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Jeffrey Zients, White House COVID-19 response coordinator, acknowledged in a press briefing that deliveries will be slow to start, especially for Pfizer’s Paxlovid. Read More
FDA investigators observed numerous quality failures during an inspection of a KVK Tech generic drug manufacturing facility in Newton, Penn., ranging from lax cleaning to incomplete investigations of complaints. Read More
In terms of approvals of new products, 2021 was the second-best year for cell and gene therapies and tissue products (The best year was 2016, when nine therapies were approved.). Read More
People vaccinated against COVID-19 who get an Omicron infection appear to have a low risk of Omicron reinfection, as well as significantly increased resistance to the Delta variant, new South African data suggest. Read More
The FDA has approved Novartis’s new drug application (NDA) for its cholesterol-lowering drug Leqvio (inclisiran) after rejecting the NDA a year ago because of manufacturing concerns. Read More
Over the past year, President Biden touted that the nearly $2 trillion Build Back Better Act would bolster the nation’s social safety net, fight climate change and introduce drug pricing reform. Read More
High-quality evidence was lacking for most of the COVID-19 diagnostics, medical devices and drugs the FDA has granted Emergency Use Authorization (EUA) since the start of the pandemic, claimed researchers at Israel’s Tel-Aviv University in a provocative analysis in the journal JAMA Internal Medicine. Read More
Though the FDA last week authorized the first COVID-19 oral antivirals for at-home use — Pfizer’s Paxlovid and Merck’s and Ridgeback Biotherapeutics’ molnupiravir — access to the pills will be limited in the new year. Read More