Shots:
The US FDA has approved Empaveli (pegcetacoplan) for C3 glomerulopathy (C3G) & primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) pts (≥12yrs.)
Approval was based on P-III (VALIANT) trial assessing Empaveli (Q2W) vs PBO in C3G & primary IC-MPGN pts (≥12yrs., n=124) for 26wks. followed by 26wk. open-label period, where all pts received Empaveli
Trial met…
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The US FDA approved 5 NDAs and 5 BLA in February 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 19 novel products in 2023
In February 2023, the major highlights drugs were, Tezspire (tezepelumab) approval for severe asthma, Altuviiio for hemophilia A
PharmaShots has compiled…
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Nancy spoke about the results from the Geographic Atrophy Insights Survey (GAINS)
Nancy also talked about the emotional burden on the patients and the devastating impact on independence caused by vision loss
The global survey was conducted by The Harris Poll on behalf of Apellis Pharmaceuticals to find the impact of GA which is a…
The US FDA has approved 4 NDAs and 1 BLAs in 2021, leading to treatments for patients and advances in the health care industry.
The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 29 novel products in 2021.
Additionally, last year in 2020, the US FDA…
In an interview with PharmaShots, Apellis' Chief Medical Officer, Federico Grossi shares his views on the data presented at ARVO 2021. The studies support AI analytics as a tool to distinctly measure disease activity well as the therapeutic effect in GA.
Shots:
Apellis presented five oral presentations from an AI collaboration with the Ophthalmic Imaging Analysis (OPTIMA)…

