GreenGene F (beroctocog alfa) / BMS, GC Biopharma - LARVOL DELTA

Green Cross “FDA inspection of blood products in the third quarter and approval of hemophilia treatment in China“ (Economic Review) - "GC Green Cross is expected to achieve significant R&D performance in the second half of this year. It is expected that the US FDA will inspect 10% of the blood product IVIG-SN, and approval of the hemophilia treatment 'Greengene F' in China is expected....Green Cross said, 'The blood product IVIG-SN 10% approval process is proceeding without any problems, and an FDA factory inspection is expected around September-October this year'. Green Cross added that the approval will be decided by February 25, 2022. The approval of Greengene F, a treatment for hemophilia, in China is only pending administrative procedures. Green Cross expected approval in China within the third quarter and launch in the first half of next year."

FDA event • Non-US regulatory • Genetic Disorders • Hemophilia

GC Pharma Announces GreenGene F Approval in China for the Treatment of Haemophilia A (Businesswire) - "GC Pharma...announced the approval of GreenGene F (Beroctocog alfa) for the control and prophylaxis of bleeding episodes in individuals with haemophilia A in China by the National Medical Products Administration (NMPA)....In the pivotal phase III clinical trial conducted in China, which served as the foundation for the approval....Through a collaboration with GC China, a leading plasma-derived haemophilia products provider in China and also a GC Pharma’s affiliate company, GreenGene F will be available in China within the first half of next year."

Launch non-US • Non-US regulatory • Genetic Disorders • Hemophilia

Gravidas with Class III Obesity: Evaluating the Abdominal Skin Microbiota Above and Below the Panniculus. (PubMed) - J Matern Fetal Neonatal Med - "In pregnant women with class III obesity, the skin microbiota in the subpannicular fold differs from and is more diverse than that on the anterior panniculus."

Journal • Biosimilar • Obesity

Safety and efficacy of B-domain deleted 3rd generation recombinant factorVIII (GreengeneF) in Korean patients with haemophilia A: Data from apost-marketing surveillance study (EHA 2016) - P=NA, N=136; "Excellent/good efficacy rate was 91.3% for hemostasis and 89.4% for hemorrhage prevention. Twelve subjects reported 13 adverse drug reactions (ADRs), which were recovered without sequelae. The frequent ADRs were gastrointestinal disorders, nervous system, vascular disorders and general disorders. In 113 previously treated patients (PTP), two patients (1.8%) developed inhibitors after intensive FVIII treatment for surgery and hematuria, respectively. The results of this PMS study support that GreenGene F^TM is safe and efficacious in the treatment and prevention of patients with hemophilia A."

Clinical data • Hemophilia

Longitudinal Survey of Microbiota in Hospitalized Preterm Very Low Birth Weight Infants. (PubMed) - "Our results suggest that while preterm infants have individualized microbiota that are detectable at birth, the differences decrease during the neonatal intensive care unit hospitalization with increasing prominence of pathogenic microbiota."

Journal • Biosimilar

GC Pharm files NDA for recombinant hemophilia drug in China (Pulse News) - "South Korean GC Pharm announced on Friday it has filed for a new drug application with the National Medical Products Administration (NMPA) in China, seeking approval for its global launch of hemophilia drug GreenGene F in China instead of the United States."

Non-US regulatory