Articles by Anna Rose Welch

71. What You Missed From Regulatory Agencies Last Week — July 7-11, 2014 7/17/2014

    GSK and Theravance’s Anoro Ellipta has received a nod of approval from the Japanese Ministry of Health, Labor, and Welfare (MHLW). Anoro Ellipta is indicated to relieve the symptoms caused by airway constriction in COPD, which affects roughly 8.6 percent of Japan’s over-40 population. The MHLW approved a once daily inhaled dosage of 25 mcg of the umeclidinium and vilanterol combination treatment following review of eight phase 3 clinical trials. This news has also triggered a $10 million milestone that Theravance will pay to GSK. The drug is expected to be released in Q3’14.