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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.

Novavax Inc Announces Positive Top-Line Results From Phase 1 Clinical Trial Of RSV Vaccine Candidate In Elderly

7:30am EDT

Novavax Inc announced positive top-line safety and immunogenicity data for respiratory syncytial virus (RSV) vaccine candidate from a dose-ranging Phase 1 study in elderly adults. All subject groups receiving the recombinant fusion (F) protein nanoparticle vaccine candidate exhibited antibody responses against RSV at 28 and 56 days post-immunization, with rises in serum anti-F immunoglobulin G (IgG) antibody levels. The highest response rates and greatest increases in antibody levels were observed in groups receiving RSV F antigen with aluminum phosphate as an adjuvant. All subjects simultaneously received a licensed seasonal trivalent influenza vaccine to ensure coverage over the influenza season. Local and systemic safety were monitored and together with the interim immunogenicity are provided here as top line data through Day 56. The study examined the immunogenicity and safety of Novavax's RSV F nanoparticle vaccine in 220 healthy elderly adults (≥60 years of age, mean age of 68 years of age). Subjects received either 60µg or 90µg of the RSV F vaccine candidate, with or without adjuvant, or a placebo. The vaccine was well tolerated with no meaningful differences in the frequencies of adverse events (AEs) between the placebo (70%) and active vaccine groups (58-75%), and no dose-related trends in AEs. The adjuvant groups had a higher incidence rate of injection site AEs (43%) compared to placebo (23%), but all such AEs were reported as mild or moderate in severity.

Norda ASA Announces Last Day of Trading

6:00am EDT

Norda ASA announced that Oslo Bors has decided to delist the shares of Norda ASA. The shares in the Company will be delisted from August 30, 2013. The last day of listing will be on August 29, 2013.

NeuroDiscovery Ltd Announces Appointment Of Chief Executive Officer And Chairman

3:39am EDT

OncoSil Medical Limited announced that Dr Neil Frazer has been appointed to the position of Chief Executive Officer effective July 2, 2013. The Board also announced the following changes, effective July 2, 2013, Mr Martin Rogers’ position on the Board has changed from Deputy Chairman to Chairman; Mr Roger Aston’s position on the Board has changed from Executive Chairman to Non-Executive Director; Mr Simon O’Loughlin has resigned as a Non-Executive Director.

Shanghai RAAS Blood Products Co Ltd to Issue New Shares for Acquisition of Company and Fund Raising

Monday, 1 Jul 2013 08:00pm EDT

Shanghai RAAS Blood Products Co Ltd announced that it has decided to issue a total of 93,652,444 shares, at the price of RMB 19.22 per share, to acquire a 100% stake in Banghe Pharmaceutical Co., Ltd, including 29,191,467 shares to Nanchang-based investment company for a 31.17% stake in Banghe Pharmaceutical, 29,809,573 shares to a Xinjiang-based investment company for a 31.83% stake in Banghe Pharmaceutical, 29,968,782 shares to Mr. Fu Jianping for a 32.00% stake in Banghe Pharmaceutical, as well as 4,682,622 shares to Xiao Xiangyang for a 5.00% stake in Banghe Pharmaceutical. After the transaction, the Company will hold a 100% stake in Banghe Pharmaceutical. The Company has also decided to issue 26,000,000 shares to RAAS China Limited through private placement, at the price of RMB 19.22 per share, to raise RMB 499,720,000. The Company will use the proceeds to develop Banghe Pharmaceutical's main business, as well as fulfill the Company's working capital.

OncoTherapy Science Inc Announces Start of Phase I Clinical Trial of OTS167

Monday, 1 Jul 2013 08:00pm EDT

OncoTherapy Science Inc announced the start of the phase I clinical trial of OTS167, which is a kind of molecular target drug targeted at kinase Maternal Embryonic Leucine zipper Kinase.

Pfizer Inc, Novartis AG May Join Amgen In Bidding For Onyx Pharmaceuticals Inc-Reuters

Monday, 1 Jul 2013 06:37pm EDT

Reuters reported that Onyx Pharmaceuticals Inc whose cancer drugs promise a strong revenue stream, is attracting preliminary buyout interest from several large pharmaceutical companies such as Pfizer Inc and Novartis AG. Onyx had rejected a recent $8.7 billion offer from larger biotech Amgen Inc as too low. Pfizer, which is due to pay Onyx royalties on a promising experimental breast cancer drug, and Novartis, with a strong franchise of cancer medicines, are among the parties interested in Onyx and its portfolio of marketed cancer treatments, the two sources said. Amgen's $120-per-share offer in June was its first and the company did not indicate if it was the best and final, according to a third person familiar with the matter, who expected Amgen to participate in the auction process. The offer represented a 38% premium to Onyx's Friday closing share price of $86.82.

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Analyst Research

Report Title Price
BYOTROL - STILL BUILDING
Provider: Edison Investment Research
$10.00
Buy
BYOTROL - CONSUMER MOVES
Provider: Edison Investment Research
$10.00
Buy
SUMMIT CORPORATION - SERVICE EXPANSION
Provider: Edison Investment Research
$10.00
Buy
LIPOXEN - TRIAL PLANS CONFIRMED
Provider: Edison Investment Research
$10.00
Buy
BYOTROL - REVENUES SHORT OF TARGETS
Provider: Edison Investment Research
$10.00
Buy

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