California's Hansen Medical inked a distribution deal with a Chinese medical device company for its intravascular robotic system, a feather in Hansen's cap as it looks to expand commercialization for its device.
The European Directorate for the Quality of Medicines has banned products from a Chinese maker of iodine after an inspection at its plant by French inspectors turned up contamination issues in its manufacturing processes, issues with its purified water system and a piece of testing equipment that may have been put in the facility just for show.
China health authorities have proposed some new regulations for conducting stem-cell clinical trials in the country, one requiring that a 30-year archive of the clinical records of stem-cell donors and patients be maintained.
Hutchison China MediTech has met the primary endpoint of progression-free survival in a Phase II clinical trial for its metastatic colorectal cancer candidate fruquintinib (HMPL-013), putting it one step closer to China approval.
China's Luye Pharma Group said it has successfully completed three Phase I clinical studies for ansofaxine hydrochloride (LY03005) in China and submitted an application for Phase II and Phase III on the same candidate to the China Food and Drug Administration.
Germany's Merck KGaA now considers the world's emerging markets as a group, with China a major driver, to be a greater revenue-producer than Europe, unit CEO Bernd Reckmann said in an interview.
Startup CardioKinetix has reported positive pivotal data from China on its catheter-based heart failure treatment, the Parachute Ventricular Partitioning Device. It expects these study results to support a regulatory submission with the China Food and Drug Administration.
China's FDA has disclosed its first approval of proton carbon ion therapy equipment by clearing the Siemens device at the Shanghai Heavy Ion Proton Hospital to treat cancer patients with radiation.
India's government has threatened to place restrictions on imports of nonessential items, including pharmaceuticals, from China if it does not ease some of its "protectionist tendencies" toward India products.
ZAI Lab of Shanghai has in-licensed from Bristol-Myers Squibb China rights to the Phase III liver cancer drug brivanib, an oral kinase inhibitor for oncology indications including hepatocellular carcinoma.