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The therapeutic equivalence of brand-name and generic narrow therapeutic index (NTI) cardiovascular drugs Generics/Research | Posted 11/02/2011

There are many physicians and patients who have concerns that the bioequivalent generics may not have an equivalent nature in terms of their clinical effect and benefit. In the realm of cardiovascu...

EMA adopts guideline on biosimilar monoclonal antibodies Guidelines | Posted 11/02/2011

EMA announced on its website that it has adopted the long-anticipated guideline on biosimilar monoclonal antibodies.

India regulatory authority to adopt CTD format for NDAs Guidelines | Posted 11/02/2011

On 28 October 2010, India’s Central Drugs Standard Control Organization (CDSCO) released new guidance for industry for submission of new drug applications (NDAs) in the common technical document (C...

US insurers switch up to 70% of drugs Reports | Posted 11/02/2011

A survey carried out by the Global Healthy Living Foundation (GHLF), a non-profit patient organisation, has shown that up to 70% of prescription medications are changed by health insurers, without...

Twelve-year biologicals exclusivity challenged Policies & Legislation | Posted 11/02/2011

US Californian Democrat Mr Henry Waxman at the World Generic Medicines Congress Americas 2010 challenged the 12-year exclusivity period for originator biologicals.

Teva increases stake in Mediwound to 51% Pharma News | Posted 11/02/2011

Israel’s Teva Pharmaceutical Industries is increasing its stake in biotechnology company MediWound Ltd to 51% under a multi-tiered deal to develop and commercialise products to treat burns and wounds.

Gedeon Richter sign biosimilars’ agreement with Mochida Biosimilars/News | Posted 11/02/2011

On 14 December 2010 Budapest-based Gedeon Richter and Tokyo-based Mochida Pharmaceutical (Mochida) announced that the two companies have entered into a comprehensive and long term license and colla...

The therapeutic equivalence of antiplatelet agents, ACE-inhibitors, statins and alpha-blockers Generics/Research | Posted 04/02/2011

The potential changes in pharmacy formulary policy, due to the availability of generic versions of cardiovascular drugs, should be based on as much evidence as possible.