Phase I
The joint venture between Walgreens and Prothena to accelerate the approval of an Alzheimer’s treatment is the latest in biotech and retail chain alliances.
The regulatory filing puts the company alongside Vertex and CRISPR, which also await FDA approval for their SCD gene therapy.
The partial clinical hold follows Foghorn’s voluntary pause of the study and is due to one patient developing irregular heartbeat following treatment with FHD-609.
Lilly investigators said they hoped to differentiate their Phase I candidate from the competitive KRAS space by making it the first to gain approval as a first-line treatment.
A unanimous FDA committee vote supported the favorable risk-benefit profile of Innoviva’s sulbactam-durlobactam for hospital-acquired A. baumannii infections.
Roche, AstraZeneca, Moderna, Merck and Affimed presented new data in liver cancer, lung cancer, melanoma and lymphoma.
The company has several targeted therapeutics in early-stage trials and preclinical development for cancer types with high expression levels of the protein.
Following mixed Phase I/II data for its homocystinuria hopeful pegtarviliase, Aeglea lays off all but 10 employees and launches a sweeping strategic review.
Data from two mid-stage studies show HI-Bio’s investigational therapy felzartamab lowers pathogenic antibody titers in patients with primary membranous nephropathy (PMN).
At the World Vaccine Congress this week, Novavax presented data suggesting that its protein nanoparticle booster generated immune responses that could protect against severe infection.
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