Friday, July 26, 2013

American Regent's anemia drug Injectafer wins FDA nod

Ligand licenses oral lasofoxifene to Ethicor Pharma | Cepheid wins FDA nod for TB and rifampin-resistance test | FDA puts Vertex's hepatitis C drug on partial clinical hold
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July 26, 2013
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American Regent's anemia drug Injectafer wins FDA nod
The FDA approved American Regent's ferric carboxymaltose injection, or Injectafer, to treat iron deficiency anemia in adults. The drug is indicated for patients with nondialysis-dependent chronic kidney disease and in those who are intolerant or nonresponsive to oral iron. The drug is improved in Europe as Ferinject. Pharmaceutical Business Review Online (7/26), PharmaTimes (U.K.) (7/26)
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Ligand licenses oral lasofoxifene to Ethicor Pharma
Ethicor Pharma secured rights to manufacture and distribute Ligand Pharmaceuticals' oral lasofoxifene for the Indian subcontinent, European Economic Area and Switzerland. Ethicor plans to distribute the drug, whose indications include osteoporosis, as an unlicensed medicinal product. The deal entitles Ligand to potential milestone fees and sales royalties. Genetic Engineering & Biotechnology News (7/24)
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Cepheid wins FDA nod for TB and rifampin-resistance test
Cepheid has been cleared by the FDA to market its Xpert MTB/RIF assay, which is used to spot Mycobacterium tuberculosis complex DNA more quickly than existing methods. The test, which runs on the company's GeneXpert Systems, is also used to spot rpoB gene mutations linked to rifampin resistance in samples found to have MTB-complex DNA. RTT News (7/25)
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FDA puts Vertex's hepatitis C drug on partial clinical hold
A midstage trial of Vertex Pharmaceuticals' investigational hepatitis C drug VX-135 was placed on partial clinical hold by the FDA. The move was made after three patients treated with 400 milligrams of the drug had elevated levels of liver enzymes. "We are committed to continuing to work closely with the FDA to provide the data needed to support evaluation of a 200 mg dose of VX-135 in the U.S.," said Chief Medical Officer Robert Kauffman of Vertex. Reuters (7/25)
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Biggest data set of cancer-related genes unveiled by scientists
The National Cancer Institute has developed a database of cancer-related genetic variations for use by researchers. "To date, this is the largest database worldwide, containing 6 billion data points that connect drugs with genomic variants for the whole human genome across cell lines from nine tissues of origin, including breast, ovary, prostate, colon, lung, kidney, brain, blood, and skin," said Dr. Yves Pommier. The data set will be available through the CellMiner and Ingenuity portals. Oncology Nurse Advisor online (7/24)
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Company & Financial News
Agios Pharmaceuticals pulls in $106M from IPO
Agios Pharmaceuticals, a Cambridge, Mass.-based cancer drug developer, secured $106 million from its initial public offering. The shares of common stock sold and their price exceeded the company's projections. The company specializes in therapies for cancer and inborn errors of metabolism, and two of its cellular metabolism-targeting drug candidates are in development with Celgene. American City Business Journals/Boston/bioflash blog/Mass High Tech (7/24)
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Stem cell-culturing company gets $2.3M boost
StemBioSys secured $2.3 million and could bring in $5.6 million more in funding. Proceeds will be used for the expansion and development of its three-dimensional stem cell culture for use with cells from tissues such as bone marrow, umbilical cord blood and fat. MedCityNews.com (7/25)
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The Latest From BIO ...
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Scientists ID gene that boosts oil palm production
An international group of researchers sequenced the genome of the oil palm and found a gene that allows some trees to produce more oil than others. The data, published in the journal Nature, could pave the way for more sustainable agriculture. "We can now use that gene in genetic testing, which will allow breeders as well as producers to know exactly what sort of tree they are planting before it produces fruit," said Robert Martienssen of Cold Spring Harbor Laboratory. BBC (7/24)
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EvaluatePharma World Preview 2013, Outlook to 2018
In this sixth annual edition report, Evaluate brings together many of our analyses to provide top level insight into the expected performance of the industry between now and 2018. The report highlights trends in Rx drug sales, patent risk, R&D spend and sales by therapy area as well as a brief review of 2012 performance. Download your complimentary report now.

Industrial & Environmental
Alaska Airlines signs agreement for aviation biofuel
Alaska Airlines announced plans to purchase aviation biofuel from Hawaii BioEnergy beginning in 2018. Founded in 2006, Hawaii BioEnergy produces biofuel from woody biomass from the islands. Alaska Airlines is the firm's first airline customer. Frequent Business Traveler (7/24)
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News from BIO
Register today for the BIO Investor Forum, Oct. 8-9, in San Francisco
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-- Eleanor Roosevelt,
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