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
The VaxIT app, developed on the Salesforce platform for Azim Premji Foundation and its partners, captures the status of vaccinations to help individuals plan and stay updated on their progress
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
The medicine is the first and only oral MET inhibitor to receive CHMP positive opinion in Europe for adult patients with advanced NSCLC harbouring alterations leading to METex14 skipping
The company is now ready to offer clinical testing anywhere in the world after early case studies conducted in Israel have demonstrated recovery within 48 hours
EMA’s CHMP advice states that Paxlovid can be used for treatment of adults with Covid-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe disease
Effectiveness of Covaxin against the Omicron variant is currently being studied
The primary objective of the ongoing trial is to determine whether ambrisentan can prevent the progression to respiratory failure and reduce the need for mechanical ventilation, among others
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
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