The check is in the mail
Schering-Plough's late user fee payments for the cholesterol absorption inhibitor Zetia (ezetimibe) led to delay in NDA submission date for Merck's Arcoxia. The payments were due Dec. 13, but FDA did not receive payment until Jan. 13. Schering and Merck have a joint venture agreement for Zetia and the fixed-dosed Zetia/Zocor combination...
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Newly published data and results presented at ESMO for Amgen’s sotorasib (AMG 510) show relatively long-lasting responses and progression-free survival in lung cancer.
IBA’s name change refines its identity as the representative of the independent and entrepreneurial beauty industry, according to the trade organization’s announcement. The group’s FDA Cosmetics Regulation Workshop, held annually since 1983 in cooperation with the FDA, will be virtual in 2020.
Justice Ginsburg wrote two decisions in pharmaceutical related-cases over the past decade, joined the majority in opinions on the scope of patents, and dissented in decisions giving protection to generic manufacturers and speech of pharmaceutical companies. Her death could impact the outcome of cases challenging the Affordable Care Act.