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(For those who wonder whether Congress will ever pass a patent reform bill, we offer the following with a tip o' the hat to Edgar Allan Poe....) Once upon a mid-day dreary, While I pondered dazed and bleary, O'er forgotten writs of Federal Circuit law and patent lore. Yes, I nodded, nearly napping, But then came a nagging tapping. Some optimist was gently rapping, Rapping at my office door. "'Tis some fool," I think I muttered, "Waxing over writs of yore, Only this, and nothing more." Ah, distinctly I remember, It was back in some December, When each separate Senate...
By most objective accounts, Donald Berwick is doing a pretty decent job as chief administrator of the Centers for Medicare & Medicaid Services, giving CMS a much-needed shot in the arm and kick in the . . . well, you know. Unfortunately, that appears to not be enough for him to keep the job beyond the end of the year, as mandated by law for "recess" appointments such as himself. Berwick, who knows the provider side of medicine as a pediatrician, is a health policy expert of some repute. He has been quite the thinker on broader healthcare questions, including...
Often times journalists go into interviews with pretty much a clear picture of what the story is going to be. There are few surprises – that is until that one kernel of information spills from the lips of a source and it completely steers the story in a different direction and gets you to look at a subject differently. Well that happened to me during the Southeastern Medical Association Conference held here in Atlanta recently. One of the panelists was speaking during a session called successful pathways to medical device innovation, when all of a sudden he paused - and...
It’s easy to understand the excitement about the PARTNER trial, sponsored by Edwards Lifesciences (Irvine, California), the company that makes the much talked about transcatheter aortic valve replacement (TAVR) device, called the Sapien. After all, given the choice between open heart surgery or a non-surgical alternative most patients would prefer the latter. However, the data from the study, which was presented earlier this week at the American College of Cardiology (Washington) annual meeting in New Orleans, showed that TAVR patients were also more likely to have a stroke following the procedure. In the study, major strokes were higher for TAVR...
Late last month, Medtronic (Minneapolis) reported that it was cancelling several of its largest contracts with group purchasing organizations (GPOs) worth more than $2 billion collectively. Medtronic said the decision to cancel five contracts with Novation (Irving, Texas) and another with Premier (Charlotte, North Carolina) will save it about $60 million a year. Wall Street reacted positively to the news and some industry watchers are wondering if other companies will follow suit and bypass GPOs to sell products directly to hospitals. GPOs – which use high volume purchasing power to secure discounts for hospitals, introduce new devices to the market,...
The recess appointment of Donald Berwick, MD, to the administrator’s position at the Centers for Medicare & Medicaid Services (CMS) last July roiled many members of Congress, and a recent Senate letter to the Obama administration expressing disfavor for Berwick’s continued presence at CMS may have finally lain to rest any chance that he had of a successful confirmation hearing. The letter, whose principal authors include Sen. Mike Enzi (R-Wyoming), the ranking GOP member of the Senate Health, Education, Labor and Pensions Committee, and Orrin Hatch (R-Utah), the ranking GOP member of the Senate Finance Committee, cite Berwick’s “past record...
Patent reform legislation has been in the news quite a bit the past few weeks in the U.S., with both chambers of Congress working on legislation that could affect the way patents are currently registered. The U.S. patent system is currently based on a first-to-invent doctrine, which means that the inventor who first conceived of the invention and then reduced it to practice by filing a patent application is considered the first inventor and is entitled to patent protection. Every other country in the world, except the Phillipines, has a patent system based on the first-to-file doctrine, in which the...
In January when the FDA unveiled its 25-point plan to change the 510(k) clearance program, currently the quickest and most commonly used pathway to getting a medical device to market in the U.S., it appeared that a smooth landing might be in the works for the med-tech industry. That landing, however, was deferred, saddling the program with one of the greatest annoyances to any airline passenger, the dreaded holding pattern, when it was revealed that 30 other more controversial recommendations from the FDA working groups were being delayed. Among the most contentious recommendations being postponed was one for CDRH...
HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) recently granted the first urgent-use licenses to four COVID-19 novel coronavirus diagnostic...
As the COVID-19 outbreak continues to dominate the news, an increasing number of companies have come forward to help. For its part, CHF Solutions Inc., of Eden...
BEIJING – Beijing-based Sihuan Pharmaceutical Holdings Group Ltd. said it has initiated clinical trials of broad-spectrum antiviral favipiravir to treat COVID-19....
Mallinckrodt plc is engaging with the U.S. FDA, NIH and the Biomedical Advanced Research and Development Authority to address the potential use of its INOmax...
HONG KONG – As the number of COVID-19 confirmed cases and deaths continue to rise globally, South Korea’s focus on testing has attracted international attention....
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