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great success.“ As of September 2016, 19 of the 26 meningitis belt countries have rolled out MenAfriVac ®. The remaining countries should introduce the vaccine this year. By 2020, the vaccine is expected to protect more than 400 million people— preventing 1 million cases of meningitis A; 150,000 deaths; and 250,000 cases of severe disability.”
USFDA to lift import alert on Sun Pharma’ s Mohali facility
Sun Pharma in a statement issued on March 14, 2017, mentioned that it was informed by the US FDA a day earlier, about the lifting of the‘ Import Alert’ imposed on the Mohali( Punjab) manufacturing facility and remove the facility from the Official Action Initiated( OAI) status. This proposed action will clear the path for Sun Pharma to supply approved products from the Mohali facility to the US market, subject to normal US FDA regulatory requirements.
The Mohali facility was inherited by Sun Pharma as part of its acquisition of Ranbaxy Laboratories in 2015. The US FDA had taken action against the Mohali facility in 2013 when it ordered the facility to be fully subject to Ranbaxy’ s Consent Decree of Permanent Injunction. Certain conditions of the consent decree will continue to be applicable to the Mohali facility.
This development as per Sun Pharma, illustrates its commitment to work closely with the US FDA and strive for 100 % cGMP compliance at its manufacturing facilities.
Hilleman Lab partners with NICED, ICMR to develop Shigella vaccine
Hilleman Laboratories, a joint-venture partnership between MSD and Wellcome Trust, has signed a Memorandum of Understanding( MoU) with the National Institute of Cholera and Enteric Diseases( NICED), an ICMR organization for further development and commercialization of the Shigella vaccines and other enteric vaccines for diarrheal diseases. This agreement was signed as an effort of Hilleman’ s mission to make affordable vaccines for the developing world population.
“ Shigella is the second most fatal organism after Rotavirus that causes severe diarrhea in children with no approved vaccine available at this time. We are pleased at this opportunity to collaborate with NICED and jointly develop Shigella vaccine for a disease whose basic pathology is not yet
72 BioVoiceNews | April 2017