Latest shared news, insight and analysis for the global pharma community
Companion Diagnostics: A Rocky Road Ahead?
Gabrielle Gessner, Citeline Senior Analyst, Infectious & Genitourinary Diseases Companion diagnostic pairs are emerging as the new face of personalized medicine, allowing treatment decisions to be specifically tailored to each patient. However, development of the drug/diagnostic pair poses increasing challenges in clinical development as regulatory policy scrambles to accommodate this new field. Companion diagnostics are drug and diagnostic pairs where safe and effective use of the drug depends on a specific diagnostic test, which can be predictive or monitoring. Predictive companion diagnostics determine which patients will respond to treatment, the appropriate dose, or those at risk for specific adverse events. Monitoring companion ...
Outlook for Obesity Drugs – Companies weighing risks and rewards of drug development
Robin Custeau, MS, Analyst, Cardiovascular & Metabolic/Endocrinology According to the World Health Organization (WHO), lifestyle related non-communicable diseases are the leading cause of death worldwide. Key contributing risk factors include elevated blood pressure, tobacco use, elevated blood glucose, physical inactivity, overweight/obesity, and elevated cholesterol, all of which contribute to the number of deaths each year from cardiovascular, metabolic or oncological causes. According to Citeline’s Trialtrove, there are more than 2,500 clinical trials currently ongoing to evaluate pharmacological interventions that target these modifiable risk factors. Thirty-five percent of these trials are industry-sponsored (Figure 1). Figure 1. Ongoing clinical trials targeting key lifestyle related modifiable ...
The Landscape of Female Sexual Dysfunction Treatment
Doro Shin, MPH, Citeline Analyst, Infectious & Genitourinary Diseases Sexual dysfunction is defined as a disturbance in or pain during the sexual response and can present in various ways. This problem is more difficult to diagnose and treat in women due to the intricacy of the female sexual response and can consist of various physical and psychological components. Female sexual dysfunction (FSD) has been categorized into four different types of disorders: desire, arousal, orgasmic, and sexual pain. The prevalence of FSD in the USA is 43% among females aged 18-59 years, but pharmaceutical treatment options remain limited. (Source: Medtrack Epidemiology Report, ...
Big Pharma + Big Pharma = Collaborative Approach to Fight Cancer
Shannon Fisher, Citeline Senior Manager, Oncology and Analytics Targeted medicines are hot. It is no surprise that they are now “getting married”. These couples are being created by top tier pharmaceutical companies partnering with each other for the combined development of their individual targeted drugs, offering a double-team approach to fighting cancer. This approach to drug development is different than the standard approach of “Big Pharma” in-licensing a promising drug or technology from a smaller company and developing it on their own or in conjunction with that company. In this new experimental tactic, development is occurring on two individual drugs, each drug ...
Peering into the Crystal Ball – A Year in Trial Outcomes
With rising trial costs and shrinking budgets, pharma companies are working more diligently than ever to identify keys to success in the clinic. But without the benefit of the proverbial crystal ball, the industry must rely on examining historical records as predictors or benchmarks of future performance. In this report, the Citeline Analytics team begins to explore this notion, and outline key findings from a retrospective analysis of clinical trial outcomes in six therapeutic areas. The findings presented here represent just the tip of the iceberg of what may be gleaned by examining clinical trial outcomes. Analysing the relationship between outcomes and ...
Analysis of clinical trial results presented at ASH 2011
The 53rd Annual American Society of Hematology Meeting and Exposition (ASH 2011) was held on December 10-13 in San Diego, CA. In this report, Citeline Analytics provides an overview of the clinical trials reported at ASH 2011 that are included in Citeline’s Trialtrove portfolio. The analysis focuses on the trial phases, leading companies, diseases, types of results reported and key drugs studied. Highlights: The vast majority of trials reported were in hematological cancers, with multiple myeloma and non-Hodgkin’s lymphoma predominating 80% of the phase I clinical trials presented were sponsored by the industry Pipeline drugs were studied in 23% of the industry sponsored trials reported Celgene ...
Biogen Idec’s BG-12 Shines At the Top of the Charts in the Treatment of Relapsing-Remitting Multiple Sclerosis
BG-12 Beats Teva’s Copaxone in Biogen Idec’s CONFIRM Trial Citeline, an Informa business unit, and the world’s leading research authority on pharmaceutical clinical trials recently reviewed results presented at the 5th Joint Triennial Congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS/ACTRIMS), a major multiple sclerosis conference which was held October 19-22, 2011 in Amsterdam. Phase III study of oral BG-12 in relapsing-remitting multiple sclerosis sparked excitement as the details of the Determination of the Efficacy and safety of oral Fumarate IN rElapsing-remitting MS (DEFINE) trial were presented at the meeting, quickly boosting BG-12 to stardom ...
Biosimilar Monoclonal Antibodies in the Pipeline: Major Players and Strategies
Fern Barkalow, Ph.D, Senior Analyst, Oncology Citeline One of the biggest challenges facing biosimilar drug developers is proving the equivalence or similarity of their biological drug to the reference product. This is particularly difficult in the case of monoclonal antibodies (mAbs), which vary greatly in properties and where even small alterations can lead to unacceptable changes in safety and efficacy. As is the case with biosimilars in general, the guidelines for the development of biosimilar forms of mAbs are better established in the European Union than they are in the US. However, the European Medicines Agency (EMA) and the US Food and Drug ...
Scrip Awards 2011 – Shortlist Announced – Are You In?
The Scrip Awards provides the industry an opportunity to acknowledge and applaud its highest achievers across all parts of the value chain, and recognise both corporate and individual achievement. Over the summer, our panel of 16 respected judges has reviewed all the entries to produce a shortlist that displays the wealth of innovation, dedication and hard work that the pharmaceutical and biotech industries have demonstrated over the past year. We are thrilled that so many of you have taken the time to submit your entries. The winners will be announced at a black tie ceremony on 3 November. Congratulations to all those ...
Biologics LCM in the Biosimilar Age
Dr Duncan Emerton; Head of Biosimilars Practice, Datamonitor Healthcare Consulting Biosimilars: a short introduction Biosimilars are broadly defined as biological products that are “similar to, but not the same as” a reference biological product which is approved in a particular country or region, and the approval of which relies on, in part, data or information in an application for the reference biological product. Biosimilars can never be said to be exactly the same as the reference product, as can be said for small molecule, chemically synthesized generics, due to the way in which biologics and biosimilars are manufactured (i.e. by living cells ...
