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Biologics in Medical Technology

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

... studies completed at the R&D labs of DSM biologics in Groningen, The Netherlands demonstrated that ... www.dsmpharmaceuticals.com . About DSM biologics DSM Biologics, a business unit of DSM ... biopharmaceutical manufacturing services, DSM biologics has co-exclusive rights, along with Dutch biotech ...

CMC ICOS Biologics and Implicit Bioscience Ltd Announce IC14 Antibody Manufacturing Agreement and Patent License

... -- Implicit Bioscience Ltd and CMC ICOS biologics today announced the execution of a manufacturing ... early pathogenesis of ALI. About CMC ICOS biologics CMC ICOS biologics is a leading contract development and ...

Isolagen, Inc. Reports Positive Top-line Results from Phase II/III Study of Isolagen Therapy(TM) to Treat Moderate to Severe Acne Scars: Study Meets All Primary Efficacy Endpoints and is Statistically Significant

... Update Regarding Isolagen's Cash Position and the biologics License Application for Wrinkles/Nasolabial Folds ... The Company is preparing to submit its biologics License Application (BLA) for Isolagen ... partnerships, and the timely filing of the biologics Licensing Application (BLA) with the FDA,. While ...

Bone Biologics Announces Significant Milestone for Spinal Fusion Surgery Using Recombinant Protein and Demineralized Bone Matrix

... is currently preparing Pre-IDE studies. Bone biologics has been developing the protein as a Platform ... both a financial and strategic partner to Bone biologics over the past four years," said Bruce A. Hazuka, ... "We are very pleased with the progress that Bone biologics has made in achieving each of their development ...

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

... Inc. (Nasdaq: INSM), a developer of follow-on biologics and biopharmaceuticals, today announced that it ... and 2015 for Neulasta(R). The Follow-on biologics Market According to published reports, an ... market trends, our entrance into the follow on biologics market may be unsuccessful, we may be unable to ...

Interface Biologics' Anti-Thrombic Additives Show Equivalent Efficacy to Commercial Heparinized Coatings

... - In a head to head comparison of Interface biologics Inc. (IBI) Endexo Anti-thrombic additives ... Ph.D., VP of MDEC. About Interface biologics Inc. Interface biologics is a biomaterials company located in ...

Dendreon Expects Interim Data Analysis for Phase 3 PROVENGE IMPACT Trial in October

... Dendreon would anticipate amending its biologics License Application (BLA) based on these interim ... for PROVENGE will not support approval for a biologics license, the risk that the FDA may interpret data ... the FDA will not approve a product for which a biologics license has been applied, the risk that the ...

Insmed CEO to Present at Congressional Briefing on Follow-On Biologics

... Patients of Passing a Follow- On biologics Approval Pathway RICHMOND, Va., July 22 ... Inc. (Nasdaq CM: INSM) a developer of follow-on biologics and biopharmaceuticals, today announced that ... in the fourth quarter of 2008. The two approved biologics represented combined 2007 worldwide sales of over ...

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

... Inc. (Nasdaq: INSM ), a developer of follow-on biologics and biopharmaceuticals for unmet medical needs, ... product, validating the idea that follow-on biologics can be a scientific reality in the U.S. and that ... Insmed has one of the most robust follow-on biologics pipelines in the industry. Building upon the ...

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

... - Company on Schedule to Have Two Follow-on biologics in Clinical Studies ... Inc. (Nasdaq: INSM), a developer of follow-on biologics (FOBs) and biopharmaceuticals, today provided an ... its IPLEX(TM) development program. Follow-On biologics Program Insmed recently received regulatory ...

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

... Inc. (Nasdaq: INSM), a developer of follow-on biologics and biopharmaceuticals, today announced that it ... a portfolio of FOBs. Members of Insmed's skilled biologics team have worked on over 50 therapeutic proteins. ... expires in 2013. The Follow-on biologics Market According to published reports, an ...

Insmed Launches National Awareness Campaign Surrounding Follow-On Biologics

... Inc. (Nasdaq: INSM), a developer of follow-on biologics and biopharmaceuticals, today announced that it ... molecule protein-based drugs, known as follow-on biologics (FOBs), which are also commonly referred to as ... two FOBs in 2008. Members of Insmed's skilled biologics team have worked on over 50 therapeutic proteins. ...

