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Biologics in Medical News

Human Genome Sciences Announces Second-Quarter 2009 Financial Results and Key Developments

... (HHS). In May 2009, HGS submitted a biologics License Application (BLA) to the FDA for ... 2009. In May 2009, HGS submitted a biologics License Application to the FDA for raxibacumab ... risks related to FDA's approval of the Company's biologics License Application for raxibacumab. If the ...

Intravenous Immune Biologics Will Suffer from the Pending Shift in Coverage from the Medical to the Pharmacy Benefit

... and single state plans say coverage of immune biologics will shift from a medical benefit to a pharmacy ... as a pharmacy benefit, but cover other immune biologics as a medical benefit. The report finds that payers expect the shift of biologics from the medical benefit to the pharmacy benefit ...

CMPI to Host Hill Briefing Tomorrow on Follow-on Biologic Drugs for Media and Congressional Staff With Reps. Eshoo and Rogers

... and Congressional Staff entitled: "A Follow-on biologics Legislation Update; Congressional Leaders and ... patient safety is the top-priority for follow-on biologics legislation," said Robert Goldberg of CMPI. "The ... that advocates for safe and effective follow-on biologics do all they can to support Representative Eshoo's ...

China's Rheumatoid Arthritis Drug Market Will More than Double by 2013

... uptake of currently available Western branded biologics and the launch of new biologics. The best ... Chinese generic versions of new Western branded biologics than for small-molecule drugs for two reasons: biologics are harder to imitate than small chemical ...

CMPI to Host Hill Briefing on Follow-On Biologic Drugs for Media and Congressional Staff with Reps. Eshoo and Rogers

... and Congressional Staff entitled: "A Follow-On biologics Legislation Update; Congressional Leaders and ... patient safety is the top-priority for follow-on biologics legislation," said Robert Goldberg of CMPI. "The ... that advocates for safe and effective follow-on biologics do all they can to support Representative Eshoo's ...

Catalyst Biosciences Announces Agreement With MedImmune to Discover and Develop Engineered Protease Therapeutics

... and license agreement with MedImmune, the global biologics unit of AstraZeneca plc, to develop novel ... therapeutics are next-generation, protease biologics engineered with the ability to catalytically ... About MedImmune MedImmune, the worldwide biologics business for AstraZeneca PLC (LSE: AZN.L, NYSE: ...

Global Autoimmune Disease Therapeutics Market to Reach $50 Billion by 2015, According to a New Report by Global Industry Analysts

... is projected to reach US$49.8 billion in 2015. biologics emerged as the leading therapeutic option in the ... enhanced penetration of existing drugs. Access to biologics in the world's largest drug market, the US, is ... represents the fastest growing segment for biologics in the global autoimmune disease therapeutics ...

CEL-SCI Scientist Invited to Discuss Plans to Launch Unique Manufacturing Process That Saves Cost While Enhancing the Shelf Life of Drugs at 5th Annual Aseptic Processing of Sterile Drug Products Conference

... to save money in the production of follow-on biologics and biosimilars (the general equivalent of ... Herceptin, Copaxon, etc.) are biologics. biologics are usually very sensitive to heat and quickly ... to companies that produce the latest drugs, biologics and stem cell derived therapies. It is an ...

American Academy of Dermatology Issues New Guidelines For the Management of Psoriasis With Systemic Medications

... and psoriatic arthritis, as well as the use of biologics and topical therapies. "While in recent years biologics have changed the treatment of psoriasis, ... administered orally and less expensive than biologics - continue to play an important role in treating ...

Fate Therapeutics Adds Pratik Multani, M.D., M.S., as Vice President Clinical Development to Advance Upcoming Clinical Programs of Stem Cell Modulators

... Stem Cell Modulators (SCMs), small molecules and biologics that guide cell fate for therapeutic purposes. ... led to the identification of small molecules and biologics that can direct stem cell proliferation and ... and unique approach of using small molecules and biologics in stem cell medicine provides a well-defined ...

