• Santhera Pharmaceuticals announces that the Office of Orphan Products Development (OOPD) at the US Food and Drug Admin-istration (FDA) has granted Santhera an award of USD 246,000 in support of its ongoing Phase I trial with omigapil (CALLISTO) in patients with congenital muscular dystrophy (CMD). Santhera is conducting CALLISTO in collaboration with the US National Institutes of Health (NIH). The FDA awards grants through the Orphan Products Grants Program to sup-port the clinical development of products for use in rare diseases where no current therapy exists.

  • Oragenics announced that it has received feedback from the U.S. Food and Drug Administration (FDA) in response to the Company’s request for a Type C meeting, concerning Phase 2 study protocols for the Company’s OM therapeutic candidate, AG013. As part of the clinical protocol for the study, Oragenics expects to file the Investigational New Drug (IND) update in late 2016 and initiate the study with AG013 in the United States and Europe during early 2017.

  • Cempra, Inc., a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, announced that the U.S. Food and Drug Administration (FDA) has scheduled a meeting of the Antimicrobial Drugs Advisory Committee on November 4, 2016 in Silver Spring, Maryland to discuss the safety and efficacy of solithromycin to treat community-acquired bacterial pneumonia (CABP).

  • Tonix Pharmaceuticals  Holding Co. which is developing next-generation medicines for fibromyalgia and post-traumatic stress disorder (PTSD), announced that it has received the final meeting minutes from the U.S. Food and Drug Administration (FDA) from an  End-of-Phase 2/Pre-Phase 3 meeting. These minutes confirmed the FDA’s acceptance of Tonix’s proposed Phase 3 studies and the planned New Drug Application (NDA) data package to support the registration of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the treatment of PTSD.

  • Bio2 Medical has announced that the Angel Catheter has received 510(k) clearance from the United States Food & Drug Administration (FDA). This 510(k) clearance includes a first ever, prophylactic indication for a medical device to protect critically ill patients at high-risk for pulmonary embolism (PE) and contraindicated for anticoagulation.  The Angel Catheter provides a novel alternative to IVC filters for PE protection in a vast patient population that has historically been underserved. The device is designed for bedside placement, without the need for fluoroscopic guidance, and is designed to be safely retrieved in all cases once no longer indicated.

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  • Mallinckrodt plc announced the U.S. Food and Drug Administration (FDA) has granted the company's request for a Fast Track designation for its Investigational New Drug (IND) application for Synacthen® Depot in the treatment of Duchenne muscular dystrophy (DMD). Synacthen Depot is a depot formulation of Synacthen (tetracosactide), a synthetic 24 amino acid melanocortin receptor agonist. Synacthen Depot is approved and marketed outside of the U.S. for certain autoimmune and inflammatory conditions, but has never been approved for use in patients in the U.S.

  • Zealand Pharma (Zealand) announced that Sanofi has submitted updated information on the pen delivery device for iGlarLixi to the U.S. Food and Drug Administration (FDA) as part of the New Drug Application (NDA) for the product. IGlarLixi is a once-daily, fixed-ratio combination of lixisenatide (AdlyxinTM) and insulin glargine 100 Units/mL (Lantus®) for the treatment of adults with type 2 diabetes.

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