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HHS has ordered the FDA to “cease further collection efforts” related to the Over-the-Counter Drug Monograph User Fee Program and has withdrawn the agency’s Dec. 29 Federal Register notice on user fee rates. Read More
The FDA made the right call in strongly advising against using a half-dose regimen of Moderna’s COVID-19 vaccine to stretch supply and vaccinate more Americans, members of the agency’s vaccine advisory panel told FDAnews. Read More
The Department of Justice quotes extensively from internal Walmart documents allegedly showing its pharmacists raised “red flags” against illicit opioid prescribers but that the company filled the prescriptions anyway, in a federal civil lawsuit filed against the company. Read More
The pharmaceutical industry will see more mergers and acquisitions in 2021 than in the pandemic-depressed year just ended, top financial firms are saying. Read More
The FDA has released a draft guidance on investigational new drug (IND) submissions by developers of individualized gene therapies that use antisense oligonucleotides (ASO), as part of the agency’s ongoing efforts to encourage orphan drugs. Read More
India’s Bharat Biotech plans to produce 700 million doses of its newly approved vaccine this year, the company’s managing director Krishna Ella said Monday. Read More
Researchers at China’s Shenzhen Institutes of Advanced Technology have found that pralatrexate, a chemotherapy drug used to treat lymphoma, may hold potential as a COVID-19 treatment and that it outperforms remdesivir in inhibiting the virus. Read More
Late Monday, the FDA’s two top officials hinted that the agency is unlikely to adopt the Trump administration’s idea of giving two half doses of Moderna’s COVID-19 vaccine to patients aged 18 to 55 in order to double the number of vaccinations being administered, as suggested by Operation Warp Speed’s chief adviser Moncef Slaoui. Read More