Japan Approves Gilead’s Filgotinib After FDA Rejected It
The rheumatoid arthritis drug, which has been touted as a potential blockbuster, will be sold under the name Jyseleca. The FDA had raised concerns about sperm toxicity, especially for the higher, 200-mg dose. The Japan go-ahead covers the 200 mg and 100 mg tablets.
FiercePharma:
Gilead's Rheumatoid Arthritis Med Filgotinib, After Cold Shoulder From FDA, Wins Global-First Nod In Japan
The FDA handed Gilead Sciences and its partner Galapagos a surprising no-go for blockbuster hopeful filgotinib last month. But that didn’t stop regulators in Japan from making a different decision on the rheumatoid arthritis drug. The country’s Ministry of Health, Labour and Welfare approved filgotinib, to be sold under the brand name Jyseleca, to treat rheumatoid arthritis in patients who haven’t responded well to conventional therapies, Gilead and its local distribution partner Eisai said Friday. (Liu, 9/25)
In other pharmaceutical news —
FiercePharma:
Bristol Myers Squibb's Opdivo Cuts Relapse Risk In Muscle-Invasive Bladder Cancer
Bristol Myers Squibb’s Opdivo has plenty of competition in its current bladder cancer indication—so it’s hoping to strike out on its own in a new area of the disease. The company revealed Thursday that its PD-1 fighter, against placebo, had lengthened the time muscle-invasive urothelial carcinoma patients could remain disease-free after surgery. All patients saw benefit, regardless of whether their tumors expressed levels of biomarker PD-L1. (Helfand, 9/25)
Stat:
Illumina And Grail CEOs Defend Their Deal To Investors
Shares of Illumina, the leader in DNA sequencing, have dropped 13% since news leaked last week that the company would be buying Grail, a startup developing a blood test to detect cancer. Obviously, not every investor loves the $8 billion deal. (Herper, 9/25)
The Wall Street Journal:
Chinese Retailer JD.Com’s Health-Care Business Plans Hong Kong IPO
JD Health International Inc., an online health-care business controlled by Chinese online retailing giant JD.com Inc., JD 2.68% filed an application to go public in Hong Kong, in a deal that people familiar with the situation said could raise at least $3 billion. The Beijing-based company said it operates China’s largest online retail pharmacy by revenue, and provides health-related services including online consultations with doctors and medical-appointment scheduling. It is also looking to expand into prescription-drug wholesaling in China. (Chiu, 9/28)
