Biopharmaceutical News and Research

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Real-time data access can improve quality and efficiency of drug development

Technologies to capture and view clinical trial data in real time offer great potential to enhance patient safety, strengthen trial quality and accelerate drug development, but they also require new guidelines to ensure trial integrity, according to the white paper "Using Real-Time Data to Drive Better Decisions, Faster" released today by Quintiles, the world's leading biopharmaceutical services company.

14 Oct 2010

Dyadic International receives sixth USPTO patent

Dyadic International, Inc. a global biotechnology company focused on the discovery, development, manufacture and sale of enzyme and protein products and solutions for the bioenergy, industrial enzyme and biopharmaceutical industries, announced today that it has been issued U.S. Patent No. 7,794,962 by the United States Patent and Trademark Office.

14 Oct 2010

Acceleron announces ACE-031 Phase 1b study results

Acceleron Pharma, Inc., a biopharmaceutical company developing novel therapeutics that modulate the growth of cells and tissues including muscle, bone, fat, red blood cells and the vasculature, today announced preliminary results from a Phase 1b study to assess the safety, tolerability and pharmacodynamic (PD) activity of ACE-031 following multiple ascending doses in healthy postmenopausal volunteers.

14 Oct 2010

Shire acquires 99.21% of Movetis shares

Shire plc, the global specialty biopharmaceutical company, announces that its wholly owned subsidiary Shire Holdings Luxembourg S.a.r.l. acquired 99.21% of the shares of Movetis NV on October 12, 2010, following a successful tender offer launched in September 2010.

13 Oct 2010

Prosensa receives £7.5M milestone payment in GSK2402968 Phase IIa trial for DMD

Prosensa, the Dutch biopharmaceutical company focusing on RNA modulating therapeutics, has announced that it received a £7.5m milestone payment from GlaxoSmithKline (GSK) as a result of achieving a data milestone in its Phase IIa open label extension trial of GSK2402968 (PRO051), being developed to treat Duchenne Muscular Dystrophy (DMD) under its agreement with GSK. The milestone payment was based upon achievement of a successful safety review, with no serious safety signals observed.

13 Oct 2010

Immunomedics receives additional patent claims for antibody therapy

Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company primarily focused on the development of monoclonal, antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced that additional claims for the patent family "Method and kit for imaging and treating organs and tissue," were issued as U.S. Patent No. 7,811,570.

13 Oct 2010

CSL to distribute Cerus' INTERCEPT Blood System in Australia, New Zealand

Cerus Corporation announced today that it has entered into an agreement with CSL Limited, Biotherapies division to distribute Cerus' INTERCEPT Blood System for platelets in Australia and New Zealand. The INTERCEPT Blood System is designed to provide increased protection from a broad range of transfusion-transmitted pathogens, including bacteria and emerging pathogens such as the dengue and chikungunya viruses.

13 Oct 2010

Auxilium receives USPTO patent for XIAFLEX product

Auxilium Pharmaceuticals, Inc. a specialty biopharmaceutical company, today announced that the United States Patent and Trademark Office issued U.S. Patent No. 7,811,560 claiming, among other things, purified collagenase, the active component in Auxilium's product XIAFLEX (collagenase clostridium histolyticum).

13 Oct 2010

Alimera to present Iluvien Phase 3 clinical trial data at AAO annual meeting

Alimera Sciences, Inc., a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that data from its Phase 3 (FAME) clinical trials for Iluvien will be presented this month at the annual meeting of the American Academy of Ophthalmology (AAO) in Chicago.

12 Oct 2010

UCB, Synosia Therapeutics announce new strategic partnership in neurology

UCB and Synosia Therapeutics announced today a new strategic partnership in neurology. Synosia has granted UCB a license for exclusive, worldwide rights to the development compound SYN-115 and rights to a second compound, SYN-118, for non-orphan indications. Both are in Phase II clinical development for the treatment of Parkinson's disease.

