Japan
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Artificial Intelligence, BioPharma
Sumitomo Schizophrenia Drug Discovered With AI Tech Fails in Two Phase 3 Trials
A schizophrenia drug candidate from partners Sumitomo Pharma and Otsuka Pharmaceutical failed to outperform a placebo in two Phase 3 studies. The compound is the most advanced program from a psychiatry and neurology collaboration spanning four drugs discovered by an artificial intelligence technology platform.
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Eisai Alzheimer’s Drug Wins Full FDA Approval, But With Sterner Safety Alert
Six months after Esai Alzheimer’s disease drug Leqembi received accelerated FDA approval, the agency has awarded the drug full approval. While the agency’s regulatory decision sets precedent for other Alzheimer’s drugs, it also flags serious safety risks.
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Payer’s Place: Dr. Anil Singh
Dr. Anil Singh shares his insights into the strategies employed by the organization to identify the most effective digital solutions for their members.
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Astellas Plots Near-Term Moves to Execute Long-Term Vision in Gene Therapy
Astellas has become an active player in gene therapy. MedCity News caught up with company executive Richard Wilson, who explained Astellas’s strategy, the clinical holds on its two most advanced programs, and the rationale behind its recent gene therapy deals.
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Takeda Pharma Pays $400M for Global Rights to Colorectal Cancer Drug
The Hutchmed drug, fruquintinib, is already approved in China for colorectal cancer. Takeda Pharmaceutical gets global rights to the small molecule, which has started a rolling submission with the FDA and is being readied for regulatory submissions in Europe and Japan.
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FDA Approval of Eisai Alzheimer’s Drug Bears Imprint of Aduhelm Review
Eisai Alzheimer’s disease drug Leqembi is now approved for the treatment of patients with an early form of the memory-robbing disease. In granting the antibody accelerated approval, the FDA employed reasoning that was the also basis for the controversial speedy regulatory nod for Biogen’s drug, Aduhelm.
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Eisai Alzheimer’s Drug Data Show Slowing of Decline But Safety Questions Linger
Eisai has presented and published full data from the Phase 3 clinical trial for its Alzheimer’s disease drug lecanemab, with results showing a statistically significant slowing decline associated with the neurodegenerative disorder. While an accelerated approval decision is expected in early 2023, the latest trial data are key because they represent the confirmatory study that could support an application for full FDA approval.
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Eisai, Biogen beat expectations with data that support Alzheimer’s drug approval
Eisai Alzheimer’s disease drug candidate lecanemab now has data from a pivotal study showing a statistically significant reduction in cognitive decline. Lecanemab is already under FDA review for potential accelerated approval but the agency has said that results from this larger study could support full approval of the antibody drug.
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Astellas pays Sutro Bio $90M to partner on cancer drugs that make cold tumors hot
Astellas Pharma has a new partner in the R&D of a type of cancer drug called an antibody drug conjugate (ADC). The Japanese pharma company reached across the Pacific Ocean to collaborate with Sutro Biopharma in a bet that Bay Area-based firm’s technology can deliver more powerful ADCs.
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Claiming Akebia agreement breach, Otsuka seeks to end anemia drug pact
Otsuka Pharmaceutical is ending its alliance with Akebia Therapeutics, a move that comes less than two months after the FDA rejected their partnered anemia drug, vadadustat, and asked for another clinical trial. Otsuka alleges unspecified breaches of the agreement by Akebia, and ending the alliance early could spare it from spending hundreds of millions of dollars more on the drug.
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Discover the Next-Gen Platform for Integrated Collaborative Care
Beyond EHRs and digital front doors, reducing the gaps in patient care journeys.
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Neuro drugs dumped by AbbVie are now heading to Neurocrine for $100M up front
AbbVie returned the rights to the drugs to Sosei Heptares earlier this year. Now Neurocrine Biosciences has agreed to pay the Japanese drug company $100 million to license the rights to these preclinical and clinical-stage compounds that address muscarinic receptors to potentially treat a range of neurological disorders.
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Takeda broadens gene therapy scope, turns to Poseida for non-viral approach
The progress of gene therapies continues to be stymied by safety risks associated with the viruses used to deliver them. Takeda Pharmaceutical is partnering with Poseida Therapeutics in a bet that the biotech’s non-viral technologies could offer a safer alternative.
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Another Eisai, Biogen Alzheimer’s drug is filed for speedy FDA review
Eisai is seeking accelerated FDA approval of lecanemab, an Alzheimer’s disease drug that is part of a research alliance with Biogen. The drug is following the same path blazed earlier this year with FDA approval of Biogen Alzheimer’s drug Aduhelm.
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Takeda therapy gets speedy FDA nod for lung cancers with rare genetic signature
Takeda Pharmaceutical drug mobocertinib was approved by the FDA to treat non-small cell lung cancer in patients whose tumors carry a rare genetic signature. With the approval, Takeda can offer an oral alternative to a recently approved Johnson & Johnson drug that targets the same mutation but is given as an infusion.