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.

Robert Califf said it when he was serving as FDA commissioner. Patient advocates have said it when testifying before Congress or commenting at public meetings. And this week, experts on the FDA’s Psychopharmacologic Drug Advisory Committee (PDAC) said it again: Doctors don’t read drug labels. Yet drug companies continue to invest millions of dollars on aspects of clinical trials that are designed to inform labeling, and FDA reviewers spend untold hours scouring the data to ferret out what should be included in the prescriber information as contraindications, warnings and cautions, boxed warnings, the mechanism of action and clinical trial findings....

Dirt. Excrement. Glass. Hair. Insects. Mold. Rodent infestation. Scouring pad fibers. Unknown particulates. They’re words too often mentioned in FDA warning letters that describe manufacturing conditions for supposedly sterile drugs. A few years ago when I was a cancer patient hooked up to an I.V. drip for three to four hours every two weeks, I found reading those warning letters a horrifying experience. With a cocktail of generic and brand drugs coming from who knows where being pumped into the port resting a few inches from my heart, I cringed at the thought of what might be entering my vein....

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...

Unintended consequences. It’s a term that’s bandied about all too often in Washington these days, as it’s become the PC way for lawmakers and agencies like the FDA to save face when they have to admit, “Oops, we didn’t think that one through very well” when confronted with the negative impacts of the laws and regulations they’ve created. A new unintended consequence could be in the offing as the FDA extends its practice of label carve-outs to biosimilars. A familiar feature of the generics scene, carve-outs have allowed the agency to approve a knock-off even though the reference drug may...

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...