Month: <span>August 2019</span>

GSK’s Nucala (mepolizumab) Receives European Commission Approval for Self-Administration in

Shots: The Nucala has received EMA’s marketing authorization for its new methods of administration i.e, a pre-filled pen and a pre-filled safety syringe with their anticipated launch in Europe in Aug’2019 The MAA is based on two P-IIIa studies (NCT03099096 & NCT03021304) which demonstrated that patients were able to administer Nucala with the pre-filled pen […]Read More

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

Exelixis Signs a Research Collaboration and Option to License Agreement

Shots: Aurigene to receive 10M upfront while Exelixis get an option to license three developed programs from Aurigene. Additionally, Exelixis and Aurgene is developing three discovery programs, for which Exelixis will pay $2.5M/program in exchange for exclusive rights for the program Exelixis will provide R&D funding for all programs. Exelixis can exercise its option until […]Read More

Novartis Reports Results of Kisqali in Second Phase P-III MONALEESA-3

Shots: The P-III MONALEESA-3 study involves assessing of Kisqali (ribociclib) + fulvestrant in postmenopausal women with HR+/HER2- advanced or m-breast cancer The second phase of P-III MONALEESA-3 study resulted in meeting its 2EPs of OS with no new observed safety signals and consistent AEs with the previous P-III study results. These results follow MONALEESA-7 study results […]Read More