![Vials of heparin filling the screen [Credit: JLMcAnally / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Heparin2-300x278.jpg)
![Vials of heparin filling the screen [Credit: JLMcAnally / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Heparin2.jpg)
Novel spectroscopy technique could improve safety and quality of heparin
Using time of flight secondary ion mass spectrometry (ToF-SIMS) enabled the detection of nanoscale quantities of glycosaminoglycan (GAG) contaminants in heparin.
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New harmonised guidance for post-approval changes released by FDA
The FDA has published its finalised guidance for drug lifecycle management, including an improved framework for the management of post-approval changes.
Johnson & Johnson to donate 200,000 vaccine regimens to curb Ebola outbreak
To prevent the spread of the Ebola virus in West Africa, Johnson & Johnson is donating vaccines for a WHO early access clinical programme.
First UK patient enrolled in Duchenne muscular dystrophy gene therapy trial
The Phase III trial will evaluate the safety and efficacy of Pfizer’s PF-06939926 gene therapy in 99 paediatric Duchenne muscular dystrophy patients across 15 countries.
Trial to assess antimicrobial nasal spray in treating mild COVID-19
The study will assess whether APR-AOS2020 can reduce the viral load of recently infected COVID-19 patients with mild symptoms.
CBD tablet significantly improves diabetic peripheral neuropathic pain
In a Phase II trial, a cannabidiol (CBD) sublingual tablet reduced pain scores in patients with diabetic peripheral neuropathy by approximately 50 percent.
CMOs should invest in biologic API manufacturing capabilities, says GlobalData
Research shows the complexity and number of biologics is increasing, as is the frequency at which their active pharmaceutical ingredient (API) production is outsourced.
FDA outlines plan for making inspections more consistent going forward
The new report shows over 8,000 planned inspections were postponed due to COVID-19 and outlines the FDA’s plan for a more consistent future state of operations.
First AI designed Alzheimer’s drug to enter clinical trials
The trial of DSP-0038, an Alzheimer’s disease psychosis drug designed using artificial intelligence, will assess its ability to improve the behavioural and psychological symptoms of dementia.
European Pharmacopoeia adopts revised Raman spectroscopy chapter
The revised Raman Spectroscopy chapter (2.2.48) will be released in October, with updates focusing on enhancing the reliability of the results.
Pakistan approves Zofin™ for compassionate use in COVID-19 patient
Organicell’s Zofin™ therapy has been approved by the Pakistani regulators to be used for a patient with severe COVID-19 on compassionate grounds.
Gene therapy successfully treats rare immunodeficiency in paediatric patients
In three Phase I/II trials an experimental gene therapy caused all but two patients with severe combined immunodeficiency to acquire and retain robust immune function for more than two years.
FDA allows Pfizer’s COVID-19 vaccine to be used in adolescents
The Comirnaty® vaccine’s emergency use authorisation has been extended to allow its administration to those 12 years of age and above in the US.
Real-time bioprocess Raman analyser market to achieve significant growth
Market research shows the adoption of process analytical technologies and investment in pharma R&D and healthcare will drive growth in the real-time bioprocess Raman analyser market.
MDMA-assisted therapy successful in PTSD patients
Three sessions of MDMA-assisted talk therapy resulted in significant symptom reductions for 88 percent of patients with severe, chronic post-traumatic stress disorder (PTSD).
