whitepaper
Whitepaper: How digital modelling supports cleanroom design
In this whitepaper, C2C’s Product & Process Development Lead explains how using digital modelling in the design process can guarantee results.
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Regs & Legs
article
Assessing pharma’s readiness for digital product information management
With new EU IDMP guidance now published, how can pharma firms reap the benefits of a digital product information management future? Here, Iperion’s Adnan Jamil explains.
news
FDA releases guidance for near infrared (NIR) analytical procedures
New final guidance will aid drug developers in developing, validating, applying and submitting near infrared (NIR) spectroscopy-based analytical procedures.
news
Forxiga approved in EU for chronic kidney disease treatment
Forxiga’s approval, based on unprecedented Phase III data, is the most significant advancement in chronic kidney disease (CKD) treatment in over 20 years.
news
Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, August 2021
The EMA's drug safety committee (PRAC) recommends updating risks of Janssen COVID-19 Vaccine, though the benefit-risk balance remains unchanged.
news
NaviFUS begins clinical trial for brain tumour treatment
NaviFUS® was approved by the Taiwan FDA for use in a new clinical trial for the treatment of terminal primary brain tumours.
news
FDA Fast Track designation given to mRNA RSV vaccine
Moderna’s mRNA respiratory syncytial virus (RSV) vaccine candidate, mRNA-1345, gains Fast Track designation in adults over 60 years old.
news
Saphnelo approved to treat systemic lupus erythematosus
AstraZeneca’s Saphnelo (anifrolumab-fnia) has been approved in the US for patients with moderate to severe systemic lupus erythematosus.
video
On-demand webinar: The art of changing QC testing methods
Learn how you can go about changing QC test methods and how this can go a long way to helping your lab achieve data integrity compliance.
news
NICE approves cost-comparison fast-track appraisal pilot
A new approach to the cost-comparison fast-track appraisal process is being piloted this summer for the review of low-risk appraisals.
news
FDA approves emergency use of REGEN-COVTM for COVID-19 prevention
The FDA have authorised REGEN-COV monoclonal antibody therapy for emergency use as prevention for COVID-19 in certain patients.
article
FDARA implementation guidance for paediatric studies of molecularly targeted oncology drugs
This article addresses early planning for paediatric evaluation of certain molecularly targeted oncology drugs, including biological products, for which original New Drug Application (NDAs) and Biological License Application (BLAs) are expected to be submitted to FDA, in accordance with The FDA Reauthorization Act (FDARA).
news
Biden Administration to support resilience of US pharma supply chain
US President announces $60 million in funding to support domestic API production and a consortium to onshore essential medicine manufacturing.
whitepaper
Case study: RMM to reduce plate counts
See how a pharma company maintained product quality and reduced risk by using an RMM analyser, while also meeting their goal of reducing plate counts by 25 percent.
news
FDA approves first interchangeable biosimilar insulin product
The first interchangeable biosimilar insulin product will help increase access and affordability of insulin for diabetics.
