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APP Pharmaceuticals announces FDA marketing approval of Deferoxamine Mesylate

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ:APCVZ) announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Deferoxamine Mesylate for Injection, USP, in two dosage strengths. Deferoxamine Mesylate is therapeutically equivalent to the reference-listed drug Desferal®, which is marketed by the innovator Novartis.

17 Sep 2009

Study: Therapy addition reduces risk of stroke and other cardiovascular events

Data from the independent KYOTO HEART study, presented recently at the European Society of Cardiology (ESC) Congress in Barcelona, Spain, and published online in the European Heart Journal demonstrated the addition of the angiotensin receptor blocker (ARB) Diovan (valsartan) to a non-ARB-based treatment regimen for high blood pressure provided a significant 45% relative risk reduction in cardiovascular events(1) including stroke, compared to conventional non-ARB treatment regimen.(1)

17 Sep 2009

Genentech releases Phase III PRIMA study findings

Genentech, Inc., a wholly-owned member of the Roche Group and Biogen Idec, today announced that a Phase III study (PRIMA) showed that patients with follicular lymphoma who continued receiving Rituxan (rituximab) alone after responding to Rituxan and chemotherapy lived longer without their disease worsening (progression-free survival or PFS) than those who did not continue to receive Rituxan.

17 Sep 2009

Fully-insured members of Capital BlueCross to receive coverage for administration fee for H1N1 Flu vaccine

Capital BlueCross announced today that it will cover an administration fee for the H1N1 Flu vaccine for fully-insured members and those with individual coverage during the upcoming 2009-2010 flu season. Self-funded groups may opt to have their coverage customized to include this benefit.

17 Sep 2009

GENova to sign extensive collaboration agreement with Beckpharma

GENova Biotherapeutics Inc. ("GENova"), a biotechnology company that develops novel therapeutic proteins that disrupt the advance of life-threatening cancers, today announced it is in final negotiations with Beckpharma Ltd. ("Beckpharma") -a pharmaceutical development company also involved in cancer treatments for an extensive collaboration agreement.

17 Sep 2009

FDA approves Sirion's Zirgan for treating acute herpetic keratitis

Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced today that the US Food and Drug Administration (FDA) has approved its New Drug Application for Zirgan(TM) (ganciclovir ophthalmic gel) 0.15% as a treatment for acute herpetic keratitis (dendritic ulcers). The FDA granted orphan drug designation to Zirgan for this indication in April 2007.

17 Sep 2009

FDA Advisory Committee recommends marketing approval for Auxilium's XIAFLEX to treat Dupuytren's contracture

Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced that the Arthritis Advisory Committee appointed by the U.S. Food and Drug Administration (FDA) recommended by a unanimous vote of 12 to 0 that XIAFLEX™ (collagenase clostridium histolyticum), a novel, first-in-class, orphan-designated, biologic, be granted marketing approval by the FDA for the treatment of Dupuytren's contracture.

17 Sep 2009

Administrative cost of H1N1 vaccine to be covered for CIGNA's customers

The spread of the H1N1 influenza virus has the potential to make this year’s flu season more severe than usual. The Centers for Disease Control and Prevention (CDC) has designated vaccination as the most powerful public health tool to control influenza.

17 Sep 2009

BioSpecifics Technologies' XIAFLEX receives marketing approval from FDA

BioSpecifics Technologies Corp. (Nasdaq: BSTC), a biopharmaceutical company developing first-in-class collagenase-based products, today announced that the Arthritis Advisory Committee appointed by the U.S.

17 Sep 2009

OCLS' partnership with V&M Industries to market Microcyn-based skin and wound care products

Oculus Innovative Sciences, Inc., a biopharmaceutical company that develops, manufactures and markets a family of products based upon the Microcyn Technology platform, which is intended to treat infections in chronic and acute wounds, announced today it has entered into a new strategic partnership with V&M Industries, Inc. for non-exclusive rights to market Microcyn-based skin and wound care over-the-counter products in the United States and Canada while providing Oculus with a significant percentage of those revenues.

16 Sep 2009

Keryx Biopharmaceuticals receives orphan-drug designation for a multiple myeloma drug

AEterna Zentaris Inc., ("the Company") a global biopharmaceutical company focused on endocrine therapy and oncology, today announced that Keryx Biopharmaceuticals, Inc., its partner and licensee for perifosine in the North American market, has received orphan-drug designation for this compound from the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma.

16 Sep 2009

Matrix Laboratories receives tentative FDA approval for its NDA

Mylan Inc. today announced that its privately held Indian subsidiary, Matrix Laboratories Limited, has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 600 mg/300 mg/300 mg.

16 Sep 2009

KemPharm announces nomination of its second pipeline candidate

KemPharm, Inc. today announced the nomination of its second pipeline candidate, KP201, based on its proprietary ligand activated therapy (LAT) platform. KP201 is a new chemical entity (NCE) for the treatment of pain with the possibility of reduced abuse potential. KP201 joins lead candidate KP106, which is a novel prodrug candidate in development for ADHD.

16 Sep 2009

Inovio’s novel platform for developing DNA based vaccines to be discussed at EmTech

Inovio Biomedical Corporation, a leader in DNA vaccine design, development and delivery, announced today that Dr. J. Joseph Kim, CEO, has been invited to present at EmTech, the Emerging Technologies Conference hosted by MIT and produced by MIT’s Technology Review magazine. The conference will take place September 22nd - 24th on the MIT campus in Cambridge, MA.

16 Sep 2009

Santaris Pharma establishes its operations in the U.S.

Santaris Pharma A/S, a privately-held biopharmaceutical company focused on developing RNA-based drugs targeted to disease-related mRNAs and microRNAs, today announced it has established operations in the United States. Internally and through its partners, the Company has a robust drug development pipeline including programs to treat metabolic disorders, infectious and inflammatory diseases, cancer and rare genetic disorders.

16 Sep 2009

Precise T cell correlates of protection need to be identified for vaccine design

T cells are key players in the immune response to HIV, which are able to delete infected cells. This capacity is used for vaccine development against HIV. "To date however, success of this strategy remains elusive. Our understanding of T cell efficacy is still limited, and we need to identify precise T cell correlates of protection that could guide rationale vaccine design", says Victor Appay, Group leader HIV Pathogenesis and Immunosenescence, Hopital Pitie-Salpetriere, Paris, at the 2nd European Congress of Immunology ECI 2009 in Berlin.

16 Sep 2009

RXi Pharmaceuticals to present in vivo data of rxRNA compounds

RXi Pharmaceuticals Corporation, a biopharmaceutical company pursuing the development and commercialization of proprietary therapeutics based on RNA interference (RNAi), today announced that it will be presenting new in vivo data on its self-delivering rxRNA compounds at a number of upcoming scientific conferences, detailed below.

16 Sep 2009