Recombinant in Medical Technology

PharmAthene Submits Proposal to BARDA in Response to Broad Agency Announcement for Advanced Research and Development for Valortim(R)

... SparVax(TM) - a second generation recombinant protective antigen (rPA) anthrax vaccine ... to chemical nerve agents RypVax(TM) - a recombinant dual antigen vaccine for plague A third ... the DHHS Request for Proposals for an Anthrax recombinant Protective Antigen (rPA) Vaccine for the ...

PharmAthene Submits SparVax(TM) Regulatory Strategy to FDA

... for licensure of SparVax(TM), a next generation recombinant protective antigen anthrax vaccine. The FDA ... SparVax(TM) is a novel second generation recombinant protective (rPA) anthrax vaccine being developed ... SparVax(TM) - a second generation recombinant protective antigen (rPA) anthrax vaccine ...

SAFC Biosciences(R) and Vivalis Collaborate to Optimize Cell Culture Media for Vaccines Production

... effective manufacturing of viral vaccines and recombinant proteins for human and veterinary use. This cell ... 2. The development of production systems for recombinant proteins and monoclonal antibodies. VIVALIS licenses its EB66 cell line for the production of recombinant proteins to biotechnology and pharmaceutical ...

Novel Valortim(R) Mechanism of Action Data Presented at the Keystone Symposia on Molecular and Cellular Biology

... SparVax(TM) - a second generation recombinant protective antigen (rPA) anthrax vaccine ... to chemical nerve agents RypVax(TM) - a recombinant dual antigen vaccine for plague A third ... the DHHS Request for Proposals for an Anthrax recombinant Protective Antigen (rPA) Vaccine for the ...

Novavax Reports Positive Preclinical Results for a Novel, Broadly Cross-Protective H5N1 Pandemic Influenza Virus-like Particle (VLP) Vaccine Candidate

... Results support that Novavax's recombinant Technology May Offer a Powerful, New Approach for ... assays. This study suggests that Novavax's recombinant VLP technology may be utilized for development of ... with human illness. "We believe that our recombinant VLP technology has the potential to be a ...

Novavax Presents Favorable Results from Phase I/IIa Pandemic Influenza Vaccine Program at World Health Organization Conference

... fully supported study continuation. VLPs are recombinant structures that mimic the size and shape of the ... disclosed last year, demonstrate that the Novavax recombinant VLP vaccine is a valid and potent approach ... Because the Novavax process involves recombinant technology and does not require a live influenza ...

Inspiration Biopharmaceuticals, Inc. Initiates Phase 1 Clinical Trial of IB1001 for the Treatment of Hemophilia B

... IB1001, an Intravenous recombinant Factor IX (rFIX) Product for the Treatment of ... 1 clinical trial of IB1001, an intravenous (IV) recombinant Factor IX (rFIX) product for control and ... About IB1001 IB1001 is an intravenous recombinant Factor IX product for the acute and preventative ...

ProFibrix Steps up Recombinant Fibrinogen Program With PER.C6(R) License From Crucell

... platform allows ProFibrix to manufacture recombinant human fibrinogen at levels that support ... during surgery or after trauma injury. Initially recombinant fibrinogen will be developed for ... to develop a systemic hemostat product based on recombinant fibrinogen to treat or prevent bleeding ...

Novavax Announces Top Line Results of Phase IIa Clinical Trial for Its Seasonal Influenza VLP (Trivalent) Vaccine Candidate

... seasonal vaccine different VLPs are recombinant structures that mimic the size and shape of a ... Novavax's influenza VLPs are produced through recombinant technology in insect cell culture, utilizing a ... Because the Novavax process involves recombinant technology and does not require a live influenza ...

PharmAthene Initiates Phase I Clinical Trial of Nerve Agent Bioscavenger Protexia(R)

... is produced in the milk of transgenic goats, is a recombinant version of human butyrylcholinesterase (BChE), ... the Department of Defense, which is seeking novel recombinant bioscavengers for prophylaxis against nerve agent ... include: -- SparVax(TM) - a second generation recombinant protective antigen (rPA) anthrax vaccine -- ...

