Anthera Announces Additional Data from Phase 2b PEARL-SC; pSivida Announces Commercial Launch of ILUVIEN Print E-mail
By Staff and Wire Reports   
Tuesday, 07 May 2013 19:15
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 7, 2013.

Anthera Pharmaceuticals (Nasdaq: ANTH)
, a biopharmaceutical company focused on developing and commercializing products to treat autoimmune diseases, announced additional data from its Phase 2b PEARL-SC study will be presented in two lecture sessions at the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology in Madrid, Spain.

Dr. Richard Furie, M.D., Chief of the Division of Rheumatology and Allergy-Clinical Immunology at the North Shore-Long Island Jewish Health System, will give two presentations summarizing the findings from the recently completed PEARL-SC Phase 2 trial with blisibimod in patients with SLE:

Novel Treatment in SLE and Sjögren's Syndrome (10:15-11:45 AM, June 13th), "Effects of Blisibimod, a Subcutaneous Inhibitor of B-Cell Activating Factor, in Patients with SLE"

New Drugs for Lupus: State of the Art (1:30-3:00 PM June 13th), "Effects of Blisibimod, an Inhibitor of B-Cell Activating Factor, on Markers of Renal Disease in Patients with SLE."

The presentations will summarize findings from a prospective analysis of the PEARL-SC clinical study demonstrating the treatment benefit of blisibimod on markers of renal disease including proteinuria Complement C3 and double-stranded DNA antibodies (ds-DNA). The presentation will also summarize the clinical effect of blisibimod on a predefined subgroup of lupus patients with more severe disease characterized by a SELENA-SLEDAI greater than or equal to 10 despite receiving corticosteroid therapy at baseline.

Two recent presentations by Dr. Morton Scheinberg, M.D., at the 10th International Congress on Systemic Lupus Erythematosus in Buenos Aires, Argentina, highlighted the effects of blisibimod on patients with more severe SLE. "Blisibimod looks promising when evaluated using the SRI-8 endpoint in patients with more severe lupus," said Dr. Scheinberg. "The corroboration of the main study findings in the subgroup of patients from Latin America lends greater confidence to the observed outcomes. The significant improvements in proteinuria observed with blisibimod are clearly important to patients with lupus, and possibly also to patients with other autoimmune renal diseases with autoantibody-associated kidney damage." The poster "Clinical Experience in Latin America with Blisibimod Amongst Subjects with Active, Moderate-to-Severe Systemic Lupus Erythematosus: Data from the Phase 2b PEARL-SC Study" and presentation "Blisibimod, an Emerging Subcutaneous Biologic Therapy for Patients with Active, Moderate-to-Severe Systemic Lupus Erythematosus" are available on www.anthera.com.



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pSivida Corp. (NASDAQ: PSDV)
, a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, announced ILUVIEN®, the first sustained release pharmaceutical product for the treatment of chronic diabetic macular edema (DME), is now commercially available in Germany. pSivida's licensee Alimera Sciences reported that the first patient has been treated following the commercial launch in Germany.

“We are very pleased ILUVIEN is now available in Germany as well as for privately insured and private pay patients in the U.K.,” said Dr. Paul Ashton, President and Chief Executive Officer. “We are also very pleased by Alimera's resubmission of the NDA for ILUVIEN to the FDA and the recently announced PDUFA goal date of October 17, 2013. We will be entitled to 20% of net profits, as defined, in each of Germany and the U.K. from sales of ILUVIEN by Alimera. If the FDA approves ILUVIEN, we would also be entitled to an additional $25 million milestone payment from Alimera as well as 20% of net profits on any sales in the U.S. by Alimera.”


Also Tuesday:



Ablynx (EURONEXT BRUSSELS: ABLX)
today announces that it has initiated pre-clinical development of its anti-IgE Nanobody®, ALX-0962, for the treatment of severe allergic asthma, with the goal of commencing Phase I clinical development in the second half of 2014.

Aeterna Zentaris Inc. (NASDAQ:  AEZS) (TSX: AEZ)
(the "Company"), a late‑stage drug development company specializing in oncology and endocrinology, today reported financial and operating results as at and for the first quarter ended March 31, 2013.

Akorn, Inc. (NASDAQ: AKRX)
, a niche generic pharmaceutical company, today reported financial results for its first quarter ended March 31, 2013.

Alimera Sciences, Inc., (NASDAQ: ALIM)
(Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that ILUVIEN®, the first sustained release pharmaceutical product for the treatment of chronic diabetic macular edema (DME), is now commercially available in Germany.

Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH)
, a biopharmaceutical company focused on developing and commercializing products to treat autoimmune diseases, today announced that additional data from its Phase 2b PEARL-SC study will be presented in two lecture sessions at the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology in Madrid, Spain.

Arena Pharmaceuticals, Inc. (NASDAQ: ARNA)
announced today that the Office of the Federal Register filed for public inspection theUS Drug Enforcement Administration's (DEA) final rule placing BELVIQ(pronounced BEL-VEEK) into Schedule IV of the Controlled Substances Act.

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA)
today reported financial results for the first quarter, including revenue from its first cancer medicine, Iclusig® (ponatinib), which was approved last December by the U.S. Food & Drug Administration.

Arrowhead Research Corporation (NASDAQ:ARWR)
, a targeted therapeutics company, today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for U.S. Patent Application Number 13/326,433 entitled, “Peptide-Based In Vivo siRNA Delivery System.”

