Biopharmaceutical News and Research

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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

Cyntellect releases new cell cytometry system

Cyntellect, Inc., a privately-held life sciences company commercializing products to advance life science and stem cell research, biopharmaceutical production, and drug discovery, today unveiled its Celigo™ adherent cell cytometry system, the Company’s new platform for non-invasive in situ live cell imaging.

21 Sep 2009

Results of Phase 1 study of Oral AEZS-112 announced by Aeterna Zentaris

Æterna Zentaris Inc. (TSX: AEZ; Nasdaq: AEZS) ("the Company"), a global biopharmaceutical company focused on endocrine therapy and oncology, today announced the completion of a Phase 1 study of its orally-active tubulin and topoisomerase II inhibitor compound, AEZS-112, in patients with advanced solid tumors or lymphoma, which may potentially provide a new therapeutic approach for the treatment of cancer.

21 Sep 2009

Sorrento Therapeutics merge with subsidiary of Quikbyte Software

Sorrento Therapeutics, Inc. ("STI"), a privately-held and development-stage biopharmaceutical company with a proprietary technology platform for the discovery and development of human therapeutic antibodies for the treatment of a variety of disease conditions, has merged with a wholly-owned subsidiary of QuikByte Software, Inc. (OTC Bulletin Board: QBSW), a publicly-traded company with no active operations.

21 Sep 2009

Bioniche Life Sciences' revenue increases by 21% for the fiscal year 2009

Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today announced financial results for its 2009 fiscal year ended June 30, 2009.

21 Sep 2009

Jennerex raises funds through private placement for clinical development programs

Jennerex, Inc. (San Francisco, CA and Ottawa, Ontario), a clinical stage biopharmaceutical company developing a proprietary breakthrough product class of targeted oncolytic virus therapeutics, today announced the Second and final closing of a private placement financing with aggregate gross proceeds of US $5,611,475, exceeding the target of US $5 million.

19 Sep 2009

Second-quarter 2009 unaudited results announced by Deltagen

Deltagen, Inc. (Pink Sheets: DGEN), a leading provider of drug discovery tools to the biopharmaceutical industry, today reported unaudited consolidated financial results for the three months ended June 30, 2009.

19 Sep 2009

Bioniche announces fiscal 2009 year-end results

Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today announced financial results for its 2009 fiscal year ended June 30, 2009.

19 Sep 2009

Biopharmaceutical company announces initial public offering

Omeros Corporation today announced the launch of its initial public offering of 6.82 million shares of its common stock. Omeros is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation and disorders of the central nervous system.

18 Sep 2009

Notice of Allowance issued by PTO for OSI's EGFR drug

OSI Pharmaceuticals, Inc. announced today that the U.S. Patent & Trademark Office has issued a “Notice of Allowance” in OSI’s reissue application for U.S. Patent No.5,747,498 (the ‘498) composition of matter patent for Tarceva® (erlotinib). The reissued patent will replace the original ‘498 patent and have the same November 2018 expiration date.

18 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

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

Cyntellect announces commercial availability of Stem Cell Manager

Cyntellect, Inc., a privately-held life sciences company commercializing products to advance life science and stem cell research, biopharmaceutical production, and drug discovery, announced today the commercial availability of Stem Cell Manager powered by LEAP.

16 Sep 2009