A study published in JAMA Internal Medicine showed Medicare has spent almost $600 million over three years on cancer treatments approved under the FDA's accelerated review pathway that were later found to offer no clinical benefit and did not improve overall survival in patients with breast, lung, urinary tract and liver cancers. Researchers said the findings underline the need to reform the FDA's accelerated approval program "so that the benefits of early access are better balanced with the downsides of spending large sums of money on drugs without clinical benefit."
A recall of two COVID-19 laboratory test kits from Abbott Molecular, an Abbott Laboratories unit, has been identified as Class 1 by the FDA due to the tests' potential for false positives. The recall is for the Alinity m Resp-4-Plex AMP and the Alinity m SARS-CoV-2 AMP test kits.
All batches of irbesartan and irbesartan/hydrochlorothiazide tablets from Lupin Pharmaceuticals are being recalled in the US over concerns that they may contain N-nitrosoirbesartan, a potential carcinogen. The Indian firm received four adverse event reports linked to irbesartan use from October 2018 to September 2021.
The FDA's Vaccines and Related Biological Products Advisory Committee has recommended a second dose of the Johnson & Johnson COVID-19 vaccine for people age 18 and older who received the single-dose vaccine at least two months ago, according to Reuters. Some advisory panel members also asked whether the initial single-dose of the J&J vaccine should be considered a two-dose regimen.
Pfizer and partner BioNTech have announced that they have submitted documentation to the European Medicines Agency on their COVID-19 vaccine to support its use in children between ages 5 to 11. The vaccine has only received authorization in the US and EU for children ages 12 and older.
Commercial production of Moderna's COVID-19 vaccine has begun at Samsung Biologics in South Korea, and the South Korean FDA has fast-tracked the company's good manufacturing practice certification application filed in September for domestic distribution. Other countries' regulatory authorities will have to issue GMP certification before Samsung can distribute the vaccines abroad.
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