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Spero Therapeutics is putting over $1 billion on the line in exchange for rights to develop SP001, an anti-CD40L antibody, for IgG4-related disease. A Phase 2 study is planned for the second quarter of 2027.
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As antibody-drug conjugates advance and move into earlier lines of treatment, drug developers have to build gentler therapies that don’t just extend survival but improve it.
FDA’s rare disease decisions are strongest when the patient community has a voice in advisory committee decisions.
The lineup at the Alzheimer’s Association International Conference will provide critical insight into where the industry is headed with regard to targets being explored to vanquish the elusive neurodegenerative disease.
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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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FDA
Vowst, the first-ever oral fecal microbiome-based therapeutic, is indicated for preventing C. diff recurrence in adults following antibacterial treatment.
Merck and AstraZeneca are seeking broad approval for Lynparza in mCRPC regardless of BRCA status.
During its Q1 earnings call Tuesday, Biogen announced a handful of program pauses and cuts and touted the potential of anticipated approvals.
Orbital will use Series A funds to advance RNA-based vaccines, immunomodulators and protein replacement therapies.
The proposed drug pricing legislations follow the Inflation Reduction Act, passed in August 2022.
Novartis is scaling back its pipeline to focus on higher-value assets with stronger commercial potential.
The regulatory filing puts the company alongside Vertex and CRISPR, which also await FDA approval for their SCD gene therapy.
Vedanta will use the funds to advance its lead asset VE303 in clostridioides difficile infection and support the development of another candidate in ulcerative colitis.
Tuesday, the FDA approved Qalsody—formerly tofersen—on a conditional basis to treat SOD1-ALS.
For those looking to transition out of academia, moving into a government role could be one of the most rewarding pathways available.