Tags : application

Biotech

Chugai Files an Application to MHLW for an Additional Indication

Shots: The application is based on P-III KATHERINE study assessing Kadcyla as adjuvant therapy vs Herceptin in ~ 1,500 patients with HER2+ early breast cancer who had invasive residual disease in the breast or axillary lymph nodes following neoadjuvant therapy including Herceptin The P-III KATHERINE study results: superiority in invasive disease-free survival as confirmed; no […]Read More

Regulatory

Sun Pharma Reports Submission of Manufacturing and Marketing Authorization Application

Shots: Sun Pharma has filed manufacturing and marketing authorization of Tildrakizumab to the PMDA for moderate-to-severe psoriasis and psoriatic arthritis in Japan Additionally, Sun Pharma has acquired Pola Pharma and will leverage Pola’s strong presence in the dermatology to commercialize Tildrakizumab in Japan which will expand Sun Pharma’s global franchise and robust its dermatology pipeline […]Read More

Regulatory

ViiV Healthcare Files NDA for Cabotegravir + Edurant (rilpivirine) to

Shots: The submission is based on P-III ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) studies results assessing Cabotegravir + Edurant (rilpivirine) (injected monthly) vs SOC (three-drug regimen) in 1,100+ patients infected with HIV + viral suppression across 16 countries for 48wks. The P-III ATLAS & FLAIR studies resulted in maintaining […]Read More

Regulatory

Celgene Files NDA for Ozanimod to the US FDA for

Shots: The NDA filing is based on P-III SUNBEAM & RADIANCE studies assessing Ozanimod vs Avonex in 1,346 & 1,320 patients with RMS across 21 countries for 12 & 24 mos. respectively In H1’19 Celegene has also filed MAA to EMA for relapsing-remitting multiple sclerosis in adults and plans to develop new therapies for RMS […]Read More