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Report urges for new Pharma standards on antimicrobials
New recommendations from a report on antibiotic use and development has underlined key actions to help mitigate antimicrobial resistance (AMR) globally.
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Antibiotics
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Curbing AMR through sustainable antibiotic manufacturing
Key recommendations highlighted in a recent report by the Access to Medicine Foundation offer pharmaceutical manufacturers ways to effectively manage the release of antibiotic waste into the environment, and thus contribute to the reduction of antimicrobial resistance (AMR).
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Antibiotic manufactured via continuous-flow for first time
Continuous-flow manufacturing of the antibiotic cefazolin can cover mass production within compact manufacturing facilities and contribute to a stable drug supply, researchers have reported.
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EMA prepares for winter antibiotic shortages
Anticipating similar demand of antibiotic use in prior winter seasons, the European Medicines Agency (EMA) has proposed key actions to mitigate supply chain issues.
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AMR certification: recognising responsibly in antibiotic manufacture
Following the recent launch of the BSI’s AMR certification, EPR invited Steve Brooks from the AMR Industry Alliance and BSI’s Courtney Soulsby to elucidate its significance for antibiotic manufacturers and the wider pharma industry.
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New AMR certification launched for antibiotic manufacturers
Following publication of the Antibiotic Manufacturing Standard in 2022 to help overcome AMR, antibiotic manufacturers can now verify their actions through a new certification.
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Could FDA recommend new antibiotic for hospital-acquired pneumonia?
A new combination antibiotic for hospital-acquired pneumonia offers advantages in dosing and tolerability, a Phase III trial has shown.
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Gut microbiome linked to cancer CAR T therapy response
For patients with B cell lymphomas, the gut microbiome may modulate the efficacy of CAR-T immunotherapy, research has found.
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EU antibiotic shortages being monitored by MSSG
The Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) have stated it is closely monitoring and responding to the current EU antibiotic shortages.
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AMR surveillance must improve, says WHO report
WHO’s Global Antimicrobial Resistance and Use Surveillance System (GLASS) report 2022 contains AMR trends for the first time since 2017.
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First faecal microbiota product approved for C. diff
The first faecal microbiota product to prevent recurrence of Clostridioides difficile infection in adults has been approved by the FDA.
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The race for a new class of antibiotics
No new antibiotic class has reached market since 1987, despite 227,808 papers published since WHO released its priority pathogens list, finds study.
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Outsourcing APIs put EU patients at risk
Teva warns APIs could disappear from European factories in five to 10 years if the industry does not see outsourcing essential medicine manufacture as risky.
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Cystic fibrosis phage therapy trial commences
The National Institute of Allergy and Infectious Diseases (NIAID)-supported clinical trial will assess whether the bacteriophage therapy WRAIR-PAM-CF1 safely reduces the quantity of Pseudomonas aeruginos bacteria in fibrocystic lungs.
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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.
