news
New variant-specific mRNA COVID-19 vaccine to enter clinical trials
Moderna has shipped the trial material for its mRNA-1273.351 vaccine candidate to the US National Institutes of Health for Phase I trials.
List view / Grid view
Drug Manufacturing
news
EU doubles its COVAX contribution, promising €1bn for safe and effective COVID-19 vaccines
The addition of €500 million to the EU’s existing COVAX Facility pledge was announced at the G7 summit virtual leaders' meeting.
article
New regulatory landscape for biosimilars in the UK and EU post Brexit transition period
As the UK enters new territory following its departure from the EU, legal experts Marie Manley and Chris Boyle from Sidley Austin explore the resultant consequences for biopharma companies and the regulatory opportunities that lie ahead.
article
Sourcing of active pharmaceutical ingredients
Considerations when sourcing active pharmaceutical ingredients (APIs) can often be condensed to ones of economy and purity. Here, Dave Elder highlights the importance of defining those attributes that impact final product quality to ensure pharma companies find the best ingredient suppliers.
news
EMA receives conditional marketing authorisation application for Janssen’s COVID-19 vaccine
The European Medicines Agency will now review additional data on the efficacy, safety and quality of the COVID-19 Vaccine Janssen, deciding whether to approve the vaccine for use in the EU.
news
Chemspec Europe 2021 postponed
The 35th International Exhibition for Fine and Speciality Chemicals will now take place as live and digital hybrid event from 29 to 30 September 2021.
article
Regulatory challenges and myths in pharmaceutical 3D printing
Although three-dimensional (3D) printing has been around for some time, many people still underestimate its capabilities. This article addresses the regulatory challenges faced by the pharmaceutical sector and aims to correct some of the most common myths surrounding the technology.
news
EMA initiates rolling review of CureVac’s CVnCoV COVID-19 vaccine
The rolling review will assess CVnCoV’s efficacy and immunogenicity data as it becomes available, speeding the decision process for an eventual marketing authorisation application.
![US Department of Justice logo on top of an American Flag [Credit: US-Department-of-Justice].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/US-Department-of-Justice-300x278.jpg)
![US Department of Justice logo on top of an American Flag [Credit: US-Department-of-Justice].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/US-Department-of-Justice-e1613474706496.jpg)
news
Fresenius Kabi Oncology Ltd to pay $50mn for destroying records ahead of an FDA Inspection
The Indian drug company pleaded guilty to concealing and destroying records containing evidence of its Kalyani plant manufacturing drugs in contravention to FDA requirements prior to a 2013 inspection.
article
CDMOs: value-based pricing is key to success
Many pharmaceutical and biotech companies outsource their product development and manufacturing. In this article, experts from Simon-Kucher & Partners explain why smart offer design and costing is key to commercial success for CDMOs.
![Male Thai child receiving oral polio vaccine from healthcare worker [Credit: frank60 / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Oral-vaccine-300x278.jpg)
![Male Thai child receiving oral polio vaccine from healthcare worker [Credit: frank60 / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Oral-vaccine.jpg)
news
Therapeutic proteins and oral vaccines market to surpass $300,000mn by 2027
The market is expected to grow at a 6.7 percent CAGR, driven by the increasing prevalence of cancer and cardiovascular diseases, as well as growing interest in biologics.
article
European Pharmaceutical Review Issue 1 2021
In this issue we discuss whether clinicians know enough about the development of biosimilars to buy in, explore the biggest M&A trends in pharma and what to expect this year and consider the importance of disaccharides in the stabilisation of biologics. The journal also features articles on the fundamentals of…
whitepaper
ebook: Spectroscopy and materials characterisation applications for pharmaceutical analysis
In this ebook, discover innovative solutions for three core areas of drug development: drug formulation, scale-up and analysis with hot melt extrusion; quality control and validation using microscopic and spectroscopic instruments; and instrumentation for nucleic acid quantification and qualification.
news
UK to revolutionise oligonucleotide medicines manufacturing
Collaborators on Grand Challenge 3 will utilise their combined expertise to transform the oligonucleotide supply chain.
news
EMA begins rolling review of Novavax’s NVX-CoV2373 COVID-19 vaccine
The review will evaluate data from preclinical and clinical studies of NVX-CoV2373 to expedite the vaccine’s marketing authorisation approval later.
