Tags : MHLW

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

Chugai’s Kadcyla (trastuzumab emtansine) Receives MHLW’s Approval for Adjuvant Therapy

Shots: The approval is based on P-III KATHERINE study assessing Kadcyla (100/160mg, IV) adjuvant therapy in 1486 patients with HER2+ early BC who did not have pathologic complete response following neoadjuvant therapy including Herceptin The results showed the superiority of Kadcyla over Herceptin in terms of the 1EPs of invasive disease-free survival. The safety profile […]Read More

PharmaShots: COVID-19 Healthcare News Monthly Updates – June 2020

Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has been named “SARS-CoV-2” (severe acute respiratory syndrome coronavirus 2) and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). The outbreak of the respiratory disease was first detected […]Read More

MHLW Approves Novartis’ Five New Therapies Expanding its Footprints in

Shots: The five therapies include Tabrecta (capmatinib) for advanced and recurrent unresectable NSCLC, Entresto (sacubitril valsartan sodium hydrate) for chronic HF, Mayzent (siponimod fumaric acid) for secondary PMS, Enerzair (glycopyrronium bromide, indacaterol acetate, mometasone furoate) and Atectura (indacaterol acetate, mometasone furoate) for different forms of asthma In 2020, Novartis has received seven approval in Japan […]Read More

Insights+: COVID-19 Healthcare News Monthly Updates – May 2020

Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has been named “SARS-CoV-2” (severe acute respiratory syndrome coronavirus 2) and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). The outbreak of the respiratory disease was first detected […]Read More

Bayer Reports Submission of MAA to the MHLW for Larotrectinib

Shots: The MAA is submission is based on P-I trial of adult patients, P-II NAVIGATE study in adult and adolescent patients and the P-I/II pediatric SCOUT study. These trials evaluate larotrectinib in 20+ histologies of solid tumors including lung, thyroid, melanoma, gastrointestinal stromal tumors, colon, cholangiocarcinoma, soft tissue sarcomas, salivary gland and infantile fibrosarcoma The […]Read More