Highlights of the EMA’s drug safety committee April meeting
In the April meeting the Pharmacovigilance Risk Assessment Committee began two new reviews of adverse events that could be caused by COVID-19 vaccines.
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Collaboration to encourage US adoption of continuous manufacturing
USP and Phlow have built a new laboratory to develop test methods and standards to facilitate broader adoption of continuous manufacturing in the US.
First AI-designed immuno-oncology drug enters human trials
The A2a receptor antagonist, which aims to inhibit the immunosuppression of T cells by adenosine, was in part designed using Exscientia’s 3D evolutionary artificial intelligence platform.
Global bioreactor market to value over $16bn by 2027
A report indicates ongoing demand for COVID-19 vaccines and other biologics, as well as increasing investment will drive a 16.6 percent CAGR in the bioreactors market.
Personalised cancer vaccine safe and potentially beneficial to patients
Mount Sinai researchers reveal that, in a Phase I trial, their personalised cancer vaccines targeting cancer neoantigens showed some early signs of potential benefit.
Novel time-temperature indicator could help preserve mRNA vaccines
Researchers have developed a novel sensor, known as a time-temperature indicator, that could be used to monitor the storage conditions of mRNA vaccines.
Global Pharmacovigilance Observatory to aid pharma’s understanding of regulatory decisions
The observatory will collate drug safety data, analyses and decisions into a single source to help pharma identify regional differences in decision-making.
New group to tackle data governance and guide digital transformation in pharma
The Pistoia Alliance's Data Governance Community of Interest will develop best practices and advance digital transformation in the pharma/life sciences industry.
GSK Consumer Healthcare to incorporate paper bottles into its packaging
To meet its ambitious sustainability targets, GSK Consumer Healthcare has joined the Pulpex paper bottle consortium.
Deception is not necessary for the placebo effect, finds new study
The study found that patients with irritable bowel syndrome taking open-label placebo reported similar improvements to those taking double-blind placebo.
NIAID doses first patient with Moderna’s variant specific COVID-19 vaccine candidate
The trial will evaluate the safety and immunogenicity of the mRNA-1273.351 vaccine candidate in 200 healthy adult volunteers.
EC approves Cabometyx® and Opdivo® combination for advanced renal cell carcinoma
The combination was approved on Phase III trial results which show it doubled progression-free survival and reduced risk of death by 40 percent, compared to standard of care.
Celonic to produce 100 million doses of CureVac’s COVID-19 vaccine candidate
Production of CureVac’s CVnCoV vaccine will take place in Germany, with over 50 million doses expected to be produced in 2021.
Evrysdi™ approved for treatment of spinal muscular atrophy in Europe
The European Commission has granted marketing authorisation to Roche’s Evrysdi™ (risdiplam) as a treatment for spinal muscular atrophy in infants, children and adults.
First ever Award for Extraordinary Impact on Health bestowed on Moderna and Pfizer
While announcing 2021’s Top 10 Clinical Research Achievement Awards, the US Clinical Research Forum revealed that Pfizer and Moderna would be honoured for their COVID-19 vaccines.
