FDA briefing documents posted ahead of Wednesday’s meeting of the Cardiovascular and Renal Drugs Advisory Committee (adcom) meeting to review the approvability of cangrelor were sufficiently positive to give shares of The Medicines Co. (NASDAQ:MDCO) a modest boost Monday. Read More
Taxus Cardium Pharmaceuticals Group Inc. inked a new deal with its Chinese investor to help fund a recently launched subsidiary aimed at advancing Generx (alferminogene tadenovec [Ad5FGF-4]), an angiogenic gene therapy candidate that has been in development for nearly 20 years, but may be finally reaching the finish line just as interest is reigniting the overall space. Read More
DUBLIN – The ongoing delay in appointing a new executive director to the Innovative Medicines Initiative (IMI), Europe’s €3.3 billion (US$2.1 billion) public-private partnership on drug research, shows no immediate signs of ending, while its interim director, EC official Irene Norstedt, has defended the initiative against a major media onslaught led by Germany’s influential current affairs magazine Der Spiegel. Read More
PARIS – Better patient safety has been the single greatest benefit of Europe’s system of pharmaceuticals regulation and legislation over the past 50 years, according to an audience vote at a Regulatory Town Hall meeting, which kicked off proceedings at the Drug Information Association’s (DIA) 27th annual European meeting at Le Palais des Congrès in Paris, Monday. Read More
As an advisory panel for the FDA prepared to take up the matter Tuesday of safety issues with Astrazeneca plc’s marketed dipeptidyl peptidase-4 (DPP-4) inhibitor for diabetes, Viking Therapeutics Inc. lowered the target for its IPO in a move that could help the firm advance the licensing deal with Ligand Pharmaceuticals Inc. – also with a strong diabetes component, though otherwise unrelated and involving drugs with a different mechanism of action). Read More
HONG KONG – China-focused biopharmaceutical stocks have not been left out of the bull markets in Hong Kong and Shanghai, which are being powered by an influx of capital and strong company performances. Read More
Researchers for Alnylam Pharmaceuticals Inc. have published preclinical data for the company’s investigational hemophilia treatment ALN-AT3, which is currently undergoing phase I clinical testing and represents “a different approach to managing hemophilia,” senior author Akin Akinc told BioWorld Today. Read More
Per a request from the U.S. Trade Representative (USTR), the World Trade Organization (WTO) will establish a dispute settlement panel at its April 22 meeting to consider China’s Demonstration Bases-Common Service Platform export subsidy program. Read More
TVM Capital Life Science, of Montreal, said it has achieved the first closing of China Biopharma Capital I at $50 million with subscription from Chongqing Lummy Pharmaceutical Co., Ltd., a pharmaceutical company based in Chongqing, China. Read More
Bone Therapeutics SA, of Gosselies, Belgium, said it has established a U.S.-based subsidiary, Bone Therapeutics USA Inc. in Boston that will enable them to move forward with its U.S. clinical trials program for fracture repair and osteonecrosis. Read More
Cytori Therapeutics Inc., of San Diego, reported preliminary follow-up data from the 12-patient, investigator-initiated Scleradec-I trial, showing no reports of adverse events or safety concerns with cell therapy candidate ECCS-50. Read More
Mylan NV, of Potters Bar, UK, said it provided Perrigo Co. plc, of Dublin, with notice of its filing of the premerger notification under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 with the U.S. Federal Trade Commission and the U.S. Department of Justice Antitrust Division regarding its proposed acquisition of Perrigo. Read More
