USFDA

Stealth BioTherapeutics (Stealth), a biopharmaceutical company developing drug candidates for treating mitochondrial dysfunction, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for MTP-131 (also known as Bendavia) for the treatment of primary mitochondrial myopathy, characterized by muscle weakness in patients with genetic mitochondrial diseases. MTP-131 is currently being studied for the treatment of primary mitochondrial myopathy in its MMPOWER trial, with results expected midyear.

The U.S. Food and Drug Administration approved a new indication for the Integra Omnigraft Dermal Regeneration Matrix (Omnigraft) to treat certain diabetic foot ulcers. The matrix device, which is made of silicone, cow collagen, and shark cartilage, is placed over the ulcer and provides an environment for new skin and tissue to regenerate and heal the wound.

The U.S. Food and Drug Administration announced that U.S. Marshals, at the agency’s request, seized nearly 90,000 bottles of dietary supplements labeled as containing kratom. The product, manufactured for and held by Dordoniz Natural Products LLC, located in South Beloit, Illinois, is marketed under the brand name RelaKzpro and worth more than $400,000.

LivaNova PLC received a Warning Letter dated December 29, 2015, from the United States Food and Drug Administration (“FDA”) alleging certain violations of FDA regulations applicable to medical device manufacturers at its Munich, Germany and Arvada, Colorado facilities.

MiMedx Group, Inc., the leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic, and Dental sectors of healthcare, announced that it has recently posted an updated "Certificate to Foreign Government" on its website that describes all of the MiMedx  sheet form allografts and the Food and Drug Administration FDA's certification that the listed products are HCT/P's.

BOCA Cleartronic, Inc., through its subsidiary ReadyOp Communications, Inc., announces that the US Food and Drug Administration (FDA) has expanded its use of ReadyOp as an integral part of their communications and incident response planning.

Ionis Pharmaceuticals, Inc.  announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to IONIS-HTTRx for the treatment of patients with Huntington's disease (HD). IONIS-HTTRx is the first therapy to enter clinical development that is designed to directly target the cause of the disease by reducing the production of the protein responsible for HD. IONIS-HTTRx has also been granted orphan drug designation by the European Medicines Agency for the treatment of patients with HD.

United-Guardian, Inc.  announced  that it has received FDA approval of its Supplemental New Drug Application to market a new single-dose form of Renacidin® (Citric Acid, Glucono delta-Lactone, and Magnesium Carbonate), the company’s proprietary irrigating solution that is used to prevent and dissolve calcifications in indwelling catheters.

MabVax Therapeutics Holdings, Inc., a clinical-stage oncology drug development company, announces that it has received notice from the U.S. Food and Drug Administration (FDA) authorizing the initiation a Phase I clinical trial with HuMab-5B1 as a therapeutic treatment for pancreatic cancer.  The Company filed an Investigational New Drug (IND) application for its lead fully human antibody product on November 30, 2015.  Patient enrollment in the Phase I clinical trial is expected to begin at multiple investigational sites in early 2016.

Matinas BioPharma Holdings, Inc., a clinical-stage biopharmaceutical company focused on identifying and developing safe and effective therapeutics for the treatment of serious and life-threatening infections, announced that on December 31, 2015, the Company filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for its lead antibacterial development candidate, MAT2501.