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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 ...

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Biologics in Medical Products

Procleix HIV-1/HCV Assay

Description:... and manufactured by Gen-Probe and is marketed worldwide as the Procleix System by Chiron Corporation. In 2002, Gen-Probe received approval of its biologics License Application (BLA) for the first FDA-approved nucleic acid test for HIV-1 and HCV in donated human blood. In the U.S. alone, the American Red ...
Company:Gen-Probe
Biologics in Medical Definition

Medical writing

... is writing documents for regulatory agencies so that drugs, devices and biologics are approved, and stay approved for marketing to humans. Regulatory ... Educational medical writing is writing documents about drugs, devices and biologics for general audiences,and specific audiences such as professional ...
Biologics in Medical Dictionary

Diphtheria

... ," Congress passed the Virus - Toxin law (also referred to as the biologics Control Act), that required licensing of biologics establishments, ... A substance created by linking a form of ...

Tetanus

... ," Congress passed the Virus - Toxin law (also referred to as the biologics Control Act), that required licensing of biologics establishments, ... Pediarix ( Diphtheria , Tetanus , Pertussis , ...

Mad Cow Disease

... : Still a concern Web Resources CDC's Health Information for International Travel: BSE and vCJD U.S. Food and Drug Administration, Center for biologics Evaluation and Research: Bovine Spongiform Encephalopathy (BSE) ... BSE (" mad cow disease ") and nvCJD; Campylobacter infections ; Chagas ...
Biologics in Biological News

CEL-SCI Corporation to Launch Aseptic Filling for Stem Cell Produced Therapies and Other Biological Products

... Herceptin, Copaxon, etc.) are biologics. biologics are usually very sensitive to heat and quickly ... find desirable. However, stem cell products and biologics do not generally lose activity when kept at 4 ... to companies that produce the latest drugs, biologics and stem cell therapies. It is an absolute ...

Musculoskeletal center wins $2.2 million for drug safety

... award will allow the UAB CERTs to pinpoint which biologics have potential safety concerns. Additionally, researchers will examine which biologics work best for specific groups of patients, ... children, minorities and the disabled. All of the biologics being studied are U.S. Food and Drug ...

New guidelines for treating rheumatoid arthritis

... Newer genetically engineered DMARDs called biologics often work in combination with earlier therapies. ... are designed to stop damaging inflammation, and biologics work to interrupt the chain of events that leads to inflammation. Newer biologics called anti-TNF agents adalimumab (Humira), ...

NEWSLETTER: Antibody Fragment Production Breakthrough with 2nd Generation EBA

... Denmark, May 12th, 2009 / b3c newswire / – Richter-Helm biologics GmbH & Co. KG announces today a technological breakthrough in the ... of antibody fragments from an E. coli expression system. Richter-Helm biologics has finalized the downstream process for Phase III clinical trial ...

La Jolla Institute signs exclusive license agreement with Medimmune on major asthma discovery

... the discovery to explore its use in the development of a potential biologics drug for treating asthma. Under the agreement, MedImmune was granted ... development, as demonstrated by its successful track record of bringing biologics to market. ...

New orthopaedic society launched to promote research, use of biologic treatments

... orthopaedic researchers. "Regenerative medicine and biologics are pushing orthopaedics into new and exciting directions," Dr. Mishra ... of several eminent scientists who recognize the immense potential of biologics to improve orthopaedic care," added Dr. Randelli. "We want to share what ...

Biotech Co. founded by UCLA Scientists to be acquired by Astellas, Pharma Inc.

... acquisition will enable Agensys to become the cornerstone of the companys biologics efforts and will allow the Agensys team to accelerate its discovery and ... efforts while working to achieve the vision of building a global leader in biologics and oncology. Agensys, originally known as UroGenesys, was created with ...

