Tags : MAA

Regulatory

Merck KGaA Reports EMA’s Validation of MAA for Tepotinib to

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

Regulatory

UCB Reports the FDA’s and EMA’s Acceptance of BLA and

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

Pharma

BioMarin Reports the Submission of MAA to EMA for Vosoritide

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

Biosimilars

Mylan and Lupin Receive EC’s MAA for Nepexto (biosimilar, etanercept)

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

Biosimilars Regulatory

Fresenius Kabi Reports EMA’s Acceptance of MAA for its MSB11455

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