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ACRO wants clinical trials or tests for most biosimilars Biosimilars/News | Posted 12/11/2009

On 14 October 2009, the Association of Clinical Research Organizations (ACRO) made recommendations for biosimilars legislation in a letter sent to the US Senate Committee on Health, Education Labor...

Exposure-response analysis on bioequivalent carbamazepine tablets not clinically relevant proof for toxicity differences Generics/General | Posted 12/11/2009

Generic immediate-release carbamazepine tablets are AB-rated generic versions of Novartis’s Tegratol. In this market, Taro is the leading supplier with half the market. Teva Pharmaceutical Industri...

Pharmaceutical sector back in the EU antitrust spotlight Pharma News | Posted 12/11/2009

The raids on 6 October 2009 on the premises of several pharmaceutical companies show that the European competition authorities are serious about taking action against suspected anticompetitive beha...

Post-marketing pharmacokinetic bioequivalence between generic and branded amoxicillin formulations Generics/General | Posted 10/11/2009

Amoxicillin is a moderate-spectrum, bacteriolytic, β-lactam antibiotic used to treat bacterial infections caused by susceptible microorganisms. It is usually the drug of choice within the class bec...

Johnson & Johnson ‘buys’ to fight generic competition Pharma News | Posted 10/11/2009

Johnson & Johnson reported on 13 October 2009 that third-quarter revenue from pharmaceuticals fell 14.1% to US$5.3 billion (Euros 3.59 billion) compared to the prior-year period, due to generic...

Switching statins in Norway after new reimbursement policy Generics/Research | Posted 05/11/2009

Norwegian scientists assessed the changes in statins prescribing in Norway after implementation of the new reimbursement regulations for statins in June 2005, as published in the British Journal of...

Possible economic benefits from generic and therapeutic statin substitution Generics/Research | Posted 05/11/2009

The group of Associate Professor O Klungel of Utrecht University, The Netherlands, assessed the potential annual savings due to generic and therapeutic substitution of statin therapy for the genera...

Actavis launches generic challenge to Pfizer’s Lipitor Generics/News | Posted 29/10/2009

On 1 October 2009, Actavis, the Iceland-based generic company, launched the most high-profile commercial challenge in Western Europe to Pfizer’s best-selling and patent-protected medicine.