Tags : MAA

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

PTC Reports the EMA’s Acceptance of MAA for Evrysdi (risdiplam)

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

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

Daiichi Reports EMA’s Validation of MAA and Accelerated Assessment for

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

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

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

Gilead Plans to Submit MAA to CDSCO for its Remdesivir

Shots: Gilead seeks CDSCO’s MAA for its anti-viral therapy remdesivir for the treatment of COVID-19. The company had a discussion with Union Health Ministry and Drugs Controller General of India (DCGI) prepare a road map for introducing remdesivir in India Following the US FDA’s approval, CDSCO can approve the therapy by waiving off clinical trials […]Read More

Bayer Reports Submission of MAA to the MHLW for Larotrectinib

Shots: The MAA is submission is based on P-I trial of adult patients, P-II NAVIGATE study in adult and adolescent patients and the P-I/II pediatric SCOUT study. These trials evaluate larotrectinib in 20+ histologies of solid tumors including lung, thyroid, melanoma, gastrointestinal stromal tumors, colon, cholangiocarcinoma, soft tissue sarcomas, salivary gland and infantile fibrosarcoma The […]Read More