Shots: The MAA submission is based on a P-Ib/II CARTITUDE-1 study assessing the safety and efficacy of cilta-cel in adults with r/r MM. The company is expected to submit MAA to EMA in H1’21 The accelerated approval milestone in EU follows the rolling submission for cilta-cel to the US FDA in Dec’2020 Cilta-cel is an […]Read More
Shots: The EMA Submission is based on P-l CHRYSALIS study to evaluate the safety and efficacy of Amivantamab as a monotherapy and in combination with Lazertinib in adult patients for the treatment of advanced NSCLC Result of CHRYSALIS Study assessed efficacy using overall response rate per Response Evaluation Criteria, CBR, DOR and PFS as well […]Read More
Shots: The MAA is based on a P-II VISION study assessing Tepotinib as monothx. in patients with advanced NSCLC of METex14 skipping alterations, prospectively assessed by liquid biopsy or tissue biopsy With the validation, the application is complete, and the EMA will now initiate the review procedure. Tepotinib is an oral MET inhibitor that inhibits […]Read More
Shots: The marketing application submissions are based on three P-III studies- BE VIVID, BE READY, BE SURE assessing the safety and efficacy of bimekizumab in adult patients with mod. to sev. chronic PsO All 3 P-III studies met their 1EPs, demonstrating that bimekizumab achieved superior skin clearance @16wks. vs PBO and Humira (adalimumab) as measured […]Read More
Shots: The MAA submission is based on dose-finding Part 1 and confirmatory Part 2 of the FIREFISH and SUNFISH studies evaluating the efficacy and safety of Evrysdi (risdiplam) in symptomatic infants with type 1 SMA aged 2-7mos. and in people with types 2/3 SMA aged 2-25 yrs/ respectively The submission also includes data from JEWELFISH […]Read More
The approval follows the EMA’s CHMP positive opinion based on a study assessing Remsima SC (120 mg) vs IV formulations in patients with Crohn’s disease and ulcerative colitis, evaluating its PK, efficacy, and safety The study resulted in high efficacy and safety comparable with IV formulation and the SC administration will also reduce the treatment […]Read More
Shots: The MAA is based on P-III study assessing the efficacy and safety of vosoritide, further supported by the long-term safety and efficacy from the ongoing P-II and P-III extension studies and extensive natural history data Following the completion of EMA’s validation, BioMarin expects the initiation of the MAA review to commence in Aug’2020. The […]Read More
Shots: The MAA validation is based on P-II DESTINY-Breast01 trial assessing Trastuzumab Deruxtecan as a monothx in patients with 2L+ HER2 positive metastatic breast cancer and the results were published in the NEJM The EMA’s CHMP validation provides the application is complete and commences the scientific review process while CHMP’s accelerated assessment is granted to […]Read More
Shots: The EC has granted MAA for Nepexto, a biosimilar referencing Enbrel (etanercept), for all indications of the reference product including RA, JIA, PsA, axSpA (including axSpA and nr-axSpA), plaque psoriasis and pediatric plaque psoriasis The EC’s approval follows the CHMP’s positive opinion which is based on a biosimilarity assessment including preclinical and clinical studies […]Read More
Shots: The MAA submission of the MSB11455 includes the results of two pivotal clinical trials including bioequivalent PK & PD data with similar immunogenicity results and includes analytical plus safety data which was comparable to pegfilgrastim Fresenius Kabi’s attempt to submit MAA is another milestone following last year’s approval and launch of the company’s adalimumab […]Read More
Copyright ©2021 PharmaShots | Powered by Octavus Consulting
