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.
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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).
EMA begins rolling reviews for a COVID-19 therapeutic and a vaccine
The European Medicines Agency (EMA) has initiated a rolling reviews of Vero Cell, an inactivated COVID-19 vaccine, and sotrovimab, a monoclonal antibody.
European molecular spectroscopy market to value $2.83bn by 2027
Research suggests the development of new instruments and growing government investments, particularly in Germany, will drive growth of the European molecular spectroscopy market.
ICMRA and WHO state clinical trial reports should be published without redaction
The International Coalition of Medicines Regulatory Authorities (ICMRA) and WHO are calling on pharma to provide voluntary unrestricted access to trial results data.
Highlights of the May 2021 Pharmacovigilance Risk Assessment Committee (PRAC) meeting
In its May meeting, the EMA’s drug safety committee (PRAC) concluded two safety signal reviews for COVID-19 vaccines and began several more.
