Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for single-dose EMEND® (fosaprepitant dimeglumine) for injection, Merck’s substance P/neurokinin-1 (NK1) receptor antagonist, in combination with other antiemetic medicines, for the prevention of delayed nausea and vomiting in adults receiving initial and repeat courses of moderately emetogenic chemotherapy (MEC). EMEND has not been studied for the treatment of established nausea and vomiting.
Takeda Pharmaceutical Company Limited and H. Lundbeck A/S announced that the U.S. Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) voted 8 to 2 that the companies presented substantial evidence to support the effectiveness of Brintellix (vortioxetine) for treating certain aspects of cognitive dysfunction in adults with Major Depressive Disorder (MDD). Earlier today, the committee also discussed that cognitive dysfunction in MDD represents an appropriate drug development target.
Boehringer Ingelheim announced that SPIRIVA® RESPIMAT® is now available for the treatment of asthma by prescription in U.S. pharmacies. The U.S. Food and Drug Administration (FDA) approved a once-daily dose of 2.5 µg for the long-term maintenance treatment of asthma in people ages 12 and older.
Targovax has submitted a study protocol to the regulatory authorities in Spain to assess its ONCOS-102 product in combination with chemotherapy in patients with malignant pleural mesothelioma (MPM), a rare type of lung cancer associated with exposure to asbestos.
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