Japan

Delta-Fly eyes NDA path despite AML phase III miss

Tue, 21 Apr 2026 12:00:00 -0400

Delta-Fly Pharma Inc. is pressing ahead with discussions with the FDA for its lead acute myeloid leukemia (AML) candidate, radgocitabine (DFP-10917), despite a phase III miss on its primary endpoint, instead leaning on earlier-stage efficacy signals and emerging combination data to support a potential path toward conditional approval.

FDA grants priority review to Merck-Daiichi’s B7-H3 cancer ADC

Tue, 21 Apr 2026 12:00:00 -0400

The U.S. FDA has accepted and granted priority review to Daiichi Sankyo Co. Ltd. and Merck & Co. Inc.’s BLA of ifinatamab deruxtecan, a B7-H3-directed antibody-drug conjugate (ADC) to treat patients with advanced extensive-stage small-cell lung cancer.

Daiichi to divest consumer health unit to Suntory for $1.5B

Tue, 21 Apr 2026 12:00:00 -0400

Daiichi Sankyo. Co. Ltd. will begin a phased sale of its consumer health subsidiary, Daiichi Sankyo Healthcare Co. Ltd., to Suntory Holdings Ltd., as the Tokyo-based drugmaker sharpens its focus on oncology.

Daiichi to divest consumer health unit to Suntory for $1.5B

Fri, 17 Apr 2026 12:00:00 -0400

Delta-Fly eyes NDA path despite AML phase III miss

Fri, 17 Apr 2026 12:00:00 -0400

Roche plots route to EMA approval for DMD gene therapy

Fri, 17 Apr 2026 12:00:00 -0400

Roche Holding AG is making good on its promise to try and convince the EMA of the benefits of Elevidys (delandistrogene moxeparvovec), announcing a further global phase III trial of the Duchenne muscular dystrophy gene therapy.

FDA grants priority review to Merck-Daiichi’s B7-H3 cancer ADC

Thu, 16 Apr 2026 12:00:00 -0400

Glyconex’s GNX-1021 cleared for clinic in Japan for GI cancers

Wed, 15 Apr 2026 09:00:00 -0400

Glyconex Inc. has received approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for the initiation of a first-in-human phase I trial of GNX-1021, the company’s lead antibody-drug conjugate (ADC) candidate, in patients with advanced gastrointestinal (GI) cancers.

Otsuka to acquire PTSD drugmaker Transcend in $1.2B deal

Tue, 31 Mar 2026 12:00:00 -0400

Otsuka Pharmaceutical Co. Ltd. is taking a neuroplastogen approach to posttraumatic stress disorder (PTSD) through its planned $1.22 billion acquisition of Transcend Therapeutics Inc. The deal gives Tokyo-headquartered Otsuka access to Transcend’s lead asset, TSND-201, an oral neuroplastogen that has begun patient recruitment for a phase III study in the U.S.

Otsuka to acquire PTSD drugmaker Transcend in $1.2B deal

Mon, 30 Mar 2026 12:00:00 -0400

Japan approves first iPSC therapy for Parkinson’s disease

Tue, 10 Mar 2026 12:00:00 -0400

Japan has approved the world’s first therapies derived from induced pluripotent stem cells (iPSCs), marking a major milestone for regenerative medicine and, potentially, a turning point in treating Parkinson’s disease.

Latest benchmark shows 35% decline in antibiotics pipeline in past 5 years

Tue, 10 Mar 2026 12:00:00 -0400

Twelve years on from the World Health Organization formally raising the alarm, antimicrobial resistance continues to grow, and despite numerous public and private incentives and initiatives, the pipeline of antibiotics in development is thinner than ever.

Ipsen pulls Tazverik from US market on secondary malignancies

Mon, 09 Mar 2026 12:05:00 -0400

Ipsen SA withdrew Tazverik (tazemetostat) from the U.S. market after evidence emerged of secondary hematological malignancies in an ongoing phase Ib/III study in follicular lymphoma.

Japan approves first iPSC therapy for Parkinson’s disease

Fri, 06 Mar 2026 12:00:00 -0500

Asahi Kasei’s $920M Aicuris buy boosts its antiviral armory

Tue, 03 Mar 2026 12:00:00 -0500

In an all-cash transaction valued at €780 million (US$920 million), Asahi Kasei Corp. offered to buy Aicuris Anti-infective Cures AG, expanding its infectious disease portfolio with a marketed cytomegalovirus product and a herpes treatment nearing an NDA.

