The U.S. NIH once again faces questions about its oversight of certain research. In the latest round, the U.S. Government Accountability Office called on the agency to do more to ensure that foreign facilities conducting NIH-funded animal research are compliant with U.S. standards and policy regarding animal care and use, as well as international standards.
The U.S. Centers for Medicare & Medicaid Services (CMS) has scaled back the list of Medicare Part B drugs facing the new inflation rebate under the Inflation Reduction Act for the first quarter of 2023.
As Seagen Inc. preps for a merger, the U.S. FDA awarded accelerated approval to the company’s big-selling Padcev (enfortumab vedotin). The approval is for a combination therapy with Merck & Co. Inc.’s Keytruda (pembrolizumab) as a first-line treatment for adults with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapy.
More than four years after it was given the authority to do so, the FDA is requiring manufacturers of opioid painkillers dispensed in outpatient settings to make prepaid mail-back envelopes available to pharmacies and other dispensers as part of their risk evaluation and mitigation strategy (REMS).
A frustrating lack of detail left analysts with little to do but speculate on the odds for a 2023 U.S. FDA approval of Ascendis Pharma A/S’s Transcon PTH (palopegteriparatide), a parathyroid hormone prodrug for hypoparathyroidism, after the company disclosed a letter from the agency citing unspecified deficiencies that preclude further discussions about labeling and postmarketing requirements.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akebia, Akero, Algo, Athos, Comanche, Decibel, Immvira, Merck & Co., Pacira, Pathovax, Renovion, Vistagen.
Whether it’s legislation calling for more transparency from pharmacy benefit managers (PBMs) or hearings held in search of a new roadmap to modernize the U.S. drug supply chain, Congress is scrutinizing and looking to clamp down on the role PBMs are playing in raising drug prices.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Blueprint, Eloxx, Epicentrx, Hansa, Juno, Pharmather, Regeneron, Transcenta.
U.S. FDA commissioner Robert Califf went to Capitol Hill ostensibly to answer questions about the agency’s budget request for fiscal 2024, but the conversation quickly focused on issues such as baby formula and food supply security.
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