Thursday, July 18, 2013

Spectrum Pharmaceuticals acquires U.S. biopharma for up to $206M

Alzheimer's drug candidate wins fast-track designation from FDA | U.S., EU regulators clear genotyping test kit from Luminex | Venaxis readies FDA application for appendicitis test
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July 18, 2013
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Spectrum Pharmaceuticals acquires U.S. biopharma for up to $206M
Spectrum Pharmaceuticals agreed to pay $11.3 million in cash as well as contingent value rights worth up to $195 million to acquire Talon Therapeutics. The deal will give Spectrum access to Talon's leukemia drug Marqibo and menadione topical lotion, which is being developed as a treatment for skin toxicity related to epidermal growth factor receptor cancer drugs. The acquisition is expected to be completed today. NBC News/The Associated Press (7/17), RTT News (7/17)
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Health Care & Policy
Alzheimer's drug candidate wins fast-track designation from FDA
The FDA granted fast-track status to Elan and Transition Therapeutics' ELND005, an experimental drug designed to reduce neuropsychiatric symptoms in patients with moderate to severe Alzheimer's disease. ELND005 is under evaluation for multiple neuropsychiatric indications "on the basis of its proposed dual mechanism of action, which includes β-amyloid anti-aggregation and regulation of brain myo-inositol levels," Elan said. Fox Business (7/17), Reuters (7/17)
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U.S., EU regulators clear genotyping test kit from Luminex
Luminex has secured clearance in the U.S. and Europe for its xTAG CYP2D6 tool, a genotyping assay kit used to help predict patients' responses to specific drugs and allow doctors to personalize treatments. The company also applied for FDA review of a kit intended to analyze the effects of medications used to treat ulcers and other conditions. American City Business Journals/Austin, Texas (7/16)
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Venaxis readies FDA application for appendicitis test
Venaxis has completed the first of a two-part futility study of its APPY1 Test and is on track to file with the FDA its application for the product. The company also is gearing up for a full European release of the blood-based test, which aids doctors in assessing whether patients with suspected acute appendicitis are at low risk for the condition. GenomeWeb Daily News (free registration) (7/16)
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House holds hearing on oversight of large compounders
Lawmakers appeared reluctant to tighten federal oversight of large-scale drug compounders at a hearing Tuesday before the House Energy and Commerce Committee's Health subcommittee, saying the service that compounders offer is important to doctors treating patients who cannot tolerate or are nonresponsive to drugs from brand-name and generic-drug makers. Still, lawmakers indicated they don't want a repeat of a meningitis outbreak tied to a compounding pharmacy, and the Senate could vote on legislation this month while a bill is being drafted in the House. PhRMA and Public Citizen argued against the creation of a new regulatory class of drug compounders. MedPage Today (free registration) (7/17)
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Study uses magnets to steer stem cells in the body
Magnets can be used to lead iron-oxide coated mesenchymal stem cells to particular points in the body, according to a study in the journal Small. Researchers used nanoparticles of iron oxide in a protective layer of polyethylene glycol and tested the cells in cultures and mice models. "Next, we plan to focus on therapeutic applications in animal models where we will use magnets to direct these cells to the precise site need to affect repair and regeneration of new blood vessels," researcher W. Robert Taylor said. MedicalDaily.com (7/16)
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Company & Financial News
Cancer drug developer brings in $52M from stock sale
Verastem, which specializes in drugs that target cancer stem cells, secured at least $52 million from a public stock offering. The Cambridge, Mass.-based firm will use the money mainly to support studies of its lead drug candidates for cancer. American City Business Journals/Boston/bioflash blog/Mass High Tech (7/17), The Boston Globe (tiered subscription model) (7/17)
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Industry Deals
Sequella gains global rights to Pfizer's tuberculosis drug sutezolid
Pfizer granted Sequella exclusive global rights to develop and commercialize its antibiotic sutezolid, which is in midstage trials for tuberculosis. Sequella will be in charge of the remaining trials, regulatory filing and commercialization. PharmaTimes (U.K.) (7/17), American City Business Journals/Washington, D.C./TechFlash blog (7/17)
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Food & Agriculture
Monsanto halts new biotech applications in Europe
Monsanto said it will take back all pending applications to grow new types of biotech crops in the European Union because of the lack of prospects for commercial growing. The firm will focus on expanding its traditional seed business and in seeking approvals to import biotech crops widely grown elsewhere. Reuters (7/17)
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Industrial & Environmental
Hog producer tapped to supply plant feedstocks to proposed N.C. biorefinery
Chemtex has tapped pork producer Murphy-Brown to furnish a variety of mostly nonedible feedstocks such as switchgrass to its proposed cellulosic ethanol plant near Clinton, N.C. The feedstocks will be grown on about 6,000 acres, about 20% of what the plant will need at capacity, Chemtex said. American City Business Journals/Raleigh/Durham, N.C./Triangle BizBlog (7/17)
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