USFDA

Alexion Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to ALXN1210, a highly innovative, longer-acting anti-C5 antibody that inhibits terminal complement, which is being evaluated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH). PNH is a debilitating, ultra-rare, life-threatening blood disorder in which uncontrolled activation of complement, a component of the immune system, results in hemolysis (destruction of a patient’s red blood cells).

Cesca Therapeutics Inc. announced  that the Company received approval from the U.S. Food and Drug Administration (FDA) for significant revisions to the Company’s pivotal study for treatment of Critical Limb Ischemia (CLI). The CLI clinical trial is designed to demonstrate the safety and efficacy of the Company’s point-of-care SurgWerks™ system for the treatment of CLI patients with limited or no treatment options. The study was first approved by FDA in June 2015, but was not initiated at that time pending funding.

CytRx Corporation , a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing new therapeutics to treat patients with cancer,  announced that, in response to a request from the company, the U.S. Food and Drug Administration (FDA) has agreed to a Type B pre-NDA meeting at which the company will seek input on its planned New Drug Application (NDA) for aldoxorubicin as a new second-line treatment for patients with soft tissue sarcomas (STS).  Assuming a positive outcome from this pre-NDA meeting, CytRx expects to submit an NDA for aldoxorubicin to the FDA in the last quarter of 2017, and, subject to FDA approval, bring aldoxorubicin to market next year.

Glenmark Pharmaceuticals, a global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) cleared the Company’s Investigational New Drug (IND) application to initiate a phase I study of its lead candidate, GBR 1302-BEAT™, in patients with HER2+ cancers. The company plans to expand the ongoing phase I clinical study to include sites in the United States for this potential first-in-class treatment, a humanized, bispecific monoclonal antibody targeting HER2 and CD3, based on the BEAT™ (Bi-specific Engagement of Antibodies based on the T cell receptor) technology platform.

Axsome Therapeutics, Inc.  announced that its Investigational New Drug Application (IND) for AXS-05 in the treatment of agitation in patients with Alzheimer’s disease (AD) has been cleared by the U.S. Food and Drug Administration (FDA). The IND clearance permits Axsome to proceed with its planned Phase 2/3 clinical trial of AXS-05 in this indication. Axsome anticipates commencing this trial in the first half of 2017.

Innocoll  announced that it has received a Refusal to File letter from the United States Food and Drug Administration (FDA) for XARACOLL, the company’s product candidate for the treatment of postsurgical pain.

Cempra, Inc. announced that the company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) relating to the company's new drug applications (NDAs) for oral and intravenous solithromycin for the treatment of community-acquired bacterial pneumonia (CABP) in adults.

The U.S. Food and Drug Administration (FDA) approved  Biogen’s SPINRAZA™ (nusinersen) under Priority Review for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. SPINRAZA is the first and only treatment approved in the U.S. for SMA, a leading genetic cause of death in infants and toddlers that is marked by progressive, debilitating muscle weakness.

Cipla Ltd, a global pharmaceutical company, has yielded a final approval for its lead MDI product Fluticasone + Salmeterol (Sereflo) from UK MHRA for its partner in the UK.

GenMark Diagnostics, Inc., a leading provider of automated, multiplex molecular diagnostic testing systems, has submitted 510(k) applications to the FDA for its ePlex sample-to-answer instrument and Respiratory Pathogen Panel.