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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 104
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Grünenthal’s non-opioid pain drug gets breakthrough tag

pharmaphorum

Grünenthal’s non-opioid pain drug gets breakthrough tag Phil.Taylor Tue, 05/23/2023 - 08:20 Bookmark this

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Amylyx ALS drug draws criticism over $158,000 price tag

pharmaphorum

The third ALS treatment to be given FDA approval, following Mitsubishi Tanabe’s Radicava ($170,000 per year) and generic drug riluzole – Relyvrio is priced at around $12,500 per 28-day prescription. Currently, the ALS drug is priced about five times higher than the top of a value-based range. ALS affects over 30,000 people in the US.

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Lutris wins FDA orphan drug tag for EGFR inhibitor-induced rash candidate

Pharmaceutical Technology

LUT014 is being investigated in an ongoing Phase II trial as a first-line treatment for EGFR inhibitor-induced acneiform rash, for which there is no approved drug.

FDA 105
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Disc wins orphan drug tag for rare blood cancer  

Pharmaceutical Technology

The humanised monoclonal antibody DISC-3405 is under investigation in a Phase I clinical trial, with data expected this year.

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FDA gives Daiichi Sankyo’s HER3 drug a breakthrough tag

pharmaphorum

Daiichi Sankyo has been granted breakthrough status by the FDA for patritumab deruxtecan, a HER3-targeted antibody-drug conjugate (ADC) in clinical trials for lung cancer. HER3 is expressed in more than 80% of EGFR-mutant NSCLC, and overexpression is associated with poor outcomes, but no HER3-targeted drugs have been approved to date.

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Japan's Ono pays $2.4B for Qinlock-maker Deciphera as biotech readies another approval run

Fierce Pharma

The price tag includes both the approved cancer drug Qinlock and another Deciphera candidate heading to the FDA’s desk in the coming months.

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