Baxter International Inc. (NYSE:BAX)
today announced that its Phase III clinical study of immunoglobulin (IG) did not meet its co-primary endpoints of reducing cognitive decline and preserving functional abilities in patients with mild to moderate Alzheimer’s disease.

BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX)
today announced financial results for the first quarter ended March 31, 2013.

BIOLASE, Inc. (NASDAQ: BIOL)
, the world's leading dental laser manufacturer and distributor, announced today that the United States Patent and Trademark Office ("USPTO") issued an office action in a reexamination proceeding rejecting all of the claims of Utah-based CAO Group, Inc.'s (the "CAO Group's") U.S. Patent No. 7,485,116 (the "116 Patent") that were subject to reexamination.

BioLineRx Ltd. (NASDAQ: BLRX)(TASE: BLRX)
, a biopharmaceutical development company, today reported its results for the quarter ended March 31, 2013.

Bio-Rad Laboratories, Inc. (NYSE: BIO)
and (NYSE: BIO.B), a multinational manufacturer and distributor of life science research and clinical diagnostic products, announced financial results today for the first quarter ended March 31, 2013.

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST)
today announced that the U.S. Food and Drug Administration (FDA) has granted the Company’s late-stage antibiotic candidate ceftolozane/tazobactam (CXA-201) Fast Track status in the previously granted Qualified Infectious Disease Product (QIDP) indications, Hospital-Acquired Bacterial Pneumonia (HABP)/Ventilator-Associated Bacterial Pneumonia (VABP) and Complicated Urinary Tract Infections (cUTI).

Genomic Health, Inc.  (Nasdaq: GHDX)
today announced that members of its management team will present at the 2013 Bank of America Merrill Lynch Health Care Conference in Las Vegas on Tuesday, May 14 at 5:00 p.m. Pacific Time (PT).

GW Pharmaceuticals plc (Nasdaq: GWPH, AIM: GWP)
, a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announces that it has received commercialization approval for its prescription medicine Sativex® in Italy.

LED Medical Diagnostics Inc. (TSX VENTURE:LMD) (OTCQX:LEDIF) (FRANKFURT:LME)
, a developer of tissue visualization detection technologies for the medical industry, today cited a recent clinical study documenting the ability of its VELscope® Vx Enhanced Oral Assessment adjunctive technology to detect cancerous and pre-cancerous lesions that are missed by conventional exams.

Isis Pharmaceuticals, Inc. (NASDAQ: ISIS)
announced today that it intends to offer for sale 9 million shares of its common stock in an underwritten public offering.  In connection with this offering, Isis intends to grant the underwriters an option to purchase an additional­­­­ 1.35 million shares of its common stock.  All shares in the offering are being offered by Isis.

Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX)
, a biopharmaceutical company focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease (the "Company"), today announced its results for the first quarter ended March 31, 2013.

Medidata Solutions (NASDAQ: MDSO)
announced that Steven Wilhite, a business leader and marketing executive with more than 25 years of experience building global brands, has been named chief marketing officer and executive vice president.

Novadaq® Technologies Inc. (TSX:NDQ) (NASDAQ:NVDQ)
, a developer of clinically-relevant fluorescence imaging solutions for use in surgical and outpatient wound care procedures, announced today the closing of its previously announced sale of 3,900,000 common shares, on a bought deal basis, at a price to the public of $12.90 per common share, pursuant to an underwriting agreement with Canaccord Genuity Inc. Prior to the closing,

Nuvilex, Inc. (OTCQB: NVLX)
should be convincing investors by now that its technology could truly change the face of healthcare.

OncoSec Medical Inc. (OTCQB: ONCS)
, a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumor cancers, announced that Punit Dhillon, President and CEO, will present at the Sachs Cancer Bio Partnering Forum at the Westin Copley Place in Boston, Massachusetts, on Tuesday, May 21, at 2:05 PM ET.

Osiris Therapeutics, Inc. (NASDAQ: OSIR)
, the leading stem cell company focused on developing and marketing products to treat medical conditions in inflammatory, cardiovascular, orthopedic and wound healing markets, announced today its results for the first quarter of 2013.

Plandai Biotechnology, Inc. (OTCQB: PLPL)
, a producer of highly bioavailable plant extracts for industries including health, wellness, nutraceutical, and pharmaceutical, today announced the formation of Phyto Pharmacare, Inc., a Delaware corporation, which will oversee all aspects of developing and marketing Phytofare™ extracts for pharmaceutical and drug applications.

The Pulse Beverage Corporation (OTCQB: PLSB)
("Pulse"), makers of PULSE® brand of functional beverages and Cabana™ 100% Natural Lemonade, today announced that it has secured Heidelberg Distributing Company, based in Ohio, to distribute both Cabana™ and PULSE® into the states of Ohio and Kentucky having a combined population base of 16 million.

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP)
today announced that the Company will present at the BofA Merrill Lynch 2013 Health Care Conference in Las Vegas, NV on Tuesday, May 14 at 4:20 p.m. PT (7:20 p.m. ET).

Sigma-Aldrich Corporation (NASDAQ: SIAL)
, a leading Life Science and High Technology company (the "Company"), announced today at its 2013 Annual Shareholders Meeting that the Company's Board of Directors approved a quarterly cash dividend of $0.215 per share.

Targacept, Inc. (NASDAQ: TRGT)
, a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, today reported its financial results for the first quarter ended March 31, 2013.



"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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