Puma Biotechnology Inc.'s CEO Alan Auerbach first became widely known in 2009 for the sale of his previous firm, Cougar Biotechnology Inc., to Johnson & Johnson for $970 million, based largely on the strength of Cougar's lead compound, abiraterone. Read More
Vivus Inc. will appeal a negative opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). The committee recommended against approval of Qsiva (phentermine/topiramate) based on concerns about potential cardiovascular and central nervous system effects over long term use, and other safety issues. Read More
By screening a thousand FDA-approved drugs in a multistep process, scientists have identified a set of drug combinations that work synergistically to inhibit HIV replication. Read More
LONDON – International Biotechnology Trust (IBT) reported strong returns for shareholders, driven by new drug approvals, high levels of merger and acquisition activity and the resilience of leading biotech companies in the current growth-stunting environment. Read More
• Durata Therapeutics Inc., of Morristown, N.J., reported in vitro data that could help support a clinical program testing antibiotic candidate dalbavancin in pneumonia. In the study, lung surfactant did not have a significant impact on the in vitro susceptibility of Staphylococcus aureus and Streptococcus pneumoniae to dalbavancin. Results were presented at IDWeek in San Diego. Read More
• Histogen Inc., of San Diego, said preliminary data from an ongoing Phase I/II study showed that its Hair Stimulating Complex (HSC) produced statistically significant improvement across all targeted hair growth parameters, with an 86 percent responder rate. The study tested HSC in 56 men with androgenetic alopecia and also was well tolerated, with no study-related adverse events reported. Data were presented at the International Society of Hair Restoration Surgery meeting in the Bahamas. Read More
• Astellas Pharma Inc., of Tokyo, said the European Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of Betmiga (mirabegron) for the symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adults with overactive bladder syndrome. Mirabegon is a once daily oral beta3-adrenoceptor agonist. Read More
• Cubist Pharmaceuticals Inc., of Lexington, Mass., reported U.S. net product revenues for antibiotic Cubicin (daptomycin) totaling $208.3 million for the third quarter, up 12 percent over the same period in 2011. Read More
Scientists from the Finnish University of Helsinki have discovered the origin of a stem cell that is critical for forming new blood vessels. Such vessels are lined with a layer of endothelial cells, and the origin of new endothelial cells during angiogenesis has been unclear. In their studies, the authors identified a rarely occurring stem cell in the vascular lining itself, and showed that such cells could generate tens of millions of offspring, and make blood vessels that could connect to existing circulation. Read More