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European Biopharmaceutical Review

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Summer 2020
   
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Analytical Methods
Risk Management for Analytical Method Development

Madalena R Testas, Daniela B Santos, and José C Menezes at 4Tune Engineering

In the biopharmaceutical industry, analytical methods are among the most critical elements for process monitoring and product release
 
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Beyond Big Data

Joern Klinger at biotx.ai

We can’t always rely on Big Data to be available; therefore, it’s worth suggesting ways of still effectively applying machine learning when that’s the case
 
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Genotoxic Impurities in Drug Products: Review of Nitrosamine Assays

Elodie Barrau, Emmanuel Desmartin, Valentina Paschetta, Davide Tartaglione, Mònica Coll Furest, and Ana Novak at Eurofins

In the past couple of years, the prevalence of nitrosamines in drug substances has made them a hot topic of conversation in the medical industry
 
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R&D on COVID-19
The Quest for a Cure

David Wilson at Avacta

It's of little doubt that there is a great need for the development of rapid diagnostic tests to tackle the COVID-19 pandemic
 
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Leveraging Health Data to Support Patient Care

Gilles Paubert at Cegedim Health Data

There are some key areas where current real-world data can add immediate value to patients, the healthcare system, and our economies



 
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Would Greater Diversity and Inclusion Improve Innovation?


Stephen Frost at Frost Included

The pharma industry is responsible for great strides in world health, yet it’s undeniable that there are still many more goals to accomplish, and a lack of diversity may be holding it back

 
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A Conversation with an Expert in Drug Development

As the world grapples with the impact of the COVID-19 pandemic, the life science industry and regulators are racing to find an effective treatment. We spoke with Colin Orford, Senior Vice President of Drug Development services at ICON plc about the direction that this work is taking
 
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Improving Drug Discovery Models
The Promise of Drug Discovery

The past few decades have seen large strides in the medical industry, but there are still many patients suffering with unmet medical needs that could benefit from further innovation, especially in drug discovery. EBR spoke to Dr Craig Fox, CSO at C4X Discovery, to ask about his thoughts on the subject

 
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Microphysiological Systems Emerging as Powerful Tools for Drug Discovery

Dr Audrey Dubourg at CN Bio

A new class of in vitro model is expected to assist drug discovery by providing robust physiologically relevant data at critical stages of R&D
 
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Features
Surfacing Missed Opportunities

David Gwyn at Amplexor

There are five areas in which richer, more holistic product information could shine a light into the life science industry’s blind spots and help transform business outcomes
 
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Base Editing and Its Application to Cell and Gene Therapy

Dr Ceri Wiggins at Horizon Discovery

CRISPR-Cas gene editing has been a force to be reckoned with in gene engineering for years, and it doesn’t seem likely this is going to change anytime soon


 
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Nova Biomedical FLEX®2

With over 1,300 employees and manufacturing facilities in Waltham and Billerica, Massachusetts, and Taipei, Taiwan, Nova Biomedical is one of the 25 largest in vitro diagnostic companies in the world and the largest privately owned in vitro diagnostic company in the US
 
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Published quarterly in
January, April,
July, and October

News and Press Releases

European Medicines Agency Commences Review of Aripiprazole 2-Month Long-Acting Injectable for the Maintenance Treatment of Schizophrenia in Adult Patients Stabilised with Aripiprazole

LONDON, UK, 17 June 2022 – Otsuka Pharmaceutical Europe Ltd. (“Otsuka”) and H. Lundbeck A/S (“Lundbeck”) today announce that the European Medicines Agency (EMA) has accepted the Marketing Authorisation Application (MAA) for aripiprazole as a 2-month ready-to-use (RTU) long-acting injectable (LAI) for the maintenance treatment of schizophrenia in adult patients stabilised with aripiprazole.
More info >>

White Papers

Biosimilars In Emerging Markets: Is It A Level Playing Field?

PRA Health Sciences (PRA)

Governments, healthcare payers, and social and health reforms, combined with the increased incidence of conditions such as cancer and diabetes are paving the way for increased uptake of biologic medicines in emerging markets. However, expensive biologic medicines can be prohibitive to many patients, creating a high level of unmet clinical need. At its best, the global expansion of biosimilars can mean a robust and steady supply of existing and new drugs reaching far-flung patient populations, but localized biosimilar drug developments, especially in China and India, combined with a lack of robust pharmacovigilance systems, threaten to derail the industry by putting patient health at risk.
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