The FDA and CDC have decided to temporarily suspend use of Janssen’s single dose vaccine while reports of rare and severe blood clots are investigated.
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12 April 2021 | By Charles River Laboratories
Join us on 1 June at 15:00 BST, as Jordi Iglesias visually summarise the ICH Q9 Quality risk management GMP document and explain how you can use the approach and tools described to proactively improve your microbiological QC assays in terms of data integrity.
The observatory will collate drug safety data, analyses and decisions into a single source to help pharma identify regional differences in decision-making.
The big debate. Beyond the data and document distinction: how to transform life sciences experiences via improved information flow
The life sciences industry may have been slower than other markets to appreciate the benefits of holistic data and document management, but that is changing rapidly now. Here, life sciences data and content management visionaries Steve Gens of Gens & Associates, Remco Munnik of Iperion and James Kelleher of Generis…
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.
The European Commission has granted marketing authorisation to Roche’s Evrysdi™ (risdiplam) as a treatment for spinal muscular atrophy in infants, children and adults.
The European Medicines Agency has published its recommendations for 2021-2022 seasonal influenza vaccine composition.
In its March meeting the EMA’s human medicines committee recommended five medicines for approval and concluded its review of regdanvimab as a treatment for COVID-19.
Abecma (idecabtagene vicleucel) was approved for adults with relapsed or refractory myeloma based on its 72 percent overall response rate in a trial.
The approval of at least one new manufacturing site based in Europe for each of the approved COVID-19 vaccines should increase supply for the EU.
The submission is the first in a series that will include dengue-endemic countries, it includes long-term Phase III safety and efficacy data for the TAK-003 vaccine candidate.
The warning letters were issued to two companies illegally selling over-the-counter cannabidiol (CBD) products for pain relief.
The recommendation will allow more data to be collected about the combination treatment while allowing patients with high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer to access the medication.