the European Parliament (MEPs) voted on 2 Apri...

Cost-cutting in Europe may affect generics sustainability Reports | Posted 18/04/2014

According to a presentation by Mr Victor Lino Mendonça, the continued focus on short-term cost containment measures may lead to an unsustainable market environment for generics and biosimilars in t...

Sun Pharma to acquire Ranbaxy creating 5th largest generics firm Pharma News | Posted 18/04/2014

India-based Sun Pharmaceutical (Sun Pharma) announced on 6 April 2014 that the company had agreed to acquire rival generics maker Ranbaxy Laboratories (Ranbaxy) in an all-stock deal worth US$3.2 bi...

WHO investigates use of a biological qualifier for biosimilars Biosimilars/General | Posted 11/04/2014

The World Health Organization is still discussing several different options on how to name biosimilars, according to the recently published executive summary of its 57th Consultation on Internation...

Quality by design for biosimilars Biosimilars/Research | Posted 11/04/2014

A study into the use of quality by design (QbD) has demonstrated how risk management can facilitate the implementation of QbD in the early-stage product development of biosimilars [1].

FDA discredits study claiming foreign generics tainted Generics/General | Posted 11/04/2014

Research suggesting that foreign generics are inferior to US generics has been discredited by the FDA’s Center for Drug Evaluation and Research Director Dr Janet Woodcock.

Development of Iranian guidelines for ‘biogenerics’ Guidelines | Posted 11/04/2014

The national regulatory authority for approval of medicines in Iran, the Iranian Food and Drug Organization (FDO), has issued its new guidelines for registration of biologicals (recombinant medicin...

Australian price cuts make PBS affordable Policies & Legislation | Posted 11/04/2014

The price cuts for 121 medicines supplied through Australia’s Pharmaceutical Benefits Scheme (PBS) have made the PBS sustainable, according to Medicines Australia, a group that represents originato...