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person in while coat holding syringes for self-injection of insulin

Biosimilar uptake will take more than competitive pricing

10 July 2020 | By George I’ons (Owen Mumford Pharmaceutical Services)

This article explores what pharmaceutical companies could be doing to promote injectable biosimilar approval and consumer uptake.

How to start up an ATMP clinical trial

7 July 2020 | By Magdalena Czarnecka (KCR)

Advanced therapy medicinal products (ATMPs) are medicines based on genes, tissues or cells. They offer revolutionary opportunities for the treatment of disease and injury; however, developers face a complex regulatory and developmental landscape to bring ATMPs to market. Here Magdalena Czarnecka offers guidance and advice on effectively initiating an ATMP…

Coronavirus: modelling the world of COVID-19

6 July 2020 | By Matt Jones (Tessella)

New data models need to be built rapidly to respond to the COVID-19 pandemic. Matt Jones explains how to do it.

Comparison of health technology assessments and time to reimbursement for Orphan Drugs

1 July 2020 | By Charlotte Poon (Charles River Associates), Ioanna Stefani (Charles River Associates), Nimisha Raj (Charles River Associates), Steven Kelly (Charles River Associates)

This article delves into four health technology assessment agencies, analysing the opportunities and challenges for orphan drugs in France, Germany, England and Scotland.

The extra mile: preparing a supply chain for a COVID-19 vaccine

29 June 2020 | By Dr Madhav Durbha (LLamasoft)

Dr Madhav Durbha explains the importance of implementing and ensuring stable supply chains to deliver potential COVID-19 vaccines.

Comparison of new vaccine approaches – COVID-19

26 June 2020 | By John Liddell (CPI)

The promise of virally vectored DNA and mRNA vaccines is tremendous in terms of vaccine safety and speed of response to new pathogens. This article explores why these approaches have attracted attention in light of the COVID-19 pandemic and why they are highly appropriate for rapid vaccine development and deployment.

Five patent issues that European biosimilar developers should consider before entering the US market

26 June 2020 | By Grace Truong (Goodwin Procter LLP), Joshua Whitehill (Goodwin Procter LLP), Natasha Daughtrey (Goodwin Procter LLP)

As patents on originator biologic medicines begin to expire, there are growing opportunities for biosimilars to enter the market at lower prices. Joshua Whitehill, Natasha Daughtrey and Grace Truong discuss key aspects of US patent law that European developers should consider before entering the American market.

Focusing on the user – improving patient adherence through packaging design

26 June 2020 | By Nikki Withers (European Pharmaceutical Review)

In an industry faced with numerous regulatory hurdles, the end-user experience can often be neglected. Nikki Withers spoke to two packaging design experts who discuss their approach to pharmaceutical packaging and why they always have the end user at the forefront of their minds.

The circuit of life: saving on manufacturing, waste and delivery-related supply chain inefficiencies

26 June 2020 | By Dr Alex Cole (CPI), Dr Dave Berry (CPI)

Many pharmaceutical companies have complicated supply chains that are inefficient and ill-equipped to deal with current demands. This article explores how digitalising the healthcare supply chain can address the pharmaceutical sector's increasing financial-, capacity- and waste-related strains associated with our ageing population and the soaring costs of new treatments.

How implantable systems and microparticle depot injections are meeting the needs of long-acting drug delivery

26 June 2020 | By Jite Okoh (LLS Health), Kimberly Zubris (LLS Health)

Implantable systems and microparticle depots are used in many areas of drug delivery to release medicines at a controlled rate within the body. The use of these long-acting dosage forms eliminates the need for frequent administrations via traditional routes of administration, which ensures patient compliance and results in improved outcomes.…

The many advantages of repurposing existing drugs

26 June 2020 | By Dave Elder (David P Elder Consultancy), Stephen Tindal (Catalent Pharma Solutions)

Repurposing existing drugs can be attractive as the process is often less risky, more cost effective and can be undertaken in less time. This article discusses the logic behind drug repurposing and the approaches that are currently being explored.

The impact of supply chain risks and LAL reliance

26 June 2020 | By Brendan Tindall (bioMerieux), Kevin Williams (bioMerieux)

For over 30 years, pharmaceutical and medical device product release has relied solely on endotoxin assays using Limulus Amebocyte Lysate (LAL). This article addresses the potential risks associated with relying on a single raw material in a fragile supply chain and explores alternative testing options.

Raman imaging in pharmaceutical research – an overview

26 June 2020 | By Damon Strom (WITec), Eleni Kallis (WITec), Harald Fischer (WITec), Miriam Boehmler (WITec), Thomas Dieing (WITec)

Since making its debut in the pharmaceutical setting, the range of applications for which Raman microscopy imaging has been used continues to grow. Here, Harald Fischer, Damon Strom, Miriam Boehmler, Eleni Kallis and Thomas Dieing demonstrate the versatility of confocal Raman imaging by exploring a variety of real-world applications.

Patents and approvals – medicines, vaccines and diagnostics for COVID-19

25 June 2020 | By Alison Dennis (Taylor Wessing), Angela Knierim (Taylor Wessing), Anja Lunze (Taylor Wessing), Jan Phillip Rektorschek (Taylor Wessing), Paul England (Taylor Wessing)

As companies race to develop a COVID-19 vaccine, various discussions about patents and ownerships of the vaccine have occurred, especially in light of funding from various governments. This article explores the patent and regulation issues, with a focus on patent extensions and suspensions for global good.

Rapid microbiological methods: A looking glass into what and how we are

25 June 2020 | By Lucpah Nekati (Graduate microbiologist)

The impact of rapid microbiological methods (RMM) on the scientific community has been widespread and profound. Lucpah Nekati explains how their numerous benefits enable deeper understanding, faster and more easily.

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