Johnson & Johnson’s drug Balversa won U.S. approval as the first targeted therapy for advanced bladder cancer, the Food and Drug Administration announced.
There were as many billion-dollar brands in 2017 as there have been in any other calendar year despite the cratering effects of massive patent cliffs in 2012 and 2015.
The top performers of the launch class of 2016 have very little in common – aside from the fact that none of them came from a “classic” big pharma house.
The U.S. FDA approved an expanded label for Merck’s anti-PD-1 therapy Keytruda as monotherapy for the first-line treatment of patients with stage III non-small cell lung cancer who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors express PD-L1 as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
Amgen and UCB announced that the U.S. FDA approved Evenity (romosozumab-aqqg) for the treatment of osteoporosis in postmenopausal women at high risk for fracture.
The FDA approved ViiV’s Dovato as a complete, once-daily, single-tablet regimen of dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg for treating HIV-1 infection in adults with no antiretroviral treatment history and no known resistance to either DTG or 3TC.
The U.S. Food and Drug Administration approved ADMA Biologics’ Asceniv to treat primary humoral immunodeficiency disease (PIDD or PI) in adults and adolescents.
The U.S. Food and Drug Administration approved Fera’s New Drug Application for Avaclyr (acyclovir ophthalmic ointment) 3% for the treatment of herpetic keratitis.
EMD Serono, a unit of Merck KGaA, announced that the U.S. FDA approved Mavenclad (cladribine) for adults with relapsing-remitting multiple sclerosis and active secondary progressive disease.
Sage Therapeutics shares were up after the company won approval for the postpartum depression treatment Zulresso (brexanalone).
Swiss drugmaker Roche Holding AG’s U.S. unit Genentech Inc. won approval for the immunotherapy Tecentriq for a tough-to-treat type of lung cancer.