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CommentWire
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Basilea has received an approvable letter from the FDA for its new drug, ceftobiprole. Against the backdrop of investigations into the safety of Ketek, and considering the scrutiny Telavancin has endured, the letter is yet another indication of the FDA's more rigorous and defensive approach to the drug approval process.
Published By Datamonitor
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18 Mar 2008 |
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Expert View
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The increase in cost-limiting measures used by governments and a constant stream of patent expiries mean that the global generics market continues to grow. Generics sales growth is slowing in mature markets like the US, where generics use is high. However, as governments look to curb healthcare spending, the introduction of pro-generic legislation will see less mature markets, like Spain, change.
Published By Datamonitor
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17 Apr 2008 |
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CommentWire
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According to the Infectious Disease Society of North America, the FDA has changed the 'breakpoints' used to determine the susceptibility cut-off for penicillins in the treatment of Streptococcus pneumoniae pneumonia. This will reinvigorate this largely genericized antibiotic class, and is indicative of increasing pressure on antibiotics as efforts are made to restrict antibiotic resistance.
Published By Datamonitor
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30 Apr 2008 |
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Expert View
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One of Barack Obama's key goals as president is to reduce healthcare costs, particularly those related to prescription medications, by increasing the importation of generic drugs. However, the majority of these, or their ingredients, are manufactured in China, and to build confidence in such products, which are often considered unsafe, the FDA will require updated IT systems and solutions.
Published By Datamonitor
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17 Nov 2008 |
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Expert View
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Cytotoxic therapy has been the cornerstone of cancer treatment for many years: indeed, despite a number of unpleasant side effects, the therapy is relatively effective. However, because of this maturity in the market, generics companies remain keen to emulate the success of several cytotoxic brands that have attained blockbuster sales over the years.
Published By Datamonitor
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28 Nov 2008 |
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Expert View
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The Pfizer-Wyeth merger will create a prescription pharmaceutical company of unprecedented scale. The combined entity would have recorded total company sales in excess of $70 billion and prescription pharmaceutical sales of over $60 billion in 2008. However, the deal is not a solution to the companies' declining sales outlooks, and profit growth will only be achieved through further cost cutting.
Published By Datamonitor
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28 Jan 2009 |
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CommentWire
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Recently released data show that the Mirapex once-daily formulation was superior to placebo in early Parkinson's disease patients, and comparable with the thrice-daily version of the drug. With generic versions of Mirapex expected in early 2010, the development of this reformulation may be too late to prevent significant revenue loss for Boehringer Ingelheim.
Published By Datamonitor
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01 May 2009 |
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Expert View
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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.
Published By Datamonitor
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23 Jun 2009 |
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Expert View
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Antipsychotic pipeline developers have been in the spotlight of late following a number of significant regulatory developments, including the FDA's approval of Johnson & Johnson's Invega Sustenna. With a global value of around $22 billion in 2008, and given their status as the leading drug class in the US, the commercial opportunity for novel pipeline antipsychotics is considerable.
Published By Datamonitor
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07 Aug 2009 |
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Expert View
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As vaccines move into indications and patient populations outside traditional target groups, improved technologies are required to overcome the hurdles associated with these novel challenges. Vaccine adjuvants are thus seen as a crucial tool to expand the vaccines market, and the current swine flu pandemic may provide an ideal proving ground to demonstrate the benefits they can bring.
Published By Datamonitor
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01 Oct 2009 |
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