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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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Phase III data for Pfizer’s respiratory syncytial virus vaccine candidate showed high levels of protection for older adults and infants.
AstraZeneca’s Imfinzi and Lynparza met primary endpoint markers in the Phase III DUO-O trial in advanced high-grade epithelial ovarian cancer, according to data released Wednesday.
Proxygen added Merck to its partner roster on Wednesday, garnering an undisclosed upfront payment plus a potential $2.55 billion in milestones.
The FDA has granted emergency use authorization to InflaRx’s vilobelimab, now to be marketed as Gohibic, for hospitalized adult patients with COVID-19, the German biotech announced Tuesday.
FDA
The Inflation Reduction Act contains provisions designed to influence drug prices. These policies might affect drug development and the prioritization of new drugs.
The Centers for Medicare and Medicaid Services released details about the patient registry it will require physicians to use to prescribe Leqembi, should it be approved by the FDA.
The money saved on canceling the existing studies is intended to fund the advancement of two other oncology pipeline assets.
With an inaugural $350 million fund, Cure Ventures launched Tuesday to support early-stage companies with cutting-edge curative technologies and help them de-risk their science
Gossamer Bio announced Monday that it is discontinuing the development of its lymphoma candidate, GB5121, following two patient deaths in the Phase Ib/II STAR-CNS study.
The FDA has approved the combination regimen of Merck’s Keytruda and Seagen and Astellas’ Padcev for the first-line treatment of locally advanced or metastatic urothelial carcinoma.