FDA Approves Talecris’s Neurologic Drug
The US Food and Drug Administration has approved Talecris Biotherapeutics’ (Research Triangle Park, NC) Gamunex as a treatment for chronic inflammatory demyelinating polyneuropathy (CIDP).
The US Food and Drug Administration has approved Talecris Biotherapeutics’ (Research Triangle Park, NC) Gamunex as a treatment for chronic inflammatory demyelinating polyneuropathy (CIDP). CIDP is a debilitating neurological disorder that results in muscle weakness and fatigue, which can lead to severe impairment of motor skills.
Gamunex, which was granted orphan drug status, now has the broadest set of FDA-approved indications of any liquid immune globulin intravenous (IGIV) therapy. Gamunex also becomes the first and only IVIG therapy approved to treat any neurological disorder in the United States. The orphan drug designation grants Talecris marketing exclusivity for the treatment of CIDP with Gamunex for seven years.
Talecris’s release
The Solution Lies with SOLBIOTE™: Achieving Sustainability, a Growing Focus in Biopharma
October 28th 2024The nexus between biopharmaceuticals and sustainability is seemingly far apart, however, it is increasingly recognized as an inevitable challenge. It is encouraged to take a sustainable approach to reducing the environmental impact of the production and supply of medicines while improving people's health; delivering the well-being of people and the planet. Yosuke Shimojo (Technical Value Support Section Manager, Nagase Viita) will unveil how SOLBIOTE™, a portfolio of injectable-grade saccharide excipients, would be a key for the biopharmaceutical development and achieving sustainability for a better future of the industry.
