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Apotex gains reprieve after Merck loses ruling―but for how long Generics/News | Posted 29/06/2012

Toronto-based pharmaceutical firm Apotex has won a stay of execution for its nasal spray generic product after a US District Court in New Jersey, USA, turned down a patent infringement claim by Mer...

Generic Adderall XR approved in the US Generics/News | Posted 29/06/2012

Shire announced on 23 June 2012 that it had lost its battle to protect its attention deficit hyperactivity disorder (ADHD) drug Adderall XR (amphetamine, dextroamphetamine mixed salts). FDA approve...

EMA finalises biosimilar monoclonal antibody guidelines Guidelines | Posted 22/06/2012

EMA announced on 15 June 2012 that it had finalised two guidance documents describing how pharmaceutical companies should develop biosimilar monoclonal antibodies. The guidelines set out how develo...

Amgen welcomes biosimilar monoclonal antibody guideline Biosimilars/News | Posted 22/06/2012

In a statement issued on 18 June 2012, biologicals major Amgen announced that the company broadly supports the scientific principles behind the guideline on non-clinical and clinical aspects for bi...

Rise in US spending on generics: a buoyant market as patents expire on brand-name drugs Reports | Posted 22/06/2012

A new IMS report notes a rise in spending on generic medicines in the US to 27%, or US$75 billion, and looks at the main changes driving the trend.

China follows the Indian and Thai route to affordable drugs Generics/General | Posted 22/06/2012

China announced measures for the Compulsory Licensing for Patent Implementation in a statement on 1 May 2012. The country is saying that it intends to become a generics producer for the domestic an...

Risk management is forgotten as FDA reform struggles through Congress Policies & Legislation | Posted 22/06/2012

FDA’s authority on new drug approvals and post-marketing reports was last updated in 2007, when Congress passed the FDA Amendments Act (FDAAA), and this time the deadline is 30 September 2012 for t...

Trials of biosimilar monoclonal antibody prove biosimilarity Biosimilars/News | Posted 22/06/2012

South Korean biotechnology company Celltrion presented the PLANET clinical studies results of phase I and phase III trials for its first monoclonal antibody biosimilar (CT-P13) of Johnson & Joh...