Dynavax Technologies Corp., of Berkeley, Calif., said the FDA will convene a meeting of its Vaccines and Related Biological Products Advisory Committee on Nov. 14-15 to discuss Heplisav
Dynavax Technologies Corp., of Berkeley, Calif., said the European Medicines Agency (EMA) accepted the marketing authorization application (MAA) filing for Heplisav, pursuing an indication for immunization against infection caused by all known subtypes of hepatitis B virus in adults, ages 18 to 70, and in patients with chronic kidney disease
Technologies Corp. (Berkeley, Calif.) Heplisav Vaccine Hepatitis B virus FDA accepted the BLA 6/27/12 Gilead Sciences Inc. (Foster City, Calif.) Elvitegravir An integrase inhibitor HIV-1 infection Submitted an NDA 6/29/12 MISCELLANEOUS Raptor Pharmaceutical Corp. (Novato, Calif.) RP103 Cysteamine bitartrate delayed-release capsules Nephropathic cystinosis NDA was accepted for review by the FDA 6/15/12 Regenicin Inc. (Little Falls, N.J.) PermaDerm A tissue-engineered skin prepared from autologous
Dynavax Technologies Corp., of Berkeley, Calif., said the FDA accepted a biologics license application for Heplisav, an investigational hepatitis B vaccine, for immunization against all known subtypes of hepatitis B virus in adults, ages 18 through 70
Technologies Corp. (unit of Medicis Pharmaceutical Corp.; Scottsdale, Ariz.) Solta Medical Inc. (Hayward, Calif.) 9/14/11 11/1/11 $35 Solta bought all outstanding shares of Medicis for $15M upon closing, and up to $20M in regulatory milestones and contingent payments Synageva BioPharma Corp. (Lexington, Mass.) Trimeris Inc. (Durham, N.C.) 6/14/11 11/4/11 ND Synageva is gaining access to the public markets through the transaction, which gives it 75% of the combined company and Trimeris a quarter
Technologies Corp. (Berkeley, Calif.) Heplisav Vaccine Hepatitis B virus Phase III data showed it was well tolerated and demonstrated superior and more durable seroprotection earlier than the licensed comparator
Dynavax Technologies Corp., of Berkeley, Calif., reported final data from a pivotal Phase III trial showing that hepatitis B vaccine candidate Heplisav provided seroprotection to 90 percent of chronic kidney disease (CKD) patients compared to 82 percent of those receiving Engerix-B (GlaxoSmithKline plc) at the primary endpoint (p = 0.01), one month after the third dose of Heplisav and the eighth dose of Engerix-B. Additional analysis showed Heplisav provided seroprotection to more than twice as
Technologies Corp. (Gainesville, Fla.) Foundation Fighting Blindness $1.5 Grant To fund preclinical studies of a gene therapy for X-linked retinoschisis (9/22) DiscoveryBioMed Inc. (Birmingham, Ala.) National Institutes of Health ND Two-year grant For validation of its cystic fibrosis corrector ligand technology (9/15) Dynavax Technologies Corp. (Berkeley, Calif.) National Institute of Allergy and Infectious Diseases $0.6 Two-year SBIR grant To fund research to characterize the role of the
Dynavax Technologies Corp., of Berkeley, Calif., said results of an early Phase III study showed Heplisav was well tolerated and demonstrated superior and more durable seroprotection earlier than the licensed comparator hepatitis B vaccine
Technologies Corp. (Berkeley, Calif.) Heplisav HBV-10 vaccine Hepatitis B virus Pivotal Phase III data showed that a short, two-dose regimen of Heplisav over one month was well tolerated and superior to a three-dose regimen over six months (2/15) Intercell AG (Vienna, Austria) Ixiaro/Jespect Vaccine Japanese encephalitis Completed a pivotal Phase III study in the Philippines and a second Phase III study in the European Union, U.S
Dynavax Technologies Corp., of Berkeley, Calif., said it held a pre-biologics license application (BLA) meeting with the FDA and agreed to submit the initial Heplisav BLA for an indication in healthy adults ages 18-70
Hauswirth is co-founder of Alachua, Fla.-based Applied Genetic Technologies Corp., which aims to use adeno-associated virus-based gene therapy for the treatment of degenerative eye disease and "might, in the future, commercialize some aspects of this work," according to the paper's conflict of interest statement Beltran said that the success of gene therapy in treating visual diseases is partly because the eye is "a small organ that you can easily get to and inject
By Anette Breindl | BioWorld Today | Tuesday, January 24, 2012
Dynavax Technologies Corp., of Berkeley, Calif., said the FDA will convene a meeting of its Vaccines and Related Biological Products Advisory Committee on Nov. 14-15 to discuss Heplisav