Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon announced today that it launched its Vistaseal fibrin sealant for managing bleeding during surgery. The sealant system is indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard techniques (suture, ligature, cautery) are ineffective or impractical. Vistaseal fibrin sealant consists […]
Grifols
J&J’s Ethicon wins clearance for devices to deliver Grifols surgical sealant
Johnson & Johnson’s Ethicon has won FDA clearance for airless spray devices to deliver Grifols’ fibrin sealant to stop surgical bleeding, the companies announced today. The Vistaseal fibrin sealant will be the first product Grifols (NSDQ:GRFS) is introducing with Johnson & Johnson (NYSE:JNJ) and Ethicon as part of a global partnership. The 510(k) clearance covers three Vistaseal […]
FDA’s Gottlieb updates on IV bag shortages after Hurricane Maria
FDA commissioner Dr. Scott Gottlieb expects that the shortage of IV fluids caused by Hurricane Maria in Puerto Rico will improve in the coming weeks and months, according to a statement issued by the agency yesterday. The regulatory chief said that the FDA is working with manufacturers like Baxter (NYSE:BAX) and B. Braun to import products […]
Grifols wins FDA nod for liquid formulation of replacement therapy for rare genetic disorder
Grifols (NSDQ:GRFS) said today that it won FDA approval for a liquid formulation of its alpha-1 antitrypsin, Prolastin-C Liquid, as a replacement therapy to treat alpha-1 antitrypsin deficiency. Prior to this approval, the company only offered Prolastin-C in a lyophilized format. The new formulation requires less preparation time and volume for infusion, according to Barcelona-based […]
Grifols pays $51m for minority stake in Access Biologicals
Grifols (NSDQ:GRFS) said today that it paid $51 million for a 49% stake in Access Biologicals, in a deal that includes an option to acquire the rest of the business. That option, for the remaining 51% share in Vista, Calif.-based Access, goes live in 2022, Grifols said. The agreement also includes a provision to supply Access with non-human-use […]
