AQUESTIVE THERAPEUTICS: Granted Temporary Restraining Order (TRO) Against Alvogen

Aquestive Therapeutics, Inc. (Nasdaq: AQST), a specialty pharmaceutical company, focused on developing and commercializing differentiated products to solve therapeutic problems, announced that the U.S. District Court for the District of New Jersey has granted a temporary restraining order (TRO) that enjoins Alvogen from initiating any launch activities related to its generic buprenorphine/naloxone sublingual film. Read More »

DAIICHI SANKYO, INC.: FDA Grants Priority Review for Daiichi Sankyo's New Drug Application for FLT3 Inhibitor Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted Priority Review for quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML). Read More »

SANOFI: FDA grants priority review for Dupixent® (dupilumab) as potential treatment for adolescents with uncontrolled moderate-to-severe atopic dermatitis

The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) in adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis, whose disease was inadequately controlled with topical therapies or for whom topical treatment was medically inadvisable. Read More »

ALLERGAN INC.: Allergan and Editas Medicine Announce Exercise of Options to Jointly Develop CRISPR Genome Editing Experimental Medicine EDIT-101

Allergan plc (NYSE: AGN), a leading global pharmaceutical company, and Editas Medicine, Inc. (NASDAQ: EDIT), a leading genome editing company, today announced that Allergan's wholly-owned subsidiary, Allergan Pharmaceuticals International Limited (Allergan), has exercised its option to develop and commercialize EDIT-101 globally for the treatment of LCA10 Read More »

ALLERGEN INC: Allergan Receives FDA Fast Track Designation for AGN-241751 for the Treatment of Major Depressive Disorder (MDD)

Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration has granted Fast Track designation for AGN-241751, an investigational new treatment for Major Depressive Disorder (MDD). AGN-241751 is a novel, oral, rapid-acting anti-depressant that recently entered Phase 2 development. Read More »

MERCK: FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) for the Treatment of Patients with Advanced Hepatocellular Carcinoma

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, as a treatment for previously treated patients with advanced hepatocellular carcinoma (HCC). Read More »

MERCK: FDA Accepts Supplemental Biologics License Application for Merck’s KEYTRUDA® (pembrolizumab) as Adjuvant Therapy in Advanced Melanoma

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S Food and Drug Administration (FDA) has accepted for standard review a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, as adjuvant therapy in the treatment of patients with resected, high-risk stage III melanoma and granted a Prescription Drug User Fee Act (PDUFA), or target action, date of February 16, 2019. Read More »