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The Department of Justice (DOJ) filed a federal civil lawsuit against Walmart Tuesday, alleging that the retailer illegally sold prescription opioids in its pharmacies and contributed to the opioid abuse crisis. Read More
The National Institutes of Health (NIH) has paused enrollment of critically ill COVID-19 patients in a phase 3 trial of various blood thinners, one of three international trials evaluating whether a full or lower dose of anticoagulants in hospitalized COVID-19 patients is more effective. Read More
“By treating the foundations simply as conduits to pay the co-pays of its own patients, Biogen violated the anti-kickback statute and undermined Medicare’s co-pay structure,” said U.S. Attorney Nathaniel R. Mendell. Read More
The FDA has placed a clinical hold on uniQure’s entire clinical development program for its investigational gene therapy for hemophilia B after a patient participating in a pivotal phase 3 clinical trial was given a preliminary diagnosis of liver cancer, the company announced Monday. The serious adverse event was included in a mid-December safety report on the trial as being possibly related to the patient’s treatment with the investigational gene therapy, etranacogene dezaparvovec (AMT-061) in October 2019. Read More
The House Select Subcommittee on the Coronavirus Crisis issued subpoenas on Monday to the chiefs of HHS and the Centers for Disease Control and Prevention (CDC), demanding documents relating to the Democrats’ investigation of alleged political tampering with coronavirus response efforts. Read More
Ending months of haggling between lawmakers, Congress passed an omnibus appropriations bill and COVID-19 relief package late Monday with a seven-day continuing resolution in place to keep the government funded at fiscal 2020 levels until the legislation is signed into law as expected. Read More
The European Commission last week exercised its option with Pfizer/BioNTech for an extra 100 million vaccine doses, for a total of 300 million — enough to vaccinate one third of the EU’s population. Read More
Novartis has received a Complete Response Letter (CRL) from the FDA regarding a new drug application (NDA) for its cholesterol-lowering drug Leqvio (inclisiran). Read More
The World Health Organization has announced that its COVAX program has now reached supply agreements for almost 2 billion doses of several promising COVID-19 vaccine candidates for distribution to less well-off countries next year. Read More
The House and Senate are expected to vote today on a combined fiscal 2021 appropriations and COVID-19 relief legislative package after passing another stopgap spending bill Sunday to keep the federal government funded for 24 hours. Read More
The import, sale and marketing of a competitor to AbbVie’s Botox wrinkle treatment must be stopped for nearly two years, the U.S. International Trade Commission (ITC) ruled this week. Read More
In a Thursday hearing of a congressional committee, two members of the Sackler family and Purdue Pharma’s current president and CEO, Craig Landau, dutifully expressed sorrow for the role played by Purdue’s former flagship product, the painkiller OxyContin (oxycodone), in the opioid abuse crisis that has killed thousands of Americans. Read More