Report: Global pharmaceutical sales hit record high in 2013 | Baxter-Halozyme immunodeficiency drug HyQvia gains FDA approval | FDA panel backs approval of NPS' thyroid drug Natpara
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September 15, 2014
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Report: Global pharmaceutical sales hit record high in 2013
A report from Thomson Reuters' CMR International unit showed global drug sales reached a high of about $980 billion last year and could increase to $1 trillion this year. The number of new molecular entities approved in the U.S., however, dropped by more than 30% from 2012 to 2013. Despite the decline in approval rate, 27 NMEs were commercialized in 2013, marking the second-highest number since 2008, data suggest. Outsourced Pharma (9/12)
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Health Care & Policy
Baxter-Halozyme immunodeficiency drug HyQvia gains FDA approval
Baxter International and Halozyme Therapeutics have been awarded regulatory approval in the U.S. to market HyQvia, a combination of human immune globulin and recombinant human hyaluronidase. The drug, a treatment for primary immunodeficiency, is intended for infusion no more than once a month, less than existing weekly or biweekly regimens. PharmaTimes (U.K.) (9/14)
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FDA panel backs approval of NPS' thyroid drug Natpara
A panel of FDA advisers endorsed the approval of NPS Pharmaceuticals' recombinant human parathyroid hormone Natpara as a long-term treatment for hypoparathyroidism. A decision is expected by Oct. 24. The drug holds orphan drug designation in the U.S. and Europe. Medscape (free registration) (9/13)
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Viamet's meningitis candidate wins orphan status from FDA
The FDA has awarded orphan drug status to Viamet Pharmaceuticals' oral antifungal agent VT-1129, which is under development for the treatment of cryptococcal meningitis. Viamet plans to seek the FDA's approval in order to start human clinical trials next year. (Raleigh, N.C.) (9/12)
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Lilly to seek FDA approval of Cyramza for colon cancer after trial success
Eli Lilly & Co. plans to submit its stomach cancer drug Cyramza for FDA review next year as a treatment for advanced colon cancer after obtaining positive results in a late-stage trial. Data showed that Cyramza, in combination with chemotherapy, was significantly more effective than placebo and chemotherapy combined in improving survival among patients with advanced colon cancer. Reuters (9/12)
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Pharma deserves appreciation, not criticism amid Ebola outbreak
The Ebola outbreak shows the benefit of having a vibrant and innovative drug industry attempting to address the worst diseases, writes Merrill Matthews of the Institute for Policy Innovation. Drugmakers, criticized for charging too much, should be recognized by the critics who would not know where to begin when it comes to inventing new treatments, Matthews writes. Forbes (9/11)
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Gene study suggests leukemia subtype may be susceptible to kinase inhibitors
A genetic study of 1,725 patients with the most common form of acute lymphoblastic leukemia found that more than 25% of them had the Philadelphia chromosome-like subtype of the illness, according to findings reported in The New England Journal of Medicine. The DNA analysis will support trials of tyrosine kinase inhibitors. Genetic Engineering & Biotechnology News (9/11)
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Company & Financial News
Cellerant wins $47.5M to develop stem cell therapy for radiation poisoning
The U.S. government has awarded $47.5 million to Cellerant Therapeutics to support the development of CLT-008, a stem cell treatment for patients with acute myeloid leukemia and acute radiation syndrome. The government could buy CLT-008, if it is approved, for the Strategic National Stockpile under Project BioShield, which ensures the availability of effective medical countermeasures against "chemical, biological, radiological or nuclear attacks." (9/12)
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Registration is open for the BIO Investor Forum!
The BIO Investor Forum, October 7-8 in San Francisco, is an international biotech investor conference focused on early and established private companies as well as emerging public companies. Register today to explore investment trends and opportunities in life sciences and connect one-on-one with key stakeholders in the industry.
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Food & Agriculture
Corn genome discovery could lead to development of better defense responses
Researchers at North Carolina State University said they have identified cellular processes and 44 key genes that appear to be involved in hypersensitive defense response in corn. The discovery, published in the journal PLoS Genetics, may help researchers improve defense responses of corn as well as other plants. The Hindu (India)/Indo-Asian News Service (9/14)
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Hot Topics
Industrial & Environmental
EIA trims U.S. ethanol production estimates for 2014, 2015
The Energy Information Administration's latest Short-Term Energy Outlook predicts U.S. ethanol output this year to average 929,000 barrels per day, down from 930,000 barrels per day in last month's estimate. U.S. ethanol production next year will average 934,000 barrels per day, down from 935,000 barrels per day in the August projection. Output averaged 940,000 barrels per day in the past three months, the EIA said. (9/11)
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Housing & registration open for the BIO Pacific Rim Summit
Taking place December 7-9, 2014 in San Diego, the BIO Pacific Rim Summit on Industrial Biotechnology & Bioenergy is the original conference dedicated to the growth of the industrial biotech and bioenergy sectors in North America and the Asia-Pacific region. Register and book your hotel room today!
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