EU Clinical Trials Register is a database of all clinical trials commencing in the European Community from 1 May 2004 onwards. No medical relationship with any participant is implied in any way. With respect to Kytril, Tazicef (ceftazidime), and the antiviral drugs Famvir and Denavir, Glaxo SmithKline would be required to submit all confidential information and know-how to the corresponding purchaser, ensure that the former sales force and management who participated in marketing the drug maintain the confidentiality of this information, prohibit former sales and marketing personnel from selling competing products (as specified in the agreement) for between six and twelve months, and require Glaxo SmithKline to contract manufacture the drugs until each purchaser obtains FDA approval to manufacture the drug for itself. EU Clinical Trials Register is a database of all clinical trials commencing in the European Community from 1 May 2004 onwards. EU Clinical Trials Register is a database of all clinical trials commencing in the European Community from 1 May 2004 onwards. EU Clinical Trials Register is a database of all clinical trials commencing in the European Community from 1 May 2004 onwards. Regulatory submissions in the European Union and Canada are on track for 2016 and planned for Japan in 2017.
The submission to the EMA follows regulatory submissions to the US Food and Drug Administration (FDA) in October of this year and to Canada regulatory authorities earlier this month, with a Japan submission planned for 2017. Brand names are trademarks either owned by and/or licensed to GSK or associated companies. Regulatory submissions in the European Union and Canada are on track for 2016 and planned for Japan in 2017. People are advised to seek a second medical/nursing opinion and to not make health related choices based solely on the advice given here. Descriptive analysis. “GlaxoSmithKline has made the decision not to pursue further worldwide development of Simplirix,” the company said in a statement. Although researchers did find the vaccine had 58 per cent efficacy against genital disease from herpes simplex virus type-1, they noted that ‘efficacy against HSV-2 infection was not observed’.
Six years after vaccination with HZ/su, gE-specific cell-mediated immune responses and anti-gE antibody concentrations had decreased by 20-25% from month 36, but remained higher than the prevaccination values. In confirmed HZ cases, QL scores were compared between the 2 groups. VE against HZ in ZOE-50 was 97.6% (95% confidence interval: 92.7–99.6) in adults ≥60 YOA. As the division expands its focus from pediatric and adolescent vaccines to include vaccines for pregnant women and the elderly population, successful launches of its Shingrix shingles vaccine and other late-stage projects will be necessary to boost market share in the US and remain sustainable. La percentuale di soggetti con eventi avversi seri, potenziali malattie immuno-mediate o morte è stata simile nel gruppo placebo e nel gruppo vaccino. We evaluated the mechanisms by which complement activation occurred in seronegative human serum. To answer these questions we need to take a closer look at what its management team had to say during its quarterly conference call.
Furthermore, GlaxoSmithKline’s management team stood by its prior full-year forecasting, which calls for a core EPS decline in the mid-teen percentage rate based on constant exchange rates and a return to core EPS growth in 2016. The company has also reported that Shingrix was 89-percent effective against postherpetic neuralgia. Most vaccines provide the immune system with key pathogen-derived molecules to help it later recognize and attack the same intruder. On Wednesday, GSK said Shingrix maintained its 90% efficacy in adults 70 and older for at least four years. At one point Advair/Seretide was an $8 billion-plus drug in terms of annual sales. This minireview is divided into the categories that the keynote speaker, Michel Klein (Canadian Network for Vaccines and Immunotherapeutics, Université de Montreal), indicated to be the basis for new vaccine development: (i) biological basis for vaccine development, (ii) new technologies, (iii) new targets, (iv) bringing a vaccine to market, and (v) current issues in vaccine development. Here we report immunogenicity and safety of 2 HZ/su doses administered at intervals longer than 2 mo.
Study team. GSK (LSE/NYSE: GSK) announced today it has begun shipping FLUARIX® QUADRIVALENT (Influenza Vaccine) doses to US healthcare providers, following licensing and lot-release approval from the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research. The Herpevac Trial evaluated a herpes simplex virus type 2 (HSV-2) glycoprotein D (gD2) subunit vaccine to prevent genital herpes. Background: The recombinant herpes zoster (HZ) subunit vaccine candidate (HZ/su) has demonstrated >90% efficacy in preventing HZ, robust immunogenicity and an acceptable safety profile in adults ≥50 years of age (YOA). This will be the first time in humans (FTIH) study with the GSK Bio recombinant gB antigen to evaluate safety and immunogenicity of this CMV candidate vaccine with a proprietary GSK adjuvant system.