Novan Provides Update on SB204 Development Program

MORRISVILLE, N.C., March 06, 2017  -- Novan, Inc. (“the Company” or “Novan”) (NASDAQ:NOVN) today announced that, after further analysis of the results from the NI-AC301 and NI-AC302 pivotal clinical trials for the Company’s topical nitric oxide-releasing product candidate, SB204, it intends to proceed with the SB204 development program. Following announcement of the top-line results for NI-AC301 and NI-AC302 last month, Novan conducted an in-depth examination of the data sets and engaged consultants in biostatistics and regulatory affairs. Based on the results of this process and its ongoing analysis, Novan intends to pursue a pre-submission meeting with the U.S. Food and Drug Administration, or FDA, to discuss the entirety of the SB204 development program in the third quarter of 2017, which could lead to a new drug application, or NDA, submission targeted in the first quarter of 2018.
Read more: Novan Inc ( NOVN )

La Jolla Pharmaceutical Company Announces Positive Top-Line Results from ATHOS-3 Phase 3 Study of LJPC-501

-- Primary efficacy endpoint analysis highly statistically significant (p<0.00001)
-- Trend toward longer survival observed
-- New Drug Application planned for second half of 2017
-- Company to host conference call and webcast at 8:30 a.m. EST on Monday, Feb. 27, 2017
La Jolla Pharmaceutical Company (Nasdaq: LJPC) (La Jolla), today announced positive top-line results from the ATHOS-3 (Angiotensin II for the Treatment of High-Output Shock) Phase 3 study of LJPC-501 (angiotensin II) in patients with catecholamine resistant hypotension (CRH).
Read more: La Jolla Pharmaceutical Company ( LJPC )

Pernix Therapeutics Prevails in Zohydro ® ER ANDA Litigation

MORRISTOWN, N.J., Feb. 23, 2017  -- Pernix Therapeutics Holdings, Inc. (NASDAQ:PTX), a specialty pharmaceutical company with a focus on Pain and CNS conditions, announced today that it received a favorable opinion in its litigation with Actavis Laboratories FL, Inc. regarding a proposed generic version of Zohydro ER. Judge Gregory M. Sleet of the United States District Court for the District of Delaware concluded that Actavis’ proposed generic versions of Zohydro ER infringe U.S. Patent Nos. 9,132,096 (which expires on September 12, 2034) and 6,902,742 (which expires on November 1, 2019) following a trial that took place in October 2016. The Judge has entered an order enjoining Actavis from engaging in the commercial manufacture, use, offer to sell, or sale in the United States, or importation into the United States of Actavis’ Abbreviated New Drug Application (ANDA) product prior to expiration of the two patents.  Actavis did not assert invalidity or unenforceability of the patents at trial. 
Read more: Pernix Therapeutics Holdings ( PTX )

Apricus Biosciences Announces Approval of Vitaros ® for the Treatment of Erectile Dysfunction in Mexico

SAN DIEGO, Jan. 18, 2017  -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that Mexico has granted Apricus’ commercialization partner, Ferring Pharmaceuticals, market approval for Vitaros®, an on-demand topical cream indicated for the treatment of patients with erectile dysfunction.
This is the twenty-sixth country in which the product has been approved, including Argentina, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Lebanon, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland and the United Kingdom.
Read more: Apricus Biosciences ( APRI )

RXi Pharmaceuticals Completes Acquisition of MirImmune Inc. and Appoints New Chief Business Officer

Acquisition expands RXi's pipeline to include cell-based immunotherapy to treat cancer
MARLBOROUGH, Mass., Jan. 9, 2017 -- RXi Pharmaceuticals Corporation (NASDAQ: RXII), a clinical-stage RNAi company developing innovative therapeutics that address significant unmet medical needs, announced today the closing of its acquisition of all of the outstanding capital stock of MirImmune Inc., a privately-held company focused on the development of next generation immunotherapies for the treatment of cancer, pursuant to that previously disclosed exclusive option agreement. 
Read more: RXi Pharmaceuticals Corporation ( RXII )

Videos / Webinars

View all videos