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BioWorld - Thursday, December 25, 2025
Home » Topics » U.S., BioWorld Asia

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Businessman, businesswoman handshake

Shionogi nabs revenue-generating ALS drugs with $2.5B Tanabe pact

Dec. 23, 2025
By Marian (YoonJee) Chu
No Comments
Shionogi & Co. Ltd. will acquire global rights to U.S. FDA approved amyotrophic lateral sclerosis therapy edaravone through a $2.5 billion acquisition deal with Tanabe Pharma Corp. Under the terms, Tanabe will form a new entity harboring both oral and intravenous (I.V.) infusion formulations of edaravone that are marketed in the U.S. as Radicava ORS and I.V. Radicava.
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Handshake with tech background

Harbour Biomed closes busy year with $1B+ BMS deal

Dec. 23, 2025
By Lee Landenberger
No Comments
Harbour Biomed has added another collaboration to its end-of-year dealmaking, this time with Bristol Myers Squibb Co. (BMS) to develop multispecific antibodies. Harbour is getting about $90 million up front, but milestones could eventually top $1 billion.
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Lock on digital globe illustration

US Biosecure Act a vote away from law

Dec. 16, 2025
By Mari Serebrov
No Comments
“If at first you don’t succeed, try, try again” seems to be the motto of U.S. lawmakers – at least when it comes to the bipartisan Biosecure Act. After missing a ride last year in the must-pass annual defense spending bill, a version of the bill that seeks to protect the genetic data of Americans while securing U.S. pharmaceutical supply chains made it into the 2026 National Defense Authorization Act, which is now just a Senate vote away from becoming law.
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Multiple sclerosis

Formation loads new Bleecker division with Lynk’s TYK2 inhibitor

Dec. 16, 2025
By Marian (YoonJee) Chu
No Comments
Formation Bio Inc. acquired ex-China rights to Lynk Pharmaceuticals Co. Ltd.’s oral TYK2-inhibitor, LNK-01006, for up to $605 million. The phase I-ready central nervous system (CNS) candidate will be developed at Formation’s newly formed subsidiary, Bleecker Bio.
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Australian coins and bills

Kazia raises AU$50M to advance PI3K/mTOR inhibitor paxalisib

Dec. 9, 2025
By Tamra Sami
No Comments
Kazia Therapeutics Ltd. raised AU$50 million (US$33.15 million) in a private placement of equity securities to advance lead candidate paxalisib, a brain-penetrant dual PI3K/mTOR inhibitor in clinical trials for brain cancer and advanced breast cancer.
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Green and red bispecific antibodies

Crescent, Kelun in two-way deal, including PD-1/VEGF bispecific

Dec. 9, 2025
By Marian (YoonJee) Chu
No Comments
Crescent Biopharma Inc. teamed with Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. to generate “parallel” data of its PD-1/VEGF bispecific antibody, CR-001. The goal is to get 2027 readouts of the bispecific as a monotherapy and as a combination therapy with antibody-drug conjugates in both the U.S. and China.
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Pfizer adds heft to obesity pipeline in $2B Yaopharma deal

Dec. 9, 2025
No Comments
A month after besting rival Novo Nordisk A/S in a bidding war for obesity drug developer Metsera Inc., Pfizer Inc. is again adding to its GLP-1 arsenal, this time via a $2 billion licensing and collaboration agreement with Yaopharma, a subsidiary of China’s Fosun Pharmaceutical Co. Ltd.
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Kidneys

Otsuka’s IgAN therapy gets a thumbs-up from the FDA

Dec. 2, 2025
By Lee Landenberger
No Comments
The priority BLA from Otsuka Pharmaceutical Co. Ltd., of Tokyo, and its U.S. subsidiary, Otsuka Pharmaceutical Development & Commercialization Inc., for sibeprenlimab to treat immunoglobulin A nephropathy (IgAN) has received accelerated approved by the U.S. FDA.
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Otsuka submits NDA for new non-stimulant ADHD therapy

Nov. 25, 2025
By Tamra Sami
No Comments
Otsuka Pharmaceutical Co. Ltd. filed an NDA with the U.S. FDA for centanafadine (formerly EB-1020), a new nonstimulant therapy for treating attention-deficit hyperactivity disorder (ADHD) in children, adolescents and adults. Centanafadine is a norepinephrine, dopamine and serotonin reuptake inhibito formulated as a once-daily extended-release capsule.
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Doctors examining lung scans

Taiho, Cullinan file rolling NDA on phase I/II zipalertinib data

Nov. 25, 2025
By Tamra Sami
No Comments
With phase I/II data in hand, Taiho Pharmaceutical Co. Ltd. and Cullinan Therapeutics Inc. began filing a rolling NDA to the U.S. FDA for accelerated approval of zipalertinib to treat patients with locally advanced or metastatic non-small-cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations who previously received platinum-based chemotherapy.
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