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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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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 drug is limited to patients who test at least 20% for a Ki-67 score on an FDA-approved test.
FDA
The FDA said that there had been concerns over the reduced effectiveness of the Moderna COVID-19 vaccine against symptomatic disease.
CRISPR Therapeutics provided updated data from its ongoing Phase I CARBON trial of CTX110, its allogeneic “off-the-shelf” CAR-T therapy for CD19+ B-cell cancers.
Genome-editing company Intellia Therapeutics and France-based SparingVision have partnered to develop new therapies for ocular diseases. The deal could be worth up to $600 million for Intellia.
A large part of the funding will go to the research and development of CIN-107 as it has shown the potential to treat primary aldosteronism and treatment-resistant hypertension.
Cue Health went public on September 24 on the Nasdaq securities exchange under the ticker symbol HLTH.
Takeda entered into a licensing pact with Poseida, Spark entered into a licensing agreement with CombiGene AB, while BridgeBio Pharma announced plans for its second annual R&D Day.
GSK shares are climbing in premarket trading on rumors that the company’s consumer health business it intends to spin off into a separate company next year is attracting interest from venture capitalists.
Teamed up with pharma giant GlaxoSmithKline, CureVac is now focusing on a more promising target – second-generation mRNA vaccines.
Two months after J&J CEO Alex Gorsky announced plans to step down, Chief Scientific Officer Paul Stoffels will retire from the life sciences giant at the end of the year.