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US Congress Passed Generic Drug User Fee Act
Jul. 26, 2012
The US Congress passed the Generic Drug User Fee Act (GDUFA) On July 9, 2012. The Act authorizes the collection of user fees from generic-drug manufacturing companies. According to FDA's website, GDUFA "will enhance global supply chain safety by requiring that generic drug facilities and sites around the world use a self-identification process to include the source of all materials used in the manufacturing of generic drugs."
The global market for medicines will reach about $1.2 trillion by 2016, said by IMS
Jul. 30, 2012
According to IMS (Institute for Healthcare Informatics), the annual global spending on medicines will rise from $956 billion in 2011 to nearly $1.2 trillion in 2016, representing a CAGR of 3-6 percent. Growth in annual global spending is forecast to as much as $70 billion by 2016.
Biologics are expected to account for about 17 percent of total global spending on medicines by 2016. Seven of the top ten global medicines by spending will be a biologic within five years.
BravoBio's JV in Beijing got Production License
Aug. 3, 2012
Huawei BravoBio, the Joint Venture of BravoBio, has got its Medical Equipment Production License from Beijing Municipal Food and Drug Administration. Huawei BravoBio is a biotech firm focusing on medical apparatus and equipments, especially on diagnostic kits for infectious diseases and routine biochemical reagents for clinical use.
HPV vaccination should be applied earlier
Aug. 10, 2012
According to a study in a US clinical center, more than half of girls 13 and older already have the infection. The experts suggested HPV vaccination to be given to girls at age 11 or 12, before they became to be sexually active.
BCG may help treat type I diabetes
Aug. 14, 2012
Harvard scientists found the common-used Tuberculosis vaccine, bacillus Calmette-Guérin (BCG), may be helpful to produce a protein that kills insulin-attacking cells, resulting in increased insulin production and a rise in C-peptide levels.
SFDA released new requirements on pharmaceutical excipients
Aug. 17, 2012
The State Food and Drug Administration (SFDA) released the Relevant Requirements on Strengthening Supervision and Management of Pharmaceutical Excipients early this month. The Requirements specified the respective responsibilities of drug makers, pharmaceutical excipients makers and regulatory departments, which will come into effect after Feb. 1, 2013.
China International Drug Safety Summit 2012 held in Beijing
Aug. 25, 2012
Invited by the organizer, Dr. Wu had a panel discussion with other senior experts on the topic "How will Enterprises Carry out Pharmacovigilance Activities to Keep In Line with Updating Pharmacovigilance Legislation?" during the meeting.
FDA approved flu vaccines for next season
Aug. 29, 2012
FDA has approved 6 vaccine manufacturers in preparation for the 2012-2013 flu season in the US. AstraZeneca, CSL, GlaxoSmithKline, ID Biomedical, Novartis and Sanofi Pasteur are in the list. The selected strains are: A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2) and B/Wisconsin/1/2010.
New adjuvant showed positive
Sept. 3, 2012
Flu, HIV or herpes virus vaccine formula with polyethyleneimine (PEI) as adjuvant showed promising results in mice. Scientists now have a new tool to consider for vaccine development.
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