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Biogen Idec Inc And Swedish Orphan Biovitrum AB Presents New Data From Phase 3 Study Of Long-Lasting Hemophilia Factor Candidate ALPROLIX

11:00am EDT

Biogen Idec Inc and Swedish Orphan Biovitrum AB announced that it presented new findings for their long-lasting recombinant factor IX candidate ALPROLIX for hemophilia B at the XXIV International Society on Thrombosis and Haemostasis (ISTH) Congress in Amsterdam, The Netherlands. Three oral presentations showcase new data that reinforce the potential safety, efficacy and pharmacokinetic profile of ALPROLIX. The data highlight the consistency of results with ALPROLIX across patient types and favorable physician ratings of efficacy in treating acute bleeding episodes and controlling bleeding during and after surgery. An evaluation of the treatment of acute bleeding episodes across the prophylaxis and episodic (on-demand) treatment arms of the phase 3 B-LONG study showed that more than 90% of bleeds were controlled with a single injection of ALPROLIX and more than 97% were controlled with two or fewer injections. Results from an analysis of the phase 3 B-LONG study showed that ALPROLIX consistently controlled bleeding during and after 14 surgeries in 12 patients with hemophilia B. Physicians reported high efficacy levels of ALPROLIX during surgery, with hemostasis (the stoppage of bleeding) rated as excellent for 13/14 surgeries and good for 1/14 surgeries.

Novation Holdings Inc Announces Acquisition Of Controlling Interest In Solar Energy Initiatives Inc

9:33am EDT

Novation Holdings Inc announced that it has acquired a controlling interest in Solar Energy Initiatives Inc. in exchange for the stock of HB&G Inc., parent of HB&G Temecula, Inc., which operates a local-themed, entertainment focused, bar and restaurant in Temecula California. The parent, HB&G, Inc. plans to start additional, local themed entertainment restaurants in Southern California, Arizona, Texas and possibly Florida over the next three years. The acquisition was in exchange for a combination of SNRY common stock and a convertible preferred stock with voting power equal to 51% of all voting stock of SNRY. Although originally announced in April, 2013, the final closing and transfer could not be completed until certain open issues with the restaurant's landlord were resolved, which has just been done. Terms of the transaction were not disclosed.

La Jolla Pharmaceutical Co Announces FDA Acceptance Of IND For LJPC-501

8:00am EDT

La Jolla Pharmaceutical Company announced that the FDA Division of Cardiovascular and Renal Products has accepted the Company's Investigational New Drug (IND) application for LJPC-501. La Jolla will start a Phase One clinical trial of LJPC-501 in patients with hepatorenal syndrome (HRS), Type 1 and Type 2.

Portola Pharmaceuticals Inc Announces Positive Phase 2 Study Results Showing Factor Xa Inhibitor Antidote PRT4445 Reverses Anticoagulant Activity Of Eliquis

7:34am EDT

Portola Pharmaceuticals Inc announced positive pharmacodynamic and safety data from a Phase 2 proof-of-concept study of investigational Factor Xa inhibitor antidote PRT4445 in healthy volunteers who were administered the Factor Xa inhibitor Eliquis (apixaban). Results showed greater than a 95% reversal of the anticoagulant activity of Eliquis was achieved within two minutes of intravenously administered high-dose PRT4445, which has a tentatively approved International Nonproprietary Name (INN) of andexanet alfa. Bleeding events occur infrequently in patients taking Factor Xa inhibitors (1-4% per year in several clinical studies involving patients taking a Factor Xa inhibitor on a chronic basis). Development of andexanet alfa, specifically designed to reverse the activity of Factor Xa inhibitors, may provide an antidote for patients who experience an uncontrolled bleeding event or require emergency surgery. Phase 2 Study Design and Results- randomized, placebo-controlled, double-blind, cohort dose-escalation Phase 2 study, 27 healthy volunteers were treated on days 1-6 with Eliquis 5 mg twice a day (to steady state) and then randomized in a 6:3 ratio to intravenous andexanet alfa (in 3 different dose cohorts -- 90 mg, 210 mg or 420 mg) or saline on day 6, three hours after receiving the last Eliquis dose. Two minutes after administration of 420 mg andexanet alfa (n=6), anticoagulant activity of Eliquis decreased by greater than 95% as measured by anti-Factor Xa activity.

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BYOTROL - STILL BUILDING
Provider: Edison Investment Research
$10.00
Buy
BYOTROL - CONSUMER MOVES
Provider: Edison Investment Research
$10.00
Buy
SUMMIT CORPORATION - SERVICE EXPANSION
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Buy
LIPOXEN - TRIAL PLANS CONFIRMED
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