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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The FDA has released a draft guidance on investigational new drug (IND) submissions by developers of individualized gene therapies that use antisense oligonucleotides (ASO), as part of the agency’s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
The World Health Organization (WHO) has granted the Pfizer/BioNTech COVID-19 vaccine an Emergency Use Listing — the first such listing by the standard-setting body since the pandemic began. Read More
An FDA investigator observed quality lapses during an inspection of Fairfield, New Jersey generic and over-the-counter drugmaker AACE Pharmaceuticals, including sticky tape on equipment used to produce drug products. Read More