Welcome to our weekly roundup of news from Asia. The biggest development? China is setting up a new structure for its drug regulator. For Teva, though, the most significant news could be this: Celltrion's manufacturing problems could be more widespread than it expected, analysts say. And WuXi NextCODE and Google Cloud teamed up on genomics data.
The China Food and Drug Administration will merge into a large, national market supervision administration, and the drug regulation function will become an agency under its umbrella. The revamp comes as Beijing rearranges its national government structure to tackle a series of new problems.
A drug manufacturing specialist told Leerink the problems cited in recent FDA warnings issued to Celltrion could well extend beyond the plant’s fill/finish operations—and that they're likely to be present at the API manufacturing operations as well. If so, that means Teva’s migraine hopeful fremanezumab, for which Celltrion makes the API, would be delayed until mid-2019.
Through a new partnership, Google Cloud will host a series of WuXi NextCODE’s services, including its GORdb genomics data structure. At the same time, key Google genomics and research tools, beginning with the DeepVariant secondary analysis pipeline, will be integrated for use on NextCODE’s platform.
Since its launch in the U.S. and EU, inflammatory bowel disease treatment Entyvio has already exceeded blockbuster sales, and developer Takeda is looking at the Asia-Pacific region for more. It targets not only previously untreated patients, but also those who've stopped responding to older biologics, and for its marketing, taps the ideas behind an IBD comic-book campaign that won kudos in the U.S.
Merck’s shingles shot Zostavax is already challenged by GlaxoSmithKline’s Shingrix in the U.S., and it is now quickly yielding market share to SK Chemicals’ Skyzoster in South Korea. Some local clinics say they have just lowered the price of their shingles vaccines, but Merck officials in the country suspect clinics simply switched to cheaper Skyzoster, influenced by SK's marketing.
The FDA issued a warning letter to Hong Kong-based OTC drugmaker Nan San Pharmaceutical for failing to conduct appropriate laboratory testing and marketing misbranded products in the U.S.