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Clinical trial setbacks have limited the near-term opportunities for some of Daiichi Sankyo’s ADCs but the drug developer is betting near-term readouts will catapult it into the top tier of oncology companies in the coming years.
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Biotech is increasingly financed, governed and regulated as though it were a mature pharmaceutical industry rather than a discovery system built around scientific uncertainty. Structural changes are needed to sustain the sector’s strategic innovation.
BioSpace examines how the FDA approval of Eli Lilly’s oral obesity drug Foundayo has ignited a key race with Novo Nordisk.
Nusano will bring a massive new radioisotope facility in Salt Lake City online by the end of the year, establishing a supply of starting materials for the next generation of radiopharmaceuticals.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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Therapeutics to halt the progression of chronic kidney disease are in Phase III trials, and others will enter that stage soon. NDAs could follow as early as 2024 with regulatory determinations in 2025.
Iovance Biotherapeutics announced the FDA’s Biologics License Application for lifileucel will likely be completed in Q1 of 2023, a short delay after the agency requested additional data.
The FDA has approved Provention’s BLA for intravenous antibody TZIELD to delay stage 3 type 1 diabetes, making it the first disease-modifying drug indicated to slow disease progression.
With the Thanksgiving season upon us, there are many reasons for biopharma and life sciences companies to say thanks, including for new leaders.
Editas Medicine is pausing its ocular gene therapy program after demonstrating a favorable safety profile and seeking a potential partner to develop EDIT-101, the company announced Thursday.
Regeneron and CytomX Therapeutics inked a deal valued at up to $2 billion to develop next-generation bispecific immunotherapies for cancer, the companies announced Thursday.
GSK has pulled out of its partnership focused on developing T-cell receptor therapeutics for solid tumors with Immatics, the German biotech revealed in its Q3 financial results published Thursday.
Alloy Therapeutics inked an antibody discovery deal with Normunity Thursday to advance the latter’s immune normalizers, antibody therapies that boost the body’s natural immune system to fight cancer.
Astellas’ Phase III SPOTLIGHT trial studying zolbetuximab in CLDN18.2-positive, HER2-negative gastric or gastroesophageal junction adenocarcinoma returned positive results.
The FDA has requested that Clovis Oncology limit the indication of its PARP inhibitor Rubraca as second-line maintenance therapy in recurrent ovarian cancer.