Puma Biotechnology, which is swiftly moving its experimental cancer drug PB272 (neratinib) into a pivotal Phase III program, has now reached agreement with the FDA on a special protocol assessment, pushing a combo approach of the experimental treatment with Xeloda into a head-to-head showdown with Tykerb plus Xeloda for treatment-resistant, HER2 positive breast cancer.
Carlsbad, CA-based Isis Pharmaceuticals nabbed a $7.5 million milestone payment from GlaxoSmithKline on the launch of a Phase II/III clinical study for ISIS-TTR.
Last summer Chelsea Therapeutics did some painful belt tightening after its stock price plunged following the FDA's decision to reject its application for Northera (droxidopa), saying the biotech would have to pull off another study of its experimental drug before it could win an OK.
The Belgium-based company says its ConfirmMDx test reaffirmed researchers' hopes that their test could produce a more personalized--and accurate--prostate cancer diagnosis when an initial biopsy comes back negative.
This morning Gilead announced that it has successfully wrapped up positive top-line data from its fourth and last Phase III study for sofosbuvir, putting the biotech on a short path to the FDA with what promises to be the first oral drug for hepatitis C.
Irish CRO Icon pulled down a monster fourth quarter, with revenue skyrocketing 24% to $300 million, and the company predicts an even brighter 2013, projecting annual revenue of up to $1.3 billion, good for a 12% jump.
Global CRO QPS has inked a deal with the Hamner Institutes, partnering up to launch QPS Hepatic Biosciences, a cell-based research unit in Research Triangle Park, NC.
U.K. biotech analysts are writing off Phytopharm as a lost cause after its lead drug proved to be a complete failure in a 400-patient Parkinson's study.
Well, the rumors were true. Right on schedule, Quintiles has filed for an IPO, saying it wants to raise $600 million, but the final haul could be far higher.
Remember those rumors back in January about a big Quintiles IPO? Somebody had some good information. The global CRO filed its S-1 with the SEC this afternoon, outlining plans to go public in one of the biggest new industry offerings in quite some time.