Japan’s Ministry of Health, Labour and Welfare granted new drug approvals and expanded indications for conditions like cancer, insomnia and Alzheimer’s disease (AD) Sept. 24, including Eli Lilly and Co.’s Kisunla (donanemab) for early symptomatic AD.
Biogen Inc. and partner Eisai Co. Ltd. said the EMA’s Committee for Medicinal Products for Human Use has adopted a negative opinion on the marketing bid for lecanemab in early Alzheimer’s disease (AD) and mild AD. The humanized anti-soluble aggregated amyloid-beta monoclonal antibody is approved in the U.S., Japan, China, South Korea, Hong Kong and Israel, and is being sold in the U.S., where it’s branded Leqembi, as well as Japan and China. Eisai, of Tokyo, will ask the CHMP to re-examine the matter.
Renalys Pharma Inc. completed a ¥6 billion (US$38.199 million) series A round that will enable it to complete a phase III trial for sparsentan for immunoglobulin A nephropathy (IgAN) in Japan. Tokyo-based Renalys in-licensed rights to sparsentan in January 2024 from Travere Therapeutics Inc. to develop the compound in Japan and 13 Asian countries to treat IgAN, a rare kidney disease.
Renalys Pharma Inc. completed a ¥6 billion (US$38.199 million) series A round that will enable it to complete a phase III trial for sparsentan for immunoglobulin A nephropathy (IgAN) in Japan. Tokyo-based Renalys in-licensed rights to sparsentan in January 2024 from Travere Therapeutics Inc. to develop the compound in Japan and 13 Asian countries to treat IgAN, a rare kidney disease.
Takeda Pharmaceutical Co. Ltd. is progressing mezagitamab to phase III trials after the CD38 monoclonal antibody showed rapid and sustained increases in platelet counts in patients with persistent or chronic primary immune thrombocytopenia (ITP) in a phase IIb trial.
Takeda Pharmaceutical Co. Ltd. is progressing mezagitamab to phase III trials after the CD38 monoclonal antibody showed rapid and sustained increases in platelet counts in patients with persistent or chronic primary immune thrombocytopenia (ITP) in a phase IIb trial.
Japanese industrial conglomerate Asahi Kasei Corp. has made an offer to acquire Swedish rare diseases specialist Calliditas Therapeutics AB for SEK11.8 billion (US$1.1 billion). The offer, at an 83% premium to the closing share price of SEK113.60 on Monday, May 27, is recommended by the three biggest shareholders and the board of Calliditas, which said the company would benefit from “being part of a larger platform.”
The U.S. Trade Representative (USTR) once again called out the usual cast of characters in this year’s Special 301 Report for not playing by the rules when it comes to protecting intellectual property. And once again, industry asked the USTR to go further by placing new players on the list.
Osaka, Japan-based Shionogi & Co. Ltd. said May 13 that ensitrelvir fumaric acid (Xocova), its oral antiviral for COVID-19, showed no statistical difference against placebo in completely resolving 15 common COVID-19-related symptoms in a global phase III Scorpio-HR trial.
AC Immune SA has landed a potential $2.2 billion deal for its anti-amyloid beta Alzheimer’s disease vaccine, ACI-24.060, with Takeda Pharmaceutical Co. Ltd., under which it will get $100 million up front and is eligible to receive an option exercise fee, plus potential development, commercial and sales-based milestones of up to $2.1 billion.
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