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News Center
FDA banned two Wockhardt plants
After banning the first Wockhardt's plant in Waluj, FDA issued a warning letter to a second Wockhardt plant in Chikalthana this month for the same reason. The plant in Chikalthana linked testing results of "trial samples" of some drugs to official samples that had not met test requirements. The U.K. has also banned most of the drugs coming out of Wockhardt's plant in Chikalthana.
AstraZeneca's quadrivalent flu vaccine approved in EU
AstraZeneca's quadrivalent flu vaccine, Fluenz, got approval from European Commission recently, being the first quadrivalent flu vaccine ever approved in the region. Before that, it also got the approval from US FDA. Fluenz has been made part of UK's childhood immunization program for kids aged 2 and 3.
Moderate alcohol consumption can boost vaccine effectiveness in monkeys
Dec 18, 2013
US Scientists recently found out that moderate alcohol could boost the effectiveness of a vaccine. The experiment was carried out in 12 male rhesus macaque monkeys. The monkeys who drank the most had lower immune responses than the control group, but the monkeys that drank moderate alcohol had stronger immune responses than the control group.
CFDA put a hold on Kangtai's Hep B vaccine after child deaths
Dec 26, 2013
CFDA put a hold on millions of doses of Hep B vaccines from Shenzhen Kangtai Biological earlier this week, after 6 deaths were reported. Starting from 1992 and with Merck's help and government support, Kangtai has been the largest producer of Hep B vaccines in China , taking up 60% of the market.
FDA collaborates with EU members to share some inspection duties
Dec. 31, 2013
To leverage inspection resources, FDA recently launched an 18 month pilot program to collaborate with the European Medicines Agency (EMA), and regulators from the U.K., France, Germany, Italy and the Netherlands to share information on the inspection of generic drugmakers in countries like China and India.
New Chinese quality standards may cause Hep B vaccine supply shortage
Jan. 5, 2014
According to Chinese new regulations, companies that failed to obtain GMP clearance by Dec. 31, 2013, are banned from producing new products. This regulation may cause shortage in Hep B supply, because none of the three main suppliers, Dalian Hissen BioPharm, Shenzhen BioKangtai and Beijing Tiantan Biological Products, which altogether take up about 80% of Chinese Hep B market, has obtained the new GMP. Dalian Hissen is not expected to receive certification until the second half of 2014 and Tiantan is yet to apply for its new site. Kangtai is now being investigated for the SAEs. But North China Pharmaceutical, previously taking up 12% of the Hep B market, received GMP certification ahead of the deadline and may get more stakes.
Giving Prevnar and flu vaccine together may raise risk of fever
Jan. 9, 2014
Researchers found out giving both Prevnar and flu vaccine to kids could induce 20 extra cases of fever per 100 vaccinations compared to just receiving either the flu shot or Prevnar 13.This study was carried out in 530 kids in a single flu season, and most kids were urban Latinos. It is unclear whether the findings would be the same for other populations and different flu seasons.
AC Immune brought the first Alzheimer's vaccine candidate targeting tau proteins into phase I trial
Jan. 13, 2014
AC Immune has brought its ACI-35 into phase I trial, which is the first vaccine candidate against phosphorylated tau proteins, twisted fibers in the brain that may cause Alzheimer's. AC Immune's another vaccine candidate, ACI-24, targeting amyloid plaques, is currently in a combined Phase I/IIa clinical trial. Earlier vaccine candidates that targeted amyloid proteins failed in the clinical trials, including Elan, Johnson & Johnson and Pfizer's.
CDC, FDA studies linked Merck and GSK rotavirus vaccines to intussusception
Jan. 15, 2014
An FDA-funded study conducted by Harvard Medical School reported 1.5 of 100,000 recipients of RotaTeq developed intussusception that can require surgery. Another CDC-backed study of GSK's Rotarix also reported 5 of 100,000 recipients developed bowel disorder. But neither is at the level that prompted the withdrawal of Wyeth's RotaShield.
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