SteadyMed Raises $30 Million in Private Placement

SteadyMed prepares to file New Drug Application (NDA) for Trevyent® in Q2 2017
 
Financing provides capital for Trevyent commercial launch preparation
 
SAN RAMON, Calif., April 21, 2017 -- SteadyMed Ltd. (Nasdaq:STDY), a specialty pharmaceutical company focused on the development of drug product candidates to treat orphan and high-value diseases with unmet parenteral delivery needs, today announced that it has entered into a definitive agreement to sell its ordinary shares and warrants to purchase its ordinary shares for aggregate gross proceeds of approximately $30 million in a private placement. The financing was led by Adage Capital Management, OrbiMed, Deerfield Management and Kingdon Capital Management.
Read more: SteadyMed Ltd ( STDY )

Theratechnologies to buy ibalizumab commercial rights

Mr. Luc Tanguay reports
 
THERATECHNOLOGIES ACQUIRES COMMERCIAL RIGHTS TO IBALIZUMAB IN THE EUROPEAN UNION AND FOUR ADDITIONAL TERRITORIES
 
Theratechnologies Inc. has reached an agreement with TaiMed Biologics Inc. for the acquisition of the commercial rights to ibalizumab in the European Union, Israel, Norway, Russia and Switzerland.
 
Ibalizumab is an investigational humanized monoclonal antibody currently being developed for the potential treatment of multidrug resistant (MDR) HIV-1 infection. Theratechnologies first acquired the commercial rights to ibalizumab in the United States and Canada in March 2016. The existing agreement between both companies has been amended to include the additional territories and related new obligations.
Read more: Theratechnologies Inc ( TH )

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 )

Videos / Webinars

View all videos

Pepperstone | Metatrader 4 Forex Broker