Pharma News

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.

PharmaCyte Biotech, Inc., a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today announced that it will be meeting with the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) on Tuesday, January 17, 2017. The meeting is to discuss numerous aspects of PharmaCyte’s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).

Lonza has concluded the divestment of its peptides business located in Braine-l’Alleud, (BE) to PolyPeptide Laboratories Holding (PPL). The facility, with approximately 280 employees, was the center for peptide chemical development and manufacturing within Lonza. The intention to divest was announced at the beginning of December 2016.

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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.

Ardelyx, Inc., a clinical-stage company, announced the initiation of a phase 3 clinical trial and an onset-of-action clinical trial evaluating RDX7675 in patients with hyperkalemia, a potentially life-threatening condition common in patients with cardiorenal disease.

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.

ContraVir Pharmaceuticals, Inc., a biopharmaceutical company, announced that the company was awarded a $297,875 CAD research grant from the National Research Council in Canada through the Council's Industrial Research Assistance Program (IRAP). Proceeds from the grant will fund a substantial portion of personnel expenses, including the hiring of additional laboratory staff, which is expected to advance preclinical development of ContraVir's potent cyclophilin inhibitor CRV431 for the Treatment of Hepatitis B (HBV).

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.

Prima BioMed Ltd announces that it has developed a new early stage product candidate, a humanised IgG4 monoclonal antibody to be known as IMP761. This antibody, developed at the Company’s laboratory in Châtenay-Malabry south of Paris, is believed to be the first agonist antibody of LAG-3.