Scientists link immune system's natural killer cells to infant liver disease

... Nutrition at Cincinnati Children's. "The next steps for translating these findings into clinical application would include pre-clinical trials of biologics to halt disease progression by blocking the Nkg2d receptor and depleting NK cells at the time biliary atresia is diagnosed," he added. Very little ...

Versartis presents positive preclinical data on 2 product candidates at ENDO 09

... Washington, DC June 10, 2009 Versartis, Inc., an emerging company developing novel biologics with enhanced properties for patients with metabolic diseases, today presented data for its long-acting product candidates, VRS-317 (hGH-rPEG) for ...

Canadian biomedical engineering pioneer receives international award

... at Ohio State University. Discoveries by Prof. Brash can be found in some of Canada's most successful biomedical companies including Interface biologics Inc. of Toronto and Angiotech Inc. in Vancouver. "The latter part of the 80s and early 90s ushered in the concept of designing biomaterials that ...
Biologics in Biological Technology

Mylan Announces Strategic Collaboration with Biocon to Enter the Global Generic Biologics Market

... secure a leading position in the emerging generic biologics industry. Mylan's Chairman and CEO Robert J. ... be one of the more comprehensive and high quality biologics initiatives reported within the industry to date. ... with our Senior Vice President and Head of Global biologics Dr. Patrick Vink and conducting extensive due ...

Biomedical Sciences Companies Expanding in Asia Invested More Than US$500 Million in Singapore

... for a biopharmaceutical manufacturing plant for biologics and recombinant therapy. This facility is Singapore's sixth biologics manufacturing plant and will produce ADVATE, ... In response to the expanding base of biologics manufacturers in Singapore, which include Baxter, ...

Fate Therapeutics Granted Exclusive License for Stem Cell Modulators by Children's Hospital Boston and Massachusetts General Hospital

... Stem Cell Modulators (SCMs) - small molecules and biologics that guide cell fate for therapeutic purposes. ... core mission to develop small molecules and biologics that modulate adult stem cells for regenerative ... led to the identification of small molecules and biologics that can direct stem cell proliferation and ...

Dendreon Reports First Quarter 2009 Financial Results

... on these data, the Company intends to amend its biologics License Application (BLA) with the U.S. Food and ... 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 ...

Osteotech Reports First Quarter 2009 Financial Results

... as the leading provider of procedure-specific biologics for the orthopedic industry," said Sam ... long-term investments based upon the premise that biologics would become key components of effective bone ... sets supports the Company's strategy to introduce biologics that can meet the needs of specific procedures ...

WuXi PharmaTech Announces Fourth-Quarter and Full-Year 2008 Results

... impacted AppTec's 2008 results, particularly in biologics manufacturing. Faced with the reality ... in full-year 2008, which excludes the biologics manufacturing operation classified as ... below). With the discontinuation of biologics manufacturing, we now define our Laboratory ...

Frost & Sullivan Recognizes ApaTech's Leadership in Orthopedic Biologics

... -- Based on its recent analysis of the device biologics market, Frost & Sullivan recognizes ApaTech ... Sullivan Company of the Year Award. The device biologics market is one of the most lucrative in the ... center of progressive research in the orthopedic biologics space, Frost & Sullivan bestows the 2009 ...

Insmed Announces Fourth Quarter and Full-Year 2008 Financial Results

... Inc. (Nasdaq: INSM ), a developer of follow-on biologics (FOB) and biopharmaceuticals, today reported ... Highlights Follow-on biologics Program Insmed entered into a ... purchase all assets related to Insmed's follow-on biologics platform. Insmed to receive a ...

CEL-SCI Corporation to Launch Aseptic Filling for Stem Cell Produced Therapies and Other Biological Products

... Herceptin, Copaxon, etc.) are biologics. biologics are usually very sensitive to heat and quickly ... find desirable. However, stem cell products and biologics do not generally lose activity when kept at 4 ... to companies that produce the latest drugs, biologics and stem cell therapies. It is an absolute ...

