Welcome to this week's FiercePharmaAsia report, which includes stories about WuXi NextCODE's $240 million series B, a long Form 483 sent to the Celltrion plant that makes Pfizer's Remicade copy, commencement of Biocon's $275 million insulin plant in Malaysia and more.
1. WuXi NextCODE raises $240M to build genomics business
WuXi NextCODE has raised $240 million in a series B round. The investment sets the genomics company up to build out its platform and strike precision medicine and diagnostics partnerships to grow its user base and data repository. It will begin with a line of tests aimed at the Chinese market. These include diagnostic tests for pediatric rare diseases, carrier screening for people planning to have children and a “whole-genome wellness scan.”
2. FDA faults Celltrion plant that makes Pfizer's Remicade copy, Inflectra
The FDA has slapped South Korea’s Celltrion with a 10-page, 12-observation Form 483, which is mainly focused on its slow response to investigating 140 customer complaints. Those were complaints over vials of the Remicade biosimilar that Pfizer has sold for several years in Europe as Remsima and launched last year in the U.S. as Inflectra, though Celltrion said the issues don’t effect Inflectra marketed in the U.S.
3. Biocon insulin plant in Malaysia wins EU manufacturing approval
Biocon’s $275 million insulin plant in Malaysia has won an EMA manufacturing certificate to produce active substances, sterile drug products and to handle quality control testing. The facility, which began commercial production this year, has 600 workers to manufacture recombinant human insulin and insulin analogs in prefilled pens, including a biosimilar of Sanofi’s Lantus.
4. Astellas goes 'Dancing with the Stars' for new Myrbetriq promotion
Astellas has teamed up with the ABC show “Dancing with the Stars” along with actress and former contestant Lea Thompson for its new promotion. The campaign, sponsored by overactive-bladder drug Myrbetriq, has two TV ads in which Thompson talks about how she rediscovered her love of dancing and encourages fans to enter for a chance to win a trip to Los Angeles for a taping of the show.
5. German regulator slaps a second Dr. Reddy's plant
Just four weeks after authorities in Germany pulled the manufacturing authorization from one Dr. Reddy’s plant in India, it has blocked a manufacturing certificate from another one there, citing six major violations. That also adds on to the drugmaker's recent issues with the FDA.
6. Fuji completes cell culture manufacturing expansion in U.K.
Fujifilm Diosynth biotechnologies has opened its $9 million, 10,000-square-foot cell culture process development laboratories in the U.K. The lab, which is part of a $130 million expansion plan the Japanese company had laid out for its biologics CMO business, will support its monoclonal antibody platform for cell culture development work.