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CHMP meeting highlights – December 2022
A total of five drugs were recommended for approval at the CHMP’s December meeting, including a gene therapy and two cancer drugs.
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Vaccines
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mRNA vaccine plus KEYTRUDA® improve melanoma survival
An mRNA vaccine plus KEYTRUDA® significantly improved recurrence-free survival in a Phase II trial for advanced melanoma patients.
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European Pharmaceutical Review Issue 6 2022
This issue includes articles on Raman mapping of pharmaceutical tablets, delivery options for mRNA therapeutics, the use of high-throughput analytics for clonal cell selection and much more...
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Catalent opens one of largest cell therapy manufacturing facilities in the world
Sited in Belgium, Catalent has opened one of the largest commercial-scale cell therapy manufacturing facilities in the world.
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Comirnaty® authorised for patients six months to four years
Comirnaty® has been authorised by the MHRA as a vaccine to protect against Covid-19 for individuals from six months to four years old.
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Vaccines Europe launches first pipeline review
In its first pipeline review, Vaccines Europe has set out four key actions to ensure adults are protected from vaccine-preventable diseases.
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Pfizer’s €1.2 billion manufacturing site expansion
Pfizer’s €1.2 billion investment in its Grange Castle site in Dublin is expected to double the plant’s capacity for manufacturing biologics.
webinar
Optimise fermentation processes by implementing respiratory gas analysis PAT
22 November 2022 | By Thermo Fisher Scientific
Watch on-demand to learn how Sanofi utilises online process mass spectrometry for continuous respiratory gas analysis to improve process insight and drive better outcomes.
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First COVID-19 impact report on global vaccine markets
A 2022 WHO report is the first to portray COVID-19’s impact on the global vaccine market, identifying that lower-income countries struggle to access critical vaccines.
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Innovation in pharma manufacturing quality systems
Over the last 10 years, there has been an important change of focus in pharma towards biotech products and personalised therapies. These important new treatments are now emerging into manufacturing, with implications for the way that quality is monitored, managed and assured. Dr Eduard Cayón sets out some practical advice.
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EMA human medicines committee (CHMP) highlights, November 2022
The Committee for Medicinal Products for Human Use (CHMP)’s November meeting consisted of approval recommendations for four medicines, including a biosimilar for osteoporosis and a new COVID-19 vaccine.
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Building an integrated vector supply to support autologous cell therapy for solid tumours
Facing limited viral vector manufacturing capacity, should companies consider further integrating their viral vector supply to address this issue? James Nanista and Josh Hunt of Adaptimmune reflect on the options.
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First needle-free COVID-19 vaccine patch
If successful in further clinical trials an innovative, cost-effective COVID-19 vaccine patch could be available as early as 2025.
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Manufacturing of anti-tau Alzheimer’s disease vaccine for clinical trials
GBF announces the manufacturing of the recombinant protein - Alzheimer’s disease vaccine, AV-1980R, for use in clinical trials.
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Could GSK offer the first RSV older adult vaccine?
The EMA has accepted a marketing application for an RSV vaccine intended for older adults, the first potential vaccine for this age group with lower respiratory tract disease.
