Sanofi Pasteur, the vaccines division of Sanofi SA, of Paris, said the FDA has approved the supplemental biologics license application (sBLA) for licensure of its four-strain influenza vaccine, Fluzone Quadrivalent, for use in children 6 months of age and older, adolescents and adults

Neumedicines is advancing the nonclinical efficacy and human safety development of Hemamax toward submission of a biologic license application under the FDA's Animal Rule for the treatment of HSARS

Bristol-Myers Squibb Co., of Princeton, N.J., and AstraZeneca plc, of London, said the FDA accepted for review and granted priority designation for the biologics license application for metreleptin in metabolic disorders associated with inherited or acquired lipodsytrophy

BioMarin Pharmaceutical Inc., of San Rafael, Calif., said the FDA accepted for review the biologics license application for Vimizim (BMN-110, elosulfase alfa), an enzyme replacement therapy under evaluation for the treatment of patients with the rare lysosomal storage disorder mucopolysaccharidosis Type IVA, also called Morquio A syndrome

Biogen Idec Inc., of Weston, Mass., submitted a biologics license application to the FDA for Plegridy (peginterferon beta-1a), the company's pegylated subcutaneous injectable candidate for relapsing forms of multiple sclerosis. (See BioWorld Today, Jan. 25, 2013

The study also will advance HemaMax toward a biologics license application submission by fulfilling the FDA requirement for a bridging study to evaluate efficacy of HemaMax with Level 1 supportive care...Seattle Genetics Inc., of Bothell, Wash., said the FDA accepted for filing its supplemental biologics license application supporting the use of Adcetris (brentuximab vedotin) for retreatment and extended duration beyond 16 cycles of therapy in relapsed Hodgkin lymphoma (HL) and systemic anaplastic

Biogen Idec Inc., of Weston, Mass., said the FDA accepted the firm's biologics license application for Eloctate (recombinant Factor VIII Fc fusion protein) for the treatment of hemophilia A. The application was based on results from the A-LONG program, showing that patients who injected Eloctate once weekly to twice weekly had low annualized bleeding rates

Inc., of Whitehouse Station, N.J., said the biologics license application (BLA) for its investigational ragweed pollen (Ambrosia artemisiifolia) sublingual allergy immunotherapy tablet was accepted for review by the FDA

A biologics license application for the drug was submitted last month

Santarus Inc., of San Diego, and Pharming Group, of Leiden, the Netherlands, said they submitted a biologics license application (BLA) for Ruconest (recombinant human C1 esterase inhibitor) for acute angioedema attacks in patients with hereditary angioedema

BioMarin Pharmaceutical Inc., of San Rafael, Calif., said it submitted a biologics license application to the FDA for Vimizim (BMN-110, elosulfase alfa), formerly known as GALNS (N-acetylgalactosamine-6 sulfatase

Inc., of Whitehouse Station, N.J., said the biologics license application for its Timothy grass pollen (Phleum pretense) allergy immunotherapy tablet was accepted for review by the FDA

Seattle Genetics Inc., of Bothell, Wash., submitted a supplemental biologics license application to the FDA for the use of Adcetris (brentuximab vedotin) in the retreatment and extended duration beyond 16 cycles of therapy in relapsed Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL

Biogen Idec Inc., of Weston, Mass., submitted a biologics license application (BLA) for its recombinant Factor VIII Fc fusion protein for the treatment of hemophilia A. The submission was based on data from A-LONG, a Phase III study showing that the drug controlled bleeding episodes in 98 percent of patients with one or two injections

The FDA accepted a biologics license application from Biogen Idec, of Cambridge, Mass., for marketing approval of recombinant factor IX Fc fusion protein for hemophilia B, granting a standard review timeline

Baxter International Inc., of Deerfield, Ill., said it submitted a biologics license application supplement to the FDA for approval of prophylaxis treatment of FEIBA NF (anti-inhibitor coagulant complex), nanofiltered and vapor-heated, in patients with hemophilia A or B and inhibitors

The FDA accepted an application from Genzyme Corp., of Cambridge, Mass., a unit of Sanofi SA, for review of its supplemental biologics license application for Lemtrada (alemtuzumab) for relapsing multiple sclerosis

According to a prospectus filed by Auxilium Pharmaceuticals Inc., of Malvern, Pa., the FDA will not review its supplemental biologics license application for Xiaflex in Peyronie's disease in an advisory committee meeting

Biogen Idec Inc., of Weston, Mass., submitted a biologics license application to the FDA for recombinant factor IX Fc fusion protein (rFIXFc) for the treatment of hemophilia B