Nabi Biopharmaceuticals Announces Successful Completion of NicVAX(R) Phase 2b Trial; Drug Shows Statistically Significant Rates of Smoking Cessation and Continuous Long-Term Smoking Abstinence at 12 Months

... through two strategic business units: Nabi biologics and Nabi Pharmaceuticals. Nabi Biologics has ... agreement with Biotest AG to sell the Nabi biologics strategic business unit to ... statements about the closing of the sale of Nabi biologics and clinical trials and studies. You can ...

Dendreon Completes Target Enrollment of 500 Patients in Phase 3 IMPACT Study of Provenge(R) For Advanced Prostate Cancer

... survival from the IMPACT study to amend the biologics License Application (BLA) and support the ... for PROVENGE will not support approval for a biologics license, the risk that the FDA may interpret data ... the FDA will not approve a product for which a biologics license has been applied, the risk that the ...

Nabi Biopharmaceuticals Announces Second Quarter 2007 Financial Results

... of two strategic business units (SBUs) -- Nabi biologics and Nabi Pharmaceuticals -- to realign and ... for these segments were: -- Nabi biologics revenues were $20.8 million in the second quarter ... and Nabi-HB products, respectively. Nabi biologics operated as a profitable SBU, with an ...

Human Genome Sciences and GlaxoSmithKline Announce Positive Phase 3 Study Results for BENLYSTA(TM) in Systemic Lupus Erythematosus

... from BLISS-76 will be analyzed after 52 weeks in support of a potential biologics License Application in the United States and Marketing Authorization ... will continue to face risks related to FDA's approval of the Company's biologics License Application for ABthrax. If the Company is unable to meet ...

Fate Therapeutics Announces First Patient Treated in Phase 1b Clinical Trial of FT1050 for Hematopoietic Stem Cell Support

... "The mission of Fate Therapeutics is to develop small molecules and biologics that modulate adult stem cells within the body for regenerative medicine," ... Therapeutics' platform of Stem Cell Modulators (SCMs), small molecules and biologics that seek to modulate adult stem cells within the body to guide a desired ...

Scientific Data Relating to Cinryze(TM) Presented at 6th Annual C1 Inhibitor Deficiency Workshop

... In February 2009, ViroPharma was granted priority review of a supplemental biologics License Application for Cinryze for the treatment of acute attacks of HAE. ... this press release include statements regarding ViroPharma's supplemental biologics License Application for Cinryze for the treatment of acute attacks of HAE ...

Human Genome Sciences Submits Biologics License Application to FDA for ABthrax(TM)

... Sciences, Inc. (Nasdaq: HGSI ) today announced that it has submitted a biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) ... will continue to face risks related to FDA's approval of the Company's biologics License Application for ABthrax. If the Company is unable to meet ...

BioVex to Report Phase I/II Clinical Trial Results for the Front Line Treatment of Head and Neck Cancer With OncoVEX GM-CSF at the 2009 American Society of Clinical Oncology Meeting

... May 15 /PRNewswire/ -- BioVex Inc, a company developing next generation biologics for the treatment and prevention of cancer and infectious disease, ... manufacturing facility. The Company is developing a new class of potent biologics for the treatment of cancer and prevention of infectious disease. ...

Data Presented at AUA Demonstrate PROVENGE Significantly Prolongs Survival for Men With Advanced Prostate Cancer in Pivotal Phase 3 IMPACT Study

... additional clinical trials for PROVENGE will not support approval for a biologics license, the risk that the FDA may interpret data differently than we do ... expected, the risk that the FDA will not approve a product for which a biologics license has been applied, the risk that the results of a clinical trial ...

Cardium Reports on Applicability of Corgentin to Stem Cell Therapies: Independent Studies Indicate that Ad5IGF-1 Potentiates Stem Cells to Improve Cardiac Function After Heart Attack

... risks and uncertainties that are inherent in the development of complex biologics and the conduct of human clinical trials, including the timing, costs and ... limited experience in the development, testing and marketing of complex biologics and therapeutic hypothermia devices and whether our efforts to accelerate ...

DSM Obtains Exclusive World-Wide License for Innovative Drug Delivery Technology

... Life Sciences applications. MediVas' technology for the delivery of biologics and drugs is based on a next generation set of polymers exclusively ... medical advancements. By combining therapeutic proteins and other biologics with a MediVas polymer, delivery routes that were previously unattainable, ...

