Biosimilars: Key developments in the regulatory environment
This report examines the structure of the biopharmaceutical industry and the strategic approaches taken to alleviate the threat posed by the biosimilar market. It also provides a comprehensive review of the current legislative and regulatory positions of key geographic regions in addition to evaluating their anticipated future legislative changes and outcomes.
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Emerging Clinical Trial Locations: Market dynamics and the changing healthcare and regulatory environment
This report provides a comprehensive examination of the clinical trial landscape in emerging countries, with specific focus on China, India, Central and Eastern Europe and Latin America. It identifies the major drivers and barriers to conducting clinical trials in emerging regions and profiles key issues for consideration when selecting a trial site.
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Key Trends In Drug-diagnostic Co-development: Identifying collaborative opportunities and navigating regulatory challenges
This report explores the potential for applying genomic-based diagnostics to new drug developments, and the resultant implications for the pharma/biotech and diagnostic industries. It also reviews 28 collaborative agreements for the co-development of drug-diagnostics and determines which combinations can be expected to result in commercial products in the near future.
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Negotiating the Emerging Biosimilars Landscape: Key developments in the regulatory environment
As regulatory obstacles to biosimilars development have become increasingly resolved, a growing number of opportunities have been created for generics companies in the biopharmaceutical market, which according to IMS data was valued at $85.9 billion in 2007. Conservative projections estimate that sales of biopharmaceutical products will exceed $135 billion by 2011.
The Top 10 Biosimilar Players: Positioning, performance and SWOT analyses
Biologics continue to outperform the global pharma market, driven by premium priced therapies for conditions that cannot be managed by conventional drugs. The rapid penetration of novel biologics and the gradual expiry of their patents will create significant market opportunities for biosimilars developers through to 2016.
New Approaches to Pharma R&D: Evolving strategies to rejuvenate R&D efficiency
With industry consolidation, the economic downturn, and an increasing threat from generics, pharma companies are coming under greater pressure to fill their pipelines with innovative drugs. However, despite the costs and risks involved in drug development, the pharma industry is finding new ways to streamline the R&D process in an effort to increase efficiency and output.
On July 10, 2009, the FDA approved Effient (prasugrel) for the reduction of thrombotic cardiovascular events in patients with acute coronary syndromes undergoing percutaneous coronary intervention. However, the approval has surprised many physicians as prasugrel has had a tortuous clinical development program, with important questions raised over its clinical benefits and the trial design.
With Japan poised to receive its first biosimilar and the US moving ever closer to the establishment of an approval pathway, the biosimilars market is set for imminent expansion. Given the size of the US market and the generic erosion which characterizes it, the sector is an attractive prospect for large and established pharmaceutical companies looking to succeed in the biosimilars sector.
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