USFDA

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.

Torn notebook recording deficiencies, lack of batch manufacturing records, use of unofficial notebooks, lack of audit trails on operation of computer systems, product mix-ups due to manufacturing deficiencies are some of the violations found by USFDA at Cadila Healthcare Ltd's two plants.

Gilead Sciences, Inc.  announced that the U.S. Food and Drug Administration (FDA) has granted priority review to the company’s New Drug Application (NDA) for an investigational, once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF)

The U.S. Food and Drug Administration issued two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally, or through the vagina. The FDA issued one order to reclassify these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices, and a second order that requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.

Hikma Pharmaceuticals PLC (“Hikma”) ,  the fast growing multinational pharmaceutical group, announces that its Abbreviated New Drug Application (“ANDA”) for Neostigmine Methylsulfate Injection USP, 5 mg/10 mL and 10 mg/10 mL, multiple-dose vials has been approved by the U.S. Food and Drug Administration (“FDA”)  and that it has launched this product in the US market.

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Addex Therapeutics, a leading company pioneering allosteric modulation-based drug discovery and development, announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to dipraglurant for the treatment of levodopa-induced dyskinesia associated with Parkinson’s disease (PD-LID). Orphan drug status provides Addex with a number of benefits including reduced development costs and seven years US market exclusivity from launch. Dipraglurant is a novel small molecule inhibitor of the metabotropic glutamate receptor 5 (mGluR5) that has successfully completed Phase II proof-of-concept testing in Parkinson's disease (PD) patients suffering from debilitating levodopa-induced dyskinesia (LID), an indication that has no approved treatment options. Addex is currently conducting an mGlu5 receptor occupancy clinical trial and is preparing to start a Phase III pivotal trial in PD-LID.