12 Oct 2010

Halozyme Therapeutics to advance core proprietary programs through key clinical inflection points

Halozyme Therapeutics, Inc., a biopharmaceutical company developing and commercializing products targeting the extracellular matrix, today announced a focusing of its resources on advancing its core proprietary programs through key clinical inflection points in 2011 and 2012, and supporting strategic alliances with Roche and Baxter such as validation of Halozyme's commercial scale manufacturing process to produce kilogram quantities of enzyme.

12 Oct 2010

BioSystem Development completes $978,000 investment round

BioSystem Development, a privately held life science analytics company, announces a recently completed investment round that raised $978,000 (USD) in funding. The proceeds will be used to expand manufacturing infrastructure and to launch new products into the biopharmaceutical development market.

12 Oct 2010

Access highlights clinical benefits of MuGard at ESMO conference

Access Pharmaceuticals, Inc., a biopharmaceutical company specializing in products for cancer and supportive care, announced the highlights from a poster presentation on European clinical experience of MuGard at this year's European Society of Medical Oncology Conference in Milan, Italy.

11 Oct 2010

ImaginAb and Imanet enter master service agreement for pre-clinical and clinical imaging

ImaginAb, Inc. and Imanet have signed a master service agreement for pre-clinical and clinical imaging. This agreement supports the development strategy for ImaginAb's pipeline of next generation diagnostic imaging agents based on recombinant antibody fragments. The Imanet™ network of Positron Emission Tomography (PET) imaging sites provides assistance in all aspects of PET imaging-based clinical trials: from proof-of-concept radiochemistry to clinical imaging, with more than 40 PET research tracers.

11 Oct 2010

AVEO presents tivozanib Phase 2 study results at ESMO Congress

AVEO Pharmaceuticals, Inc. a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that previously reported results from its Phase 2 study evaluating tivozanib for the treatment of advanced renal cell carcinoma (RCC) were presented at the 35th European Society for Medical Oncology (ESMO) Congress in Milan, Italy.

11 Oct 2010

OXiGENE announces ZYBRESTAT Phase 2/3 study results at ESMO Congress

OXiGENE, a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced that an ongoing analysis of positive results reported earlier from a randomized, controlled, Phase 2/3 study of ZYBRESTAT (fosbretabulin, CA4P) were presented today at the 35th European Society of Medical Oncology (ESMO) Congress in Milan, Italy by Julie Ann Sosa, M.D., F.A.C.S., of Yale University.

11 Oct 2010

Promising clinical data of ImmunoGen's lorvotuzumab mertansine to be presented at ESMO conference

ImmunoGen, Inc., a biopharmaceutical company that develops targeted anticancer therapeutics using its Targeted Antibody Payload (TAP) technology, today announced the presentation of encouraging clinical data for the Company's lorvotuzumab mertansine (IMGN901) targeted anticancer compound at the 35th European Society for Medical Oncology (ESMO) Conference being held in Milan, Italy, October 8-12, 2010.

11 Oct 2010

Auxilium commences dosing in global XIAFLEX phase III program for Peyronie's disease

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced that the first subject has been dosed in the global phase III program of XIAFLEX® for the treatment of Peyronie's disease. Peyronie's disease is the development of scar tissue on the penis that can cause the penis to curve during erection, often interfering with or preventing intercourse and resulting in psychological distress or bother for the patient.

11 Oct 2010

Ipsen announces sale of shares in PregLem Holding to Gedeon Richter

Ipsen today disclosed that it has sold its shares in PregLem Holding SA to Gedeon Richter Plc, as have all PregLem's other shareholders.

11 Oct 2010

BiondVax commences Multimeric-001 flu vaccine Phase IIa clinical study

BiondVax Pharmaceuticals Ltd., an Israeli biopharmaceutical company at the forefront of global efforts towards the development of a Universal Influenza Vaccine, today announced that it has begun to immunize subjects in a Phase IIa clinical trial of the Multimeric-001 Universal Flu Vaccine candidate. The study will evaluate the safety and immunogenicity of the Multimeric-001 vaccine.

11 Oct 2010