Breaking News

Teva, Active Biotech to Continue Nerventra Development

May 23, 2014

Despite CHMP opinion, companies will pursue multiple sclerosis indication

Teva Pharmaceutical and Active Biotech will continue development of Nerventra (laquinimod) following the Committee for Medicinal Products for Human Use (CHMP) opinion to recommend against approval for the treatment of relapsing-remitting multiple sclerosis (RRMS) in the EU.
 
Both companies remain committed to the clinical development program for multiple sclerosis (MS) and will evaluate the CHMP feedback to determine potential next steps. To confirm the benefits of the drug on disability progression, Teva is conducting the Phase III CONCERTO trial, the largest MS trial with disability progression as the primary endpoint. Teva is also investigating the potential of Nerventra in progressive forms of MS.  
 
“We are disappointed with the outcome of the re-examination and will be working with the EMA to make Nerventra available to multiple sclerosis patients in the EU,” said Michael Hayden, Teva's president of Global R&D and chief scientific officer. “We believe Nerventra has a favorable risk-benefit profile and the potential to fulfill an unmet need for a treatment that decreases disability progression, and protects against brain volume loss, two important goals in the management of MS.”

blog comments powered by Disqus
  • Cold Chain Packaging Trends

    Cold Chain Packaging Trends

    Kristin Brooks, Contract Pharma||February 4, 2016
    Susan Li of UPS discusses supply chain trends, challenges, and packaging innovations

  • Packaging Equipment Trends Preview

    Packaging Equipment Trends Preview

    Kristin Brooks, Contract Pharma||January 26, 2016
    Christian Treitel of Bosch Packaging Technology discusses trends and capabilities

  • Filings Update

    Filings Update

    December 1, 2015
    Roche, Pfizer, Janssen, BMS and more

  • Elemental Impurity Testing

    Elemental Impurity Testing

    Dr. Andrew Fussell, PANalytical ||January 28, 2016
    Advances in elemental impurity testing aid compliance with new USP requirements

  • Fit-For-Purpose Assay Development in Bioanalysis

    Fit-For-Purpose Assay Development in Bioanalysis

    Franklin Spriggs, Ligand Binding Assay Group Leader; Ashley Brant, Program Manager, AIT Bioscience||January 28, 2016
    The success of bioanalytical studies relies on the selection of the most suitable analytical method but the timeline of method development and types of analyses involved vary greatly.

  • Optimizing Collaboration Effectiveness in Alliance Partnerships

    Optimizing Collaboration Effectiveness in Alliance Partnerships

    Mary Jo Lamberti, Phil Birch, Ranjana Chakravarthy, Ken Getz, Tufts CSDD||January 28, 2016