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12/9/2016

The FDA has granted orphan drug status to Biohaven's BHV-0223, an investigational treatment for amyotrophic lateral sclerosis. The drug is a sublingual tablet formulation of riluzole.

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eMPR.com
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FDA, Biohaven, Riluzole
12/9/2016

Provectus Biopharmaceuticals and the Pediatric Oncology Experimental Therapeutics Investigators Consortium have entered into a joint research agreement focused on the firm's late-stage ablative immunotherapy candidate PV-10 as a potential pediatric cancer treatment. Provectus and the consortium will also work with several National Cancer Institute cancer centers included in POETIC.

12/9/2016

The European Commission has approved the use of AbbVie's Venclyxto, or venetoclax, as a monotherapy for chronic lymphocytic leukemia in adults with or without 17p deletion or TP53 genetic mutation whose condition did not improve after treatment with chemoimmunotherapy and a B-cell receptor inhibitor.

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PharmaTimes (U.K.)
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European Commission, EU
12/9/2016

Takeda Pharmaceuticals and Arcturus Therapeutics agreed to collaborate on the development of RNA-based treatments for gastrointestinal-related disorders including nonalcoholic steatohepatitis in a deal of undisclosed value. The firms will use Arcturus' LUNAR therapeutic delivery platform and UNA Oligomer chemistry.

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PharmaBiz.com (India)
12/9/2016

A round of Series A financing has pulled in $18.9 million for immuno-oncology firm Eutilex. The South Korea-based company will use the proceeds to help construct a manufacturing site and back a midstage study of 4-1BB, an autologous T-cell therapy that targets TNFRSF9.

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BioCentury
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Eutilex
12/9/2016

South Africa signed an import agreement with the US to allow the import of biotech white and yellow maize, according to the South African Cereals and Oilseeds Trade Association. SACOTA Executive Director De Wet Boshoff defended biotech food and said biotech maize undergoes vigorous scientific testing and verification processes that show it is safe.

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South Africa, US
12/9/2016

A new-drug application has been submitted by Gilead Sciences to the FDA for its single-tablet regimen of sofosbuvir, velpatasvir and voxilaprevir with supporting data mainly from two late-stage trials. The combination therapy is designed to treat six types of chronic hepatitis C virus infection in patients with compensated cirrhosis or without cirrhosis who have taken direct-acting antiviral agents.

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Gilead Sciences, FDA
12/9/2016

Baxalta has received a Form 483 from the FDA, listing inspection observations such as inadequate sampling to ensure compliance with labeling standards and inappropriate use of investigation methods. The agency also observed that the firm failed to correct observations from its 2014 inspection regarding broken vials.

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FDAnews
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FDA, Baxalta
12/9/2016

The FDA has granted an orphan drug designation to Viking Therapeutics' VK0214, an orally available thyroid receptor beta agonist designed to manage X-linked adrenoleukodystrophy. The drug is being studied under preclinical models of the rare and often fatal metabolic disease.

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PharmaBiz.com (India)
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Viking Therapeutics
12/9/2016

The European Commission has expanded the indications for Novartis' Lucentis, or ranibizumab, approving its use as a treatment for patients whose vision is impaired because of choroidal neovascularization for reasons other than neovascular age-related macular degeneration or secondary to pathologic myopia. The decision was supported by the results of a study demonstrating the drug's ability to significantly improve patients' visual acuity by roughly 10 letters at two months, which lasted until the end of the yearlong study.