Latest news with #Otsuka
Mint
18-07-2025
- Health
- Mint
Otsuka, Lundbeck's PTSD Drug Fails to Win US FDA Panel Support
Otsuka Pharmaceutical Co.'s medicine for post-traumatic stress disorder with partner H. Lundbeck A/S failed to win the backing of US regulatory advisers, a major setback in the drugmakers' bid to bring the first new drug for the condition to market in more than two decades. The panel of external advisers to the Food and Drug Administration voted 10-to-1 on Friday that the efficacy of the companies' brexpiprazole tablets marketed under the brand name Rexulti — in combination with sertraline — hadn't been established. Panelists struggled to make sense of Otsuka and Lundbeck's supporting evidence, which included one successful study and one in which combining Rexulti with sertraline showed no effect on the symptoms of PTSD. 'I'm looking at these studies and I'm just not convinced the combination offers me as a clinician a new tool in the toolbox,' said Murray Raskind, a psychiatrist at the University of Washington. The Psychopharmacologic Drugs Advisory Committee's recommendations aren't binding, but are often followed by the agency. FDA Commissioner Marty Makary has repeatedly mentioned PTSD as a condition for which new medicines are needed, specifically for veterans. 'We owe it to that community to review some of the potential therapeutics and get a decision out without any delays,' he said in June. The drugmakers have been seeking to broaden the approved usage of brexpiprazole, which is currently cleared for treating schizophrenia in adults and adolescents, as well as an an adjunctive therapy to antidepressants in adults with major depressive disorder. In 2023, the FDA also approved brexpiprazole for the treatment of agitation associated with dementia due to Alzheimer's disease. The drug was discovered by Otsuka, and the Japanese drugmaker is co-developing it with Lundbeck. Post-traumatic stress disorder or PTSD affects about 5% of the population in the US in a given year, according to the companies. It can develop after life-threatening or traumatic events and only two medications — sertraline and paroxetine — are approved in the US to treat it. The drugs' response rates rarely exceed 60%, and fewer than 30% of patients experience full remission, according to the FDA. This article was generated from an automated news agency feed without modifications to text.
Asahi Shimbun
04-07-2025
- Science
- Asahi Shimbun
New study on atomic nuclei overturns 70-year-old theory
The latest study has shown that heavy atomic nuclei are shaped like almonds. (Mutsumi Mitobe) Some atomic nuclei are not shaped like rugby balls, as a longstanding theory suggests, but are instead somewhat flattened, like almonds, according to a new study by Japanese scientists. A team from the Riken national research institute and elsewhere published this new theory recently in an international science journal. The scientists said their research results, which overturn the last 70 years of established theory on atomic nuclei shapes, could be useful for discovering new elements. The nucleus, located in the center of an atom, is composed of protons and neutrons. The shape of a nucleus is an essential characteristic that affects its stability. Research on atomic nuclei shapes began in the 1930s. At first, nuclei were assumed to be round like soccer balls. However, experimental results were found that could not be explained by spherical nuclei. During the 1950s, Aage Niels Bohr, Ben Roy Mottelson and Leo James Rainwater theorized that heavy atomic nuclei have ellipsoidal shapes—like rugby balls. This went on to become an established theory, which earned the trio the Nobel Prize in Physics in 1975. However, Takaharu Otsuka, a Riken senior visiting scientist who led the Japanese team, said he had his first doubts about the established theory 50 years ago, the same year that Bohr and others were awarded the Nobel Prize in Physics. Otsuka was a graduate student of nuclear physics at the time. He said that, no matter how hard he thought, he never understood why atomic nuclei had to be shaped like rugby balls with circular sections. 'It must be like that, since everybody says so,' he said he thought at the time. But doubts lingered in his mind. Otsuka began studying the subject in earnest sometime around 2010. In the latest study, the team of Japanese scientists reworked the theory on the shapes of heavy atomic nuclei by focusing on quantum theory effects and the forces acting between protons and neutrons—neither of which were considered in the 1950s. Their study showed that an almond-like nucleus shape, with elliptical sections perpendicular to the longest axis, allows the protons and neutrons in the nucleus to be bound together more strongly, making the nucleus more stable than a rugby ball-like nucleus shape with circular sections would. Simulations using the Fugaku supercomputer also support the new theory, the physicists said. 'I want young people to cherish any doubts that they may have, because technological advances could allow those doubts to be verified one day,' said Otsuka. About 300 types of atomic nuclei are stable and found naturally on Earth. Some 3,000 more types have been found to exist when created artificially. Otsuka said he believes that more than 1,000 types of atomic nuclei likely have the deformed almond shape.
