Japan

Takeda Reports First Patients Dosing in P-I/II Study of Novavax’s COVID-19 Vaccine Candidate in Japan

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Shots: Takeda is providing rapid & sustained access to COVID-19 vaccines in Japan through partnerships with Novavax and Moderna. Earlier, Takeda has completed enrollment in the P-I/II study of TAK-919 in Japan The studies are designed to include 200 healthy Japanese adults followed by 12mos.… Read More »Takeda Reports First Patients Dosing in P-I/II Study of Novavax’s COVID-19 Vaccine Candidate in Japan

Roche Concludes the License Agreement with Chugai for AT-527 to Treat COVID-19 in Japan

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Shots: Chugai gets exclusive development and commercializing rights for AT-527 in Japan Earlier, Roche and Atea collaborated to jointly develop AT-527. If approved, Atea to distribute AT-527 in the US and Roche will be responsible for global manufacturing and distribution outside the US AT-527 is… Read More »Roche Concludes the License Agreement with Chugai for AT-527 to Treat COVID-19 in Japan

Daiichi Sankyo Signs an Outsourcing Agreement with AstraZeneca for COVID-19 Vaccine in Japan

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Shots: Daiichi Sankyo signs an outsourcing Agreement to Manufacture AstraZeneca COVID-19 Vaccine AZD1222 in Japan Following the AstraZeneca’s agreement with the Japanese government to manufacture and supply COVID-19 vaccine, Daiichi Sankyo will use undiluted solutions to manufacture COVID-19 vaccines in the Japan including vial filling… Read More »Daiichi Sankyo Signs an Outsourcing Agreement with AstraZeneca for COVID-19 Vaccine in Japan

AstraZeneca’s Trixeo Aerosphere Receives EU’s Approval for the Maintenance Treatment of COPD

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Shots: The approval is based on P-lll ETHOS involve the assessing of Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) vs Bevespi Aerosphere and PT009 in adult patients with mod. to sev. COPD. P-III KRONOS study also supported the approval The study showed a reduction in rate of… Read More »AstraZeneca’s Trixeo Aerosphere Receives EU’s Approval for the Maintenance Treatment of COPD

Alvotech and Fuji Pharma Extends Agreement for the Commercialization of Four Biosimilars in Japan

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Shots: The agreement strengthens the ongoing collaboration b/w the companies signed in 2018 to commercialize Alvotech’s biosimilar portfolio in Japan Fuji Pharma currently owns a minority stake in Alvotech and now can enter new therapeutic areas following the agreement With the extension of the agreement,… Read More »Alvotech and Fuji Pharma Extends Agreement for the Commercialization of Four Biosimilars in Japan

Chugai Reports NDA Submission of Risdiplam to the MHLW as the First Oral Drug for SMA in Japan

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Shots: The NDA submission is based on FIREFISH study assessing Risdiplam in infants with symptomatic SMA Type 1 & SUNFISH study in children and young adults with SMA Type 2 or 3 FIRESISH study results: improvement in survival and motor milestones in infants. SUNFISH study… Read More »Chugai Reports NDA Submission of Risdiplam to the MHLW as the First Oral Drug for SMA in Japan

Takeda strikes $1B RNAi deal with Arrowhead Pharmaceuticals

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The companies will partner on development and commercialization of ARO-AAT, Arrowhead’s Phase II RNA-interference drug for alpha-1 antitrypsin-associated liver disease, a rare genetic disorder. An analyst wrote that the deal makes sense given Takeda’s position in the AAT-augmentation therapy market.

AstraZeneca’s Imfinzi (durvalumab) Receives MHLW’s Approval for Extensive-Stage Small Cell Lung Cancer

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Shots: The approval is based on P-III CASPIAN study assessing Imfinzi + etoposide and either carboplatin/ cisplatin CT or Imfinzi & CT+ tremelimumab vs CT as monothx. as 1L treatment in 805 patients with ES-SCLC. The trial used an FD of Imfinzi (1,500mg, q3w for… Read More »AstraZeneca’s Imfinzi (durvalumab) Receives MHLW’s Approval for Extensive-Stage Small Cell Lung Cancer

Solasia Signs a License Agreement with Isofol to Develop and Commercialize Arfolitixorin for mCRC in Japan

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Shots: Isofol to receive $100M as up front, development, regulatory and commercial milestones, and clinical development cost and is eligible to receive royalties on sales of the therapy and retain its right to the therapy in ROW Solasia will lead clinical development activities in Japan… Read More »Solasia Signs a License Agreement with Isofol to Develop and Commercialize Arfolitixorin for mCRC in Japan

What About the Sodium in Miso?

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According to the second World Cancer Research Fund/American Institute for Cancer Research expert report, “[s]alt is a probable cause of stomach cancer,” one of the world’s leading cancer killers. If the report’s estimate of an 8 percent increase in risk for every extra gram of… Read More »What About the Sodium in Miso?