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International Society for Stem Cell Research (ISSCR) releases new guidelines
The ISSCR has released updated guidelines for stem cell research and clinical translation of stem cell-based therapies.
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Biologics
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First patient dosed with multi-variant second-generation COVID-19 vaccine
The first-in-human trial of OSE Immunotherapeutics’ multi-variant, second-generation COVID-19 vaccine has enrolled and dosed its first participant.
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Moderna’s COVID-19 vaccine 93 percent effective in adolescents
New Phase II/III study data shows Moderna’s COVID-19 vaccine is safe and immunogenic in patients aged 12 to less than 18 years old.
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Evolving your adverse event monitoring strategy for the post-COVID data influx
Marketing authorisation holders are increasingly challenged to identify all potential adverse events (AEs) and proactively address them with each new product that comes to market. In this article, Alison Sloane, General Manager of Vigilance Detect at IQVIA, discusses how adopting technology can not only streamline pharmacovigilance processes, but also address…
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Talquetamab shows promise in multi-drug refractory multiple myeloma patients
New Phase I data shows 65 percent of triple-class and 83 percent of penta-drug refractory multiple myeloma patients responded to talquetamab.
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Industry hustling to ensure supply of recombinant vector COVID-19 vaccines
A new report suggests pharma is working hard to combat worldwide viral vectors shortage that could threaten the COVID-19 vaccine rollout.
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Stem cell therapy shows promise in COVID-19 respiratory distress
JadiCell™ was shown to significantly improve survival in COVID-19 patients with Acute Respiratory Distress Syndrome (ARDS) and also reduce lung scarring associated with long-COVID-19.
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Article: Replacing blue dye ingress with gas ingress CCI testing
This article describes headspace gas ingress as a CCI test method, which is increasingly being implemented to replace blue dye.
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EU secures up to 1.8 billion additional doses of Comirnaty® COVID-19 vaccine
Pfizer and BioNTech have agreed to supply Europe with 900 million additional doses of Comirnaty® with the option to request 900 million more in future.
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EMA’s human medicines committee (CHMP) meeting highlights, May 2021
In its latest meeting the CHMP recommended eight medications for approval, 17 medicines for indication extension and concluded reviews of two COVID-19 treatments.
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Stelara® “a compelling option” for the treatment of Crohn’s disease
Janssen has released abstracts for four studies evaluating Stelara® (ustekinumab) in Crohn's disease (CD) and ulcerative colitis (UC).
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Article: Evaluating CCI of sterile vials using gas ingress
The article describes how CCI can be determined using Headspace gas ingress as a CCI test.
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Curative cell and gene therapies and healthcare system disruption
In this article, experts from Charles River Associates discuss how the introduction of cell and gene therapies will impact upon various aspects of the healthcare system, from provision of care to delivery and supply, and pricing and market access.
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Are COVID-19 vaccines effective for immunocompromised patients with haematological malignancies?
A new study will evaluate COVID-19 vaccines in patients with haematological malignancies who have received cellular therapy.
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Ziltivekimab shows promise in atherosclerosis trial
Ziltivekimab was found to reduce inflammatory biomarkers of atherosclerosis by up to 93 percent in patients with chronic kidney disease and high cardiovascular risk.
