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News Center
FDA approved flu vaccines for pregnant women
Sept. 5, 2012
US-FDA recently approved 6 flu vaccines to be used in pregnant women. About 9000 pregnant women were given the vaccine. The flu vaccine was found out to be safe, even in the first trimester.
All adults should get a booster DTaP dose
Sept. 10, 2012
US CDC has revised its recommendation on the DTaP vaccine, a vaccine protects against tetanus, diphtheria, and pertussis. Pertussis, or whooping cough, is surging across the States in recent years. CDC now urges all adults to get a booster dose.
BravoBio attended NEXTBIO 2012
Sept. 14, 2012
Sponsored by CPhI, NEXTBIO CHINA 2012 held in Renaissance Pudong Hotel. BravoBio was invited to give a speech on VLP innovative vaccine project against EV71 virus.
The US vaccine market keeps rising in following years
Sept. 17, 2012
According to Transparency Market Research, being the largest market for vaccines globally, the US market is forecast to reach USD 17.4 billion in 2018 from 12.8 billion in 2012, with an estimated CAGR of 5.3%. The factors that make vaccine market growing incrementally include increasing cases of infectious diseases, mandatory vaccination, the threat of pandemic flu, and rising need internationally.
Drug Safety Blacklist Management Rules will soon be implemented in China
Sept. 20, 2012
The SFDA issued the Drug Safety Blacklist Management Rules, which will be implemented as of Oct. 1, 2012. According to the Rules, relevant information of those who received administrative punishments on account of severe violations of laws, regulations and rules on drug and medical devices management will be publicized on governmental websites for social supervision and enhanced management.
Currently best selling Vaccines
Sept. 26, 2012
According to FierceVaccines, Prevnar 13 is the best selling vaccines worldwide, with 1.847 billion USD sales in the first half of 2012. Merck (M) and GlaxoSmithKline (G) each had 6 vaccines in the top 20 best sales list. Sanofi (S), Pfizer (P), Novartis (N) and Emergent BioSolutions (E) had 4, 2, 1 and 1 vaccine(s) respectively.
The top 20 best sales vaccines are: Prevnar 13 (P), PENTAct-HIB (S), Gardasil (M), Pediarix (G), Hepatitis Vaccine Franchise (G), Celtura (N), Varivax (M), Cervarix (G), RotaTeq (M), Synflorix (G), Rotarix (G), Zostavax (M), Prevnar (P), Fluzone/Vaxigrip (S), Menactra (S), Pneumovax (M), Adacel(S), MMR-II (M), Boostrix (G) and Biothrax (E).
FDA is open to speedy trials for drugs with risks
Oct. 8, 2012
FDA is working on a new plan to speed up the approval for drugs with "special medical use", including obesity treatments and new antibiotics. Although it takes time for the plan to be implemented, the industry will benefit from the prospect of doubling drug approval rates.
SFDA issues Guiding Opinions on Electronic Supervision of Drugs
Oct. 11, 2012
SFDA recently issued the Guiding Opinions on Electronic Supervision of Drugs based on related regulations and the Technical Guidance for Electronic Supervision of Drugs, in order to further standardize the electronic supervision of drugs and improve efficiency.
SFDA released 2011 Annual Report on Drug Registration Approval
Oct. 13, 2012
The State Food and Drug Administration (SFDA) recently released the 2011 Annual Report on Drug Registration Approval. According to the report, 718 applications for production were approved last year, including 644 domestic and 74 foreign corporate. 621 applications for clinical trials got green light in 2011, among which 39 were new molecules and 110 were international multi-centered trials.
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