BEIJING – China's position as a global power in active pharmaceutical ingredients (API) could be jeopardized by the ongoing and worsening trade war with the U.S. Perhaps more worrisome for the pharma industry, any disruption to Chinese supply chains could have a serious impact on drug manufacturing and accessibility globally.

BEIJING – The ongoing trade war between the U.S. and China has helped put the biotechnology field on the U.S. foreign investment restriction list, causing a chilling effect on the market. With the amount of Chinese money entering the U.S. biotech sector dropping sharply, many believe it is the U.S. that is taking the hit in this sector.

The U.S. FDA has granted breakthrough device designation to Laboratory for Advanced Medicine Inc. (LAM) for its liquid biopsy blood test for the detection of liver cancer. The test, which analyzes the DNA methylation pattern of cell-free DNA (cfDNA), is designed to detect the presence of hepatocellular cancer as early as stage 1, with both high specificity and sensitivity.

The FDA's September 2018 draft guidance for considerations of benefit-risk determinations for several device types, including PMAs, said that the agency "intends" to hold an advisory committee hearing if the FDA has any questions about the post-market data generated by the accompanying post-approval study. The final guidance pulls back on that language, but only slightly, stating that the agency "generally expects" to hold an advisory hearing in this circumstance, a difference in language that may or may not translate to a difference in function.

Edwards Lifesciences Corp.'s buy of Cas Medical Systems Inc. (Casmed) this spring appears to have borne fruit. The Irvine, Calif.-based company reported that the U.S. FDA has granted clearance for a smart cable enabling compatibility between the company's Foresight tissue oximetry (brain oxygenation) sensors and the Hemosphere advanced monitoring platform.

BEIJING – Multinational antibody specialist Hifibio Therapeutics Inc. said it closed a $67 million series C financing round to advance its drug candidates for cancer and autoimmune disorders.

BEIJING – The trade war has escalated. On Aug. 23, China announced retaliatory tariffs on $75 billion of U.S. exports, 10 days after the U.S. slapped the same amount on $300 billion of Chinese goods. Once again, the med-tech sector is neck deep in this tariff tit-for-tat.

Drug pricing legislation will be high on the to-do list when the U.S. Congress returns from its August recess next week, as both the Senate and the House are expected to take action this month on competing packages of provisions aimed at controlling prescription drug prices.

Quarterly financial reporting for public companies is costly and ties up senior management and board members for several days before each quarterly earnings report is released and the 10-Q is filed. Could this process be made more efficient and less frequent, such as a semi-annual filing like many reporting companies based in Europe have implemented? That was one of the questions considered by a roundtable hosted by the SEC's Division of Corporation Finance where key stakeholders delved into the impact of short-termism on U.S. capital markets and whether the SEC's current reporting system needs to be changed to ease administrative and other burdens on reporting companies.