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HUNTSVILLE, Ala. – Doctors have been able to add another weapon in their arsenal to help fight the flu this year. For the first time in 2 decades, the FDA approved a new flu drug, Xofluza, to fight the flu. Xofluza is the brand name and the medication itself is Baloxavir Marboxil. It treats the flu with just one dose. When patients who have had symptoms for less than 48 hours take this medication, the...

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Research we’re watching In December 2018, the FDA issued a warning about certain antibiotics known as fluoroquinolones, a drug class that includes ciprofloxacin (Cipro) and levofloxacin (Levaquin). The drugs are associated with rare ruptures or tears in the body’s main artery, the aorta, which can cause serious, sometimes fatal bleeding. Cases were reported in people taking these antibiotics orally or by injection. Because of this risk, the FDA is advising doctors to try to avoid...

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Having spent over three decades without an approval, Immunomedics has a troubled past that culminated in a management shakeup at the behest of an activist shareholder campaign that was meant to rejuvenate the company’s fortunes. But that hope was shattered when the FDA rejected the company’s breast cancer drug in January, citing manufacturing issues. To be sure, the company was not expecting the rejection. It hired a sales force back in November in anticipation of...

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Food and Drug Administration Commissioner Scott Gottlieb is threatening "unprecedented" action against America’s most popular tool to quit smoking. Cheered on by a cacophony of moral entrepreneurs, an increasingly hysterical FDA is lunging towards policies that will cripple the e-cigarette industry, which is now the biggest challenger to traditional cigarettes. The trigger for Gottlieb’s ire is recently released data from the 2018 National Youth Tobacco Survey showing a surge in teen vaping. The percentage of...

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Leaders at the Food and Drug Administration charged with implementing the Food Safety Modernization Act knew agricultural water standards weren’t going to be met by someone in Washington D.C. snapping their fingers. They decided more time for education and training would be required. The original 2018 compliance date for the FSMA water quality standards was moved forward to 2022. The FDA enlisted 45 state agricultural departments to help get growers and others in the food...

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The FDA has released the Form 483 issued to Immunomedics. (FDA) Immunomedics received an FDA complete response letter last month tied to manufacturing concerns about its breast cancer antibody-drug conjugate. When pressed by analysts, company executives dodged questions of whether it stemmed from a preapproval inspection of its plant last year. Now the FDA has released the Form 483 from the inspection showing big issues with data integrity at the Morris Plains, New Jersey, plant...

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In the midst of the digital revolution, no industry remains untouched. Every sector from finance to manufacturing to transportation is seeing itself been drastically redefined by the influx of new innovations and devices. The healthcare industry, one of the most sensitive sectors when it comes to change (after all, the stakes are rarely higher than your well-being), is learning both how to adapt to the new technology while maintaining a high-degree of oversight. After all,...

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