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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. The company noted that the ODD from the FDA is not an approval for the use of XORLO, a formulation of oxypurinol.

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Two novel biosimilars approved in EU and US

European Pharmaceutical Review

The authorisation is based on clinical data, including findings from a Phase III clinical trial comparing Omlyclo ® to the reference product in patients with chronic spontaneous urticaria up to Week 40, according to Celltrion.

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Can Hepatitis C drugs reduce symptoms of PTSD?

European Pharmaceutical Review

The researchers studied 254 VA patients who were diagnosed with PTSD and hepatitis C between October 1999 and September 2019. Patients’ symptoms were monitored for PTSD and hepatitis C virus between two clinical visits over eight to 12 weeks. MDMA-assisted therapy successful in PTSD patients.

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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

Patients will receive the digital therapy through their mobile phone applications over a 12-week period, and its efficacy will be evaluated based on the difference in the number of monthly migraine days. According to the company, patients often do not achieve full remission with a solely pharmacotherapeutic approach.

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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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Early diagnosis in Alzheimer’s disease: A first step towards better care

Clarivate

Personalized care relies on pharmacological and non-pharmacological interventions aimed at (temporarily) relieving cognitive and non-cognitive symptoms (Alzheimer’s Association, n.d.; Currently, of the eight drugs approved by the U.S. Food and Drug Administration, 2023 and 2024). In 2022, the U.S.