Drug Development

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Mixed headlines have plagued the cell and gene therapy space of late. We believe that a renewed case of optimism is not only warranted but essential if these therapies are to reach their full potential.
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.
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Eledon Pharmaceuticals announced positive topline results from its Phase IIa clinical trial evaluating tegoprubart in patients with amyotrophic lateral sclerosis (ALS).
The FDA has decided to extend the Prescription Drug User Fee Act (PDUFA) review date for TG Therapeutics’s ublituximab until December 2022.
RhoVac AB announced Tuesday that its candidate therapeutic for prostate cancer failed to meet targets in a Phase IIb study.
GSK announced that it is acquiring Affinivax for up to $3.3 billion to gain its novel class of developmental vaccines and its MAPS technology.
The ASCO Annual Meeting being held in June 3 to 7 will introduce hundreds of posters, abstracts and presentations of cancer studies, preclinical and clinical. BioSpace looks at three presenters.
The long weekend saw BMS’s Opdivo, Novartis’s Kymriah and Roche’s Evrysdi win FDA approvals in new indications.
Although there are many mechanisms proposed that contribute to neuroinflammation and damage caused by inflammaging in the brain, INmune Bio has focused on tumor necrosis factor (TNF).
The American Society of Clinical Oncology meeting will be underway next week in Chicago, and companies are preparing to share data from their pipelines. Here’s a look.
Protagonist Therapeutics announced updated promising data from its phase II Revive clinical trial, which is evaluating the safety and efficacy of rusfertide in patients with polycythemia vera (PV).
TikoMed’s contribution to the fight is ILB, a novel patented formulation of a modified glycosaminoglycan that works to tackle ALS through neurotrophic and myogenic effects.