Clinical Development

Celgene Corp. recently released positive Phase 3 data for its cancer drug Abraxane in combination with gemcitabine (Lilly’s chemotherapy drug) for the treatment of advanced pancreatic cancer.  The Abraxane study, nicknamed MPACT (Metastatic Pancreatic Adenocarcinoma...

Portland, Oregon-based Galena Biopharmaceuticals has begun recruiting breast cancer patients for its Phase III PRESENT (Prevention of Recurrence in Early-Stage Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) trial. ...

When planning Phase 1 trials, there are many high profile cost-drivers — from patient recruitment to CRO contracting.  For many therapeutic areas, these functions will require the most money and time on the part of the clinical trial team.  However, for the...

The pharmaceutical industry is feverishly searching for the next big drug to replace lost revenue from patent expirations on major blockbuster medicines.  Drugs with more than $30 billion in annual revenue lost patent protection in the last two years.  Patent...

As exciting a field as companion diagnostics (CDx) is, few, if any, people would argue that such tests are necessary for every compound.  Most companies recognize the time and resource sacrifices that CDx requires, and only focus such tasks on certain therapeutic...

Finding patients in a very specific disease state is difficult enough, but in the shadow of Phase III, it’s nearly impossible.  In fact, next to Phase IV, Phase III patient enrollment looks easy.  Phase IV patient recruiters are stuck competing not only with...

As the pharmaceutical industry continues to focus on orphan diseases and other areas with unmet clinical needs like oncology, Phase I trials have adapted to better serve the medical community.  To quickly get new treatments to patients that need them most, Phase...

The drug industry’s reliance on companion diagnostics (CDx), particularly among large companies, has grown in recent years. According to the BasePair Group, CDx Partnerships with pharma have more than doubled between 2011 and 2012. Cutting Edge Information found...

Imagine receiving an invitation to a banquet at which everything is free and attendees win prizes—but only if they arrive on time. Wouldn’t it make sense for potential attendees to use technologies (such as mobile calendars or GPS devices) to help them determine...

Drug launches are frequently delayed for years due to unexpected clinical challenges and/or regulatory hurdles. Completing clinical trials in a timely manner, even for a single product, is a daunting task. Not surprisingly, when companies develop companion diagnostics...