The cancer drug Abraxane (nab-paclitaxel) chalked up another weak showing in third quarter earnings for Celgene Corp., and Jacqualyn Fouse, global head of hematology and oncology, blamed the "big impact from the first wave" of immuno-oncology (I-O) therapies. Read More
Reflecting the concerns voiced by nearly three dozen patients in a public hearing, members of the FDA's Antimicrobial Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted Thursday to recommend changes in how systemic fluoroquinolone drugs are labeled to treat a trio of non-life-threatening infections. Read More
Scientists reported Thursday on a class of molecules that could partially dissolve cataracts in mice, as well as human cataracts that had been surgically removed. Read More
Gilead Sciences Inc. continued to raise the bar in treatments for HIV-1 infection with the FDA approval of its once-daily single-tablet regimen branded Genvoya. Read More
HONG KONG – As part of the efforts to reform its drug registration system, China has decided to pilot a marketing authorization holders (MAH) system that allows individuals and research institutes to market drugs. Read More
The FDA added another drug to the asthma armamentarium, with the approval of Glaxosmithkline plc's Nucala (mepolizumab) as an add-on maintenance therapy for patients who have a history of severe asthma attacks despite being on treatment and who have an eosinophilic phenotype. Read More
Hanmi Pharmaceutical Co. Ltd. picked up its biggest partnership yet in a potential €3.9 billion (US$4.25 billion) global deal with Sanofi SA to develop a portfolio of long-acting diabetes treatments. Read More
Probiodrug AG, of Halle, Germany, priced 676,589 shares, issued through a private placement, at €20 (US$21.76) apiece, for total proceeds of €13.5 million. Read More
Tapimmune Inc., of Jacksonville, Fla., moved its corporate headquarters to Jacksonville. The company, previously based in Seattle, said the move is intended in part to bring it in closer proximity to its collaborators at the at the Mayo Clinic in Jacksonville. Read More
Xenoport Inc., of Santa Clara, Calif., said net product sales for Horizant (gabapentin enacarbil) extended-release tablets nearly doubled to $11 million for the third quarter of 2015, compared to $5.6 million for the same period in 2014. Read More
Astrazeneca plc, of London, and its Medimmune unit released data from key abstracts that will be presented at the American College of Rheumatology meeting in San Francisco. Read More
