Welcome to this week's FiercePharmaAsia report, which includes stories about Astellas' $102.5 million deal for Universal Cells, Celltrion's FDA warning letter's impact on Teva, Korea's digital health initiative and India's decision on a cardiac stent price cap.
1. Astellas pledges $102.5M for universal donor cell company
Astellas is paying $102.5 million for Seattle-based Universal Cells. The latter’s technology could produce universal donor cells that don’t require donor matching or immune-suppressing therapy and don’t stimulate rejection. The new deal came as one of several Astellas has made in the emerging cell therapy market.
2. FDA tells Celltrion a consultant may be in order for its troubled biologics plant
Teva was hit by an FDA warning letter issued to a Celltrion plant in South Korea. Approvals of the generic drugmaker’s migraine drug and two biosimilars, the rights to which it recently gained by paying Celltrion $160 million, were delayed. Teva CEO Kåre Schultz said the issue was not related to the API production area where its products are being made. He said Teva was in talks with the FDA to determine the implications but that it could delay approvals.
3. Korea pools patient data to enable digital health schemes
In an effort to build up a digital health initiative, South Korea will collect genetic and other medical data from millions of patients. Korea intends to use the data to support the development of drugs and medical devices. It also envisages the data helping predict disease outbreaks and identifying trends worthy of further investigation.
4. India rejects pleas for liberalization of stent price cap policy
A price cap on cardiac stents imposed by officials in India forces companies to sell new stents for the same price as older products. After rejecting industry requests to pull stents from the market, India again turned down manufacturers’ call for a raise on the price cap.