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CHMP meeting highlights – July 2024
In its July meeting, the EMA’s human medicines committee recommended 14 medicines and held a negative opinion for authorising lecanemab to treat Alzheimer’s disease.
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pulmonary arterial hypertension (PAH)
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CHMP meeting highlights – June 2024
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended several new medicines, including positive opinions for treatments for rare disorders.
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First-in-class biologic approved for rare lung disease
The biologic therapy offers a novel therapeutic option that targets a new treatment pathway in pulmonary arterial hypertension (PAH).
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Combination therapy significantly improves pulmonary hemodynamics
Janssen’s single tablet of macitentan plus tadalafil significantly improved pulmonary hemodynamics in a Phase III trial for pulmonary arterial hypertension (PAH).
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EMA’s PRAC confirms recommendation to withdraw amfepramones
The EMA’s safety board verifies that amfepramone-containing products for obesity should not be sold, due to higher-associated health risks.
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What impact does disease rarity have on rare and orphan drug pricing?
Bhavesh Patel, Cécile Matthews and Owen Male at CRA’s Life Sciences Practice assess the relationship between drug pricing for rare disease therapies and disease prevalence in Europe, taking a closer look at payer assessments of orphan drugs in Germany.
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Top 10 biopharma workplaces in the US
A Fortune report reveals the best 10 places to work in the US biopharmaceutical industry.
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Researchers develop method to produce protein drugs from lettuce
Scientists have divised a way to manufacture protein drugs using lettuce leaves, which has presented a potential drug for pulmonary arterial hypertension.
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FDA grants Orphan Drug Designation to sotatercept
Orphan Drug Designation has been given to sotatercept for the treatment of patients with pulmonary arterial hypertension.
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Inhaled dry powder formulation of treprostinil works well in PAH patients
A formulation of treprostinil as an inhaled dry powder has proven to be safe and effective, as reported in the safety analysis of a Phase III trial...