Insmed Initiates Clinical Study for Follow-on Biologic Version of Neulasta(R)

... INS-20. Insmed's INS-20 is a pegylated recombinant form of human G-CSF, and an FOB of the ... bioequivalence of INS-19, the Company's recombinant human granulocyte colony stimulating factor ... over 20 years." About INS-20 Pegylated recombinant human G-CSF is a chemically modified version ...

NOVAVAX Featured at Clinton Global Initiative 2008 Annual Meeting

... influenza vaccine using the company's proprietary recombinant virus-like particles ("VLPs"). As one of the ... influenza VLPs are produced through recombinant technology in insect cell culture, utilizing a ... Because the Novavax process involves recombinant technology and does not require a live influenza ...

PharmAthene Presents Data for Protexia(R) and Valortim(R) at 2008 BARDA Industry Conference / PHEMCE Stakeholders Workshop

... Mr. Wright continued. Protexia(R), a recombinant version of human butyrylcholinesterase (BChE), is ... include: -- A study of non-pegylated recombinant BChE in a guinea pig model provides new data that ... toxins. About Protexia(R) Protexia(R) is a recombinant version of human butyrylcholinesterase (BChE), a ...

Novavax Announces Favorable Results from Phase I/IIa Pandemic Influenza Vaccine Program

... expansion to the 90 mcg dose. VLPs are recombinant structures mimicking the size and shape of ... data are exciting because they demonstrate that recombinant VLPs are a valid and potent vaccine approach ... Because the Novavax process involves recombinant technology and does not require a live influenza ...

BioMarin Initiates Phase 1 Clinical Study of PEG-PAL in PKU

... the Phase 1 clinical study of PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase) for the treatment ... with PKU. About PEG-PAL PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase) is ... and sickle cell disease, and PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase), which is currently ...

Insmed Provides Update on Follow-On Biologics and IPLEX(TM) Programs

... IPLEX(TM) IPLEX(TM) is a complex of recombinant human insulin-like growth factor-I (rhIGF-I) and ... products come off patent." About INS-19 recombinant human G-CSF is a protein that is produced in ... of Neupogen(R). About INS-20 Pegylated recombinant human G-CSF is a chemically modified version ...

Protalix BioTherapeutics Extends Research Agreement With Yissum Based on Promising Acetylcholinesterase Program Results in Animal Study

... system to generate a broad spectrum of human recombinant therapeutic proteins." Nava Swersky Sofer, ... development and commercialization of proprietary recombinant therapeutic proteins to be expressed through its ... a proprietary method for the expression of recombinant proteins that Protalix believes is safe and ...

Halozyme Therapeutics Announces Peer-Reviewed Publications of the INFUSE-LR Clinical Trial Results and Clinical Practice Experience With Hylenex

... R et al. Initial Experiences with Subcutaneous recombinant Human Hyaluronidase (rHuPH20). J Pall Med. ... includes the active pharmaceutical ingredient recombinant human hyaluronidase (rHuPH20) and is approved by ... and only FDA-approved hyaluronidase from a recombinant human source. Sub-Q hydration is the introduction ...

Baxter Announces Recombinant Factor IX Development Program For Hemophilia B

... it has initiated pre-clinical programs to develop recombinant Factor IX proteins to treat hemophilia B. Baxter will develop both an unmodified recombinant Factor IX therapy for treatment of acute bleeding ... and a chemically modified, long-acting version of recombinant Factor IX therapy for prophylaxis of bleeding ...

CSL Behring Study in Animal Models Shows Feasibility of Developing a Half-Life Extended Recombinant FVIIa that Retains Biologic Activity

... In data presented at the ASH 49th annual meeting recombinant factor VIIa-albumin fusion protein seen as ... activity comparable to wild type rFVIIa. recombinant factor VIIa (rFVIIa) may be used to control ... need during surgical interventions." recombinant VIIa-FP represents CSL Behring's initial ...

