The news summaries appearing in BIO SmartBrief are based on original information from news organizations and are produced by SmartBrief, Inc., an independent e-mail newsletter publisher. The information is not compiled or summarized by BIO. Questions and comments should be directed to SmartBrief at bio@smartbrief.com.

Today's Top Story

• FDA gives orphan-drug designation to OXiGENE's leukemia drug
  The FDA granted orphan-drug status to OXiGENE's OXi4503, an experimental drug for acute myelogenous leukemia. The drug has demonstrated strong tumor-fighting activity in preclinical and clinical trials, CEO Peter Langecker said. OXiGENE plans to apply for orphan drug designation in the European Union. An early-stage trial is being backed by the Leukemia & Lymphoma Society. Pharmaceutical Business Review Online (11/22)     

Health Care & Policy

• Actelion seeks European approval for PAH drug macitentan
  Actelion Pharmaceuticals submitted an application to the European Medicines Agency seeking approval to market Opsumit, or macitentan, to treat pulmonary arterial hypertension. The company is positioning macitentan to be the successor of its blockbuster PAH drug Tracleer, which will lose its patent protection in 2015. Reuters (11/22)     

• Ablynx, Algeta collaborate on cancer drug R&D
  Belgian firm Ablynx and Norway-based Algeta entered into an agreement to discover and develop cancer drugs using their proprietary technologies. The collaboration will focus on a novel targeted thorium conjugate, a combination of Ablynx's nanobodies and Algeta's thorium-227 alpha-pharmaceutical payload. PharmaTimes (U.K.) (11/22)     

• Genzyme's MS drug Aubagio wins Australian approval
  The Australian Therapeutic Goods Administration approved Genzyme's Aubagio in a 14 milligram oral dose to treat patients with relapsing multiple sclerosis. The approval was based on positive results of the TEriflunomide Multiple Sclerosis Oral study. Pharmaceutical Business Review Online (11/22)     

• Thermo signs licensing deal with Fujirebio for sepsis test
  Thermo Fisher Scientific has agreed to license to Fujirebio its PCT assay, which is used to diagnose sepsis early. The deal, whose terms were not made public, allows Japan-based Fujirebio to offer the test on its Lumipulse line of laboratory instruments. American City Business Journals/Boston (11/21)     

• Xoma's hypertension drug combo performs well in Phase III study
  A late-stage trial found that six weeks' worth of Xoma's experimental hypertension drug, a combination of perindopril arginine and amlodipine besylate, is more effective than either drug separately in lowering sitting diastolic and systolic blood pressure. Xoma could license the combination to a firm that specializes in cardiovascular drugs. American City Business Journals/San Francisco/Biotech SF blog (11/20)     

Company & Financial News

• Kiadis pulls in close to $13M for trial of cell-based treatment
  Kiadis Pharma secured about $13 million in financing from new and existing investors. Proceeds will go toward a midstage trial and a Phase II/III trial of the firm's ATIR, an investigational cell-based treatment designed to permit stem cell transplantations for blood cancer patients with haploidentical donors. Pharmaceutical Business Review Online (11/21)     

• PlantForm lands DARPA contract to develop nerve agent antidote
  The U.S. Defense Advanced Research Projects Agency awarded PlantForm a contract worth $1.77 million to improve an enzyme that enhances protection against sarin gas and other nerve agents. "The prime application of this enzyme is in people who will be going into an area where the gas has been or might be released," president and CEO Don Stewart said. PlantForm will collaborate with Kentucky BioProcessing, Aragen Bioscience and Defence Research and Development Canada on the project. The Guelph Mercury (Ontario) (11/19)     

Food & Agriculture

• Staple crop genomics studies share $25.5M grants
  The U.K. Biotechnology and Biological Sciences Research Council awarded grants totaling $25.5 million to 11 international research projects that aim to enhance staple crops using genomic technologies. The projects will seek to identify genes and markers that could be used to improve drought resistance, disease and pest tolerance, environmental adaptation, and yields by examining the genomes of beans, wheat, rice and other crops essential in Asia and sub-Saharan Africa. The grant program is funded by BBSRC, the U.K. Department for International Development, the Bill and Melinda Gates Foundation, and India's Ministry of Science. GenomeWeb Daily News (free registration) (11/21)     

Hot Topics

Top five news stories selected by BIO SmartBrief readers in the past week.

• FDA OKs first seasonal flu vaccine made using animal cell cultures (Reuters)

• EU backs approval of Sanofi's diabetes and colorectal cancer drugs (CNBC)

• Why Proposition 37 lost in California (Western Farm Press)

• FDA gives OK to Mesoblast for mesenchymal precursor cell production (Australian Life Scientist)

• Roche's Avastin forestalls progression, death in brain cancer study (CNBC)

• Results based on number of times each story was clicked by readers.

Industrial & Environmental

• 38 U.S. senators express support for Pentagon's biofuels plan
  A group of 38 senators wrote a letter to the Senate leadership, seeking the elimination of provisions in the defense spending bill that would curtail the Department of Defense's ability to invest in renewable fuels. "Alternative fuels will not supplant fossil fuels entirely; however, replacing even a fraction of the fuels consumed by DOD with domestic alternative fuels has the potential to advance U.S. national security, improve strategic flexibility and insulate the defense budget against spikes in the cost of fossil fuels," the lawmakers wrote. Roll Call (free content) (11/25)     

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