In proposing a national coverage determination to limit coverage of a class of Alzheimer’s drugs to those being used in clinical trials approved by the U.S. Center for Medicare & Medicaid Services or the NIH, CMS appears to be treading in FDA territory. “For the first time ever, Medicare is second-guessing FDA – and not only on work that it has already done, but on work FDA will do in the future,” said George Vradenburg, chair and co-founder of Us Against Alzheimer’s, a patient advocacy group. “HHS [the Department of Health and Human Services] is clearly at war with itself, with one agency approving this class of drugs and another slamming the door shut on treatment. . .. Does CMS no longer trust the FDA’s work?”
The existence of prior art isn’t always readily evident when companies in the device and diagnostic spaces file patent applications with the U.S. Patent and Trademark Office (PTO). As it turns out, literature describing that prior art need not be widely distributed to invalidate a patent as Quest Diagnostics Inc., of Secaucus, N.J., recently discovered, an object lesson for all in the med-tech space that research for prior art must be exhaustive if a patent is to hold up over time.
The FDA reported a class I recall of the Wirion embolic protection device by Cardiovascular Systems Inc. (CSI), of St. Paul, Minn., due to reports of nine instances of device malfunction. The agency said the filter portion of the device can be difficult to withdraw under some circumstances and thus lead to separation, although the FDA noted that no deaths have been reported in association with the issue despite the risk of embolization. The FDA’s device center also posted a Jan. 11 notification against the use of two tests by Lusys Labs Inc., of San Diego, for the SARS-CoV-2 virus.
Where’s the plan? That was the underlying question Jan. 11 as Biden administration health officials faced frustration and tough questions from both Democrats and Republicans on the Senate Health, Education, Labor and Pensions (HELP) Committee about how the U.S. government is responding to the surge of COVID-19 infections caused by the omicron variant.
Owens & Minor Inc. (O&M) sent Apria Inc. shares out of the ballpark with the announcement of its acquisition of the at-home health care company for $1.45 billion in cash early this morning. Apria’s stock (NASDAQ:APR) closed Friday at $29.72, opened today at $37.16 and rose incrementally throughout the day to close at $37.48. O&M’s stock (NYSE:OMI) ended the week at $45.08; it ebbed sharply to $40.19 on the news before recovering to $45.35 at the end of the trading day.
The FDA has posted a draft guidance responding to changes in the law regarding device shortages during public health emergencies. The guidance says that manufacturers should advise the FDA of any impending shortages, but the key qualifier, that of a “meaningful disruption” in production, may be sowing confusion in the industry.
This could be a make-or-break week for Biogen Inc., with the U.S. Centers for Medicare & Medicaid Services (CMS) expected to announce a draft coverage decision for the company’s Alzheimer’s drug, Aduhelm.
Space travel has known effects on human health and biology. Some, such as loss of bone density, are well understood, while others, like inflammation, are not. Now, organ-on-a-chip maker Emulate Inc. is conducting experiments on the International Space Station U.S. National Laboratory (ISS-NL) aimed at revealing clues to how the brain functions in microgravity.
University of California San Diego engineers have developed tiny 2D sensors that pop up to become a 3D assemblage of microscopic sensors for directly measuring the movement and speed of electrical signals inside the heart. According to nanoengineering professor Sheng Xu, the nanotechnology has enormous implications for heart doctors anxious to better diagnose and treat arrhythmia, heart attack and other diseases.
Within hours of a Jan. 5 vote on COVID-19 boosters for adolescents, U.S. CDC Director Rochelle Walensky endorsed the Advisory Committee on Immunization Practices’ (ACIP) recommendation that all adolescents aged 12-17 years should receive a booster dose five months after their primary series. The recommendation applies to the Pfizer Inc.-Biontech SE COVID-19 vaccine, as it’s the only one authorized in the U.S. for use in adolescents.
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