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Biogen touted an “unprecedented” drop in tau in a Phase 2 trial, backing the company’s decision to take diranersen to Phase 3 despite a missed primary endpoint and seemingly supporting the anti-tau approach.
FEATURED STORIES
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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Read our takes on the biggest stories happening in the industry.
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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The FDA placed 4D Molecular Therapeutics’ gene therapy program, 4D-310, on clinical hold, the company announced Thursday.
The discovery of novel Alzheimer’s biomarkers is enabling better trial selection, earlier pipeline decision making and new targets for therapeutics.
Sanofi is discontinuing its Phase III study of tolebrutinib, an investigational BTK inhibitor for myasthenia gravis.
Keytruda could be on its way to snagging another indication as a first-line therapy for endometrial cancer after the company announced positive Phase III results Friday.
FDA
Wednesday, the FDA approved GSK’s daprodustat, now to be marketed as Jesduvroq, for the treatment of anemia due to chronic kidney disease in adult patients.
Karuna Therapeutics acquired exclusive rights to Goldfinch Bio’s investigational TRPC4/5 channel candidates in a deal potentially worth $520 million.
Roche is dropping its investigational AKT inhibitor ipatasertib, which was being assessed in a Phase III trial for castration-resistant prostate cancer, as well as several other candidates.
Novartis is cleaning house, cutting its Huntington’s disease program along with several others. The company announced multiple program stops and delays in its full-year 2022 report Wednesday.
The partners will combine Miromatrix’s single-use bioengineered liver with Baxter’s PrisMax system, which is designed to provide individualized therapies to patients.
GSK has dropped two assets, an investigational celiac disease therapeutic and a Staphylococcus aureus vaccine hopeful, from its pipeline.