Amgen Inc. again set analysts and investors abuzz with phase II/III data on its protein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab, now dubbed Repatha, presented at the American College of Cardiology's (ACC) annual scientific session in San Diego. Read More
DUBLIN – Valeant Pharmaceuticals International Inc., looks finally to have gotten its bid for Salix Pharmaceuticals Ltd. over the line, but it has paid a high price to pull off the deal. Read More
LONDON – The World Health Organization (WHO) has convened the first global ministerial conference on dementia to inspire a coordinated worldwide drive to tackle the disorder, which in its various forms now represents far and away the leading contributor to disability and dependency in old age. Read More
Cidara Therapeutics Inc. became the latest firm to file for a proposed IPO, aiming to raise $69 million to advance its preclinical antifungal compounds into human testing, even as the rate of biotech IPO pricings looks to be dropping off. Read More
Though plenty of firms have taken the IPO route lately thanks to an upbeat financial climate, Pulmatrix Inc. chose a reverse-merger strategy with Ruthigen Inc., just as Catalyst Biosciences Inc. did earlier this month with Targacept Inc. Read More
A watchdog group is once again calling on Health and Human Services (HHS) to withdraw a draft FDA guidance that provides best practices for distributing scientific and medical publications on new risk information for approved drugs and biologics. Read More
Nantworks Inc. and Sorrento Therapeutics Inc. have expanded their ongoing collaboration with a deal to discover and develop cancer immunotherapies derived from Sorrento's G-MAB library against Nantworks-identified neoepitopes of tumor-specific antigens drawn from its growing body of genomic and proteomic data. Read More
Macrophage Therapeutics Inc., of Dublin, Ohio, a subsidiary of Navidea Biopharmaceuticals Inc., reported it executed definitive agreements for its previously announced $2.5 million round of standalone financing, led by Platinum-Montaur Life Sciences and Michael Goldberg, CEO of Macrophage. Read More
strong>Blueprint Medicines Corp., of Cambridge, Mass., said data were published in Cancer Discovery that highlight the antitumor activity of BLU9931, a selective, covalent inhibitor of fibroblast growth factor receptor 4 (FGFR4). Read More
Aslan Pharmaceuticals Pte. Ltd., of Singapore, reported results from a phase I trial of ASLAN002 (BMS-777607), a small-molecule dual inhibitor of the cMET receptor tyrosine kinase and RON immune checkpoint, showing that the drug was safe and well tolerated at all doses tested in 39 solid tumor patients, who received treatment for a minimum of 28 days as both once-daily and twice-daily dose regimens. Read More
Merck & Co Inc., of Whitehouse Station, N.J., said it expects the FDA to issue a complete response letter for its new drug application for sugammadex, a medicine to reverse the effects of anesthesia, after the agency canceled the March 18 meeting of the Anesthetic and Analgesic Drug Products Advisory Committee, which was scheduled to discuss the resubmitted application. Read More
Astrazeneca plc, of London, reported full results from the PEGASUS-TIMI 54 outcomes trial, which enrolled more than 21,000 to study Brilinta (ticagrelor) tablets plus low-dose aspirin compared to placebo plus low-dose aspirin, for the treatment of chronic secondary prevention of atherothrombotic events in patients who had experienced a heart attack one to three years prior to study enrollment. Read More
