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New indication of Prevnar 13 approved by USFDA
Feb. 16, 2013
USFDA approved Wyeth's Pneumococcal 13-valent Conjugate Vaccine (known as Prevnar 13) to include the prevention of invasive pneumococcal disease in children 6 years through 17 years of age caused by serotypes contained in the vaccine.
Good result from RSV vaccine trial of Novavax
Feb. 17, 2013
A Phase 1 trial was performed by Novavax to evaluate the safety and immunogenicity of its recombinant respiratory syncytial virus (RSV) fusion (F) protein nanoparticle vaccine. The vaccine candidate was well tolerated without dose-related increases in adverse events. Measures of immunity indicate that neutralization, anti-RSV F IgG titers and palivizumab competing antibodies were induced at levels that have been associated with decreased risk of hospitalization.
Australia begins HPV vaccination for boys
Feb. 22, 2013
More than a million Australian girls ages 12 to 16 have received HPV vaccination. On Feb 15, Australia began to give Gardasil to boys aged 12-13 years and the government will vaccinate boys 14 and 15 years old in the next few months. Totally more than 280,000 boys will get free Gardasil injections this year.
Sanofi Pasteur MSD 6-in-1 pediatric vaccine gets EMA Approval
Feb. 28, 2013
Sanofi Pasteur MSD, a joint venture between MSD and Sanofi Pasteur in Europe, got approval from the European Medicines Agency's Committee for its 6-in-1 pediatric vaccine to protect infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b.The brand name will be Hexyon in Western Europe and Hexacima in Eastern Europe.
FDA panel approved quadrivalent flu vaccine
Mar 4, 2013
FDA panel recently approved quadrivalent flu vaccines which contain two "A" strains and two "B" strains. Currently there are two companies that already have quadrivalents approved, namely GlaxoSmithKline and AstraZeneca's MedImmune.
The newly revised GSP of China issued
Mar 6, 2013
The newly revised Good Supply Practice for Pharmaceutical Products (GSP) was officially issued recently. It will go into effect as of June 1, 2013. The revised GSP sets higher qualification requirements and higher standards for engaging in drug distribution.
India takes pentavalent vaccine to 5 million children
Mar 12, 2013
Five million Indian children were vaccinated with the five-in-one pentavalent shots in just over a year. The vaccine offers protection against diphtheria, tetanus, whooping cough, hepatitis B and Haemophilus influenzae B (Hib). There are about 27 million children under one year in the country at any given point of time. At present, the vaccines are being procured by UNICEF, with funding from GAVI. The operational costs are borne by the Indian government.
BravoBio was honored as Asia's Best Startup in Bioscience
Mar 16, 2013
Together with the other seven startups in Asia Pacific region, BravoBio was honored as Asia's Best Emerging Company of the Year 2013 by BioSpectrum.
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Chinese National Essential Medicine List (2012 edition) released
Mar 21, 2013
The National Essential Medicine List (2012 edition) was recently released. The new list consists of three parts: chemical medicines and biological products, Chinese proprietary medicines, and prepared slices of Chinese crude drugs; and includes 317 chemical medicines and biological products and 203 Chinese proprietary medicines. The number of chemical medicines and biological products in the list is approaching to that in the WHO current model list of essential medicines.
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