Japan

Arcutis and Sato Announce Strategic Collaboration and Licensing Agreement for Topical Roflumilast in Japan
Under the terms of the agreement, Arcutis will receive an upfront payment of $25 million, and potentially an additional $40 million if certain regulatory and sales milestones are achieved. Arcutis is also eligible to receive tiered, low double-digit percentage royalties.

Bridgebio Pharma And Kyowa Kirin Announce Partnership With An Upfront Payment Of $100 Million For An Exclusive License On Infigratinib In Skeletal Dysplasias In Japan
QED Therapeutics grants Kyowa Kirin an exclusive license to develop and commercialize infigratinib for achondroplasia, hypochondroplasia, and other skeletal dysplasias in Japan.

Astellas and Kelonia Therapeutics Enter into Research and License Agreement to Develop Novel Immuno-Oncology Therapeutics
Under the terms of the agreement, the companies plan to combine Kelonia's iGPS® with Xyphos' ACCEL™ technology to develop innovative in vivo CAR-T Cell therapies*2 targeting up to two programs.

Ono Enters into a Drug Discovery Collaboration and Option Agreement with Shattuck Labs to Generate Bifunctional Fusion Proteins
Shattuck will generate fusion proteins for certain targets using its proprietary protein engineering technologyand provide Ono with drug candidates for further optimization and clinical development.

Pfizer and Astellas’ XTANDI® Approved by U.S. FDA in Earlier Prostate Cancer Treatment Setting
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Pfizer Inc. (NYSE: PFE) today announced that the companies received an approval by the U.S. Food and Drug Administration (FDA) of a supplemental New Drug Application for XTANDI

Astellas to Acquire Propella Therapeutics
Astellas, through a U.S. subsidiary, and Propella have entered into a merger agreement pursuant to which Astellas will acquire Propella.

Japan to scrap rule requiring testing of new drugs on Japanese
apan will ease regulations on clinical trials for new drugs developed overseas, Nikkei has learned, scrapping the rule that in principle drugs' safety must be tested on Japanese before they can be launched in the domestic market.

Takeda Receives U.S. FDA Approval of FRUZAQLA™ (fruquintinib) for Previously Treated Metastatic Colorectal Cancer
The approval of FRUZAQLA is based on data from two large Phase 3 trials: the multi-regional FRESCO-2 trial, data from which were published in The Lancet, along with the FRESCO trial conducted in China, data from which were published in JAMA.

Takeda’s ADZYNMA (ADAMTS13, recombinant-krhn) Approved by U.S. FDA as the First and Only Recombinant ADAMTS13 Enzyme Replacement Therapy for the Treatment of Congenital Thrombotic Thrombocytopenic Purpura (cTTP)
The U.S. Food and Drug Administration (FDA) has approved ADZYNMA (ADAMTS13, recombinant-krhn) for the prophylactic and on-demand treatment of adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP). ADZYNMA is the first and only FDA-approved recombinant ADAMTS13 (rADAMTS13) protein designed to address an unmet medical need in people with cTTP by replacing the deficient ADAMTS13 enzyme.

Novartis claims ex-staffer jumped to Takeda with ‘thousands’ of sensitive files
Novartis believes a former employee of its Egyptian affiliate made off with thousands of files before jumping ship to Takeda.






