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News Center
Sinovac's HFMD vaccine will get CFDA marketing approval soon
Mar. 26, 2015
Sinovac's HFMD vaccine is under China FDA review of supplementary documentation, and it will expect on-site inspections and marketing approval soon. Last year, China reported 2.8 million HFMD cases, Next in line, Sinovac has pneumonia vaccine against 23 types of bacteria to begin clinical trials in mid-summer this year.
Chinese Ebola vaccine achieved positive PhI data
Mar. 26, 2015
Another Ebola vaccine candidate--a recombinant adenovirus type-5 vaccine based on the virus strain from 2014 epidemic developed by Beijing Institute of Biotechnology and Tianjin CanSino Biotechnology achieved positive data in phase I trial in Jiangsu Province involving 120 healthy adults, with 95% of the low dose test group showing a positive immune response, and all 40 of the high dose group exhibiting a response and making more antibodies. Novavax is also developing a vaccine based on the 2014 Ebolavirus strain, and it expects Phase I trial data after mid-2015.
Pfizer withdrew vaccine sales business in China
Apr. 5, 2015
Pfizer had to pull its vaccine sales business out of China because the expiration of the import license of Prevenar, its top-selling treatment and also its only vaccine sold in China.
Duke University got $20M from NIH to develop HIV vaccine
Apr. 9, 2015
Biolink Bio-pharmaceutical Innovation and Tech-transfer meeting (BioPh&ICSE) was held in Beijing from Jan 22 to Jan 23 .
Dr.Wu was invited as a panelist to share his thoughts on biotech innovation and collaboration
Merck will start Ebola vaccine phase III in Sierra Leone
Apr. 16, 2015
Merck and its partner NewLink's Ebola vaccine candidate, rVSV-EBOV, is in Phase II/III trials in Liberia and Phase III trials in Guinea. Led by US CDC and local help in Sierra Leone, Merck will start phase III trial in Sierra Leone soon, and the trial will involve 6,000 health and frontline workers in areas that were hit hard by the Ebola epidemic in the past few months.
Sinovac to start Pneumo conjugate vaccine trial in China
Apr. 22, 2015
Pfizer is working to bring Prevenar 13 back to China market after recently pulling its vaccines sales because of the expiration of the import license. But it may face the potential competition from Sinovac as the latter will soon begin clinical trial for a Pneumococcal 13-valent conjugate vaccine. Sinovac is also working to combine its top two moneymakers (hep A and B vaccines) into a combo for the rapidly growing private market.
Phase III results show GSK malaria vaccine's efficacy falls over time
Apr. 28, 2015
In a Phase III trial involving 15,000 children in Africa, early results showed that children who received three doses of the vaccine were half as likely to have malaria infection in the year after vaccination. But if without a booster dose at 4th year, significant efficacy against severe malaria was not shown. However GSK's malaria vaccine is the most advanced and it filed for EMA regulatory approval last July. EMA might approve and recommend the vaccine by the end of this year.
FDA panel approved Amgen's T-Vec for melanoma treatment
Apr. 29, 2015
Last Month,FDA advisory committee approved Amgen's dual-acting cancer vaccine/viral therapy, talimogene laherparepvec (T-Vec) for treating melanoma, which makes T-Vec about to be the second vaccine to treat cancer behind Dendreon's Provenge approved in 2010.
Amgen explores Keytruda/T-Vec combo in cancer treatment
Jun. 3, 2015
Apart from it's melanoma-fighting vaccine (T-Vec) pending for FDA approval, Amgen now collaborates with Merck to start a Phase I open-label trial to test T-Vec in combination with the PD-1 drug, Keytruda, in patients with head and neck cancer. The two companies has also started a randomized Phase III trial to test the combo to treat advanced melanoma recently.
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