Biopharmaceutical News and Research

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Oculus launches Microcyn Skin & Wound HydroGel OTC

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 chronic and acute wounds, today launched Microcyn Skin & Wound HydroGel for both the U.S. professional and over-the-counter markets. The Microcyn HydroGel received FDA 510(k) marketing clearance in May of this year.

29 Sep 2009

Laureate Pharma sign development and manufacturing agreement with ZZ Biotech

Laureate Pharma, Inc., a full-service biopharmaceutical development and protein production company, today announced that it has entered into a development and manufacturing agreement with ZZ Biotech, LLC. According to the agreement, Laureate will produce Activated Protein C variant under cGMP conditions. Terms of the manufacturing agreement were not disclosed.

28 Sep 2009

Auxilium Pharmaceuticals declares pricing of common stock shares

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced the pricing of a public offering of 3 million shares of its common stock.

26 Sep 2009

RXi Pharmaceuticals acquires self-delivering rxRNA technology platform from Advirna

RXi Pharmaceuticals Corporation, a biopharmaceutical company pursuing the development and commercialization of proprietary therapeutics based on RNA interference (RNAi), today announced that it has recently acquired direct ownership of technology for which it had previously exercised its option to exclusively license from Advirna LLC.

25 Sep 2009

Qrxpharma forms an alliance with Liaoning Nuokang Medicines to commercialise its venomics assets

QRxPharma Limited,announced today a strategic alliance with Liaoning Nuokang Medicines Co. Ltd. ("Nuokang"), a Chinese biopharmaceutical company based in Shenyang, China, to develop and commercialise QRxPharma's venomics assets for the Chinese market.

25 Sep 2009

Partial success reported in the Phase 3 trial of HIV/AIDS vaccine

GeoVax Labs, Inc., an Atlanta-based, biopharmaceutical company developing human vaccines for HIV/AIDS (HIV-1, Human Immunodeficiency Virus), was pleased to hear the announcement today of partial success in the recently completed Phase 3 trial in Thailand of a candidate HIV/AIDS vaccine owned by Sanofi-Aventis and Global Solutions for Infectious Diseases.

25 Sep 2009

Octapharma AG submits Biological License Application for its octagam(R) 10% to FDA

Octapharma AG recently submitted its Biological License Application for octagam(R) 10% (human normal intravenous immunoglobulin, liquid) to the U.S. Food and Drug Administration (FDA) with the goal of expanding the biopharmaceutical company's U.S. immune globulin therapy portfolio by early 2010. The application was submitted for the treatment of Idiopathic Thrombocytopenic Purpura (ITP), a blood-clotting disorder that can result in excessive bruising and bleeding.

24 Sep 2009

ThromboGenics completes enrollment for MIVI-TRUST clinical trial

ThromboGenics NV, a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, vascular disease and cancer, announces today that it has completed the enrolment of the US Phase III trial evaluating microplasmin for the non-surgical treatment of eye disease.

24 Sep 2009

Court rules in favor of Eli Lilly for Evista's method-of-use patents

The U.S. District Court for the Southern District of Indiana today upheld Eli Lilly and Company's (NYSE: LLY) method-of-use patents on Evista(R) (raloxifene HCl tablets). In the case of Eli Lilly and Company v. Teva Pharmaceuticals Industries Ltd., the court ruled in favor of Lilly on all accounts for these method-of-use patents, including the patent doctrines of obviousness, enablement, and inequitable conduct.

24 Sep 2009

New Fluorescence Molecular Tomography imaging systems from VisEn Medical

VisEn Medical Inc., a leader in fluorescence in vivo imaging from research through medicine, announced the launch and availability of a new Fluorescence Molecular Tomography (FMT) imaging system -- the FMT 1500, and an advanced version of its FMT 2500, the FMT 2500 LX.

23 Sep 2009

NASDAQ halts trading in CombinatoRx's common stock

CombinatoRx, Incorporated (NASDAQ: CRXX) announced that NASDAQ has halted trading in the Company’s common stock today.

23 Sep 2009

Alimera Sciences starts pilot study of Iluvien intravitreal insert

Alimera Sciences, Inc., a privately held biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today reported that enrollment has begun for a pilot study to assess the safety and efficacy of Iluvien(R) in patients with macular edema secondary to retinal vein occlusion.

23 Sep 2009

Second annual study of FDA drug review released

PAREXEL Consulting, a business unit of PAREXEL International (Nasdaq: PRXL) and a leading global life sciences consultancy serving the biopharmaceutical and medical device industries, today released its second annual study on the state of the U.S. Food and Drug Administration (FDA) drug review process.

From Parexel 23 Sep 2009

Research reveals balancing act between sugar-coated nanoparticles

A research team at the National Institute of Standards and Technology (NIST) studying sugar-coated nanoparticles for use as a possible cancer therapy has uncovered a delicate balancing act that makes the particles more effective than conventional thinking says they should be. Just like individuals in a crowd respecting other people's personal space, the particles work because they get close together, but not too close.

23 Sep 2009

FDA committees to review Neuromed’s NDA for Exalgo

CombinatoRx, Incorporated (NASDAQ: CRXX) and Neuromed Pharmaceuticals, Inc., a privately-held biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has posted on its website briefing documents for the September 23, 2009 joint meeting of its Anesthetics and Life Support Advisory Committee and its Drug Safety and Risk Management Advisory Committee.

23 Sep 2009

China SFDA awards Jiangsu Yanshen a new drug certificate and production license for its H1N1 vaccine

Simcere Pharmaceutical Group (NYSE: SCR) ("Simcere" or the "Company"), a leading manufacturer and supplier of branded generic and innovative pharmaceuticals in China, today announced that Jiangsu Yanshen Biological Technology Stock Co., Ltd ("Jiangsu Yanshen"), in which Simcere holds a 37.5% stake, was awarded a new drug certificate and production license from China's State Food and Drug Administration (SFDA) on September 18 for Jiangsu Yanshen's H1N1 vaccine.

22 Sep 2009

Emissary Capital begins investment research coverage on Sinobiopharma

Emissary Capital Group, Inc. has initiated investment research coverage on Sinobiopharma, Inc. (OTC Bulletin Board: SNBP) with a Buy rating and target price of $1.00-$1.25.

22 Sep 2009

GeoVax requests FDA meeting to discuss IND for its therapeutic HIV/AIDS vaccine

GeoVax Labs, Inc. (OTC Bulletin Board: GOVX) (the "Company"), an Atlanta-based, biopharmaceutical company developing human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents, today announced that it has requested a pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA) to discuss a proposed IND for GeoVax's therapeutic vaccine as a treatment for individuals infected with HIV/AIDS.

22 Sep 2009

Interim data from Micromet's T-cell engaging BiTE antibody study for treating solid tumors

Micromet, Inc. (Nasdaq: MITI), a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases, today presented first interim data from a phase 1 dose-escalation clinical study for BiTE antibody MT110, the first T-cell engaging antibody for the treatment of solid tumors.

22 Sep 2009

Provectus' Phase 2 clinical trial of PV-10 for metastatic melanoma complete

Provectus Pharmaceuticals, Inc. (OTC BB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, has completed the treatment portion, including all protocol-allowed retreatments of all patients, of its Phase 2 clinical trial of PV-10 for metastatic melanoma. The study involved treatment of 80 subjects with Stage III or Stage IV metastatic melanoma.

21 Sep 2009