Drug Development
The company’s first-in-class small molecule imipridone, ONC201, showed strong efficacy results in two early-stage clinical trials of 71 pediatric patients with H3K27M-mutant diffuse midline gliomas.
FEATURED STORIES
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
With immunology and inflammation blockbusters like AbbVie’s Skyrizi and Rinvoq reeling in nearly $7 billion combined in the third quarter, the pipeline-in-a-product strategy has never been more attractive.
The cholesterol-lowering drug is part of a suite of medicines that also includes MariTide and that Amgen Chief Medical Officer Paul Burton hopes will make the company the “undisputed leader in the management of cardiometabolic risk for patients” by 2030.
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Researchers at Case Western University looked at the real-world experiences of 13,644 patients who were treated with Paxlovid or Lagevrio (molnupiravir) during the first half of 2022.
Ryvu and Opthea have new funding to work with, Tessa Therapeutics and Enlivex kick off new trials and Revive Therapeutics amends the Phase III protocol for its COVID-19 hopeful.
Researchers recently developed a peptide called A1R-CT that could ultimately have therapeutic applications in both epilepsy and Alzheimer’s disease.
Blueprint Medicines’ Ayvakit is headed to the FDA for a new indication after the drug hit the mark in Part 2 of the PIONEER trial for non-advanced systemic mastocytosis.
I-Mab quietly announced that its partner AbbVie is ending a Phase IB trial on lemzoparlimab for two types of cancers, despite a $2 billion deal inked in 2020.
All other ongoing and pending studies of Sanofi’s amcenestrant, including the early-stage breast cancer trial AMEERA-6, will also be discontinued.
Novavax seeks EUA for COVID-19 Booster, a 100-year-old TB vaccine may protect against the disease and public health officials struggle with fall planning.
Weeks after AstraZeneca and Daiichi Sankyo were able to move the bar in the treatment of metastatic breast cancer with Enhertu, Gilead is answering that challenge with Trodelvy.
Clene Nanomedicine’s CNM-Au8 demonstrated surprising improvements in some MS patients, despite the study being halted early due to COVID-19.
After more than two decades of attempts to develop a universal influenza vaccine, the global COVID-19 pandemic intensified the need for a broader vaccine for both illnesses.