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CHMP’s September 2023 meeting highlights
In its September 2023 meeting, the EMA’s human medicines committee (CHMP) recommended nine medicines for approval and the extension of therapeutic indications for 11 medicines.
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Vaccines
webinar
RMMs and endotoxin testing: efficiency gains and regulatory perspectives
13 September 2023 | By Veolia Water Technologies & Solutions, Sievers Instruments
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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Implementing 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.
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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European 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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$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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CHMP 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.
whitepaper
Report: 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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GSK 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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Pfizer 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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UK 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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CDMO 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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CPHI 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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New 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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MHRA 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.
