Accelerated, rather than full, approvals were prominent. As usual, cancer registrations predominated—including Amgen’s Lumakras, a first-in-class covalent targeter of KRAS in lung cancer. The other big news was the controversial go-ahead from the US Food and Drug Administration (FDA) for Biogen’s Alzheimer’s monoclonal antibody (mAb) Aduhelm, which later was given a narrower label by the agency; the approval prompted calls by the acting FDA head for a federal investigation into interactions between the drug developer and regulators. Click here to original publication. Fonte: 904 news Nature Biotechnology…
FDA new drug approvals in Q2 2021
Among the 13 FDA approvals during the second quarter of 2021, one has undoubtedly been the biggest talking point. Biogen’s Alzheimer disease drug Aduhelm (aducanumab) has become one of the most controversial authorizations for some time, with much debate about whether the FDA… Click here to original publication. Fonte: 578 | August 2021 | volume 20 www.nature.com/nrd…
First approval of a complement C3 inhibitor opens up auto- immune and inflammatory opportunities
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. Click here to original publication.…
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. 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. Click here to original publication.…
2020 FDA drug approvals
Despite the disruptions caused by COVID-19, the FDA’s Center for Drug Evaluation and Research (CDER) approved 53 novel therapeutics in 2020. This is the second highest total ever, falling just short of 2018’s all-time high of 59, and tying with the 1996 approval cohort. Click here to original publication. Fonte: NaTure RevIewS | DRUg DISCOVERY volume 20 | February 2021 | 85 …
Drug pipeline 3Q20
US Food and Drug Administration (FDA) approvals in 3Q show no effect of the pandemic, with roughly the same number of approvals as in 3Q19. The agency granted three accelerated approvals for cancer indications, including two that target CD19 in unique ways (Gilead’s Tecartus, which has circulating malignant cells removed during manufacturing, and MorphoSys’s Monjuvi, which has modifications to the Fc portion). The first small-molecule exon-skipping drug, Roche’s Evrysdi, was approved. The saga of Biogen’s monoclonal aducanumab may finally come to a resolution in…
FDA approves first BCMA-targeted therapeutic
The FDA has approved GlaxoSmithKline (GSK)’s belantamab mafodotin for relapsed or refractory multiple myeloma. The antibody–drug conjugate (ADC) is the first therapeutic from the crowded BCMA-targeted pipeline to secure approval. Click here to original publication. Fonte: Nature Reviews | Drug Discovery volume 19 | OCTOBER 2020 | 659…
FDA new drug approvals in Q1 2020
In a quarter that was marked by the rapid spread of the COVID-19 pandemic, drug approvals continued (Table 1), but launching was a completely different matter. Zeposia (ozanimod), the most eagerly awaited new drug of the quarter, is not going to reach patients with multiple sclerosis soon, after Bristol- Myers Squibb announced that it would be delaying its debut. Click here to original publication. Fonte: Nature Reviews | Drug DIScovery NEWS & ANALYSIS volume 19 | May 2020 | 299…
IGF-1R drugs travel from cancer cradle to Graves’
One of the most intensively investigated molecular targets in oncology proves its therapeutic worth for thyroid eye disease. The first antibody drug targeting the insulin-like growth factor 1 receptor (IGF-1R) won regulatory approval in January — although not for the treatment of cancer, the indication first pursued more than a decade ago in some 30 different development programs involving experimental IGF-1R inhibitors. Instead, Horizon Therapeutics’ Tepezza (teprotumumab) became the first and only medicine approved by the US Food and Drug Administration for the treatment of thyroid eye disease (TED), a visionthreatening autoimmune disorder, also known…