All Parenterals and sterile injectables articles – Page 6
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Webinar
RMMs and endotoxin testing: efficiency gains and regulatory perspectives
Learn how Rapid Microbiological Methods can provide results in less than 45 minutes and endotoxin assays can be set up in less than 10 minutes to improve contamination control and reduce risk.
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ArticleImplementing the future of mRNA therapeutics
Here, Chief Scientist Bruce Lahn of the CDMO VectorBuilder discusses best practices, common problems, and possible solutions to mitigate risk and free up capacity when developing and designing mRNA therapeutics.
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NewsNovel vaccine delivers significant survival in lung cancer trial
The most advanced therapeutic cancer vaccine in clinical development has demonstrated a 41 percent reduction of the risk of death for non-small cell lung cancer (NSCLC) in a Phase III trial.
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Whitepaper
Technical document: Introducing: Ami Polymer's Sterile Sampling Systems
Next-Gen Sterile Sampling System: Pinnacle Compliance - USP Standards 87, 88, 85, 661.1, 788, 71, and ISO 11737-1 for Unparalleled Pharma & Biopharma
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ArticleBioprocessing & Bioproduction In-Depth Focus 2023
In this in-depth focus are articles on reducing production time for allogenic CAR T-cell therapies and the complexities of mRNA development, from design intricacies to scalability.
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ArticleEuropean Pharmaceutical Review Issue 4 2023
EPR Issue 4 includes articles on fridge-free vaccines, dry powder drug delivery, Annex 1, contamination control strategy and more.
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News$2 billion mRNA-based oncology therapy market anticipated by 2029
As the pharmaceutical industry awaits the first regulatory approval of an mRNA-based oncology therapy, research predicts BioNTech will lead the market by 2029, which by then, is anticipated to value $2 billion.
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NewsCHMP recommends updated Omicron vaccine
Pfizer and BioNTech’s adapted Omicron XBB.1.5 COVID-19 vaccine has been recommended for two additional indications in the EU.
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WhitepaperReport: Accelerate the RMM validation process
To address the perceived barrier to entry for rapid microbiological methods, new validation packages are now available for Celsis® rapid microbial detection.
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NewsGSK shingles vaccine achieves 100 percent efficacy in China trial
In the first-ever efficacy trial of GSK’s Shingrix in China, no cases of shingles (herpes zoster) were reported after administration of the vaccine, new data shows.
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NewsPfizer maternal RSV vaccine approved
The US Food and Drug Administration (FDA) has authorised an RSV vaccine for pregnant individuals, which in one study, reduced the risk of severe LRTD by 81.8 percent within 90 days after birth.
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NewsUK medicines manufacturing to get innovation boost
A multi-million investment is set to enhance UK medicines manufacturing in three key areas: intracellular drug delivery, digitalisation and automation and nucleic acid medicines.
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NewsGlobal RNA therapy clinical trials market to reach $3.5 billion by 2030
Research states that the rising success rate of RNA-based COVID-19 vaccines and demand for personalised medicines is driving the global RNA therapy clinical trials market.
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NewsCDMO to manufacture SARS-CoV-2 intranasal vaccine
In a collaboration between the Institutes of Health (NIH) and CDMO Exothera, an intranasal vaccine for SARS-CoV-2 will be manufactured for use in a clinical Phase I/II trial in Africa and the US.
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NewsCPHI to return to Milan in 2024
CPHI, the global pharmaceutical exhibition will take place in Milan, Italy from 8-10 October 2024.
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NewsNew vaccine development centre to strength UK's capabilities
The UK’s new vaccine development and evaluation centre will target pathogens for which a vaccine does not exist or could be improved, supporting pandemic preparedness.
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NewsMHRA authorises new COVID-19 vaccine
The new COVID-19 vaccine authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) contains an adjuvant and is indicated to be given to patients over 16 years.
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WhitepaperWhitepaper: EPIQ – Solution Brief
EPIQ is a single platform for Quality, Document, and Learning Management. It offers integration across departments for a seamless quality management.
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Whitepaperebook: Key biomarkers of immunomodulation
Altasciences has published an ebook sharing comprehensive information about testing biomarkers of immunomodulation as part of your drug development program.
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NewsBeyfortus approved for US infants against RSV disease
The only monoclonal antibody approved for passive immunisation to protect infants in their first RSV season has been approved by the US Food and Drug Administration (FDA).