Sandoz submits Biologics License Application for proposed biosimilar trastuzumab to US FDA
Trastuzumab is monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2+) breast cancer and metastatic gastric cancers
Trastuzumab is monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2+) breast cancer and metastatic gastric cancers
The NMPA approval is based on the positive data of GEMSTONE-302 study, a multi-center, randomized, double-blind, phase III study that evaluated the efficacy and safety of Cejemly or placebo in combination with chemotherapy in first-line stage IV NSCLC patients
Sputnik Light as a booster significantly increases virus-neutralizing activity against Omicron based on sera 2-3 months after revaccination and is a universal booster to other vaccines inducing stronger antibody and T-cell response
Authorized booster increases Omicron neutralizing antibody levels approximately 37-fold
The deepCDR engine combines deep sequencing and deep learning methods with a proprietary mammalian display process to select from a wide range of antibodies and rapidly identify candidates with the highest possible affinity and developability profiles
Syngene will also build and operate a new dedicated drug development laboratory to accelerate the advancement of Amgen R&D projects
In Japan, breast cancer is the most common cancer in women, with approximately 92,000 cases of breast cancer diagnosed in 2020
The company will manufacture a cancer immunotherapy product from 2022
Ichnos will receive an upfront payment of Euro 20.8 million as well as additional development and commercial milestone payments and tiered royalties based upon future global sales
Phase 1 study of quadrivalent flu vaccine (mRNA-1010) successfully boosted titers against all four strains in older and younger adults, even at lowest dose; no significant safety concerns were observed
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