Welcome to this week’s FiercePharmaAsia report, which includes stories about WuXi AppTec's IPO preparation for its core businesses, Shionogi and Purdue's new constipation med approval, EMA's decision to suspend about 300 drug applications helped by an Indian CRO, and more.
Unlike the media’s previous speculation of a reverse takeover, CRO giant WuXi AppTec, once listed on the NYSE, has chosen to reenlist its core drug R&D businesses on China’s common stock market through a normal IPO. The company’s API subsidiary STA is traded on China’s new OTC market, and it filed a draft IPO application for its biologics unit on HKEX in early January.
AstraZeneca’s Movantik and Valeant’s Relistor now have a third competitor jumping into the opioid-induced constipation arena. Japan’s Shionogi and Connecticut’s Purdue Pharma had their med Symproic approved by the U.S. FDA. With a Schedule II controlled substance designation, Symproic is expected to hit the market mid-summer.
Last December, the EMA started an investigation into meds whose studies were conducted at Indian CRO Micro Therapeutic Research Labs in response to data integrity concerns raised by regulators at several European countries. Now, even though there is “no evidence of harm or lack of effectiveness of the medicines,” it wants about 300 marketed meds and applications involved to be suspended.
Serum Institute of India’s rotavirus vaccine candidate showed better efficacy than Merck’s RotaTeq and GlaxoSmithKline’s Rotarix in a late-stage trial in Africa. The vaccine can tolerate much higher temperatures to the point that refrigeration is not required during storage, putting it in a strong position to notch an approval from the World Health Organization.
After a series of warning letters, all of Wockhardt’s manufacturing facilities targeting the U.S. market are under FDA oversight, but the Indian generics maker still managed to get a new product—a copy of Pfizer’s penicillin antibiotic sterile injectable Zosyn—approved in the U.S., by using contractors for API manufacturing and commercial production.
MedyMatch has inked a deal to integrate its artificial intelligence-based decision-support technology with Samsung’s medical imaging machines in prehospital settings. The pair will concentrate first on improving early stroke assessment in emergency vehicles by equipping them with Samsung NeuroLogica CereTom diagnostic CT imaging.