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This ebook explores the intellectual property rights waiver for COVID-19 treatments, vaccines, diagnostics and technologies, its potential ramifications for the drug development industry and potential solutions for overcoming COVID-19 vaccination inequalities.
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.
Here, Lucinda Cash-Gibson and Francesco Patalano discuss why the pharmaceutical industry is collaborating to develop protocols for patient-centric integrated platform trials and what the clinical research industry may look like in future.
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).
Here, Kallik’s Bob Tilling discusses the importance of acting early and embracing technology to comply with EU MDR labelling requirements, citing challenges from the recent scramble by many Class III medical device manufacturers to meet their May 2021 deadline.
In this final article on the TRIPS waiver for COVID-19 vaccines, medicines, diagnostics and technologies, EPR’s Hannah Balfour considers whether it is the correct strategy to overcome COVID-19 treatment inequalities and explores other options.
Cyber hackers target businesses of all shapes and sizes, but the pharmaceutical industry remains a prime target, especially as these companies undergo digital transformation and move high value data online. But how can the industry protect itself from the threat of cyber attack? Jack Garnsey, Product Manager at VIPRE SafeSend…
Here, David Leitham, senior vice president and general manager at AspenTech, explains how implementing PAT pushes the industry towards Pharma 4.0.
Here, FreeMind Group’s Ayal Ronen explains the application process for funding by US Government agencies, exploring the challenges and potential benefits of applying for non-US entities.
Even now 65 percent of drugs being approved come from biopharma companies and within a decade that is expected to rise to 85 percent. This is great news for a world hungry for new breakthrough treatments. As growth in pre-clinical and clinical work intensifies globally, Ahmed Bouzidi, Vice President of…
Timelines for assessing the potential for contamination of medicinal compounds with nitrosamines have been revised. Here, Dave Elder explains the EMA’s and FDA’s positions and the likely scenarios to be encountered.
In this article, Dr Harsh Shah and colleagues summarise their research into the importance of characterising physicochemical characteristics that can result in stress-induced solid-state changes in Narrow Therapeutic Index (NTI) drugs.
In this article, EPR’s Hannah Balfour discusses the potential impact of waiving intellectual property rights for COVID-19-related medicine and technology on pharma, biopharma and biotech companies.
The COVID-19 pandemic has exposed various issues with the software and data processes employed in the pharmaceutical industry and spurred rapid digital transformation at a rate never before seen in the sector. In this article, Jordan Stobaugh, Principal Research Scientist at AbbVie, discusses how software can improve data management and…
“Continuous improvement” is a buzz phrase in the biopharmaceutical industry. Despite its reference in numerous regulatory and guidance documents, resistance to improvement remains strong in microbiological quality control.
