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    Second Generation TKIs Will Require Survival Data to Supplant Gleevec in Front-Line CML

    by Elizabeth Krutoholow Newly approved therapeutics for chronic myelogenous leukemia (CML) or so-called second generation tyrosine kinase inhibitors (TKIs) like Ariad’s Iclusig and Pfizer’s Bosulif will require data showing survival improvements before clinicians adopt them in the front-line setting, according to Dr. Elias Jabbour, Associate Professor in the Department of Leukemia, at The University of Texas MD Anderson Cancer Center. Read more >>> 

    EU Lemtrada Decision Key to Genzyme CVR Holders

    By Andrew Berens, MD Senior Healthcare Analyst, Bloomberg Industries Sanofi’s multiple sclerosis (MS) drug Lemtrada may soon be recommended for European approval, where revenue is especially important to holders of Genzyme contingent value rights linked to the drug’s success. Read more >>>

    AstraZeneca’s Bestselling Drug May Get Patent Boost With Omthera Deal, Optimer Deal Possible

    Compiled by Sam Fazeli, Director Bloomberg Industries Europe and Asthika Goonewardene, Pharmaceuticals Equity Research Analyst AstraZeneca’s bid to buy Omthera is driven by Epanova, an experimental treatment for patients with high levels of triglycerides that could be combined with the large pharma company’s best-selling medicine Crestor in an effort to stave off generic competition.   [...]

    Raptor May Obtain European Regulatory Nod for Rare Disease Drug Procysbi

    Compiled by Andrew Berens, MD, Senior Healthcare Analyst, Grace Guo, Bloomberg Industries and Elizabeth Krutoholow   Raptor may secure a second regulatory nod this week for its drug Procysbi, which treats a rare disease known as for nephropathic cystinosis.   The company won FDA approval for the medicine for the treatment of the rare metabolism [...]

    Amgen Data on T-Vec to Be Published This Week

    Data for Amgen’s talimogene laherparepvec (T-VEC) in advanced melanoma is among many abstracts that will be published ahead of the American Society of Clinical Oncology (ASCO) annual meeting. Abstracts will be available on May 15 at 6 p.m. ET. Click here to continue reading

    Specialty Pharmaceutical Revenue Growth Driven by Niche Demand

    by Andrew Berens, MD, Senior Healthcare Analyst, Bloomberg Industries   Increasing demand in niche therapeutic areas has driven 11 percent revenue growth among specialty pharmaceutical companies during the last five years. The sector has benefited from new product launches, fresh income streams from label expansions and entry into diversified geographical markets. Mergers and acquisitions has [...]

    Biotech Company Owns Clinical Trial Property Held by CRO

    By Jason M. Brocks, Legal Analyst,Bloomberg Law A recent U.S. District Court decision emphasizes the importance to research sponsors and contract research organizations(CROs) of understanding the terms set out in their agreements, particularly those terms relating to the responsibilities of each party upon termination of the arrangement. Pharmaceutical, medical device and biotechnology companies that sponsor [...]

    Avanir May Gain Second Regulatory Backing for Nuedexta

    by Andrew Berens, MD, Senior Healthcare Analyst and Grace Guo, Bloomberg Industries Avanir’s Nuedexta may receive a decision from the Committee for Medicinal Products for Human Use (CHMP) this week as a treatment for pseudobulbar affect (PBA). Approval in the EU would be the second regulatory nod for the drug. PBA is also called emotional [...]

    Diabetes Market Growing in China

    by Sam Fazeli, Director Bloomberg Industries, Europe The diabetes market is rapidly growing in China, leading to a significant opportunity for companies with complete diabetes portfolios like Novo Nordisk and Sanofi. In addition to urbanization and obesity rates, diabetes prevalence has been fueled by the region’s aging population. The prevalence of the disease increased at [...]

    Litigation Restricts Cash-Poor on U.S. Biosimilar Path

    By Asthika Goonewardene, Pharmaceuticals Equity Research Analyst, Bloomberg Industries The cost of allegations that process patents may have been infringed under a biosimilar application may deter small generic developers from pursuing approval through the 351(k) pathway, which was specifically set up for copies of cheaper biologic drugs. The FDA created an abbreviated pathway for generic [...]

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