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Generics - Legislation
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The international humanitarian body Médecins Sans Frontières (MSF) has written to the Indian prime minister, Dr Manmohan Singh , expressing concern that the EU-India free trade agreement, which will have its sixth negotiating round in Brussels in ...
The plenary session at the Drug Information Association’s Euromeeting in Monaco this week took the curious form of an enforced debate on pharmaceutical R&D productivity between representatives from the industry and regulatory authorities. The motion ...
The US FDA has issued two new draft guidance documents regarding clinical trial designs: Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics, and Guidance for Industry: Non-inferiority Clinical Trials. The guidances, ...
Takeda has given further details of two new in-house projects in early clinical development in the oncology area, which signal its increasing research emphasis on this therapeutic sector. The Japanese firm is looking to build up its presence in ...
A US federal advisory panel has released six recommendations concerning gene patents. Most significantly, the panel advises that Congress exempt gene patents from infringement liability in certain areas, specifically by limiting the ability of ...
 
Hospitals' failure to pay pharmaceutical companies and newly announced price cuts are just some of the challenges facing the sector in Greece, Elizabeth Sukkar, Scrip's world editor, discovers. ...
The pharmaceutical industry has long eyed Turkey as one of its key emerging markets, but recent government action, which could see medicine access delayed by years, is giving it a wake-up call, ...
US agencies are making inroads in the use of comparative effectiveness research to support more robust decision-making. Observational studies are an emerging force in this area and promise to ...
 
Jeff George took over as head of Sandoz, Novartis's generics business, in late 2008. With a big push in emerging markets, a leadership position in biosimilars and an expanded focus on injectables, he ...
With an emerging biotech sector and increasing levels of innovation, Asia is viewed by Roche as an attractive source of projects for potential licensing, and the company is building up its regional ...
As big pharma braces itself for the 2012 "winter of discontent", when several key drugs lose patent protection, these patent expiries also represent an opportunity for other firms. e-Therapeutics is ...
 
As the US Congress debates the shape of a permanent comparative effectiveness research (CER) programme and who should run it, the agencies that received $1.1 billion in CER funding under an economic ...
On July 8th, 2009, the European Commission reported on its 18-month inquiry into competition in the pharmaceuticals sector. Bill Batchelor of Baker & McKenzie 's Brussels antitrust practice ...
Cancer treatment is undergoing a revolution, driven by ageing populations, advanced technologies and an increasingly informed society. Health economics considerations and top-up payments are gaining ...
 
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