Tags : EMA

Novartis’s Iptacopan (LNP023) Receives EMA’s Prime Designation for C3 Glomerulopathy

Shots: EMA has granted PRIME designation for iptacopan (LNP023) in C3 glomerulopathy (C3G). PRIME designation enhancing the development of medicine targeting unmet medical need. Results of P-II interim analysis for iptacopan in C3G will be presented at ASN 2020 Additionally, the company is investigating iptacopan in P-III study in PNH patients with residual anemia despite […]Read More

BioNTech and Pfizer Initiates Rolling Submission to EMA for SARS-CoV-2

Shots: The Rolling Submission is based on the preliminary results from pre-clinical and early clinical studies in adults, which shows that BNT162b2 triggers the production of neutralizing antibodies and TH-1 dominant CD4+ and CD8+ T cells that target SARS-CoV-2. BioNTech and Pfizer plan to work with the EMA’s CHMP to complete the rolling review process […]Read More

Galecto’s GB0139 Receives the US FDA’s and EMA’s Orphan Drug

Shots: The US FDA and EMA has received ODD to Galecto’s GB0139 for the treatment of IPF. GB0139 showed significant reduction of YKL-40 biomarker in fibrosis, inflammation, tissue remodeling diseases in its first clinical study after 14 days of treatment The EMA cited GB0139’s clinically relevant biomarker data in IPF patients which provides financial incentives, […]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

Insights+ Key Biosimilars Events of July 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a “reference […]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

PharmaShots: COVID-19 Healthcare News Monthly Updates – June 2020

Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has been named “SARS-CoV-2” (severe acute respiratory syndrome coronavirus 2) and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). The outbreak of the respiratory disease was first detected […]Read More