Remove index subjects a
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US FDA grants approval to Incyte’s Opzelura cream for vitiligo treatment

Pharmaceutical Technology

As per results at week 24, nearly 30% of subjects receiving Opzelura attained ?75% 75% improvement from baseline in the facial Vitiligo Area Scoring Index (F-VASI75), the primary endpoint, versus nearly 8% and 13% of subjects who received vehicle in TRuE-V1 and TRuE-V2, respectively.

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US FDA grants approval for BMS’ Sotyktu to treat plaque psoriasis

Pharmaceutical Technology

These 52-week trials assessed the safety and efficacy of a 6mg once daily dose of Sotyktu versus placebo and Otezla (apremilast) in a total of 1,684 subjects aged 18 years and above. Additionally, the percentage of subjects who attained PASI 75, PASI 90 and sPGA 0/1 versus Otezla at weeks 16 and 24 comprised the key secondary endpoints.

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Health Canada to review Arcutis’ roflumilast cream NDS for plaque psoriasis

Pharmaceutical Technology

Nearly one out of four subjects in these two trials were enrolled in sites in Canada. offered statistically significant improvement compared to a vehicle on secondary endpoints, including on Intertriginous Psoriasis Area Severity Index-75, decline in itch, IGA Success and subject perceptions of symptoms.

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Novel PAT system could enable adaptive process control

European Pharmaceutical Review

Data-driven models that are developed using multivariate data analysis (MVDA) and machine learning (ML) are subject of a lot of research. The refractometry-based PAT system In the research, the PAT system used is a novel advanced refractive index (RI) profiling technology. For instance. Williams et al.

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Novo Nordisk, Kry partner on digital programme for obesity

pharmaphorum

The impact of the digital programme on patients will be tracked through improvements in body mass index (BMI) and other variables in a study involving around 1,000 subjects, to gauge how well it is working over time. It is estimated that more than half (53%) of the adults living in the EU are considered to be overweight or obese.

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Futura eyes FDA filing as topical ED drug passes phase 3 test

pharmaphorum

The FM71 trial was carried out in 96 male subjects with organic and psychological ED, with the gel compared to oral tadalafil (5 mg) over a 24-week period using endpoints agreed with the FDA. The company says MED3000 has a unique evaporative mode of action, stimulating nerve endings to cause an erection.

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Novo Nordisk gets NICE okay for obesity drug Wegovy

pharmaphorum

NICE has backed use of the Wegovy (semaglutide) for people with a body mass index (BMI) of 35 kg/m2 or more and at least one weight-related ailment – such as high blood pressure, high cholesterol or diabetes – as part of a weight management programme involving exercise and a reduce-calorie diet. kg/m2 lower.

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