Six months out from the World Health Organization ending the global health emergency brought on by the pandemic, there’s no need for the World Trade Organization to expand a five-year intellectual property (IP) waiver for vaccines to COVID-19-related drugs, devices and diagnostics.
At first glance, the U.S. FDA’s draft guidance for evidentiary expectations for 510(k) implants seems to demand more rigor on these applications, but some in industry believe that several of these elevated requirements offer little or no commensurate benefit. Geeta Pamidimukkala of the Advanced Medical Technology Association (Advamed) said the draft would seem to require that manufacturers preemptively explain the exclusion of animal testing, a requirement she said creates more work for both industry and FDA without offering a meaningful benefit.
The U.S. FDA has commenced with a pilot program for companion diagnostics (CDx) for oncology therapies, which fulfills in part a 2014 agency guidance on the use of CDx. The FDA expects to enroll only nine reference drugs and the associated companion test, but the pilot program is part of the FDA’s controversial attempt to deal with lab-developed tests (LDTs), specifically those tests that are used to determine whether a patient is likely to respond to a particular oncology treatment.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: CGBio, Endosound, Pulnovo.
Jiangsu Atom Bioscience and Pharmaceutical Co. Ltd. has received FDA clearance of its IND application for a phase I trial in the U.S. of ABP-745, an anti-inflammatory oral small-molecule drug, for the treatment of acute gout.
Of all that happened in 2023, Medicare price negotiations probably top the list as the biggest U.S. biopharma disruptor. Although Congress cleared the way for the negotiations last year when it passed the partisan Inflation Reduction Act, they weren’t fleshed out until this year when the Centers for Medicare & Medicaid Services issued guidance detailing the rules of the negotiating road. And as usual, the devil is in the details.
The med-tech industry had high hopes in 2023 regarding Medicare coverage for breakthrough medical devices, but those hopes were dashed when the U.S. Centers for Medicare & Medicaid Services (CMS) withdrew the associated draft rule and will instead issue a “notice” regarding the Transitional Coverage for Emerging Technologies (TCET) concept.
In keeping with a provision in the Inflation Reduction Act, the U.S. Department of Health and Human Services will not implement a final rule removing the anti-kickback safe harbor for the rebates drug companies pay pharmacy benefit managers until Jan. 1, 2032.
In his latest effort to boost the U.S. manufacturing base, President Joe Biden is invoking the Defense Production Act (DPA) to expand the domestic production capabilities for essential medicines, medical countermeasures (MCMs) and their critical inputs.
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