Pharma News

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.

NeuroVive Pharmaceutical AB, the mitochondrial medicine company, announced that the company is scheduled to present the 9th Annual Biotech Showcase Conference held January 9-11, 2017 in San Francisco, US. During the presentation, an update regarding NeuroVive's research and development programs will be provided. The presentation will include the company’s two orphan drug projects, NeuroSTAT in clinical phase II for the treatment of traumatic brain injury (TBI), and the discovery project NVP015 targeting genetic mitochondrial diseases. Also, the preclinical out-licensing projects related to the large NASH indication, NV556 and NVP022, will be presented.

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.