All Pharmacovigilance and safety oversight articles – Page 16
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NewsNovel LAI antipsychotic approved in EU
The long-acting injectable (LAI) formulation is indicated as a once-every-two-months treatment for adults with schizophrenia.
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NewsQuality risk management in radiopharmaceutical production
A quality risk assessment of a Good Manufacturing Practice (GMP) radiopharmaceutical production site found that dispensing was the most critical phase of the process.
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NewsFirst-in-class biologic approved for rare lung disease
The biologic therapy offers a novel therapeutic option that targets a new treatment pathway in pulmonary arterial hypertension (PAH).
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NewsDrug safety driving pyrogen testing market expansion
A lack of standardised testing methods and subsequent delayed product approvals is limiting growth of the pyrogen testing market, according to a report.
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NewsCHMP meeting highlights: March 2024
At the Committee for Medicinal Products for Human Use (CHMP)’s March meeting, twelve medicines received positive opinions for marketing authorisations, including a new antibiotic and a novel oral medicine for a rare blood disorder.
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NewsNext-gen Moderna COVID-19 vaccine shows promise
Phase III data shows that mRNA-1283 has a similar safety profile to Moderna's approved COVID-19 vaccines, the company states.
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NewsResearchers propose novel test for pyrogen detection
An alternative in vitro pyrogen detection test using transfected THP-1 cells detected endotoxin and nonendotoxin pyrogens with good sensitivity, stability and predictability, a study shows.
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NewsFDA approves innovative gene therapy for MLD
Following US FDA approval of Lenmeldy™ (atidarsagene autotemcel) for early-onset metachromatic leukodystrophy (MLD), the US wholesale acquisition cost of the gene therapy has been set to $4.25 million.
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NewsParkinson’s infusion treatment demonstrates advantage over oral delivery
Delivering the traditional Parkinson’s treatment via subcutaneous infusion over a 24-hour period was shown to be safe and effective, research found.
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NewsMycoplasma testing market expected to value nearly $2 million by 2031
Technology innovations and a stronger focus on developing novel drugs to treat chronic diseases, are key drivers for the global mycoplasma testing market up to the next decade, research states.
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NewsAnalytical technique may advance medical cannabis quality control
Combining near-infrared spectroscopy (NIR) hyperspectral imaging (HSI) and machine learning could offer a simpler, non-invasive alternative to established analytical techniques such as chromatography, research suggests.
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NewsFDA approval could shape liver disease treatment landscape
A novel liver therapy authorised under US Food and Drug Administration (FDA) Accelerated Approval, is a potential game-changer in the NASH treatment space.
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ArticleDeveloping a new treatment paradigm for IgAN
On World Kidney Day 2024, Dr Marshall Fordyce, CEO of Vera Therapeutics explores the challenges of treating kidney disease and shares why the company’s lead candidate could become the first self-administered B-cell modulation therapy.
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NewsRapid pseudomonas aeruginosa detection method developed
Research suggests the rapid detection method “will enable the timely implementation of microbiological monitoring strategies for large batches of medications”.
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NewsJ&J reveal long-term data for novel oral peptide
The new data suggests the IL-23 receptor antagonist peptide has potential to address the high unmet need of a durable and convenient oral option in moderate-to-severe plaque psoriasis.
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ArticleLive biotherapeutic products: bridging innovations and challenges in manufacturing
In our third instalment of EPR's exclusive ‘Microbiome therapeutics: microscope to medicine’ series, Tue Hodal, Chief Technology Officer and Lorenz Rindisbacher, Chief Quality Officer, Bacthera, explore how live biotherapeutic products (LBPs) represent a transformative shift in medicine, highlighting their unique challenges and potential.
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ArticleData integrity considerations in pharma and life sciences
In this Q&A, data expert Joseph S Boakai addresses decisive factors impacting data integrity in the pharma and life sciences industries.
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NewsManufacturer retracts acquisition deal due to “data integrity issues”
According to Olympus Corporation, concerns about the non-vascular metallic stents were found post-closing following the agreed acquisition of Taewoong Medical Co., Ltd.
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NewsPreventing fungal contamination in pharmaceuticals
While fungal contamination detection in pharmaceutical manufacturing remains a challenge, preventive practices and policies must be followed, research states.
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NewsSemaglutide could provide novel dual benefit in diabetes and kidney disease
The new data suggests Novo Nordisk’s small molecule treatment semaglutide could become the first GLP-1 treatment option for patients with type 2 diabetes and chronic kidney disease (CKD).