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BioWorld - Thursday, June 8, 2023
Home » Topics » Japan, BioWorld Asia

Japan, BioWorld Asia
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Heartseed raises ¥2B to continue trials of iPSC-derived cardiomyocytes for heart failure

May 30, 2023
By Tamra Sami
No Comments
Heartseed Inc. raised ¥2 billion (US$14.3 million) in a series D round to continue the phase I/II Lapis trial of its allogeneic induced pluripotent stem cell (iPSC)-derived cardiomyocytes for heart failure. The lead asset, HS-001, is an investigational cell therapy consisting of clusters of purified heart muscle cells (cardiomyocyte spheroids) derived from iPSCs that are designed to restore heart muscle and function in patients with advanced heart failure.
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Cerebellum, brain stem, spinal cord

Reprocell reports mixed results for phase II Stemchymal trial in spinocerebellar ataxia

May 30, 2023
By Tamra Sami
No Comments
Regenerative medicine product Stemchymal, an allogeneic adipose-derived mesenchymal stem cell treatment, missed the primary efficacy endpoints in two phase II spinocerebellar ataxia trials conducted in Japan and Korea, but a subpopulation analysis showed efficacy signals in patients with more severe conditions, Reprocell Inc. reported.
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Woman cooling off in front of fan

Nothing flashy: FDA approves Astellas’ menopause drug

May 16, 2023
By Lee Landenberger
No Comments
The U.S. FDA has approved a non-hormonal treatment from Astellas Pharma Inc. to reduce the number and severity of hot flashes. Veozah (fezolinetant), an oral, once-daily compound that targets the neurokinin-3 (NK3) receptor, is approved for treating moderate to severe vasomotor symptoms due to menopause. It’s the first NK3 receptor antagonist the FDA has greenlighted for the indication. The approval came on May 12, well before its May 22 PDUFA date. The PDUFA date was originally set for Feb. 22 but the FDA extended it, saying it needed more time to complete the NDA’s priority review. Veozah’s wholesale acquisition cost is $550 for a month’s supply and should be available by early June.
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Brain and encephalography

JCR partners with Angelini on biologic therapies for epilepsy

May 16, 2023
By Zhang Mengying
No Comments
Angelini Pharma SpA and JCR Pharmaceuticals Co. Ltd. signed an exclusive worldwide agreement for the development and commercialization of biologic therapies for epilepsy based on the J-Brain Cargo technology.
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Japanese money and medicine

Biopharma CEOs urge Japan for open dialogue on innovation, pricing reforms ahead of G7 summit

May 9, 2023
By Tamra Sami
No Comments
Ahead of the upcoming G7 summit to be hosted in Japan this month, a delegation of 24 CEOs from the Biopharmaceutical CEOs Roundtable met with Japanese Prime Minister Fumio Kishida to discuss global priorities and to flag concerns over drug pricing policies in Japan.
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Global handshake silhouette

In the ADC race, Eisai and Bliss enter one of the year’s biggest deals

May 9, 2023
By Lee Landenberger
No Comments
In the latest deal from the burgeoning antibody-drug conjugate (ADC) space, Eisai Co. Ltd. and privately held Bliss Biopharmaceutical (Hangzhou) Co. Ltd. reached a development and commercialization agreement that could be worth up to $2 billion. The massive collaboration is the eighth largest so far this year and one of three that involve ADCs in the year’s top 10 deals.
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SNBL acquires Satsuma to launch nasal powder for migraine

April 18, 2023
By Doris Yu
No Comments
Shin Nippon Biomedical Laboratories Ltd. (SNBL) agreed to acquire Satsuma Pharmaceuticals Inc.as part of a deal worth as much as $220 million that includes rights to the STS-101 migraine drug. Shin Nippon will pay 91 cents in cash per share, as well as a non-tradeable contingent value right worth up to $5.77 per share based on the potential sale, license, or other grant of rights of Satsuma’s migraine drug STS-101.
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Japanese money and medicine

Pharma groups urge Japan’s MHLW to reform pricing policies

April 18, 2023
By Tamra Sami
No Comments
Pharma groups are calling on Japan’s Ministry of Health, Labour and Welfare (MHLW) to reconsider its current drug pricing policies that include annual price cuts on innovative drugs.
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Antibody-drug conjugate illustration

Innate out-licenses antibodies for celiac disease to Takeda in deal worth $400M

April 4, 2023
By Tamra Sami
No Comments
Innate Pharma SA inked a licensing deal that grants Takeda Pharmaceutical Co Ltd exclusive worldwide rights to research and develop antibody-drug conjugates using a panel of selected Innate antibodies against an undisclosed target, with a primary focus in celiac disease.
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Close-up of eye with digital focus

Aurion victorious with Vyznova cell therapy approval in Japan

March 28, 2023
By Caroline Richards
No Comments
Japan’s PMDA has approved Aurion Biotech Inc.’s cell therapy, Vyznova, for the treatment of bullous keratopathy of the cornea, making it the first-ever approval of a cell therapy to treat corneal endothelial disease.
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