Human Genome Sciences Announces Fourth-Quarter and Full-Year 2008 Financial Results and Key Developments

... Services (HHS). Also under the contract, the Company plans to file a biologics License Application (BLA) with the FDA in the second quarter of 2009. HGS ... to acceptance of future shipments and FDA's approval of the Company's biologics License Application for ABthrax, if and when it is submitted. If the ...

American Academy Of Orthopaedic Surgeons 2009 Annual Meeting 'Highlights and Hot Topics'

... anesthetics due to the possible risk of chondrolysis. Orthopaedic biologics Hold Promise ( ... potential therapeutic agents are now being explored. Many of these new biologics are focused at stimulating bone growth and bone fusion. Advances also ...

Ambrx and Merck Serono Expand Collaboration Through ARX424 Multiple Sclerosis Drug Development Alliance

... Ambrx Inc. is a clinical stage biopharmaceutical company with a broad biologics platform that allows it to create best-in-class protein therapeutics, ... completed initial clinical trials. The company has further validated its biologics platform through substantial partnerships with Eli Lilly and Company and ...

Halozyme Therapeutics Announces Roche Begins Phase 1 Clinical Trial and Selects Fourth Exclusive Biologic Target

... through our collaboration. Roche is a global leader in the development of biologics and we are excited that they have selected a fourth exclusive target, in ... agreement with Roche to provide rHuPH20 for use in formulations with biologics directed against Roche targets covered under the licensing and ...

Dendreon Announces Interim Data From Phase 3 PROVENGE IMPACT Trial

... additional clinical trials for PROVENGE will not support approval for a biologics license, the risk that the FDA may interpret data differently than we do ... expected, the risk that the FDA will not approve a product for which a biologics license has been applied, the risk that the results of a clinical trial ...

Dendreon Initiates Phase 2 Trial of PROVENGE in Patients With Localized Prostate Cancer Prior to Surgery

... additional clinical trials for PROVENGE will not support approval for a biologics license, the risk that the FDA may interpret data differently than we do ... expected, the risk that the FDA will not approve a product for which a biologics license has been applied, the risk that the results of a clinical trial ...

BioVex Reports Positive Phase II Clinical Trial Results of OncoVEX GM-CSF in Metastatic Melanoma at the 2008 American Society of Clinical Oncology Meeting

... to commence in the first quarter of 2009, with a potential projected biologics licensing application (BLA) filing in late 2010. BioVex President and ... based in Woburn, MA. The Company is developing a new class of potent biologics for the treatment of cancer and prevention of infectious disease. The ...

PacificGMP Completes GMP Product Fill for Trius Therapeutics

... president of PacificGMP. "Although our client base consists of mainly biologics drug developers, PacificGMP has completed projects for a variety of other ... process design, development and scale-up, to preclinical and clinical biologics manufacturing, purification and fill/finish. More information can be found ...

Northfield Laboratories Inc. Presentation at FDA/NIH Workshop on Hemoglobin-Based Oxygen Carriers

... safety or effectiveness of PolyHeme, our ability to successfully file a biologics License Application, our ability to be granted priority review of our biologics License Application, our ability to obtain FDA approval to market PolyHeme ...

Dendreon Presents Data Correlating the Cumulative Potency of PROVENGE(R) to Overall Survival

... additional clinical trials for PROVENGE will not support approval for a biologics license, the risk that the FDA may interpret data differently than we do ... expected, the risk that the FDA will not approve a product for which a biologics license has been applied, the risk that the results of a clinical trial ...

Insmed Provides Update on IPLEX(TM) Expanded Access Program in Italy for the Treatment of Amyotrophic Lateral Sclerosis

... -- Insmed Inc. (Nasdaq: INSM), a developer of follow-on biologics and biopharmaceuticals, today provided an update on the IPLEX(TM) Expanded ... may experience negative market trends, our entrance into the follow on biologics market may be unsuccessful, our common stock could be delisted from the ...

Insmed Receives FDA Orphan Drug Designation for IPLEX(TM) in the Treatment of Myotonic Muscular Dystrophy

... -- Insmed Inc. (Nasdaq: INSM), a developer of follow-on biologics and biopharmaceuticals, today announced that the Food and Drug ... may experience negative market trends, our entrance into the follow on biologics market may be unsuccessful, our common stock could be delisted from the ...

