As the number of drug shortages continues to grow in the U.S. and globally, the FDA is issuing a draft guidance spelling out drug and API manufacturers’ responsibility to give the agency a timely, informative heads-up about changes in their production that could lead to a shortage.
Despite an early stumble, the U.S. FDA granted emergency use authorization (EUA) to the C5a inhibitor Gohibic (vilobelimab) from Inflarx NV for treating COVID-19 in hospitalized adults. A year ago, an initial phase III analysis had failed to show a statistically significant effect on the primary endpoint of 28-day all-cause mortality though there was a relative reduction in mortality in the active arm vs. placebo.
The possibilities of cures for cancer and other tough-to-treat diseases and the ability to further personalize medicine are creating a lot of excitement about the future of radiopharmaceuticals as both therapy and diagnostics. To reach that future, industry and researchers will have to overcome a lot of challenges, not the least of which stem from the multiple government agencies involved in regulating the source material, development, distribution and use of radioactive drugs and devices.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acasti, Aim, Amarin, Astellas, Caribou, Gennova, Hutchmed, Pfizer, Phathom, Scisparc, Seagen, Shionogi.
The U.S. FDA has been working for some time to develop less clunky regulatory mechanisms for digital health products, but Jeff Shuren, director of the agency’s Center for Devices and Radiological Health, has been touting a voluntary alternative pathway (VAP) as a modernized approach to premarket review.
To help drug manufacturers comply with the technical requirements of RCD 753/2022 and other related standards regarding proof of a drug’s safety and efficacy, Brazil’s Anvisa issued three new guidelines for submitting registration requests for new or innovative synthetic and semi-synthetic drugs.
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).
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