KaloBios Pharmaceuticals' investigational new drug application for benznidazole as a treatment for patients with Chagas disease received FDA approval. KaloBios intends to file a new-drug application in the first quarter next year under the abbreviated 505(b)(2) pathway.
Sarepta Therapeutics opened its Andover, Mass.-based Research and Manufacturing Center, which will initially start development of up to seven investigational Duchenne muscular dystrophy drugs by the end of the year. Included in the Sarepta pipeline to be advanced in the facility are late-stage-ready DMD treatments that skip exon 53 and exon 45, a preclinical candidate that skips exon 52 and discovery-phase candidates designed to skip exons 8, 35, 43, 44, 50, and 55.
Researchers from China have developed purple biotech rice that can reduce the risk of cardiovascular disease, diabetes, certain cancers and other chronic disorders. Scientists used a transgene stacking system called TransGene Stacking II that assembles a large number of genes in single vectors so that the plants produce high levels of anthocyanins.
The Institute of Chemical Technology Mumbai and L&T Hydrocarbon Engineering have agreed to collaborate to build second-generation ethanol plants in India. Under the deal, L&T will provide construction and engineering services while the institute will provide its multifeedstock technology.
An investigational new drug application has been filed by Trovagene for its Phase Ib/II study assessing PCM-075 for treatment of acute myeloid leukemia.
Almirall has been granted approval by the European Commission for its oral dimethyl fumarate therapy Skilarence for use as a first-line induction and maintenance treatment for adult patients with moderate to severe plaque psoriasis. Almirall intends to commercialize the drug in Iceland, Norway and all EU states in the third quarter.
Janssen's continuous manufacturing with real-time release testing for the production of 600-mg Prezista, or darunavir, tablets has been approved by the European Medicines Agency. The process will occur at Janssen's Gurabo, Puerto Rico, production plant.
About 61,538 pounds of Sam's Choice Asian Style Beef Wonton Ravioli were recalled by Wornick because they might include milk as an undeclared ingredient. The recalled products were distributed nationwide to retail stores.
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