Puma Biotechnology Inc. said its Phase III trial of PB272 (neratinib) will be conducted under a special protocol assessment from the FDA, providing specific guidance for design, endpoints and statistical analysis in the trial. Read More
LONDON – How different does a drawing of an elephant have to be before it stops looking like an elephant? How similar does a fingerprint have to be before we can say it is the same as the one found at the crime scene? Read More
Oncolytics Biotech Inc.'s broad cancer program with the reovirus variant Reolysin gained $32 million worth of gross-proceeds firepower with the pricing of a public stock sale of 8 million shares at $4 each. Read More
LONDON – If the European market for biosimilars could be worth $4 billion by 2017, why has progress been so slow in gaining market authorizations for biosimilars in recent years? Read More
BOSTON – Research backed by the Armed Forces Institute of Regenerative Medicine (AFIRM) since its formation in April 2008 will within the next five years lead to a range of marketed products that, taken together, will vastly improve the treatment of severe facial injuries, reducing the amount of surgery required and providing superior structural, functional and aesthetic results. Read More
• Gilead Sciences Inc., of Foster City, Calif., said it reached an agreement in principle with Teva Pharmaceuticals Industries Ltd., of Jerusalem, settling litigation concerning the patents protecting Viread (tenofovir disoproxil fumarate), Gilead's treatment for HIV infection and chronic hepatitis B virus. Read More
• Onyx Pharmaceuticals Inc., of South San Francisco, said Leukemia published results from the Phase II study known as PX-171-005, testing Kyprolis (carfilzomib) in patients with relapsed and refractory multiple myeloma and varying degrees of renal insufficiency. Read More
• Mundipharma International Corp., of Cambridge, UK, said results from the StiL NHL-1 study published in The Lancet showed that a first-line treatment regimen of bendamustine plus Rituxan doubled progression-free survival compared with CHOP plus rituximab in newly diagnosed patients with indolent non-Hodgkin's lymphoma and mantle cell lymphoma. Read More
• UCB SA, of Atlanta, submitted regulatory filings in the U.S. and Europe to extend the marketing authorization for Cimzia (certolizumab pegol) for the treatment of adults with active psoriatic arthritis and for active axial spondyloarthritis. Read More
• The Medicines Co., of Parsippany, N.J., reported 2012 net revenue increased by 15.2 percent, to $558.6 million, from $484.7 million in 2011. U.S. net revenue from anticoagulant Angiomax (bivalirudin) increased by 10.9 percent, to $501.7 million, compared with $452.3 million in 2011, while international net revenue from the drug, branded Angiox outside the U.S., jumped by 47.4 percent, to $46.5 million, compared with $31.6 million in 2011. Read More
