Briefing documents for Tuesday's meeting of the FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) showed reviewers are unconvinced about Vertex Pharmaceuticals Inc.'s Orkambi, which consists of the firm's already approved Kalydeco (ivacaftor) and lumacaftor combined for homozygous F508del cystic fibrosis (CF) patients. Read More
A week after reporting first quarter financials and continuing to tout GCS−100 as a first-in-class galectin-3 inhibitor to treat chronic kidney disease (CKD), La Jolla Pharmaceutical Co. is ditching the candidate, along with follow-on LJPC−1010, its second-generation galectin-3 inhibitor. Read More
Neuroderm Ltd. shares (NASDAQ:NDRM) rose $1.24, or 10.9 percent, to close at $12.62 on Friday as investors welcomed the lifting of an FDA clinical hold that was blocking progress on U.S. studies of the company's Parkinson's disease treatments ND0612H and ND0612L. Read More
HONG KONG – The discovery of a novel mechanism for blood pressure (BP) regulation in a study by researchers at the Riken Brain Science Institute (BSI) in Wako, Japan, could have important implications for the control of elevated BP and may lead to the discovery of new antihypertensive medications. Read More
DUBLIN – Sensorion SAS, the latest addition to France's lengthening list of quoted biotechnology firms, is among a growing clutch of companies developing drugs for disorders of the inner ear. Read More
Neurovive Pharmaceutical AB, of Stockholm, said it completed the directed share issue, whereby about 1.6 million new shares were issued, bringing SEK70 million (US$8.5 million) to the company. Read More
Orexigen Therapeutics Inc., of San Diego, reported a first quarter loss of 14 cents per share on net sales of $11.5 million, all attributable to the first full quarter of the company's obesity drug Contrave (naltrexone and bupropion) following its October 2014 U.S. launch. Read More
Specialised Therapeutics Australia, of Melbourne, Australia, and Helsinn Group, of Lugano, Switzerland, said the Therapeutic Goods Administration approved Akynzeo (netupitant/palonosetron) to prevent acute and delayed nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy (CINV). Read More
Jazz Pharmaceuticals plc, of Dublin, and Concert Pharmaceuticals Inc., of Lexington, Mass., disclosed results from the recently completed phase I trial with JZP-386, a deuterium-containing analogue of sodium oxybate, evaluating the safety, pharmacokinetics and pharmacodynamics (PD) in 30 healthy volunteers. Read More
Researchers from the Dana-Farber Cancer Institute have identified a resistance mutation to AZD9291, a much-anticipated third-generation targeted drug that can kill cancer cells with the T790M mutation. Read More