Associated Press
23-06-2025
- Business
- Associated Press
Harbour BioMed Enters Global Strategic Collaboration with Otsuka to Advance BCMAxCD3 Bispecific T-Cell Engagers
CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SHANGHAI, June 22, 2025 /PRNewswire/ -- Harbour BioMed (HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology, today announced a global strategic collaboration with Otsuka Pharmaceutical Co., Ltd. ('Otsuka') to advance BCMAxCD3 bispecific T-cell engagers for the treatment of autoimmune diseases. Under the terms of the agreement, Otsuka is granted an exclusive license to develop, manufacture, and commercialize HBM7020, a BCMAxCD3 bispecific T-cell engager globally, excluding Greater China (Mainland China, Hong Kong, Macau and Taiwan). In return, Harbour BioMed will receive a total of $47 million in upfront and near-term payments. The company is also eligible for additional payments of up to $623 million upon the achievement of specified development and commercial milestones, as well as tiered royalties on future net sales. This strategic collaboration establishes a foundation for potential future partnerships between the two companies in the T-cell engager area. 'We are delighted to collaborate with Otsuka, a global healthcare leader renowned for its innovative approach to addressing unmet medical needs,' said Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed. 'This collaboration underscores the strength of Harbour BioMed's proprietary Harbour Mice® and HBICE® technology platforms, which enable the rapid development of fully human bispecific antibodies with optimized safety and efficacy profiles. By leveraging our unique capabilities, we are well-positioned to advance next-generation biotherapeutics that can make a meaningful difference in patients' lives worldwide.' Makoto Inoue, President and Representative Director of Otsuka Pharmaceutical, noted, 'Otsuka is expanding our development pipeline in the autoimmune disease field by leveraging the antibody drug platform of our subsidiary Visterra, and the small molecule drug discovery platform of our subsidiary Jnana. HBM7020 is expected to demonstrate efficacy in a broad range of autoimmune diseases in which B cells play a major role in disease pathogenesis, and we hope to contribute further to the field of specialized autoimmune diseases and thereby benefit patients.' About HBM7020 HBM7020 is a BCMAxCD3 bispecific antibody generated using Harbour BioMed's fully human HBICE® bispecific technology and Harbour Mice® platform. It is designed to crosslink target cells and T cells by binding to BCMA and CD3 on the cell surface, leading to potent T cell activation and targeted cell elimination. By incorporating dual anti-BCMA binding sites for enhanced cell targeting and monovalent-optimized CD3 activity to minimize cytokine release syndrome (CRS), HBM7020 has demonstrated potent cytotoxicity with broad therapeutic potential in both immunological and oncological diseases. In August 2023, HBM7020 obtained IND clearance from the National Medical Products Administration (NMPA) to commence a Phase I trial for cancer in China. About Harbour BioMed Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology. The company is building a robust and differentiated pipeline through internal R&D capabilities, strategic global collaborations in co-discovery and co-development, and selective acquisitions. Harbour BioMed's proprietary antibody technology platform, Harbour Mice®, generates fully human monoclonal antibodies in both the conventional two heavy and two light chain (H2L2) format and the heavy chain-only (HCAb) format. Building upon HCAb antibodies, the HCAb-based immune cell engagers (HBICE®) bispecific antibody technology enables tumor-killing effects that traditional combination therapies cannot achieve. Additionally, the HCAb-based bispecific immune cell antagonist (HBICATM) technology empowers the development of innovative biologics for immunological and inflammatory diseases. By integrating Harbour Mice®, HBICE®, and HBICATM with a single B-cell cloning platform, Harbour BioMed has built a highly efficient and distinctive antibody discovery engine for developing next-generation therapeutic antibodies. For more information, please visit . About Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Co., Ltd. is a total healthcare company that focuses on each individual's potential to enhance their well-being. Our medical-related business provides treatments and diagnostics for both physical and mental health. Our nutraceutical business supports daily health maintenance and improvement. Otsuka's unique products and services are based on scientific evidence, under the guidance of our corporate philosophy: Otsuka-people creating new products for better health worldwide. For further information, please visit View original content to download multimedia: SOURCE Harbour BioMed
Yahoo
23-06-2025
- Business
- Yahoo
Harbour BioMed Enters Global Strategic Collaboration with Otsuka to Advance BCMAxCD3 Bispecific T-Cell Engagers
CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SHANGHAI, June 22, 2025 /PRNewswire/ -- Harbour BioMed (HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology, today announced a global strategic collaboration with Otsuka Pharmaceutical Co., Ltd. ("Otsuka") to advance BCMAxCD3 bispecific T-cell engagers for the treatment of autoimmune diseases. Under the terms of the agreement, Otsuka is granted an exclusive license to develop, manufacture, and commercialize HBM7020, a BCMAxCD3 bispecific T-cell engager globally, excluding Greater China (Mainland China, Hong Kong, Macau and Taiwan). In return, Harbour BioMed will receive a total of $47 million in upfront and near-term payments. The company is also eligible for additional payments of up to $623 million upon the achievement of specified development and commercial milestones, as well as tiered royalties on future net sales. This strategic collaboration establishes