Inspiration Biopharmaceuticals Announces Filing of IND for Novel Recombinant Factor IX Product, IB1001, for the Treatment of Hemophilia B

... clinical trials with IB1001, an intravenous recombinant Factor IX (rFIX) product for the on demand and ... B is caused by a deficiency of Factor IX. About recombinant Protein Manufacturing Technology Inspiration ... lead product candidate, an intravenous recombinant Factor IX, has completed preclinical testing and ...

GeoVax Successful HIV/AIDS Vaccine Trial Data Presented at AIDS Vaccine 2007 Conference

... MD in a talk "HIV-1 DNA Prime followed by recombinant MVA Boost is Well Tolerated and Immunogenic When ... and filed patent applications. GeoVax's DNA and recombinant MVA HIV/AIDS vaccines: -- Uses DNA for priming the vaccine responses and recombinant MVA to boost the vaccine response (DNA/MVA ...

Protalix BioTherapeutics Treats First Patient in Phase III Clinical Trial of prGCD

... prGCD, a proprietary plant cell expressed recombinant form of human Glucocerebrosidase (GCD) for the ... a proprietary method for the expression of recombinant proteins that Protalix believes is safe and ... cost-effective, industrial-scale production of recombinant therapeutic proteins. Protalix has reached ...

ImmuneRegen BioSciences Reports Material Transfer Agreement with VaxGen, Inc.

... VaxGen's recombinant Protective Antigen Anthrax Vaccine to be tested ... of VaxGen's anthrax vaccine candidate, recombinant Protective Antigen, or rPA, to be tested at one ... is separate from VaxGen's effort to partner its recombinant anthrax vaccine program with another company ...

NOVAVAX Achieves Pandemic H1N1 Influenza Production Milestone

... and successful test of our VLP technology. With further scale up, recombinant influenza VLP vaccine technology has the potential to expand vaccine surge ... particle (VLP) technology. The company produces these VLP-based, potent, recombinant vaccines utilizing new and efficient manufacturing approaches. Additional ...

New Data Supports Significant Economic and Clinical Value of MENOPUR(R) in IVF

... Hormone. Efficacy and safety of highly purified menotropin versus recombinant follicle-stimulating hormone in in vitro fertilization/intracytoplasmic ... et al. Clinical outcome following stimulation with highly purified hMG or recombinant FSH in patients undergoing IVF: a randomized assessor-blind controlled ...

CeNeRx BioPharma Obtains Rights to Novel Drug Candidate for Prevention and Treatment of Neurodegeneration Disorders

... a potential therapy for neuropathies and neurodegenerative diseases, but recombinant NGF lacks key qualities needed for successful CNS drugs," said Dr. Daniel ... NGF, but without the pharmacokinetic and administration challenges of recombinant NGF. Most notably, CXB909 crosses the blood brain barrier, has a long ...

DSM Announces Yield Boosts of 5-10 Fold With XD(R) Technology for Mammalian Manufacturing Platforms

... available media. The XD(R) Technology has been tested for antibody and recombinant protein production across multiple cell lines, and the increase was ... the high-producing PER.C6(R) human cell line as a production platform for recombinant proteins and monoclonal antibodies. The combination of the PER.C6(R) human ...

Corgenix, Tulane Announce Award of NIH Grant Extending Hemorrhagic Fever Virus Product Development Program

... the original grant awarded in 2005, the group developed and patented new recombinant proteins for Lassa virus and developed several viral detection products ... maturation. The company's contract division has developed over 150 recombinant proteins in multiple expression systems including 12 biologic drugs in ...

PharmAthene to Host a Conference Call and Webcast on Wednesday, April 29th at 4:30 PM to Provide an Update on the SparVax(TM) rPA Anthrax Vaccine Program

... programs include: SparVax(TM) - a second generation recombinant protective antigen (rPA) anthrax vaccine Third generation rPA ... associated with exposure to chemical nerve agents RypVax(TM) - a recombinant dual antigen vaccine for plague For more information ...

XTL Biopharmaceuticals Announces the Acquisition of the Use Patent on Recombinant Erythropoietin (rHuEPO) for the Treatment of Multiple Myeloma

... with Bio-GAL Ltd, a private company, for the rights to a use patent on recombinant Erythropoietin ("rHuEPO") for the prolongation of multiple myeloma ("MM") ... Erythropoietin is available as a therapeutic agent produced by recombinant DNA technology in mammalian cell culture, rHuEPO, which is used in ...

