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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.
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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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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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PhaseBio plans to file Chapter 11 bankruptcy and sell off its bentracimab assets under a stalking horse arrangement with an unnamed “large pharmaceutical company.”
The FDA greenlit AstraZeneca’s tremelimumab in combination with its checkpoint inhibitor Imfinzi as a treatment for patients with unresectable hepatocellular carcinoma.
Alpine Immune Sciences has voluntarily terminated enrollment in two clinical trials of its immuno-oncology asset, davoceticept, after a second patient death.
Top-line data from Tricida’s VALOR-CKD trial showed veverimer failed to meet its primary endpoint and does not slow progression in patients with metabolic acidosis and CKD.
In a Phase III trial comparing Novartis’ experimental iptacopan against AstraZeneca’s Soliris and Ultomiris in paroxysmal nocturnal hemoglobinuria, iptacopan demonstrated superiority.
Myovant Sciences agreed to be acquired by Sumitovant Biopharma for $2.9 billion - three weeks after turning down a previous offer.
New data from Scholar Rock’s Phase II TOPAZ trial showed its investigational antibody apitegromab improves quality of life in types 2 and 3 spinal muscular atrophy patients.
The FDA released guidelines Thursday in an attempt to clarify processes for assessing a drug candidate’s efficacy while examining several endpoints, simultaneously.
Shares of Immunic stock have plunged more than 70% in premarket trading after an early peek at its Phase Ib psoriasis drug candidate has so far failed to distinguish itself from placebo.
Johnson & Johnson will lay off 64 employees from its Manhattan-based pharmaceutical supplies business in the early part of 2023.