Tags : Japan

COVID-19 Regulatory

Takeda Reports NDA Submission to Import and Distribute Moderna’s mRNA-1273

Shots: Takeda has submitted an NDA to MHLW to import and distribute Moderna’s (mRNA-1273/ TAK-919) in Japan Takeda is conducting a P- I/II study assessing the safety and immunogenicity of two vaccinations of TAK-919 (100μg, given 28 days apart) in 200 participants aged ≥20yrs. followed through 12mos. after the second vaccination. Takeda has completed enrollment […]Read More

Biotech COVID-19

Roche Concludes the License Agreement with Chugai for AT-527 to

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 an investigational, oral, purine nucleotide prodrug, currently being evaluated in […]Read More

COVID-19

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

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 and packaging Additionally, Daiichi Sankyo will continue to work to […]Read More

Regulatory

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

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 mod. or sev. exacerbations. EMA’s CHMP has recommended the MAA […]Read More

Biotech COVID-19

Chugai In-Licenses Roche’s Antibody Cocktail for COVID-19 in Japan

Shots: Chugai get an exclusive development and commercialization agreement in Japan for Roche’s Ab cocktail of casirivimab and imdevimab to combat COVID-19 Earlier, Roche & Regeneron collaborated for the development & commercialization of Ab cocktail where Regeneron will distribute the treatment in the US while Roche will be lead manufacturing and distribution activities outside the […]Read More

Regulatory

Chugai Reports NDA Submission of Risdiplam to the MHLW as

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 results: improvement in motor function in people aged 2-25 with […]Read More