Seeking to further diversify its product lines, specialty pharma Amag Pharmaceuticals Inc. will pay $600 million in cash plus $75 million in stock, or approximately 3.2 million newly issued shares, to purchase privately held Lumara Health Inc. (previously K-V Pharmaceutical Co.). Lumara shareholders will receive another $350 million, contingent on the achievement of sales milestones. Read More
A pivotal trial of Bristol-Myers Squibb Co.'s Opdivo (nivolumab), presented at the European Society of Medical Oncology (ESMO) conference in Madrid, on Monday, heralded a potential end to chemotherapy in treating BRAF wild-type melanoma, with response rates to the programmed death-1 (PD-1) immune checkpoint inhibitor reaching 32 percent of patients vs. 11 percent on chemotherapy. Read More
In a deal valued at up to $410 million, Tokyo's Daiichi Sankyo Co. Ltd. offered to buy San Diego-based Ambit Biosciences Inc., along with its pivotal-stage cancer drug quizartinib. Read More
Two key events that will shape the future of medicines regulation in Europe are taking place on Thursday. The European Parliament, which is holding confirmation hearings this week on the incoming team of European Commissioners, will scrutinize a controversial proposal from Jean Claude Juncker, the president of the new commission, to transfer oversight of the EMA back to the EU's Directorate General (DG) for Enterprise, which now has the new – and unwieldy – name of DG Internal Market, Industry, Entrepreneurship and SMEs. Read More
LONDON – The head of the EMA, Guido Rasi, has ordered an immediate review of Ebola virus infection treatments currently under development, to provide an overview of experimental products that are being rushed into patient trials in West Africa. Read More
Late Friday Atlanta-based Alimera Sciences Inc. received the green light from the FDA for its Iluvien implant, indicated for diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. Read More
Avanir Pharmaceuticals Inc., of Aliso Viejo, Calif., closed its public offering of approximately 20.1 million common shares, including approximately 2.7 million shares exercised in full for overallotments, to raise approximately $230.2 million. Read More
As the next step in developing a system that will enable verification of the accuracy of ceiling prices for 340B drugs, the Health Resources and Services Administration (HRSA) must require quarterly pricing data from drugmakers. Read More
Atox Bio Ltd., of Ness Ziona, Israel, said it was awarded a Biomedical Advanced Research and Development Authority (BARDA) contract of up to $24 million over 4.5 years to develop AB103 to treat necrotizing soft-tissue infections (NSTIs) and, potentially, infections caused by biothreats and public health threats that end in sepsis. Read More
Seattle Genetics Inc., of Bothell, Wash., and Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, reported phase III data showing that Adcetris (brentuximab vedotin) met its primary endpoint in Hodgkin lymphoma patients, with a statistically significant 75 percent improvement in progression-free survival vs. placebo (p = 0.001). Read More
Bristol-Myers Squibb Co., of New York, disclosed multiple regulatory milestones for its PD-1 immune checkpoint inhibitor, Opdivo (nivolumab), including FDA acceptance for priority review of a biologics license application for previously treated advanced melanoma patients, with a PDUFA date of March 30, 2015. Read More
Oncomed Pharmaceuticals Inc., of Redwood City, Calif., presented data from two phase Ib trials of demcizumab (anti-DLL4, OMP-21M18) in pancreatic cancer and non-small-cell lung cancer (NSCLC), demonstrating that the drug, in combination with standard-of-care chemotherapy, was well tolerated, especially in patients where the company's risk mitigation, monitoring and truncated dosing strategies have been employed. Read More
