Contributor: Efua Edusei
Decision Resources’ Pharmaview team will be present at the annual American Society of Clinical Oncology (ASCO) conference in Chicago, from the 31st of May through the 4th of June 2013. We shall provide our insights and analysis on the major breakthrough therapies, updates in treatment algorithms, and novel pathways of interest in the treatment of cancer. Below is a summary of key abstracts and data which we expect will be highlights at this year's conference.
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Contributor: Eamonn O'Connor
I have just returned from the Heart Rhythm Society meeting in Denver, CO. The meeting was heavily focused on surgical and device implantation procedures, and particularly around anticoagulation in the peri-procedural setting. Two of the studies presented during the first late-breaking clinical trials session were focused on this issue.
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Contributor: Gideon Heap
If recent regulatory decisions in the obesity space have given a renewed sense of optimism in the United States, the opposite is true in Europe.
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Contributor: Tim Blackstock
Rarely a day goes by without mention in the media of obesity and its comorbidities, including type 2 diabetes mellitus and hypertension. There are constant reports on the significant impact of the obesity epidemic on patients, healthcare resources, and society. Patients, physicians, and politicians have long been highlighting the need for safe, effective, and simple treatments.
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Contributors: Stefanie Matlok and Matthew Scutcher
In the last six months, Eli Lilly has announced that its GLP-1 analogue, dulaglutide, has met its primary end point in a series of trials comparing its safety and efficacy with current diabetes agents. As potentially the fifth GLP-1 analogue to market in the United States and Europe, dulaglutide will be entering a competitive environment where it is more important than ever for new market entrants to differentiate themselves from existing agents.
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Contributor: Eamonn O'Connor
The rapidly growing diabetes population is expected to increase from current estimates of 370 million patients globally to over 550 million by 2030. Present estimates put diabetes-related healthcare costs in the region of $470 billion, a figure that is expected to grow in line with the increasing diabetic population. As a result, the diabetes market offers drug companies a major opportunity for growth and innovation.
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Contributor: Donny Wong
While America waits for Arena and Eisai to finally get the green light from the FDA and the DEA to begin marketing the weight-loss drug Belviq (lorcaserin), Arena shareholders and European patients are waiting with bated breath for a nod from the CHMP, which will pave the way for the European Medicines Agency to approve marketing authorization for Belviq.
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Contributor: Rob Dubman
I have been attending the National Kidney Foundation (NKF): Spring Clinical Meetings this week in Orlando, FL. NKF is expecting over 2,500 attendees with a floor of about 40+ exhibitors participating. The conference offers attendees varying educational experiences, covering a broad array of topics, including new topics in dialysis care, clinical challenges, controversies in home dialysis, bundling, transplant medicine, guideline updates and new products in development.
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Contributor: Gideon Heap
On March 29, the FDA approved Janssen Pharmaceuticals’ canagliflozin (Invokana), making it the first SGLT-2 inhibitor approved for the treatment of type 2 diabetes in the United States. Bristol-Myers Squibb and AstraZeneca’s SGLT-2 inhibitor dapagliflozin (Forxiga) has already been approved in Europe, but FDA rejection in January 2012 opened a window of opportunity for canagliflozin to secure the lucrative first-in-class status in the United States.
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Contributor: Conor Walsh, Ph.D., M.Sc.
For the second time, the FDA has issued a complete response letter (CRL) to Janssen regarding their supplemental new drug application (sNDA) to market rivaroxaban (Xarelto) for the reduction of the risk of cardiovascular events in acute coronary syndrome (ACS) patients.
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