Grail Inc. reported on June 4 the first results of its Pathfinder study evaluating its assay for the early detection of 50 cancers, showing a positive predictive value of 44.6%. With a total of 6,629 study participants across more than 140 clinical study sites, the blood test is supported by what the health care company believes to be the “largest clinical study program in genomic medicine.”

The American Society for Clinical Oncology’s (ASCO) virtual annual meeting began June 3 with the release of late-breaking abstracts, including LBA-1 on “Olympia: A phase 3, multicenter, randomized, placebo-controlled trial of adjuvant olaparib after (neo)adjuvant chemotherapy in patients with germline BRCA1 and BRCA2 mutations and high risk HER2-negative primary breast cancer.”

Collectively, lysosomal storage disorders (LSDs) are caused by malfunctions in metabolic enzymes in the lysosome system. Depending on which enzyme is missing, toxic metabolites accumulate. While the LSDs are highly heterogenous – even within one disease, presentation can vary widely – neurodegeneration is a common feature in these disorders.

Multinational players are changing the way they look at China as a source for innovation as it accelerates efforts in areas such as digital health in pursuit of desire to make a global impact.

It’s no secret that physicians are the interface between device makers and the patient, but their role in cybersecurity has been limited to date. However, Christian Dameff, assistant professor of biomedical informatics and computer science at the University of California San Diego, said its time to engage physicians once they are in practice and to include cybersecurity in medical school education, two efforts he said would go a long way toward improving medical device cybersecurity in the clinical setting.

Multinational players are changing the way they look at China as a source for innovation as it accelerates efforts in areas such as digital health in pursuit of desire to make a global impact. At the Chinabio Partnering Forum, panelists representing Pfizer Inc., Merck & Co. Inc., Sanofi SA and Johnson & Johnson all shared what they have witnessed there and how they’re already tapping China-sourced innovations.

The FDA’s presenters at this year’s joint FDA/Xavier med-tech conference presented on a range of issues, such as the breakthrough devices premarket program and the agency’s postmarket surveillance efforts. However, the two FDA presenters both remarked that these functional areas are hampered by lack of resources, suggesting the agency has a unified message about resources that permeates negotiations for the next device user fee agreement.

China saw $28.5 billion invested in its life sciences sector in 2020, which was double the previous year’s amount and sets a five-year high. Partnering activities and IPOs also grew exponentially over the last five years to set records.

The negotiations for the next device user fee agreement are well underway, and there are signs that the FDA is looking for a significant boost in user fees from device makers. However, Rep. Anna Eshoo (D-Calif.) told members of the MDMA that no member of Congress should believe that user fees relieve Congress of its responsibility “for funding the agency in a robust way.”