Drug Development
The company reported results Friday from the KEYNOTE-811 trial in which the anti-PD-1 therapy took an important step toward FDA approval for rare esophageal tumors.
FEATURED STORIES
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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BioSpace connected with Theodore Laetsch, M.D., lead investigator of the pediatric larotrectinib trial (SCOUT), to gain more insight into the drug, the trial and how patients’ lives are being affected.
Quris has developed an alternative to testing on animal models, and each one is smaller than the head of a pin. It holds the potential to increase the currently terrible odds in drug development.
Otsuka and Lunbeck report positive Phase III results in agitation in Alzheimer’s, Acer’s vEDS program hits Phase III and BridgeBio’s primary hyperoxaluria type 1 program progresses.
Companies are still developing and refining treatments and preventions for COVID-19, but not all of them are approved or authorized. Here’s a look at the latest COVID-19 news.
Capping off the first half of the year is a flurry of clinical trial wins. BioSpace takes a look at some of the most exciting ones:
There’s quite a bit of movement on the Omicron-specific booster shot and updated supply deals, despite world leaders shifting their attention away from the COVID-19 pandemic.
Many of Innate Pharma’s cancer-fighting products are making clinical progress. BioSpace spoke with the company’s head of product portfolio strategy and business development, Yannis Morel, Ph.D.
The FDA’s decision came after researchers found cases of drug-induced liver injury in some patients. Tolebrutinib is being evaluated for relapsing types of MS, MG, nrSPMS, and PPMS.
Angion Biomedica Corp. discontinued a Phase II kidney disease trial while Novo Nordisk missed the mark in a NASH study.
BioNTech announced it is partnering with Pfizer to begin testing a next-generation universal vaccine against coronaviruses, including SARS-CoV-2, the coronavirus that causes COVID-19.