In its first untitled letter of the year, the FDA's Office of Prescription Drug Promotion (OPDP) rapped Hospira Inc., a Pfizer Inc. company based in Lake Forest, Ill., for not submitting a promotional video touting Precedex (dexmedetomidine hydrochloride) before putting it on YouTube. The video also fails to include risk information and presents "arousability" as a benefit rather than a warning or precaution for the injected sedative labeled for use in surgery and other intensive care settings. In addition, the video doesn't spell out pertinent usage information, including the fact that the drug should not be infused for more than 24 hours. OPDP instructed Hospira to remove the video immediately and to respond to the letter by Jan. 29. Read More
Allergan plc, of Dublin, said the FDA approved its supplemental new drug application to update the label for Dalvance (dalbavancin) for injection. The expanded label will include a single dose administered as a 30-minute intravenous infusion for the treatment of acute bacterial skin and skin structure infections (ABSSSIs) caused by designated susceptible gram-positive bacteria in adults, including infections caused by methicillin-resistant Staphylococcus aureus. Dalvance was first approved in May 2014 for the treatment of ABSSSI in adults. (See BioWorld Today, May 27, 2014.) Read More
Moberg Pharma AB, of Stockholm, said it plans a bond issue, in part, to finance accretive acquisitions that will strengthen platforms for its strategic brands in the U.S. and allow for additional brands, increase international distribution and prepare for initiation of phase III studies for MOB-015, a topical formulation to treat nail fungus. Read More
A congressional committee is trying to force indicted pharma exec Martin Shkreli to appear at a hearing next week on two drug companies' extreme price hikes for newly acquired drugs, even if it has to offer him immunity. Read More
Treating mouse models of Alzheimer's disease with an antibody that blocks PD-1, the same molecule targeted by Merck & Co Inc.'s Keytruda (pembrolizumab), helped them clear amyloid plaque and improved their cognitive performance, scientists from the Israeli Weizmann Institute of Science reported in the Jan. 18, 2016, issue of Nature Medicine. Read More
DUBLIN – Vasopharm GmbH raised €20 million (US$21.7 million) in a new funding round to take its lead molecule, VAS203, into a European phase III registration trial in traumatic brain injury (TBI). The study is due to begin in the coming months and is due to read out in 2019. Read More
Philogen SpA's "idea is to stop [melanoma] when you have metastases, but only at the skin," co-founder Dario Neri told BioWorld Today, as his firm launched its pivotal trial in about 200 patients testing Darleukin against stage IIIb/c disease, which "almost invariably" worsens to often-fatal stage IV within two years. Read More
DUBLIN – Abingworth has raised $105 million for its first dedicated clinical co-development fund, which will extend its focus on putting up cash to help big pharma progress its pipeline without damaging its all-important P&L line. Read More
Vtv Therapeutics Inc., of High Point, N.C., said it is enrolling the first patients in the company's phase II LOGRA (aLlosteric Oral Glp1 Receptor Agonist) study, a randomized, double-blind, placebo-controlled, parallel group trial of TTP273, an oral, small-molecule GLP-1R agonist. Read More
