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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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Biologics
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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.
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CMOs should invest in biologic API manufacturing capabilities, says GlobalData
Research shows the complexity and number of biologics is increasing, as is the frequency at which their active pharmaceutical ingredient (API) production is outsourced.
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Pakistan approves Zofin™ for compassionate use in COVID-19 patient
Organicell’s Zofin™ therapy has been approved by the Pakistani regulators to be used for a patient with severe COVID-19 on compassionate grounds.
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FDA allows Pfizer’s COVID-19 vaccine to be used in adolescents
The Comirnaty® vaccine’s emergency use authorisation has been extended to allow its administration to those 12 years of age and above in the US.
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Real-time bioprocess Raman analyser market to achieve significant growth
Market research shows the adoption of process analytical technologies and investment in pharma R&D and healthcare will drive growth in the real-time bioprocess Raman analyser market.
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EMA begins rolling reviews for a COVID-19 therapeutic and a vaccine
The European Medicines Agency (EMA) has initiated a rolling reviews of Vero Cell, an inactivated COVID-19 vaccine, and sotrovimab, a monoclonal antibody.
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Highlights of the May 2021 Pharmacovigilance Risk Assessment Committee (PRAC) meeting
In its May meeting, the EMA’s drug safety committee (PRAC) concluded two safety signal reviews for COVID-19 vaccines and began several more.
