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FDA issued Glaxo a warning letter for FluLaval plant
Jul. 1, 2014
After an inspection from March 31 to April 9 of this year, FDA has issued a warning letter to GSK's FluLaval influenza vaccines in Ste-Foy, Quebec for not doing its part to avoid contamination. The warning letter resulted in GSK tossing more than 20% of the lots produced this year.
BravoBio attended 6th Human and Veterinary Vaccine Industry Summit in Changchun
Jul. 6, 2014
BravoBio attended 6th Human and Veterinary Vaccine Industry Summit which was held in Changchun from July 4th to 5th, 2014. Dr.Wu chaired the morning session in July 4th. He also attended the panel discussion that afternoon and made some suggestions on how to enhance government-coporate communication.
The top 5 vaccines by 2020
Jul. 7, 2014
The top 5 vaccines are namely, pfizer's Prevanar (a pneumococcal 13-valent conjugated vaccine), Sinofi's Pantocel (Diphtheria, pertussis/whooping cough; tetanus; polio; Haemophilus influenzae type B), Merck's Gadasil (Human papillomavirus), Sinofi's Fluzone (Influenza) and GSK's Pediarix (Diphtheria; tetanus; pertussis/whooping cough; hepatitis B; polio). Pfizer's Prevanar is now taking the lead with $3.76 billion sale in 2013 and is expected to widen its lead with sales growing more than 61% over the next 5+ years, predicted by EvaluatePharma.
BravoBio attended World Vaccine Congress Aisa 2014 in Singapore
Jul. 7, 2014
The World Vaccine Congress Aisa 2014 was held in Singapore in June 9-11 this year. Ms.Xiaoshu Zhang, Director of Business Development gave a speech on Novel Vaccines for Emerging Diseases.
Novartis supplies US with Flucelvax ahead of upcoming flu season
Jul. 10, 2014
Novartis starts to supply at least 30 million doses of its cell-culture Flucelvax vaccine and egg-based Fluvirin to fight against the upcoming flu season beginning in October. Though Novartis doesn't have a quadrivalent vaccine like GSK, Sanofi or AstraZeneca, but its Flucelvax is preservative and antibiotic-free and it has got a FDA-licensed plant in Holly Springs, NC, which is the country's first pandemic-ready site.
Sinofi's dengue virus vaccine got positive phase III data
Jul. 11, 2014
Sinofi's dengue virus vaccine got positive phase III data in a study of 10,275 children aged 2 to 14 across Asia, reducing the incidence of dengue by 56.6%. A three-shot regimen cut hemorrhagic fever, by 88.5% and reduced hospitalizations by 67%. But while the vaccine was effective against serotypes 1, 3 and 4, it posted just 34.7% efficacy in serotype 2.
An additional IPV shot provides greater protection in children
Jul. 17, 2014
An extra dose of the inactivated polio vaccine (IPV) could help further protect children under 5 years old in high-risk countries, like Afghanistan, Nigeria and Pakistan. A new study showed that the additional IPV dose boosted levels of protective antibodies against poliovirus compared with no vaccine. The supplementary IPV dose could also boost herd immunity in children already vaccinated with oral poliovirus vaccine (OPV).
GSK submits the world's first experimental malaria vaccine for EMA approval
Jul. 25, 2014
It has taken GSK 30 years to finally submit the world's first experimental malaria vaccine to EMEA for regulatory review. In a phase III trial that involved 15,000 children in 7 countries, the vaccine posted weaker-than-hoped-for prevention numbers and displayed waning immunity. But with no other vaccines available now, GSK's experimental vaccine together with other treatments can still help control malaria. GSK will sell the vaccine for 5% more than the manufacturing cost and reinvest the profit into malaria research.
Sanofi may file for dengue vaccine approval in Q1 next year
Aug. 1, 2014
Sinofi has been working on dengue virus vaccine for more than 20 years and now it plans to submit approval application for the world's first dengue vaccine candidate in the first quarter of 2015. Sinofi will first launch the vaccine in Latin America countries like Mexico, Brazil and Colombia and then target Asian countries like Singapore and Malaysia. In a Phase III study of 10,275 children across Asia, the candidate posted just 34.7% efficacy against serotype 2, one of four dengue virus strains.
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