Asahi Kasei’s $920M Aicuris buy boosts its antiviral armory

Thu, 26 Feb 2026 12:00:00 -0500

Innovacell’s $91M Tokyo IPO to fund incontinence cell therapies

Tue, 24 Feb 2026 12:00:00 -0500

Innovacell Inc. launched a ¥14.16 billion (US$91.2 million) stock sale on the Tokyo Stock Exchange Feb. 24, ending a near two-year lull of biotech listings in Japan while signaling a dynamic year ahead for cell-based therapeutics.

Astellas and Vir in $1.3B deal for CD3 T-cell engager

Tue, 24 Feb 2026 12:00:00 -0500

Astellas Pharma Inc. and Vir Biotechnology Inc. have signed a global co-development pact to advance VIR-5500, Vir’s PRO-XTEN dual-masked CD3 T-cell engager targeting prostate-specific membrane antigen for treating prostate cancer. Under the deal terms, San Francisco-based Vir will receive $335 million in up-front and near-term payments, including $240 million in cash, $75 million in equity investment and a $20 million near-term milestone. Vir is also eligible to receive up to $1.37 billion in development, regulatory and sales-based milestones plus royalties on ex-U.S. sales.

Japan endorses two iPSC drugs for approval under CEA pathway

Tue, 24 Feb 2026 11:00:00 -0500

Japan is backing conditional approvals of Amchepry (raguneprocel, Sumitomo Pharma Co. Ltd./Racthera Co. Ltd.) and Reheart (Cuorips Inc.), positioning them to become the world’s first induced pluripotent stem cell-derived (iPSC) therapies to receive regulatory clearance.

Takeda’s oral narcolepsy drug steps closer to FDA approval

Tue, 24 Feb 2026 11:00:00 -0500

The U.S. FDA accepted, with priority review, Takeda Pharmaceutical Co. Ltd.’s NDA submission for oveporexton (TAK-681), bringing the oral orexin receptor 2 agonist closer to clearance in narcolepsy type 1.

Japan endorses two iPSC drugs for approval under CEA pathway

Fri, 20 Feb 2026 12:00:00 -0500

Takeda’s oral narcolepsy drug steps closer to FDA approval

Wed, 11 Feb 2026 12:00:00 -0500

Iambic raises the bard in AI, pens $1.7B Takeda deal

Tue, 10 Feb 2026 11:00:00 -0500

Iambic Therapeutics Inc.’s multiyear technology and discovery pact with Takeda Pharmaceutical Co. Ltd. could help the San Diego-based firm advance its own pipeline in a big way.

Iambic raises the bard in AI, pens $1.7B Takeda deal

Mon, 09 Feb 2026 12:00:00 -0500

Iambic Therapeutics Inc.’s multiyear technology and discovery pact with Takeda Pharmaceutical Co. Ltd. could help the San Diego-based firm advance its own pipeline in a big way.

Amgen quits Kyowa Kirin deal, returns rocatinlimab

Tue, 03 Feb 2026 12:00:00 -0500

Amgen Inc. quit a development deal with Kyowa Kirin Co. Ltd., returning global rights for rocatinlimab, Kyowa Kirin’s T-cell rebalancing therapy being investigated for moderate to severe atopic dermatitis.

Why many global drugs never reach Japan

Tue, 03 Feb 2026 12:00:00 -0500

For years, Japan’s “drug lag” was shorthand for slow regulatory reviews and delayed approvals compared with the U.S. and Europe. But even as regulatory timelines have shortened, review capacity has expanded and international alignment has improved, Japanese patients still face gaps in access to innovative drugs.

Amgen quits Kyowa Kirin deal, returns rocatinlimab

Mon, 02 Feb 2026 12:00:00 -0500

Why many global drugs never reach Japan

Thu, 29 Jan 2026 12:00:00 -0500

Asia roundup: Shionogi ups Viiv stake, Fosun spinoff plans, more

Tue, 27 Jan 2026 00:00:00 -0500

Shionogi & Co. Ltd. and Fosun Pharmaceutical (Group) Co. Ltd. were involved in separate divestment transactions this week, with Shionogi buying out Pfizer Inc.’s stake in Viiv Healthcare Ltd. to lift its holding to 21.7%.

Asia roundup: Shionogi ups Viiv stake, Fosun spinoff plans, more

Fri, 23 Jan 2026 12:00:00 -0500