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Vicore’s lung disease digital therapy gets breakthrough tag

pharmaphorum

Vicore gets FDA breakthrough status for Almee, a cognitive behavioural therapy (CBT) digital health therapy used to support people with pulmonary fibrosis

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FDA puts breakthrough tag on Roche, Lilly Alzheimer’s test

pharmaphorum

Roche and Eli Lilly have been granted breakthrough status by the FDA for their pTau217 blood test for Alzheimer's disease.

FDA 110
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Cybin bags breakthrough tag for psychedelic depression drug

pharmaphorum

Cybin files a $150m placement on the back of new clinical data with its psychedelic drug CYB003 for depression and an FDA breakthrough designation.

FDA 95
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Click bags FDA breakthrough tag for schizophrenia DTx

pharmaphorum

Digital health company Click Therapeutics has won an FDA breakthrough device designation for CT-155, a digital therapeutic (DTx) for the negative symptoms of schizophrenia, like social withdrawal and apathy, that tend not to respond well to antipsychotic drugs.

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MindMed gets FDA breakthrough tag for LSD in anxiety

pharmaphorum

In another inflection point for the psychedelic medicines category, Mind Medicine (MindMed) has claimed breakthrough status from the FDA for its LSD-based treatment candidate MM120 as a treatment for anxiety.

FDA 87
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bluebird bio wins back-to-back landmark FDA approvals for first-in-class gene therapies

Pharmaceutical Technology

Spark Therapeutics’ Luxturna, indicated for inherited retinal disease (IRD), was the first gene therapy to be approved, in 2017, with a price tag of $850,000 for each eye. Prior to bluebird's approvals, there were only two FDA-approved gene therapies for inherited conditions on the market.

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Cost of disease-modifying therapies for multiple sclerosis continues to rise in US

Pharmaceutical Technology

DMTs for MS have a high price tag, particularly in the US. The development and approval of safe and reliable curative therapies would be a major breakthrough in the treatment of MS, with considerable implications for patients’ financial circumstances and health-related quality of life.