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  • Aralez Pharmaceuticals Inc., a global specialty pharmaceutical company, announced that the US Food and Drug Administration (FDA) has approved once-daily Yosprala, the only prescription fixed-dose combination of aspirin, an anti-platelet agent, and omeprazole, a proton pump inhibitor (PPI) in the US. Yosprala is indicated for patients who require aspirin for secondary prevention of cardiovascular (CV) and cerebrovascular events and who are at risk of developing aspirin associated gastric ulcers. The company is expanding its US sales force by 85 representatives in September to a total of 110 high quality sales representatives and plans to begin the US promotional launch of Yosprala the first week in October.

  • Novavax, Inc., announced topline data from two clinical trials of its RSV F-protein recombinant nanoparticle vaccine candidate (RSV F Vaccine) in older adults.  The Resolve™ trial, a Phase 3 trial of our RSV F Vaccine in 11,856 older adults (60 years of age and older), did not meet the pre-specified primary or the secondary efficacy objectives, and did not demonstrate vaccine efficacy. Consistent with our previous clinical experience, the vaccine was well tolerated.

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  • Dr Reddy’s Laboratories Ltd recently announced that it has expanded its strategic collaboration with Amgen, one of the world's leading independent biotechnology companies, to market and distribute three of Amgen’s medicines in India in the therapy areas of oncology and osteoporosis. Under the terms of the collaboration, Dr Reddy’s will commercialise XGEVA (denosumab), Vectibix (panitumumab) and Prolia (denosumab) in India.

  • AstraZeneca announced two new randomised, placebo-controlled Phase IIIb outcome trials with Forxiga (dapagliflozin), an SGLT-2 inhibitor currently indicated for the treatment of type-2 diabetes. These two large outcome trials will help to define the potential role of dapagliflozin in the management of chronic kidney disease and chronic heart failure respectively, in people with and without type-2 diabetes.

  • Array BioPharma announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) related to BEACON CRC, a global Phase 3 trial of encorafenib and Erbitux® (cetuximab), with or without binimetinib, versus standard of care in patients with BRAF-mutant colorectal cancer (CRC) who have previously received first-or second-line systemic therapy.

  • Fluxion Biosciences, Inc. announced that it has launched a new imaging system, the IsoFlux Cytation Imager, designed to work exclusively with the IsoFlux Liquid Biopsy System and CTC Enumeration Kit. The IsoFlux Cytation Imager comes pre-configured with all components and software required for automated CTC image acquisition.

  • Merck announced that a Phase 3 study (VERTIS SITA2) of ertugliflozin, an investigational oral SGLT2 inhibitor for the treatment of patients with type 2 diabetes, met its primary endpoint. Both 5 mg and 15 mg daily doses of ertugliflozin showed significantly greater reductions in A1C* of 0.69 percent and 0.76 percent, respectively, compared with placebo (p<0.001, for both comparisons), when added to patients on a background of sitagliptin (100 mg/day) and stable metformin (≥1500 mg/day). These study results were presented for the first time during an oral session at the 52nd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Munich, Germany.

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