A clinical study presented at the European Society of Cardiology congress has concluded that AstraZeneca's (NYSE:AZN) heart drug Brilinta is safe to use in an ambulance when heart attack patients are being rushed to hospital, although its early use does not provide any extra benefit.
Some experts had hoped that a Brilinta-aspirin combo taken before the patient arrives would further boost the chance of restoring healthy blood flow to the heart by minimizing delays.
However, prospects for the drug did improve last month, after the U.S. government closed an investigation into a major clinical trial of Brilinta that was used to win marketing approval.
LCZ696 reduced the risk of death from cardiovascular disease by 20%, reduced heart failure hospitalizations by 21% and reduced the risk of all-cause mortality by 16%. All the results were highly statistically significant.
The twice-daily tablet acts to enhance the protective neurohormonal systems of the heart while simultaneously suppressing the harmful system. Current therapies act only to block the harmful effects.
Novartis intends to submit its NDA to the FDA by the end of 2014 and its MAA to the EC in early 2015.
IVC interim President and CEO Robert K Gudbranson says, "Altimate is a strong business, but it is outside of Invacare's core North America/Home Medical Equipment product portfolio. I am grateful to the associates at Altimate for the contributions that they have made to Invacare. The net proceeds from this divestiture give us the opportunity to strengthen our balance sheet through the continued reduction of debt."
Shares of United Therapeutics (UTHR +23.1%) jump on 5x surge in volume after a court rules that Sandoz (NVS +0.3%) failed to prove that United's '007 and '117 Remodulin (treprostinil) patents are invalid and that United proved that Sandoz's ANDA will infringe on patent '117.
Remodulin accounted for almost 45% of United's 1H sales of $612.2M.
Imris (NASDAQ:IMRS) receives a letter from NASDAQ notifying the company that the bid price for its stock has traded below the minimum listing level of $1.00 for 30 consecutive trading days. Under exchange rules, it has 180 calendar days to regain compliance. If, during the grace period, bid prices close above $1.00 for ten consecutive trading days the matter will be closed.
The National Institute of Allergy and Infectious Diseases (NIAID) awards BioCryst Pharmaceuticals (NASDAQ:BCRX) a contract modification for an additional $2.4M to fund a dose ranging efficacy study of an intramuscular formulation of BCX4430 in non-human primates for the treatment of Ebola infection. BioCryst expects to begin testing within weeks.
In September 2013 NIAID awarded a $22M five-year contract to the company to help fund the development of BCX4430.
AmSurg Corp. (NASDAQ:AMSG) declares its first cash dividend of $1.2979 per share for its 5.25% Mandatory Convertible Preferred Stock, Series A-1. The dividend is payable on October 1, 2014 to shareholders of record September 15, 2014.
Subsequent quarterly dividends will be $1.3125 per share when declared by the BOD.
U.S. District Court of the Western District of Louisiana Judge Rebecca Doherty rules that the label of Takeda Pharmaceuticals' diabetes drug Actos did not adequately warn patients about the increased cancer risk. The $9B punitive damages awarded by a U.S. jury will stand for the time being.
The company made a separate of the verdict in April. Legal observers do not believe that the full amount of the award will stand.
Eli Lilly (NYSE:LLY) co-promoted Actos from 1999 to 2006. It says that Takeda agreed to indemnify it for its losses and expenses in the matter under the terms of its agreement.