Bioepis, we will continue to demonstrate our enduring commitment to biosimilars by further strengthening our pipeline and widening the availability of approved treatments for cancer patients across the US. In randomized, controlled clinical trials, the per-patient incidences of NCI-CTC Grade 3-4 neutropenia and of febrile neutropenia were higher in patients receiving trastuzumab products in combination with
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myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was similar among patients who received trastuzumab and those who did not Sales of electronic-cigarettes could be halted if companies don't stop marketing the devices to youth, U.S. Food and Drug Administration Commissioner Dr. Scott Gottlieb warned. He's said he's horrified at the recent rise in teen use of the e-cigarettes and that FDA efforts to get companies to voluntarily eliminate candy-flavored products and aggressive marketing have had little
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effect, NBC News reported. "I'll tell you this. If the youth use continues to rise, and we see significant increases in use in 2019, on top of the dramatic rise in 2018, the entire category will face an existential threat," he said Friday. "It will be game over for these products until they can successfully traverse the regulatory process," Gottlieb warned. The FDA has the authority to block e-cigarette sales and force makers to go through the formal FDA approval process, but has not
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