Bone Biologics Announces UCB-1 (NELL-1) Bone Growth Protein Production Process With Aragen Biosciences

... UCB-1 (NELL-1) recombinant protein. Bone biologics has been developing the protein as a platform ... produced UCB-1 (NELL-1) at a purity level Bone biologics believes is sufficient for IDE submission. ... cell line and process we have developed for Bone biologics can be scaled up to provide protein at purity and ...
Biologics in Biological Dictionary

Biologics

... biologics include a wide range of medicinal products such ... biological processes . Vaccines, Blood & biologics . 2009 CBER Foreign Regulators Seminar ... Safety & Availability ( biologics ) ... Science & Research ...
Other Contents
(Date:10/1/2014)... (PRWEB) October 01, 2014 Join the more ... Eating Disorder Treatment Center’s first ever charity golf tournament to ... people with eating disorders who cannot afford treatment. The tournament ... Club in Eureka, Mo. , The day-long event starts ... A reception and award dinner will begin at 5 p.m. ...
(Date:10/1/2014)... Innovations announces the upcoming airing of Innovations ... October 20, 2014 at 7:30 a.m. EST/PT via Discovery ... the scenes to learn about Break the Cycle’s comprehensive ... practical help and information Break the Cycle provides to ... of abuse, how to navigate the legal system, and ...
(Date:10/1/2014)... 01, 2014 Scientists at the University ... that target immune system proteins has the power to ... posted details of the new study on their website. ... , Researchers in the UWA School of Pathology and ... to mice with mesothelioma with promising results. , ...
(Date:10/1/2014)... (PRWEB) October 01, 2014 October is ... awareness and early detection plans while raising money for ... support Breast Cancer Awareness Month in the effort ... wants to promote the importance of having access to ... water may be linked to certain forms of cancer. ...
(Date:10/1/2014)... Two bicyclists began a journey on ... country in an effort to raise funds and awareness ... cyclists, a father-daughter team, plan to bike more than ... and finishing in Key West Florida. Funds raised ... a national nonprofit organization that assists post-9/11 service members, ...
Breaking Medicine News(10 mins):Health News:Project HEAL Benefit Golf Tournament Gaining Momentum 2Health News:Project HEAL Benefit Golf Tournament Gaining Momentum 3Health News:Innovations to Explore Breakthroughs in Health and Wellness in Upcoming Episode Airing Monday, October 20, 2014 via Discovery Channel 2Health News:New Mesothelioma Study Says Mice Cured by Immuntherapy “Cocktail”, Reports Surviving Mesothelioma 2Health News:Pelican Water Supports Breast Cancer Awareness Month with Order Donations 2Health News:Father-Daughter Cycling Duo to Ride Cross-Country to Benefit Hope For The Warriors 2
(Date:9/30/2014)... is published today in the first authoritative scientific study ... on both sides of the grouse moor management debate. ... the Ecohydrology of River basins) project has shown that ... support red grouse populations for gun sports, has significant ... properties, river water chemistry and river ecology. , A ...
(Date:9/30/2014)... all have in common? Unlike most eukaryotic multicellular ... diploid, these organisms are all polyploid, meaning they have ... have 3 and 4 sets of chromosomes, respectively, and ... in fact most plant species are polyploid. Polyploidy, or ... but only recently, with the development of molecular tools, ...
(Date:9/30/2014)... team of environmental scientists and engineers, led by ... a three-year, $5.25 million grant from the U.S. ... Research to make a direct positive impact on ... and disposal of radioactive contaminants. , "Understanding the ... dealing with environmental aspects of nuclear technologies is ...
Breaking Biology News(10 mins):Grouse moor burning causes widespread environmental changes 2Gene doubling shapes the world: Instant speciation, biodiversity, and the root of our existence 2Gene doubling shapes the world: Instant speciation, biodiversity, and the root of our existence 3Gene doubling shapes the world: Instant speciation, biodiversity, and the root of our existence 4Researchers get $5.25 million to advance nuclear technologies in South Carolina 2
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