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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, Oct 2021
EMA's drug safety committee (PRAC) assessed risks with COVID-19 vaccines and identified no risk of death with Imbruvica and ACE inhibitors.
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Drug Safety
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IV suramin may be a promising autism treatment, shows Phase II study
PaxMedica's intravenous (IV) suramin known as PAX-101 had mixed results in Phase II study, but shows potential to reduce autism symptoms.
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Serial radiation therapy an effective alternative for kidney cancer
The single-arm study showed that radiation therapy is an effective noninvasive alternative treatment for renal cell carcinoma (RCC).
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Stelara® shows promise to treat gut diseases in new analyses
Two new analyses displayed positive data supporting Stelara for the treatment of Crohn's disease and ulcerative colitis.
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CHMP recommends COVID-19 vaccine Spikevax booster dose
The European Medicines Agency (EMA)'s human medicines committee (CHMP) concludes that a booster dose of Spikevax can be administered in adults aged 18 or over.
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SEC-MS: a “powerful tool” for ADC analysis, find researchers
Research shows size exclusion chromatography (SEC) with mass spectrometry (MS) enables the simple, quick and reliable analysis of antibody-drug conjugates (ADCs).
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Model accurately predicts cyclodextrin formulation stability
The model determines cyclodextrin complex stability constants as a function of pH and temperature, helping to optimise formulations using cyclodextrin.
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Less than lifetime limits for N-nitrosamine mutagenic impurities
Here, Dave Elder discusses the determination of less than lifetime (LTL) limits for highly potent N-nitrosamine compounds and how to ensure safety in dosing.
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CHMP initiates rolling review of molnupiravir for COVID-19
The European Medicines Agency's human medicines committee (CHMP) begins its rolling review of the investigational oral antiviral molnupiravir.
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X-ray imaging enables automated parenteral product particulate inspection
X-ray imaging was able to detect all common particulates in lyophilised drug product and provide information of the cake structure in a new study.
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Imfinzi™ improves overall survival in biliary tract cancer (BTC) patients
Imfinzi plus chemotherapy is the first immunotherapy combination to demonstrate superior clinical outcomes over standard of care for BTC.
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Second Phase III study supports Dupixent® for eosinophilic oesophagitis
Dupixent® reduced eosinophilic oesophagitis symptoms by 64 percent compared to placebo and met primary endpoints in second Phase III study.
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Comirnaty® booster dose displays high efficacy in Phase III study
The vaccine showed a relative vaccine efficacy of 95.6 percent and is the first efficacy results from a COVID-19 vaccine booster trial.
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Opdivo® approved in Europe to treat a range of cancers
Opdivo® (nivolumab) has been approved by the European Commission for gastric, gastroesophageal junction (GEJ), or oesophageal adenocarcinoma.
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Pepsin key for fast and efficient AAV peptide analysis, finds study
Researchers have created a new workflow using pepsin to expedite the LC-MS analysis of adeno associated virus (AAV) capsid proteins for gene therapies.
