news
FDA authorises Comirnaty® for emergency use in five to 11 year olds
The US Food and Drug Administration has authorised the emergency use of COVID-19 vaccine Comirnaty in children aged five to 11 years.
List view / Grid view
Regulation & Legislation
news
Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, Oct 2021
EMA's drug safety committee (PRAC) assessed risks with COVID-19 vaccines and identified no risk of death with Imbruvica and ACE inhibitors.
article
Designing an ATMP manufacturing facility: from concept to completion
Remy Martin, business development specialist at cell and gene therapy manufacturing consultant, eXmoor Pharma, discusses 10 key considerations when creating a manufacturing facility, to ensure it meets requirements for both immediate needs and future growth.
news
CHMP recommends COVID-19 vaccine Spikevax booster dose
The European Medicines Agency (EMA)'s human medicines committee (CHMP) concludes that a booster dose of Spikevax can be administered in adults aged 18 or over.
article
Towards a solution for the access challenges faced by combination treatments
In this article, Takeda UK present their Value Attribution and Voluntary Arbitration Frameworks, a potential solution for the combination treatment challenge.
whitepaper
Product hub: Documentation at your fingertips
Digitalised Eppendorf products support customers on their way to a paperless lab whilst in compliance with good laboratory practice (GLP).
article
Co-creating solutions that advance global health innovation – IFPMA’s role
The COVID-19 pandemic has altered and continues to shape our lives. Here, Thomas B Cueni, Director General of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), gives insight into how the pandemic gave impetus to the organisation’s manifesto to innovate and save lives.
whitepaper
Brochure: The new Sievers M500 online TOC analyser
The Sievers reagentless membrane conductometric TOC detection method delivers reliable, robust and accurate data for pharmaceutical water applications.
news
NICE does not recommend tucatinib in new draft guidance
The UK regulator concluded that breast cancer patients taking tucatinib live longer, but it is unclear how long for and whether it is cost effective.
article
Less than lifetime limits for N-nitrosamine mutagenic impurities
Here, Dave Elder discusses the determination of less than lifetime (LTL) limits for highly potent N-nitrosamine compounds and how to ensure safety in dosing.
news
CHMP initiates rolling review of molnupiravir for COVID-19
The European Medicines Agency's human medicines committee (CHMP) begins its rolling review of the investigational oral antiviral molnupiravir.
whitepaper
Case study: Delivering a world class cell and gene therapy suite
RoslinCT and Connect 2 Cleanrooms have worked in partnership to deliver a world-class cell and gene therapy facility.
news
FDA releases new guidance for drug and biological product data
The FDA has released new draft guidance: “Data Standards for Drug and Biological Product Submissions Containing Real-World Data.”
article
Formulation, Development & Delivery In-Depth Focus 2021
Discover how to plan for post‑market clinical follow-up compliance under the new EU Medical Device Regulation (MDR), and formulate live biotherapeutic products to enhance their effects in this in-depth focus.
news
Opdivo® approved in Europe to treat a range of cancers
Opdivo® (nivolumab) has been approved by the European Commission for gastric, gastroesophageal junction (GEJ), or oesophageal adenocarcinoma.