a foundation for potential future partnerships between the two companies in the T-cell engager area. "We are delighted to collaborate with Otsuka, a global healthcare leader renowned for its innovative approach to addressing unmet medical needs," said Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed. "This collaboration underscores the strength of Harbour BioMed's proprietary Harbour Mice® and HBICE® technology platforms, which enable the rapid development of fully human bispecific antibodies with optimized safety and efficacy profiles. By leveraging our unique capabilities, we are well-positioned to advance next-generation biotherapeutics that can make a meaningful difference in patients' lives worldwide." Makoto Inoue, President and Representative Director of Otsuka Pharmaceutical, noted, "Otsuka is expanding our development pipeline in the autoimmune disease field by leveraging the antibody drug platform of our subsidiary Visterra, and the small molecule drug discovery platform of our subsidiary Jnana. HBM7020 is expected to demonstrate efficacy in a broad range of autoimmune diseases in which B cells play a major role in disease pathogenesis, and we hope to contribute further to the field of specialized autoimmune diseases and thereby benefit patients." About HBM7020 HBM7020 is a BCMAxCD3 bispecific antibody generated using Harbour BioMed's fully human HBICE® bispecific technology and Harbour Mice® platform. It is designed to crosslink target cells and T cells by binding to BCMA and CD3 on the cell surface, leading to potent T cell activation and targeted cell elimination. By incorporating dual anti-BCMA binding sites for enhanced cell targeting and monovalent-optimized CD3 activity to minimize cytokine release syndrome (CRS), HBM7020 has demonstrated potent cytotoxicity with broad therapeutic potential in both immunological and oncological diseases. In August 2023, HBM7020 obtained IND clearance from the National Medical Products Administration (NMPA) to commence a Phase I trial for cancer in China. About Harbour BioMed Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology. The company is building a robust and differentiated pipeline through internal R&D capabilities, strategic global collaborations in co-discovery and co-development, and selective acquisitions. Harbour BioMed's proprietary antibody technology platform, Harbour Mice®, generates fully human monoclonal antibodies in both the conventional two heavy and two light chain (H2L2) format and the heavy chain-only (HCAb) format. Building upon HCAb antibodies, the HCAb-based immune cell engagers (HBICE®) bispecific antibody technology enables tumor-killing effects that traditional combination therapies cannot achieve. Additionally, the HCAb-based bispecific immune cell antagonist (HBICATM) technology empowers the development of innovative biologics for immunological and inflammatory diseases. By integrating Harbour Mice®, HBICE®, and HBICATM with a single B-cell cloning platform, Harbour BioMed has built a highly efficient and distinctive antibody discovery engine for developing next-generation therapeutic antibodies. For more information, please visit About Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Co., Ltd. is a total healthcare company that focuses on each individual's potential to enhance their well-being. Our medical-related business provides treatments and diagnostics for both physical and mental health. Our nutraceutical business supports daily health maintenance and improvement. Otsuka's unique products and services are based on scientific evidence, under the guidance of our corporate philosophy: Otsuka-people creating new products for better health worldwide. For further information, please visit View original content to download multimedia: SOURCE Harbour BioMed Sign in to access your portfolio
Reuters
08-06-2025
- Business
- Reuters
Otsuka's kidney disease therapy trial results heat up battle with rival Vera
June 6 (Reuters) - Otsuka's (4578.T), opens new tab experimental therapy for a potentially life-threatening kidney disease more than halved severe levels of protein in the urine of patients, intensifying the battle for an effective new treatment with rival Vera Therapeutics (VERA.O), opens new tab. The Japan-based company said on Friday its therapy, sibeprenlimab, cut proteinuria levels by 51.2% in patients with Immunoglobulin A Nephropathy, also known as Berger's disease, at nine months in a late-stage trial. The data comes just days after Vera said its drug, atacicept, reduced protein levels in patients' urine by 46%, compared with a 7% reduction with a placebo, meeting the main goal of a 428-patient late-stage study. Shares of the U.S.-based drug developer slid 31% to $20.89. Analysts, however, said that though data from Otsuka's sibeprenlimab might look superior, it was unlikely that doctors would interpret it that way. The difference between the two datasets is not too clinically diverse to affect demand for Vera's drug, said Jefferies analyst Farzin Haque. Berger's disease causes abnormal protein buildup in the kidneys and could eventually lead to the organ's failure. Analysts have estimated the U.S. market for its treatments could be worth as much as $10 billion. Otsuka has already applied for the FDA's accelerated approval for its therapy to treat the disease. However, its sales would largely depend on whether the treatment can improve kidney function, analysts said. Even if the drug gains accelerated approval, Otsuka said it plans to study whether it can preserve the organ's ability to filter toxins from blood, measured as the glomerular filtration rate (eGFR). "The magnitude of the protein reduction should translate into eGFR preservation down the line, because ultimately that's what patients are going to be asking for," Dana Rizk, the trial's investigator and a professor of medicine at the University of Alabama in Birmingham, told Reuters. The study is expected to be completed in early 2026.
