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Enabling multi-dimensional biotherapeutic analysis
EPR highlights the development of a simple, flexible two-dimensional liquid chromatography-native mass spectrometry method for the in-line analysis of biotherapeutics.
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Therapeutics
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Economics and risks of FDA’s Quality management maturity rating programme
Ensuring that pharmaceutical manufacturers not only adhere to current good manufacturing processes but go beyond to embrace a culture of quality has far-reaching consequences for the industry, the health care community and consumers. A focus on quality across many sectors of the economy has demonstrated direct economic benefits accruing to…
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Injection could help postpartum depression, says study
Data demonstrated that a one-time injection of the drug BRII-296 is safe and effective for most patients with postpartum depression (PPD).
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Lecanemab diminishes mental deterioration in early Alzheimer’s
Phase III trial confirmed Eisai’s lecanemab significantly decreased cognitive decline in patients with mild Alzheimer’s disease.
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Is TEE the key for novel antibiotics?
Research suggests a Transferable Exclusivity Extension (TEE) system is “the only existing option capable of incentivising antibiotic R&D in a sustainable manner” for Europe.
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HPLC-MS/MS for NDMA impurity determination in sartans
EPR summarises the development of a HPLC method for the detection, separation and quantification of N-nitrosodimethylamine (NDMA) in both olmesartan API and finished formulations.
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Large diabetic drug comparison study releases results
Two of the four diabetes drugs tested (insulin glargine and liraglutide) in combination with metformin, extended the blood glucose stability period for patients.
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Medicinal cannabis monograph proposed by US Pharmacopeia
A monograph outlining the analytical methods and acceptance criteria for cannabis chemotypes has been released for comment by USP’s Herbal Medicines Compendium.
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HPLC determination of common cold formulations
EPR highlights a high-performance liquid chromatography (HPLC) method which enables the detection of both chlorpheniramine maleate and ibuprofen in formulation.
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Ultomiris for generalised myasthenia gravis
The first and only long-acting C5 inhibitor, Ultomiris (ravulizumab), has been permitted in Europe for adults with generalised myasthenia gravis.
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FDA and NIH partner to understand ALS
The Critical Path for Rare Neurodegenerative Diseases (CP-RND) partnership was launched to develop breakthrough treatments for neurodegenerative diseases like amyotrophic lateral sclerosis (ALS).
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First patient dosed with HIV gene therapy
According to researchers, the CRISPR-based gene therapy, EBT-101, has the potential to change the future of HIV therapeutics.
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Using RWE in rare disease drug development: effective innovations with historical controls
With a growing number of therapies under development for rare diseases, ICON’s Dr William Maier discusses how real-world evidence (RWE) can be effectively used as a historical control (HC), overcoming challenges presented in clinical development.
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EMA human medicines committee (CHMP) highlights, September 2022
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended 12 medicines for approval, including those for rare diseases, osteoporosis and cancer.
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First bispecific antibody approved in EU to combat leading causes of vision loss
Roche’s Vabysmo® (faricimab) has been approved in Europe as a four-monthly treatment for wet age-related macular degeneration and diabetic macular oedema.
