YONGIN, South Korea--(BUSINESS WIRE)--GC Pharma (KRX:006280) today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) in response to its Biologics License Application (BLA) for ‘ALYGLO (Immune Globulin Intravenous (Human), 10% Liquid)’. The FDA issues a CRL to indicate that the review cycle for an application is complete but the application cannot be approved in its current form.
YONGIN, South Korea--(BUSINESS WIRE)--GC Pharma (formerly known as Green Cross Corporation) (KRX: 006280), a South Korean biopharmaceutical company, today announced unaudited consolidated financial results for the year ended 31 December 2021.
YONGIN, South Korea--(BUSINESS WIRE)--GC Pharma (006280.KS) today announced that the European Medicines Agency (EMA) granted orphan drug designation (ODD) to Hunterase ICV (intracerebroventricular, generic name: idursulfase-beta (recombinant)) for the treatment of mucopolysaccharidosis type II (Hunter syndrome) in the European Union.
Industry sources said Janssen conducted a site inspection of GC Pharma’s drug manufacturing facility this month. The inspection was said to have gone through without any particular issues.
Mirum Pharmaceuticals has a target action date of September 29, 2021, for its New Drug Application (NDA) for maralixibat to treat cholestatic pruritus in patients with Alagille syndrome. The drug is an oral apical sodium-dependent bile acid transporter inhibitor. The NDA is being evaluated under a Priority Review pathway.
Two more local companies have newly joined the “K-mRNA vaccine consortium,” a local alliance of pharmaceutical companies dedicated to co-developing and co-producing homegrown messenger RNA vaccines.
YONGIN, South Korea--(BUSINESS WIRE)--GC Pharma (006280.KS) today announced the approval of GreenGene F (Beroctocog alfa) [Recombinant Human Coagulation Factor VIII for injection] for the control and prophylaxis of bleeding episodes in individuals with haemophilia A in China by the National Medical Products Administration (NMPA). GreenGene F was initially approved by the Korean health authority in 2010 for control and prevention of bleeding episodes in patients with haemophilia A.
GC Pharma (006280.KS) and Tottori University today announced a worldwide licensing and collaboration agreement for the orally administrable chaperone drug of GM1 gangliosidosis (GM1). GM1 is one of the inherited lysosomal storage diseases caused by mutations in the GLB1 gene, that progressively destroys nerve cells in brain and spinal cord. It occurs in approximately 1 out of every 100,000 newborns. There is currently no cure.
GC Pharma (formerly known as Green Cross Corporation) (KRX: 006280), a South Korean biopharmaceutical company, today announced unaudited consolidated financial results for the three months ended 30 June 2021.
YONGIN, South Korea--(BUSINESS WIRE)--GC Pharma (006280.KS) today announced that the United States Food and Drug Administration (FDA) accepted the company’s Biologics License Application (BLA) for 'GC5107 (Immune Globulin Intravenous (Human),10% Liquid)’ intended for the treatment of Primary Humoral Immunodeficiency (PI), a class of inherited genetic disorders that causes an individual to have a deficient or absent immune system.