Sanofi Pasteur Initiates Phase II Trial of Cell Culture-Based Seasonal Influenza Vaccine

... achieved under a subcontracting agreement between Sanofi Pasteur and Lonza biologics plc (Lonza Group). As the world leader in the research, development and ... About Lonza Group Lonza biologics plc, is a biotechnology contract manufacturer and biologics service ...

Cytokine PharmaSciences Initiates Phase I Study of Oral Anti-Inflammatory Agent, CPSI-2364

... the clinic," said Dennis F. Willson, president and CEO of Cytokine PharmaSciences. "As a small molecule, CPSI-2364 is less expensive to produce than biologics and can be given orally. Moreover, because it is not a protein, CPSI-2364 is not expected to generate antibodies that could neutralize its activity ...

Bioniche Life Sciences Inc. and Endo Pharmaceuticals Sign Licensing Agreement for Urocidin(TM)

... data analysis and conduct. It provides assurance that, if the trial endpoints are met, they will serve as the basis for product approval under a biologics Licensing Application (BLA). An SPA gives a clear pathway to registration of MCC when the trial endpoints are achieved. This trial received Fast ...

Leading Experts Endorse Bioheart's Muscle Stem Cell MyoCell Therapy

... to restore contractile function of the damaged heart. About Bioheart, Inc. Bioheart, Inc. is committed to delivering intelligent devices and biologics that help monitor, diagnose and treat heart failure and cardiovascular diseases. Its goals are to improve a patient's quality of life and reduce ...

MedImmune Funds Study to Help Gain Insights Into Full Burden of RSV Disease Among Premature Infants

... of every 38 emergency room trips, and inpatient hospital stays for one out of every 334 children. About MedImmune MedImmune, the worldwide biologics business for AstraZeneca PLC (LSE: AZN.L, NYSE: AZN ), has approximately 3,100 employees worldwide and is headquartered in Gaithersburg, Maryland. ...
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(Date:12/17/2014)... , Dec. 15, 2014  HITLAB SM ... Clinical Practices (GCP) audit to confirm its adherence ... regulations. This accomplishment enables HITLAB to conduct regulated ... the highest principles for patient safety and research ... global healthcare access, quality, and delivery with innovative ...
(Date:12/15/2014)... Research and Markets ( http://www.researchandmarkets.com/research/87pph8/global_facial ... "Global Facial Recognition Market 2015-2019" report to ... Facial recognition is a technology ... system measures the overall facial feature of a ... the distance between eyes. Facial recognition is used ...
(Date:12/11/2014)... , Dec. 10, 2014  Data Sciences ... monitoring, has released a new series of digital ... preclinical toxicology researchers. M series, part of the ... collect the best possible physiologic data when incorporating ... Adding functional endpoints to toxicology studies has evolved ...
Breaking Biology News(10 mins):HITLAB Completes GCP Audit for FDA Smart Device & App Compliance 2Global Facial Recognition Market 2015-2019: Key Vendors are 3M Cogent, Cognitec Systems, NEC and Safran Group 2Global Facial Recognition Market 2015-2019: Key Vendors are 3M Cogent, Cognitec Systems, NEC and Safran Group 3New telemetry implants expected to change how large animal toxicology studies are conducted 2
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Breaking Medicine News(10 mins):Health News:BellasDress.com’s Christmas Sale: Trendy Wedding Dresses With Big Discounts 2Health News:RP International founder, Helen Harris Dies on Christmas Eve Just Hours Before Her Holiday Television Broadcast to Raise Funds to Cure Blindness was Broadcasted Nationally 2Health News:RP International founder, Helen Harris Dies on Christmas Eve Just Hours Before Her Holiday Television Broadcast to Raise Funds to Cure Blindness was Broadcasted Nationally 3Health News:RP International founder, Helen Harris Dies on Christmas Eve Just Hours Before Her Holiday Television Broadcast to Raise Funds to Cure Blindness was Broadcasted Nationally 4Health News:LunaDress Provides Professional Tips On Shopping Wedding And Prom Dresses 2Health News:Don't Let Burns Mar Your Holidays 2Health News:Breast Cancer Chemo Tied to Small But Significant Leukemia Risk 2Health News:Breast Cancer Chemo Tied to Small But Significant Leukemia Risk 3
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