Daria Husni is Assistant Editor to Pharmaceutical Technology.
Sirio Europe Announces New Softgel Formulations
The new products aim to aid consumers with menopause and eye health-related issues.
FDA Approves Biosimilar to Treat Multiple Sclerosis
This is the first biosimilar to Tysabri, an injection for adults with multiple sclerosis.
Alterity Therapeutics Given European Composition of Matter Patent for Neurodegenerative Diseases
The patent grants Alterity 20 years of exclusivity over a new class of iron chaperone drug candidates.
Revive Therapeutics Announces Initiation of New Bucillamine Formulation Development
The formulation will be used to mitigate emerging infectious diseases and public health emergencies.
Vaccine for Respiratory Syncytial Virus in Infants Granted Breakthrough Therapy Designation
The immunization, meant to protect infants aged six months or lower, is given to pregnant individuals at a gestation period of 32 to 36 weeks.
EMA Reviews Data on Paternal Exposure to Valproate
The assessment aims to determine whether valproate use in men could lead to neurodevelopmental disorders in their children.
Absci and Caltech Collaborate to Accelerate Affordable HIV Therapeutic Vaccine
A major grant from the Bill & Melinda Gates Foundation will bolster efforts to fight the global HIV/AIDS epidemic.
Novartis Finalizes Chinook Therapeutics Acquisition in Deal Worth Up to $3.5 Billion
Novartis has completed its acquisition of biopharma company Chinook Therapeutics.
FDA Releases Guidance on Intake Limits for Nitrosamine Drug Substance-Related Impurities
The guidance can help both applicants and manufacturers limit the mutagenic and carcinogenic potential of NDSRIs.
FDA Approves First Oral Treatment for Postpartum Depression
The new drug could be a powerful tool for patients suffering depressive symptoms after birth.
FDA Grants Orphan Drug Designation to Treatment of Malignant Glioma
The investigational drug was developed to activate a novel uptake pathway, allowing antineoplastic drugs to combat solid tumors more successfully.
FDA Warns that Tydemy May Have Reduced Effectiveness
Lower levels of an active ingredient may result in unexpected pregnancies.
FDA Approves OTC Opioid Overdose Treatment
The nasal-spray drug can be used to reverse the effects of opioid overdose.
FDA Releases Guidance on Standards Related to Pharmaceutical Quality
The program aims to aid submissions from external stakeholders and FDA staff.
FDA Guidance on Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals
The guidance document outlines recommendations to limit potential carcinogenic risk.
Update on Storm Damage to Pfizer Facility in North Carolina
The damage to the facility, which produces 8% of US injectable drug consumption, should not significantly affect the current supply.
EMA Extends OPEN Framework to More Medicines
The framework is now expanded beyond COVID-19 vaccines and treatments.
EMA Publishes Draft Reflection Paper on Artificial Intelligence in Medicine
The paper highlights the potential of AI in the medicinal product lifecycle and the approach that developers should take with it.
EU Takes Steps to Prevent Antibiotic Shortages Next Winter
These recommendations will keep key antibiotics for respiratory infections available when they are needed most.
FDA Publishes Draft Guidance on Human Cellular and Gene Therapy Products
The document’s recommendations outline what studies and reports are required for changes to cell and gene therapy manufacturing.
FDA Approves Preventative Therapy for Respiratory Syncytial Virus in Infants and Toddlers
The new drug may help vulnerable children resist RSV in the coming fall and winter season.