The U.S. SEC released guidance Nov. 29 that could impact how drug and medical device companies shape, and report, their executive compensation packages when it comes to "spring-loaded awards.”
As part of its real-world evidence (RWE) program, the U.S. FDA released a draft guidance Nov. 29 on using registries to support regulatory decision-making for drugs and biological products.
A number of members of the U.S. House of Representatives have penned a letter to the Centers for Medicare & Medicaid Services (CMS) in support of the Medicare Coverage of Innovative Technology (MCIT) rule, the second time in recent weeks the agency has heard from Congress. The net effect of these letters is to suggest that Cures 2.0, which would provide Medicare coverage of breakthrough devices, is not on solid footing, which if true would suggest that the Biden administration’s Advanced Research Projects Agency for Health (ARPA-H) is similarly endangered.
PERTH, Australia – Australian health technology company Planet Innovation is expanding its footprint into the U.S. with the acquisition of the North American operations of Germany’s medical device manufacturer BIT Analytical Instruments GmbH.
It’s decision time for oral drugs that could help the world return to normal even in the midst of the COVID-19 pandemic. The U.K. already has granted emergency authorization to Merck & Co. Inc. and Ridgeback Biotherapeutics Inc.’s antiviral, Lagevrio (molnupiravir), and the EMA is expected to complete its evaluation of the oral drug within the next few weeks. In the U.S., the FDA could announce its decision on Lagevrio shortly after its Antimicrobial Drugs Advisory Committee weighs in Nov. 30 on emergency use authorization.
Following an FDA priority review, Takeda Pharmaceutical Co. Ltd.'s oral antiviral, maribavir, has won U.S. approval as the first drug in the country to treat resistant cytomegalovirus (CMV) infection and disease in adult and pediatric transplant recipients. The drug will be marketed as Livtencity.
The U.S. Court of Appeals for the Federal Circuit recently decided an appeal of a patent lawsuit involving Cardionet LLC, of Conshohocken, Pa., invalidating the Cardionet patent for lack of subject matter eligibility. While the patent offers a significant improvement in the functionality of any computer that uses the Cardionet algorithm, the Federal Circuit declared that the invention does nothing more than use the computer as a tool to express an abstract idea.
The FDA has continued a series of device risk classifications with the formal announcement that general containment systems used with power morcellators will henceforth be deemed class II, moderate-risk devices.
Former FDA Commissioner Stephen Hahn is being asked to spill the beans on political interference at the U.S. agency during the emergence of COVID-19 last year.
U.S. trading partners are raising concerns about the FDA’s continued delays in inspecting foreign drug manufacturing facilities due to the COVID-19 pandemic and related travel restrictions.
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