Actavis plc, of Dublin, confirmed that the U.S. District Court for the District of New Jersey found that U.S. Patent Nos. 7,645,459 and 7,645,460 protecting bisphosphonate Atelvia (risedronate sodium delayed-release tablets, 35 mg) in the U.S. are invalid. Read More
Chiasma Inc., of Newton, Mass., said phase III data presented at the Endocrine Society meeting in San Diego, showed baseline responses of acromegaly patients to injectable somatostatin analogues can predict response to Chiasma's octreotide, an oral somatostatin analogue. Read More
Alimera Sciences Inc., of Atlanta, said net revenue increased by approximately $760,000, or 81 percent, to $1.7 million for the fourth quarter of 2014, compared to $940,000 in the fourth quarter of 2013. Read More
Biommune Technologies Inc., of Vancouver, British Columbia, demonstrated in vivo that anticancer activity induced by small-molecule drugs can make cancer cells more visible to the immune system. Read More
Biosimilar approvals in the U.S. are expected to increase during the next five years, but safety concerns among physicians and the need for greater regulatory clarity concerning therapeutic interchangeability could hinder market uptake, according to a new Tufts Center for the Study of Drug Development (CSDD) study. Read More
HONG KONG – Starting March 5, Japan's regulator suspended a subsidiary of Novartis AG from manufacturing or selling drugs, citing a string of unreported negative side effects patients suffered after using the company's drugs. Read More
FDA reviewers gave agency advisors the proverbial chin nod in documents briefing them on Kythera Biopharma Inc.'s submental fat reduction drug, ATX-101 (deoxycholic acid), ahead of a March 9 advisory committee meeting, saying company data support a "favorable benefit-risk assessment" of the injectable, an appraisal that boosted Kythera shares (NASDAQ:KYTH) 25.3 percent to $50 on Thursday. Read More
Several studies have shown surprising effects of antidepressants in patients with cardiovascular problems. A paper published in the March 5, 2015, issue of Science Translational Medicine indicated that the antidepressant Paxil (paroxetine, Glaxosmithkline plc) was better than beta blockers at treating heart failure after an experimental heart attack in mice. Read More
The latest foray in the oft-thorny RNAi patent landscape sees Arrowhead Research Corp. nabbing the entire RNAi portfolio of Novartis AG, picking up rights to a host of intellectual property (IP) and assets, including an existing license agreement with RNAi powerhouse Alnylam Pharmaceuticals Inc., a pipeline of three preclinical candidates and a patent estate the Pasadena, Calif.-based biotech said falls safely outside the scope of competitors' IP. Read More
Mallinckrodt plc plans to amp up its hospital-based drug portfolio with the acquisition of privately held Ikaria Inc. in a transaction valued at approximately $2.3 billion. Hampton, N.J.-based Ikaria, which is focused on therapies and delivery systems for critically ill infants in hospital neonatal intensive care unit (NICU) settings, markets Inomax, a continuous flow version of inhaled nitric oxide. Read More
Takeda Oncology Inc., of Cambridge, Mass., said the New England Journal of Medicine published phase III data showing that Velcade (bortezomib)-based therapy was found to be more effective than standard of care in previously untreated mantle cell lymphoma patients. Read More