Lilly drug gets FDA nod to treat lung cancer | Senate bill aims to boost access to new antibiotics | Sanofi's 4-strain flu vaccine wins FDA approval
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December 15, 2014
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Lilly drug gets FDA nod to treat lung cancer
The FDA has approved the use of Eli Lilly's Cyramza, or ramucirumab, combined with docetaxel to treat patients with metastatic non-small cell lung cancer whose condition worsened after receiving platinum-based chemotherapy. The approval was based on data from a late-stage study that showed a ramucirumab-docetaxel combination therapy resulted in a better overall survival rate. Medscape (free registration) (12/12), PharmaTimes (U.K.) (12/13)
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Health Care & Policy
Senate bill aims to boost access to new antibiotics
Legislation to streamline the review of antibiotics was introduced by Sens. Orrin Hatch, R-Utah, and Michael Bennet, D-Colo. The Promise for Antibiotics and Therapeutics for Health Act would allow the FDA to expedite approval of antibacterials for "an identifiable, limited patient population upon determining that the drug treats a serious or life-threatening condition and addresses an unmet need." Regulatory Focus (12/11), Modern Healthcare (subscription required)/Vital Signs Blog (12/11), PharmaTimes (U.K.) (12/11)
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Sanofi's 4-strain flu vaccine wins FDA approval
The FDA has approved Sanofi Pasteur's Fluzone Intradermal Quadrivalent vaccine for use in adults who are 18 to 64 years old. The vaccine offers protection against influenza A subtype viruses and type B viruses. Healio (free registration)/Infectious Disease News (12/12)
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FDA approves HTLV confirmatory assay for blood screening
MP Biomedicals has received FDA approval for its MP Diagnostics HTLV Blot 2.4, an enzyme immunoassay that differentiates between human T cell lymphotropic virus-I and HTLV-II. The test is intended for use after initial screening has identified the presence of HTLV-I/II. Medscape (free registration) (12/11)
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Celgene's Abraxane yields high-response rate in breast cancer trial
A late-stage trial showed patients with early high-risk breast cancer who started neoadjuvant chemotherapy with Celgene's Abraxane, or nab-paclitaxel, demonstrated significantly higher pathological complete response rate compared with those who took conventional solvent-based paclitaxel. This is the first time in trial sponsor German Breast Group's 18 years of neoadjuvant studies that response rates "could be strongly increased by replacing a key component of the standard neoadjuvant chemotherapy instead of just adding additional agents to it," group Chairman Gunter von Minckwitz said. PharmaTimes (U.K.) (12/12)
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Ebola vaccine trial temporarily delayed over side effects
Researchers at the University Hospitals of Geneva have temporarily stopped a clinical trial of an experimental Ebola vaccine being developed by Merck & Co. and NewLink Genetics after four of 59 volunteers experienced joint pain 10 to 15 days after vaccination. The trial will resume on Jan. 5, giving researchers time to coordinate with other teams testing the vaccine. CBS News/The Associated Press (12/11), Bloomberg (12/11), National Post (Canada)/The Canadian Press (12/11)
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10 ways to inspire creativity in your staff.
Fostering creative business practices isn't as hard as it seems and can lead to smart solutions. Use these ten techniques to help inspire and encourage creativity in your staff. Read the article and learn 10 ways to get the creative juices flowing.

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Roche strikes deal to purchase AvanSci Bio's MilliSect products
Roche Diagnostics agreed to acquire the entire MilliSect tissue extraction product line from AvanSci Bio. The purchase allows Roche to address tumor heterogeneity and to use the tumor-enriched sample to combine diagnostic hematoxylin and eosin staining with sequencing analysis. FDAnews (12/11)
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Prostate cancer drug developer gets $8M from investors
Innocrin Pharmaceuticals, a Durham, N.C.-based firm spun off from Viamet, secured $8 million in a recent funding round. The firm plans to initiate a midstage trial in 2015 to assess the efficacy of its experimental drug VT-464 in prostate cancer patients who failed to respond to Zytiga or Xtandi. (12/11)
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Clinical Trial Data Transparency Forum: Expert insights
Hear industry and academic thought leaders - from Duke Clinical Research Institute, GlaxoSmithKline, Eli Lilly and more - share valuable insight on their clinical trial data transparency and sharing initiatives. This video covers a number of key perspectives and trends.

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Food & Agriculture
China could approve biotech corn for import soon, Syngenta says
Syngenta expects its biotech corn Agrisure Viptera, also called MIR 162, to receive import approval from the Chinese government soon. Traders say Ukraine, a rival exporter, is dealing with a grain shortage and having difficulty fulfilling supply contracts with China. Reuters (12/12)
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Hot Topics
Industrial & Environmental
EPA has been late in issuing RVOs for a total of 27 months, analyst says
The Environmental Protection Agency has been late in issuing the renewable volume obligations for a total of 27 months in the 60 months since November 2009, when it last met its deadline, writes Dave Juday, principal of The Juday Group. Next year, that is likely rise to at least 40 months, Juday notes. The Government Accountability Office has warned that the late releases "contribute to industry uncertainty, which can increase costs because industry cannot plan and budget effectively," Juday writes. (12/11)
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News From BIO
Fall 2014 BIO Therapeutic Newsletters
The BIO Emerging Companies Section Policy Team has compiled the latest news to keep you informed on the action in Washington with respect to the disease category on which your company is focused. Topics covered include: Allergy/Infectious Disease/Antiviral; Cardiology/Pulmonology/Blood; Nephrology/Endocrinology/Metabolism/Gastroenterology; Neurology/CNS; Oncology; and Rheumatology/Anesthesia/Inflammation/Pain. BIO has attempted to include updates from biotech stakeholders around Washington, including Congress, FDA, NIH and patient organizations. Access our Fall 2014 Therapeutic Newsletters. Should you have any comments or questions, please contact Matt Stross.
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