InVitria Showcases Cell Culture Productivity Enhancers at BioProcess International

... ingredient and biopharmaceutical formulation excipient. Cellastim is a recombinant protein and has been shown to improve mammalian cell culture ... cell lysis. Lysobac is used in bacterial fermentation to improve recombinant protein yields.(see http://www.Lysobac.com ) For more information ...

Insmed Announces First Human Bioequivalence Data for a Follow-on Biologic by a U.S. Company

... that it has demonstrated the bioequivalence of INS-19, the company's recombinant human granulocyte colony stimulating factor (G-CSF), compared to ... 10 years and $236 billion to $378 billion over 20 years." About INS-19 recombinant human G-CSF is a synthetic version of a human G-CSF that is produced in ...

Schering-Plough Announces Phase III Data for Sustained Follicle Stimulant

... started cycle) was similar to that achieved in patients receiving 200 IU recombinant FSH (follitropin beta) (38.1 percent per started cycle). The number of ... alfa 150 mcg or a daily dose of 200 IU recombinant FSH, followed by recombinant FSH (maximum 200 IU/day) from stimulation day 8 onward. Starting on ...

Halozyme Therapeutics Announces Phase I Clinical Trial Results Demonstrating that the Combination of Recombinant Human Hyaluronidase (rHuPH20) With Humulin R(R) and with Humalog(R) Yields Faster, More Physiologic Insulin Kinetics and Better Predictability

... Sessions. The data showed that combining the company's proprietary recombinant human hyaluronidase enzyme (rHuPH20) with Humulin R(R) (regular insulin ... in studies with diabetic patients, the co-formulation of rHuPH20 with recombinant insulin products may close the gap between currently available therapies ...

Bayer HealthCare Celebrates 20th Anniversary of Kogenate(R) Product Line and 8 Billion IU Milestone at 2008 WFH World Congress

... clinical trials began in May 1988 in Bonn, Germany. This advent of recombinant factor VIII technology represented a leap forward in the delivery of safe, ... people living with hemophilia. We are the only company with a long-acting recombinant factor VIII protein in human clinical trials. We are also creating new and ...

New Data on MAGE-A3 Cancer Immunotherapy Support Potential Novel Options of Treating Non-Small Cell Lung Cancer and Melanoma

... been conducted. In this study, the ASCI, which is a combination of MAGE-A3 recombinant protein and a GSK proprietary Adjuvant System, was evaluated and resultant ... cancer immunotherapeutics combine tumor antigens, delivered as purified recombinant proteins, and GSK's proprietary Adjuvant Systems which are specific ...

Amylin Pharmaceuticals Initiates Phase 2B Dose-Ranging Clinical Study of Pramlintide/Metreleptin Combination Treatment in Obesity

... combinations of pramlintide, an analog of the natural hormone amylin, and recombinant human leptin (r-metHuLeptin; metreleptin) for the treatment of obesity. ... obesity studies was mild, transient nausea. Metreleptin (methionyl recombinant leptin; r-metHuLeptin) is an analog of human leptin, a neurohormone ...

Insmed Initiates Clinical Study for Follow-on Biologic Version of Neupogen(R)

... a follow-on biologic (FOB) product candidate. Insmed's INS-19, which is a recombinant form of human G-CSF, is a follow-on biologic of the FDA-approved product ... 10 years and $236 billion to $378 billion over 20 years." About INS-19 recombinant human G-CSF is a synthetic version of a human G-CSF that is produced in ...

PharmAthene's Recombinant Butyrylcholinesterase (rBChE) May Play A Neuroprotective Role in Alzheimer's Disease

... peptides for use in the field of Alzheimer's disease. About Protexia(R): recombinant Human Butyrylcholinesterase (rBChE) Protexia is a pegylated form of recombinant human butyrylcholinesterase (rBChE), a potent organophosphorous (OP) ...