After the latest round of tariff war escalation, nearly all U.S. medtech exports to China are now subject to additional tariffs. Takeda's Alunbrig triumphed over Pfizer's Xalkori in a head-to-head first-line ALK-positive lung cancer trial. The U.S. FDA criticized Zhejiang Huahai Pharmaceutical, which is linked to the global valsartan recall, for making manufacturing process changes without formal evaluation. And more.—Angus Liu
After the Trump administration imposed 10% tariffs on $200 million worth of imports from China early this week, China returned fire with tariffs on $60 billion of U.S. goods, including $3.5 billion in medtech-related trade. Added to tariffs levied this past summer, the latest round totals nearly all U.S. medtech exports to China in 2017, or about $4.75 billion, according to AdvaMed, the industry’s trade association.
Competition in ALK-positive lung cancer is heating up. Takeda’s Alunbrig showed it could reduce the risk of disease progression or death by 51% compared with Pfizer’s Xalkori in front-line setting. Despite other rivals in Novartis’ Zykadia and Roche’s Alecensa, Takeda believes Alunbrig could lead the pack, with the potential to reach blockbuster status. By comparison, Xalkori got $290 million in the first half of 2018.
FDA inspectors spent two weeks examining the plant of Zhejiang Huahai Pharmaceutical, the Chinese API maker whose carcinogen-tainted valsartan triggered a global recall. In an 11-observation Form 483, the FDA berated the company for making process changes without formal risk assessments. It also found that the changes in producing the valsartan API were made earlier than originally suggested.
Eli Lilly is paying $50 million upfront to license an oral “phase 1 ready” GLP-1 receptor agonist from Chugai Pharmaceutical. There are several GLP-1s already on the market, including Lilly’s own once-weekly injection Trulicity. And Novo Nordisk has been turning up positive data in support of its highly anticipated oral semaglutide.
Astellas’ annual C3 contest of creative nontreatment cancer care ideas has come down to three finalists: a pediatric wearable device to monitor temperature and detect infections; a digital audio series proposed for Nigeria using local actors to address myths in breast cancer treatment; and an advanced microscope that can provide diagnostic-quality images directly from tissue.
China’s PharmaBlock, which designs and synthesizes novel building blocks for small-molecule drug R&D, has acquired a GMP-compliant manufacturing facility from Porton Pharma Solutions in Shangyu, China, to meet surging demand. The 1,436,000-square-foot site is equipped with reactors with combined reactor volume of over 180,000L.