Welcome to this week's FiercePharmaAsia report, which includes stories about Dr. Reddy's most recent drug recall and more issues at its plants, China's approval of a domestic Ebola vaccine based on the virus behind the 2014 outbreak and more.
1. Dr. Reddy's, fighting to recover from FDA warning letter, recalls 500K heartburn tablets
It was only last July when Dr. Reddy’s recalled more than 84,000 famotidine tablets produced for CVS. This time around, it is recalling 569,000 more sold at CVS and at Walmart under the Equate label. These drugs, as indicated by the Class III recall, aren’t likely to cause harm to humans. Regulatory issues with several of its plants have cost the Indian drugmaker dearly.
2. China approves domestic Ebola vaccine developed from recent outbreak
China has approved an Ebola vaccine co-developed by a military research unit and domestic company CanSino. It is the first based on the virus strain behind the recent 2014 epidemic in West Africa. Compared to the GlaxoSmithKline and Merck & Co. candidates, it also requires less stringent storage conditions. Perhaps the only problem raised so far is the durability of its efficacy.
3. WHO experts endorse Bharat Biotech’s typhoid vaccine for young children
No currently available typhoid vaccines are meant for children younger than 2, but a new conjugate vaccine manufactured by India’s Bharat Biotech as Typbar-TCV could change that. Following a phase 2b study that puts the vaccine’s efficacy at as high as 87%, the World Health Organization’s Strategic Advisory Group of Experts on Immunization has recommended it for those over 6 months.
4. Clinigen strengthens global ethical access lead with new Japanese buy
After opening shop in Japan a year earlier, Clinigen Group, a leader in managed access, has further expanded its business there via purchase of International Medical Management Corporation, Japan’s largest supplier of unlicensed medicines. The news also comes as the company is in the process of a £150.3 million acquisition of Quantum Pharma.
5. FDA slaps India API drugmaker Vital Labs with warning letter
Indian API maker Vital Laboratories was slapped with an FDA warning letter over manufacturing and record-keeping issues at its Plant II located in Vapi, Gujarat. Following an inspection in 2015, the FDA classified another facility of Vital’s in Vapi as unacceptable for drug manufacturing.