HONG KONG – South Korean biomarker-based molecular diagnostic firm Genomictree Inc. has built a U.S. unit in Pasadena, Calif., with an investment of KRW12 billion (US$10 million). The Daejeon, South Korean-based company first disclosed its plan to build the U.S. branch in March.

Lantheus Holdings, of North Billerica, Mass., has entered a deal to acquire New York-based Progenics Pharmaceuticals Inc., which develops medicines and other technologies to target and treat cancer. "This transaction leverages our core capabilities, including proven commercial and operational expertise while diversifying our revenue stream by broadening our presence in emerging uses of radioisotopes in precision diagnostics as well as the exciting field of radiopharmaceuticals in oncology treatment," Lantheus President and CEO Mary Anne Heino said on a call related to the deal.

While regulatory science can lag behind technology advances, the FDA has for the past few years been exploring ways to harness the potential of artificial intelligence (AI) to streamline drug development and the approval process. A nexus for its efforts is the Information Exchange and Data Transformation (INFORMED) initiative anchored in the agency's Oncology Center of Excellence (OCE). At its inception in 2016, INFORMED was designed to tap into the power of big data and advanced analytics to improve disease outcomes.

The draft Medicare physician fee schedule (MPFS) is always an event for makers of drugs and devices, and this year is no exception. This time, the draft proposes non-controversially to formalize the specialty practice of heart failure and transplant cardiology, a move that was anticipated. While telehealth would enjoy a renewal of momentum under the terms of the draft, novel oncology drugs would be reimbursed at the wholesale acquisition cost plus 1.35 percent, a considerable shave from the current standard of WAC+6.

Watson Health is working hard to demonstrate the seriousness of its ongoing efforts in oncology, highlighting its research and customers at the recent American Society of Clinical Oncology (ASCO) conference. The Boston-based IBM business had six presentations at ASCO based on its data and touted that its oncology product is being used at more than 55 cancer centers globally. But experts in the field of machine learning suggest that the real innovation and value-add for machine learning in oncology is in the analysis of radiology images, which are not addressed by the medical record and...

You have to hand it to the cancer lobby. It really has the U.S. federal government wrapped around its little finger. Some will say I'm overstating the case, but is that really a solid argument? Let's examine the evidence. Mortality, economic impact boxes? Not checked First, let's look at overall mortality in the U.S. According to the National Center for Health Statistics, heart disease was responsible for more than 614,000 deaths in 2013, while the various cancers claimed fewer than 592,000 lives. If you add cerebrovascular deaths (more than 133,000) into the...

A few years back my brother-in-law Sam was starting a new job and was required to get a physical as part of the hiring process. A standard X-ray revealed a spot on his lungs and further testing confirmed it was cancer. The diagnosis came about two years after he’d quit smoking, but he had been a smoker for many years and was somewhere in his early 40s. Thankfully, because it was caught and treated so early, he is still with us today and doing great. But what if he hadn't had that physical? Earlier this week the U.S. Preventive Services...

By JIM STOMMEN, Medical Device Daily Contributing Writer  The arguments going on these days over the prostate cancer screening test known as prostate-specific antigen (PSA for short) might make one think that there’s something wrong with the test itself. Not so. The argument by what we will refer to as the “anti” side of the issue is with what happens after the routine blood test comes back with a positive finding. Those folks, who go by the name U.S. Preventive Services Task Force, maintain that the PSA test leads to demonstrative levels of over-treatment, doing so to such an extent...

Late last month, the American College of Radiology Imaging Network (ACRIN; Philadelphia) along with the National Cancer Institute’s Lung Screening Study Group released the results of the National Lung Screening Trial (NLST). The study supports the idea that CT Screening in older, heavy smokers can reduce mortality rates by 20% compared to standard chest X-rays.  Nearly 53,000 current and heavy smokers between the ages of 55 and 74 at 33 sites across the U.S. were enrolled in NLST. (See full study here) It should be pointed out however that the study results show that CT Screening in these patients turned up a high...