The FDA has approved Apellis Pharma-ceuticals’ complement protein C3 inhibitor pegcetacoplan for paroxysmal nocturnal haemoglobinuria (PNH). With this approval the pegylated cyclic peptide will now compete with Alexion/AstraZeneca’s first-in-class blockbuster anti-C5 antibody eculizumab in this rare disease. But complement modulators could have activity in common diseases too. Para acessar a publicação na íntegra clique aqui …
FDA approval for Biogen’s aducanumab sparks Alzheimer disease firestorm
The FDA has granted a controversial accelerated approval to Biogen’s anti-amyloid antibody aducanumab. Despite a lack of evidence that the therapy improves cognitive outcomes, the FDA approved the antibody based on its ability to lower the level of amyloid plaques in the brain. Para acessar a publicação na íntegra clique aqui Click here to original publication.…
Upcoming market catalysts in Q3 2021
Upcoming catalysts for the third quarter of 2021 include approval decisions by the US Food and Drug Administration (FDA) on teplizumab for the treatment of type 1 diabetes (T1D), anifrolumab for the treatment of systemic lupus erythematosus (SLE) and oportuzumab monatox for the treatment of bladder cancer. Para acessar a publicação na íntegra clique aqui …