The U.S. FDA advises health care providers (HCPs) to avoid using Monoject syringes distributed by Cardinal Health with syringe pumps or patient-controlled analgesia (PCA) pumps because of incompatibilities between the Monoject interface and the pumps.
The U.S. FDA’s predetermined change control program (PCCP) is the talk of the med-tech town, but this novel regulatory mechanism has its limitations, said Cassie Scherer, senior director for digital health policy at Medtronic plc.
The renal denervation hypothesis of hypertension was initially viewed with some skepticism, and Dublin-based Medtronic plc. endured a major setback when clinical trial data failed to make a compelling case for approval for the Symplicity Spyral. However, the company finally landed an FDA approval for the device, opening the gates to a new and significant market opportunity even with competition already on the market.
South Korea’s Ministry of Food and Drug Safety (MFDS) will head an international team of regulatory experts from 19 drug agencies worldwide, including the U.S. FDA and China National Institute for Food and Drug Control (NIFDC), to draft an international standard for artificial intelligence (AI)-based software.
Janet Woodcock, one of the longer-tenured U.S. FDA center directors in the agency’s history, is set to retire sometime in 2024, although the exact date has not been set.
Low expectations on Wall Street for the Pulmonary-Allergy Drugs Advisory Committee (PADAC) sit-down on Merck & Co. Inc.’s P2X3 receptor antagonist gefapixant for chronic cough (CC) translated to negative balloting by panelists. PADAC members were polled on a single question: Does the evidence demonstrate that [Merck’s] gefapixant provides a clinically meaningful benefit to adults with refractory or unexplained CC? The results came out 12 no, 1 yes.
Along with Enhertu, Astrazeneca plc now has another breast cancer treatment in its portfolio and it may also become a blockbuster. Truqap (capivasertib), combined with the company’s Faslodex (fulvestrant), is now U.S. FDA-approved for treating hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer.
In efforts to strengthen cooperation between the U.S. and South Korea’s life sciences sector, industry organizations like Biocom California and KoreaBIO are helping foster cross-border collaboration as Korea looks to ramp up the so-called Bio Economy 2.0. KoreaBIO, which stands for the Korea Biotechnology Industry Organization, in its latest feat welcomed a trade delegation run by the San Diego Regional Economic Development Corp. and the World Trade Center San Diego in November 2023, helping bolster cooperation between companies in Korea and in the San Diego and Tijuana, Mexico, regions.
The U.S. FTC’s policing of Orange Book patent listings begs the question of when, and whether, the FDA will deliver on its commitment to provide more clarity on the types of device patents that can be listed as covering a “drug product.”
After Cormedix Inc. navigated manufacturing issues that slowed the process, the U.S. FDA approved the antibacterial and antifungal solution Defencath to reduce catheter-related bloodstream infections adults with kidney failure.
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