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Santa Fe, Calif.-based over-the-counter (OTC) drugmaker Creative Essences drew a lengthy Form 483 report with eleven observations following an FDA inspection of its facility in late August and early September. Read More
The president’s controversial “most favored nation” strategy for lowering U.S. drug prices has been placed on hold by a federal judge pending an evaluation of its legality. Read More
President Trump signed Congress’ combined appropriations and COVID-19 relief package late on Sunday, averting a looming federal government shutdown. Read More
By the end of 2022, drug, device and biologic product sponsors that are required to submit a risk evaluation and mitigation strategy (REMS) will have to do so electronically, the FDA said in a final guidance issued last week. Read More
Merck has signed a contract to supply up to 100,000 doses of its experimental COVID-19 treatment, MK-7110, to the U.S. government for $356 million, provided the investigational biologic earns the FDA’s approval or Emergency Use Authorization. Read More
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