Wall Street scrambled to figure out the consequences of word from Amgen Inc. and partner UCB SA regarding the 4,100-patient phase III ARCH study with bone-forming agent Evenity (romosozumab) that turned up a surprise safety signal not seen in the previous FRAME experiment in more than 7,000 patients. "Romo nomo?" asked Leerink analyst Geoffrey Porges in a research report. Read More
Citing recent drug recalls due to Burkholderia cepacia complex (BCC), the FDA Monday reminded manufacturers of the need to establish procedures designed to prevent objectionable microorganism contamination of nonsterile drugs, use scientifically sound and appropriate acceptance criteria and test procedures, test in-process materials during production and investigate any failure to meet specifications. Read More
Otsuka Pharmaceutical Co. Ltd., of Tokyo, reported top-line results from an additional phase III trial of tolvaptan in adults with autosomal dominant polycystic kidney disease (ADPKD), showing that patients treated with the selective V2 vasopressin receptor antagonist had a reduction in estimated glomerular filtration rate (eGFR) that was significantly less than in patients receiving placebo (p Read More
Roche Holding AG's interleukin-6 antagonist, Actemra (tocilizumab), gained a supplemental approval Monday, becoming the first FDA-approved treatment for giant cell arteritis (GCA), a chronic form of vasculitis for which the only current treatment option involves steroids. Read More
FDA briefing documents framing a Wednesday Oncologic Drugs Advisory Committee (ODAC) review of Puma Biotechnology Inc.'s lead candidate, neratinib, highlight tolerability and trial amendment issues, but still appear supportive of the drug's efficacy as an extended adjuvant treatment for HER2-positive early stage breast cancer, analysts said. The news sent Los Angeles-based Puma's shares (NASDAQ:PBYI) up 39.2 percent in heavy trading Monday, to close at $52.60. Read More
The U.S. Supreme Court Monday fenced in patent trolls, making it harder for them to graze in friendly court jurisdictions when going after corporations, including drug and device companies, for patent infringement claims. Read More
HONG KONG – China continues to roll out reforms for the pharmaceutical industry, the latest of which is a set of improvements to clinical trial regulations. Read More
Viacyte Inc., of San Diego, said it raised $10 million from Asset Management Partners, W.L. Gore & Associates Inc., certain undisclosed current investors, and JDRF, a global organization funding type 1 diabetes research, who are providing grant funding. Read More
Anavex Life Sciences Corp., of New York, reported new preclinical data for Anavex 2-73 in the neurodevelopmental disorders Angelman syndrome, Fragile X syndrome and Rett syndrome at the Antiepileptic Drug Trials conference in Aventura, Fla. Read More
