The Oncologic Drugs Advisory Committee (ODAC) gave a green light Thursday to Rockwell Medical Inc.'s lead candidate, an iron maintenance therapy for dialysis patients with stage V chronic kidney disease. Read More
Investors this morning will find out more about the fate of Aeterna Zentaris Inc.'s new drug application (NDA) for Macrilen (macimorelin), an oral ghrelin agonist for use as a diagnostic in evaluating adult growth hormone deficiency (AGHD) in the wake of a complete response letter (CRL) from U.S. regulators. Read More
Investors and analysts scrambled Thursday to divine portent from a heap of newly released abstracts previewing December's American Society of Hematology (ASH) annual meeting. Karyopharm Therapeutics Inc. led the pack of abstract news gainers, with shares (NASDAQ:KPTI) rising 10.7 percent to $41.73 on news that its lead candidate, selinexor (KPT-330), demonstrated a disease control rate of 80 percent in 10 patients with relapsed and refractory aggressive non-Hodgkin's lymphoma (NHL). Read More
Less than a week after reporting disappointing third quarter earnings, Aegerion Pharmaceuticals Inc. cheered the Street by disclosing an agreement with Astrazeneca plc to acquire the approved orphan drug Myalept (metreleptin for injection) for $325 million up front, with no milestones or royalties attached. Read More
WASHINGTON – Device makers are keeping a close eye on developments in the nation's capital after the Nov. 4 GOP landslide, and opponents of the device tax and supporters of tax reform excited about the prospects that Congress will move bills to address both issues. Read More
Discovery Laboratories Inc., of Warrington, Pa., said third quarter sales of Surfaxin (lucinactant) to the company's specialty distributor totaled about $219,000 and said demand sales into hospitals grew about 60 percent to $116,000 compared to the second quarter of 2014. Read More
Cardio3 Biosciences SA, of Mont-Saint-Guibert, Belgium, acquired medical device firm Corquest Medical Inc., of Miami, which specializes in the development of devices and technologies for cardiac surgery. Read More
Genmab A/S, of Copenhagen, Denmark, offered additional data from the interim analysis of the Arzerra (ofatumumab) phase III study, PROLONG (OMB112517). The study evaluated ofatumumab maintenance therapy vs. no further treatment (observation) in patients with a complete response or partial response after second- or third-line treatment for chronic lymphocytic leukemia. Read More
Ipsen SA, of Paris, said the FDA approved a new device to deliver Somatuline Depot (lanreotide). The single-use syringe is available in 60 mg, 90 mg and 120 mg dosages and includes additional safety features. Read More
