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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Machine vision allows real-time monitoring and control of low concentration APIs
Machine vision-based concentration determination enabled the accurate real-time monitoring and control of continuous powder blending.
Using co-processed excipient reduces PAT measurement errors, finds study
New research shows co-processed excipient is superior to non-co-processed when using near infrared (NIR) process analytical technology (PAT) to monitor direct compression tableting.
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.
FDA joins Bespoke Gene Therapy Consortium (BGTC) for rare diseases
The consortium also consists of 10 pharmaceutical companies and five organisations to accelerate gene therapies to treat rare diseases.
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).
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.
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.
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).
NICE does not recommend tucatinib in new draft guidance
The UK regulator concluded that breast cancer patients taking tucatinib live longer, but it is unclear how long for and whether it is cost effective.
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.
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.
FDA releases new guidance for drug and biological product data
The FDA has released new draft guidance: “Data Standards for Drug and Biological Product Submissions Containing Real-World Data.”
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.
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.
