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FDA Grants Orphan Drug Designation to Thrombotic Thrombocytopenic Purpura Drug
GC1126A is designed to treat the rare blood disorder.
GC Biopharma Corp. announced that GC1126A has been granted orphan drug designation by FDA. This will provide certain incentives, such as tax credits for clinical development costs.
The drug is a treatment for Thrombotic Thrombocytopenic Purpura, a rare and life-threatening blood disorder that can cause the formation of small blood clots.
GC1126A is designed to evade antibodies, providing it with a longer half-life within the body.
In a press release, a spokesperson for GC Biopharma said, “We are dedicated to collecting data to develop a Best-in-Class treatment for such rare disorders. We remain committed to our mission of providing patients with new treatment options by continuously developing innovative drugs."
The Weight-Loss Gold Rush: Legal and Regulatory Implications
July 11th 2024Jim Shehan, chair of the FDA Regulatory practice, Lowenstein Sandler, discusses how the FDA and other regulators likely to respond to the increased public interest and potential off-label use of GLP-1 drugs, what needs to be done for GLP-1s to be covered, advice for investors and financiers considering entering the weight-loss medication market and more.
Healthcare Marketing Strategies for Reaching Diverse Audiences
May 14th 2024Amanda Powers-Han, Chief Marketing Officer, Greater Than One, and Pharmaceutical Executive Editorial Advisory Board member, discusses how improved DE&I in healthcare marketing strategies can not only reach diverse audiences more effectively but also contribute to improved patient care outcomes, challenges faced in crafting culturally sensitive messages, and much more.
