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Product Report
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 Regulatory Issues - Europe continues to make strides while the US lags behind
The drive for increased cost savings by healthcare providers is increasing the focus on boosting the biosimilar market. With a regulatory approval pathway in place in Europe and substantial guidelines to support biosimilar development, the European biosimilars market is significantly more advanced than the US, where plans for a biosimilar regulatory approval pathway have stalled.
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Product Report
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Hematological Malignancies - Pursuit for the next blockbuster intensifies
Unmet needs across the hematological malignancies remain high, with most traditional therapies conferring low levels of specificity and high toxicity. Pipeline candidates classified as molecular targeted therapies, cytotoxic therapies and immunotherapeutic agents, may offer attractive therapeutic additions and Datamonitor's insight into their clinical and commercial potential is provided.
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Product Report
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Disease Modification in Rheumatoid Arthritis - Competition for the anti-TNF failure
The treatment of Rheumatoid Arthritis (RA) has been rapidly evolving over the last decade. The success of the next wave of novel RA therapies depends on their ability to address the key issue of cost effectiveness, as the patient population for anti-TNF's is reaching a maximum and competition moves to anti-TNF failure patients.
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Product Report
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Regulatory and development issues hurdles exist but are surmountable
Europe serves as a model for other countries looking to define their own regulatory approval criteria. The US is on the brink of passing legislation to establish a statutory pathway for biosimilars approval but the opposing interests of biosimilar and innovative companies may result in further delays. Development of biosimilars presents many challenges and potential pitfalls.
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Product Report
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Monoclonal Antibodies Report Part II: Companies - Holding mAbs in portfolio promises protection against the looming 2011-12 patent cliff
This report provides a comprehensive strategic analysis of the mAb market out to 2012 by company. It identifies four 'established' and four 'emerging' players within the mAb sector which are forecast to play the most commercially significant role within this market. The report assesses how these players will be insulated from the impact of generic competition as a result of mAb market penetration.
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Product Report
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Acute Stroke - TPA spurs infrastructure changes for the better
Stroke is one of the top three leading causes of death worldwide and an area of high unmet needs. TPA is limited to a low number of ischemic stroke patients due to a short therapeutic time window, but it is still the best therapy available. TPA is responsible for major changes and advances in the way stroke patients are cared for, which is expected to evolve further.
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Product Report
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Systemic antifungals
The systemic antifungals market accounts for $3.1bn of the total $41bn anti-infectives market. A wave of new products coinciding with patent expiry of two widely used compounds will shake up the market for systemic infections, further polarizing between winners and losers. Key changes are forcing a rethink of management strategies and clinical trial design.
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Product Report
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HIV - Novel NNRTIs address crucial unmet need
Treatment of HIV has come a long way since the discovery of the virus. Although no real cure has been found yet, the last few decades have seen the introduction of many classes of drugs that suppress the replication of the virus. As therapeutics have improved dramatically in terms of efficacy, safety and convenience, the bar for new drugs has been raised considerably.
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Product Report
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Non-Hodgkin's Lymphoma - Is there room to emulate Rituxan's success?
Non-Hodgkin's lymphoma (NHL) is the most common hematological malignancy and is comprised of around 30 different disease subtypes. Each of these present with a distinct set histological, genetic and clinical characteristics. Treatment options in NHL include chemotherapy, targeted therapies, stem cell transplantation and radiotherapy.
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