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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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Biologics
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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.
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UK patients with rare blood disorders receive new treatment option
NICE has recommended that Ultomiris (ravulizumab) be available on the NHS for patients with paroxysmal nocturnal haemoglobinuria and atypical haemolytic uraemic syndrome.
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News: Endotoxin automation is achieved with microfluidics for simple, compliant BET
Automated endotoxin testing is achieved in a compact platform, leveraging microfluidic liquid handling. QC labs simplify BET with easier, compliant assays using less LAL.
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Case study: New trends: reducing GWP impact on GMP freeze drying processes
How to turn an older refrigeration system in an existing freeze-dryer into a new environmentally friendly cooling system.
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Article: Effects of deep cold storage at -80°C on CCI
This article describes the effects of deep cold storage on the container closure integrity of sterile product vials.
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Driving biopharma innovation post COVID-19
Ahmed Bouzidi, VP of Biotech Strategic Development at ProductLife Group, discusses the opportunities – and funding and regulatory challenges – facing small and mid-sized biopharma companies as they deliver innovation to the global market.
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Evinacumab shows promise in severe hypertriglyceridemia trial
The investigational antibody evinacumab was able to lower triglycerides by up to 82 percent in severe hypertriglyceridemia patients with acute pancreatitis.
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mRNA COVID-19 vaccination is immunogenic in the immunocompromised
Research suggests patients who receive COVID-19 vaccines prior to a transplant and subsequent immunosuppression may be protected from the disease.
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New harmonised guidance for post-approval changes released by FDA
The FDA has published its finalised guidance for drug lifecycle management, including an improved framework for the management of post-approval changes.
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Johnson & Johnson to donate 200,000 vaccine regimens to curb Ebola outbreak
To prevent the spread of the Ebola virus in West Africa, Johnson & Johnson is donating vaccines for a WHO early access clinical programme.
