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US FDA grants orphan drug status for XORTX’s oxypurinol

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to XORTX Therapeutics’ oxypurinol to treat autosomal dominant polycystic kidney disease (ADPKD) patients. We look forward to our upcoming meeting with the FDA on 1 May 2023 to discuss our planned Phase III clinical programme for XORLO.”

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How NLP Helps Life Sciences Companies Unlock Insights from Drug Labels

PM360

When developing content for new drug labels, life sciences companies’ regulatory teams face challenges in gathering intelligence to better understand competitive factors, market dynamics, and effective approval strategies. Food and Drug Administration (FDA) or European Medicines Agency (EMA).

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Click Therapeutics kicks off digital therapy remote trial for migraine

Pharmaceutical Technology

in December 2022, the digital therapy, called CT-132, secured a Breakthrough Device designation from the US Food and Drug Administration (FDA) as an adjunctive preventive treatment for episodic migraine in patients above the age of 18 years. Its use is especially applicable in mental health and neurology.

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Can Hepatitis C drugs reduce symptoms of PTSD?

European Pharmaceutical Review

“Many people have PTSD, but there [are] few effective pharmacologic treatments and limited drug development for PTSD,” commented Gradus. There are two current medications – sertraline and paroxetine – approved by the US Food and Drug Administration (FDA) for treating PTSD symptoms.

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Otsuka and Lundbeck’s sNDA for Rexulti gains US FDA approval

Pharmaceutical Technology

Otsuka Pharmaceutical and H Lundbeck have received approval for the supplemental new drug application (sNDA) from the US Food and Drug Administration for Rexulti (brexpiprazole) to treat agitation associated with dementia due to Alzheimer’s disease.

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The future of medical cannabis development in Europe

European Pharmaceutical Review

3 With established drug development pathways, we are accustomed to a rigid structure of translation from bench to bedside. It is estimated that only one in 10 drugs that enter Phase I trials are subsequently licensed by the US Food and Drug Administration (FDA).

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Q32 Bio and Horizon partner to develop autoimmune disease treatment

Pharmaceutical Technology

Recently, Q32 concluded a Phase I clinical trial to evaluate the pharmacokinetics, pharmacodynamics and safety of ADX-914, which showed a pharmacological effect on T cells in healthy subjects. antibody, ADX-914 re-regulates adaptive immune function by hindering IL-7 and TSLP-facilitated signalling.