Shares of Dendreon Corp. – which have plummeted nearly 70 percent in just over a month – edged up 52 cents on Friday in the wake of a restructuring that will eliminate about one-quarter of the biotech's workforce, or roughly 500 employees.
This year's FDA approval of Horizant (gabapentin enacarbil) for restless legs syndrome came with a twist: XenoPort Inc. and partner GlaxoSmithKline plc originally developed and submitted the drug for approval via the "traditional" 505(B)(1) pathway; only after receiving a complete response letter did the firms shift their strategy, refile via the 505(B)(2) pathway, and gain approval. (See BioWorld Today, Feb. 19, 2010, and April 8, 2011.)
For years, the drug industry has known its cost of developing a new product – estimated at $1.3 billion – is not sustainable. For years, companion diagnostics have been considered as a potential solution to that problem. And for years, the result has been a lot of talk, but very little action.
The FDA's draft of PDUFA V was generally in line with expectations, particularly following the preview Janet Woodcock delivered to Congress in July. (See BioWorld Today, July 11, 2011.)
If you read our post earlier this week (Top 5 Tips for Pitching BioWorld), you know what kind of news BioWorld Today covers. Here are five more helpful hints regarding how to work with us: How to contact us. Our direct phone numbers are on page two of BioWorld Today or here. Aside from the DC and science beats mentioned in Tip #4, we don’t specialize, so you can reach out to any of us. If you know your news is not cover-worthy (i.e. a patent, a personnel appointment, fast track or orphan drug designation, an early stage trial initiation,...
After six years in biotech PR and five years as a biotech journalist, I have both written and received a heckuva lot of pitches. I know how hard media pitching can be, and I always try to take the time (when you’re not calling me on deadline) to give PR pros feedback on why we will or won’t cover their news. Here’s the stuff I find myself explaining most often: Read our news. This might seem obvious, but you have no idea how many times people call me to pitch news we’ve already covered in that morning’s paper, or they...
With this month's FDA approval of Adcetris (brentuximab vedotin), Seattle Genetics Inc. can lay claim to many firsts: first commercial product for the Bothell, Wash.-based biotech, first new drug for Hodgkin lymphoma patients in more than 30 years, first antibody-drug conjugate to gain FDA approval and first anti-CD30-targeted therapy approved. (See BioWorld Today, Aug. 22, 2011.)
