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Mesoblast Submits Clinical Efficacy and Safety Data to FDA in Rolling Biologics License Application for Remestemcel-l

Mesoblast Limited (Nasdaq: MESO) announced that the United States Food and Drug Administration (US FDA) has confirmed receipt of Mesoblast’s filing of clinical efficacy and safety data for remestemcel-L in its rolling Biologics License Application (BLA) for the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD). The final module will be filed during January, and Mesoblast will request an expedited FDA review of the BLA under the product candidate’s existing Fast Track designation. …read more […]

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What Happens When an Airline Opens a Restaurant?

(Bloomberg Opinion) — The Mid Valley Megamall in Kuala Lumpur has more than 100 restaurants, cafes, and snack stands to meet every kind of craving. As of this month, that list includes a novel and seemingly quixotic option: Santan, a cafe that serves airplane food in cardboard boxes.As restaurant concepts go, “quick airplane food” isn’t an obvious winner. But Santan is owned and operated by AirAsia Group Bhd, the region’s most successful budget airline. With profits declining in the industry, the company is looking to diversify — it wants to reduce flying from 80% of its business to about 40% …read more […]