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FDA to allow generics makers to change labelling Policies & Legislation | Posted 22/11/2013

On 8 November 2013 the US Food and Drug Administration (FDA) announced that it had published its proposed rule allowing generics makers to change their labelling in the Federal Register.

Ireland high drug prices cannot be justified Pharma News | Posted 22/11/2013

The European Commission’s troika mission to Ireland has told Government TDs (Members of Parliament) that the cost of pharmaceutical drugs in the country cannot be justified. Drug prices in the coun...

FDA awards grant to study generic transplant drug tacrolimus Generics/Research | Posted 22/11/2013

The US Food and Drug Administration (FDA) has awarded a federal grant worth US$2.3 million to researchers at the University of Cincinnati, Ohio, USA, in order to continue studies into tacrolimus, a...

First generic 30 mg Focalin XR capsules approved Generics/News | Posted 22/11/2013

On 18 November 2013, Mylan Pharmaceuticals announced the launch of generic dexmethylphenidate hydrochloride extended-release (ER) capsules, 30 mg.

Price components of pharmaceutical expenditure Generics/Research | Posted 15/11/2013

In the second of a series of four articles on pharmaceutical expenditure, Vogler and co-authors take a top down approach to the concept of pharmaceutical expenditure and its use as an indicator in...

Biosimilars ruling has implications for future patent challenges Biosimilars/News | Posted 15/11/2013

Biosimilars manufacturers may not be able to make early challenges on biologicals patents according to a ruling which rejected Sandoz’s request to invalidate patents for Amgen’s blockbuster autoimm...

EMA launches public catalogue of drug shortages Pharma News | Posted 15/11/2013

The European Medicines Agency (EMA) announced on 4 November 2013 the launch of its public catalogue on supply shortages of drugs.

Etanercept biosimilar has comparable pharmacokinetics to Enbrel Biosimilars/Research | Posted 15/11/2013

An etanercept biosimilar (CHS-0214) from fledgling biotech company Coherus Biosciences (Coherus) has shown comparable pharmacokinetics in a pivotal clinical study.