BIO chief urges Congress to increase BARDA, biodefense funding | Sanofi drug for multiple sclerosis wins FDA approval | Roche drug gets expanded FDA approval to treat ovarian cancer
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November 17, 2014
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BIO chief urges Congress to increase BARDA, biodefense funding
In order for the U.S. government to be prepared for future outbreaks like the current Ebola crisis, Congress needs to provide adequate, stable funding for federal biodefense programs, primarily those supported by the Biomedical Advanced Research and Development Authority, writes BIO President and CEO Jim Greenwood. The present Ebola outbreak shows that funding allocated for the development of medical countermeasures is not enough, Greenwood writes. The Hill/Congress Blog (11/14)
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Health Care & Policy
Sanofi drug for multiple sclerosis wins FDA approval
Sanofi has won the FDA's approval to market Lemtrada, or alemtuzumab, as a treatment for relapsing forms of multiple sclerosis. The drug will carry a boxed warning on its label due to risks of potentially fatal autoimmune diseases and serious infusion reactions. The monoclonal antibody drug is now cleared in over 40 countries. Medscape (free registration) (11/15), Reuters (11/15)
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Roche drug gets expanded FDA approval to treat ovarian cancer
The FDA has granted Roche approval to market its cancer drug Avastin, or bevacizumab, combined with chemotherapy, as a treatment for platinum-resistant, recurrent ovarian cancer. The approval was based on late-stage trial data that showed Avastin plus chemotherapy was more effective than chemotherapy alone in lowering the risk of disease progression or death. The drug already is approved for the treatment of five other types of cancers. PharmaTimes (U.K.) (11/15), Fox Business/The Associated Press (11/14)
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Roche's Group A strep test scores FDA clearance
The FDA has cleared Roche to market a polymerase chain reaction-based test that can identify the presence of Group A streptococcus bacterial DNA by analyzing throat swab samples. The cobas Strep A test takes just 15 minutes to generate results when used with the company's cobas Liat System, according to Roche. GenomeWeb Daily News (free registration) (11/13)
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Glaxo applies for expanded indication of eltrombopag in Europe
GlaxoSmithKline has filed an application to the European Medicines Agency for the expanded indication of Revolade, or eltrombopag, to include adults with severe aplastic anemia who have had a poor response to immunosuppressive therapy. The submission is bolstered by results of three Phase II trials supported by the National Institutes of Health. Pharmaceutical Business Review Online (11/13)
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BioCardia receives approval for late-stage trial of cell therapy for heart failure
The FDA has approved BioCardia's application to begin a late-stage study of its bone marrow-derived CardiAMP Therapy as a treatment for heart failure. The trial will involve 250 patients at as many as 40 centers. A biomarker panel will be used to identify potential participants with potent bone marrow cells. FDAnews (11/14)
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Company & Financial News
Successful drugmakers active in M&A, report finds
A Bain & Co. study found that mergers and acquisitions were used to some degree to build strengths by the 10 most successful drugmakers in the last two decades. Because failure is so common in drug development, acquisitions play an important role in filling the pipeline. The Economist (tiered subscription model) (11/15)
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Bristol to spend nearly $1B on new Ireland biologics plant
Bristol-Myers Squibb said it plans to invest about $900 million to build a 322,917-square-foot biologics production facility at its existing Cruiserath site in County Dublin, Ireland. The facility will have laboratory and office space, six bioreactors and a purification area. PharmaTimes (U.K.) (11/14), Genetic Engineering & Biotechnology News (11/14)
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Food & Agriculture
Judge stops Maui County from enforcing biotech-crop law
U.S. Magistrate Judge Barry Kurren ordered Maui County to delay the implementation of a law that would prohibit the planting of biotech crops until he hears legal arguments against the law. Last week, Monsanto and a Dow Chemical subsidiary filed a lawsuit to challenge the validity of the Maui initiative. The firms claimed that the state has jurisdiction and that the law would negatively affect the local economy. Associated Press (11/14)
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Hot Topics
Industrial & Environmental
Report: Biofuel use is growing worldwide
Biofuels now make up 1% of energy used worldwide, according to a report from the U.N. Conference on Trade and Development. Bioethanol and biodiesel are now "established commodities traded daily in all continents," the report states. (11/13)
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News From BIO
New BIO Survey Tool: FDA/Sponsor Interactions During Drug Development
BIO is conducting a first-of-its-kind survey on FDA/Sponsor Interactions During Drug Development. BIO's new survey tool gives participants 24/7 access to provide input on their experiences with FDA regarding current drug development programs. This valuable feedback will enable BIO to provide real-time information to FDA and will inform BIO's policy priorities in the upcoming user fee negotiations that will begin in 2015. Companies are encouraged to share their insights by signing up. All data collected will be blinded and aggregated, and participants will receive exclusive access to reports and analysis throughout the survey process. If you have any questions, please contact Charles Crain.
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Failure will never overtake me if my determination to succeed is strong enough."
-- Og Mandino,
American author
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