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FDA grants t2cure orphan drug designation for t2c001 in Buerger's Disease

t2cure GmbH, a biopharmaceutical company developing and marketing stem cell-based regenerative therapies, announced today that the FDA has granted orphan drug designation to t2c001 for the treatment of Buerger's Disease. The Company also announced that in a concurrent application in Europe the EMA's Committee for Orphan Medicinal Products recently recommended t2c001 for orphan designation to the European Commission.

24 Jun 2010

AVEO receives EMA orphan medicinal product designation for tivozanib

AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced it has received orphan medicinal product designation for tivozanib (N-{2-chloro-4-[(6,7-dimethoxy-4-quinolyl)oxy]phenyl}-N'-(5-methyl-3-isoxazolyl) urea hydrochloride monohydrate), its oral, triple VEGF receptor inhibitor, for the treatment of renal cell carcinoma by the European Medicines Agency (EMA).

24 Jun 2010

FDA schedules Advisory Committee meeting to review Orexigen's Contrave NDA

Orexigen® Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, today announced that the U.S. Food and Drug Administration (FDA) has tentatively scheduled a Division of Metabolic and Endocrine Drug Products Advisory Committee meeting on December 7, 2010 to review the Company's New Drug Application (NDA) for Contrave® (naltrexone sustained release (SR)/bupropion SR) for the treatment of obesity.

24 Jun 2010

Tikcro Technologies reports net income of $1.9 million for first-quarter 2010

Tikcro Technologies Ltd. today reported results for the first quarter ended March 31, 2010.

24 Jun 2010

Anthera commences enrollment in pivotal VISTA-16 Phase 3 clinical study of varespladib

Anthera Pharmaceuticals, Inc., a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation and autoimmune disorders, today announced patient enrollment has commenced in the Company's pivotal VISTA-16 (Vascular Inflammation Suppression to Treat Acute Coronary Syndrome for 16 Weeks) Phase 3 clinical study of varespladib (A-002).

23 Jun 2010

Santaris Pharma, miRagen collaborate to develop microRNA-targeted medicines for cardiovascular disease

Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies and miRagen Therapeutics, Inc., a biopharmaceutical company focused on developing innovative microRNA-based therapeutics for cardiovascular and muscle disease, announced today that they have formed a strategic alliance to develop microRNA-targeted medicines for the treatment of cardiovascular disease.

23 Jun 2010

Prosensa, GSK initiate additional programs for DMD

Prosensa, the Dutch biopharmaceutical company focusing on RNA modulating therapeutics, announces the initiation of two further programmes under its existing alliance with GSK covering novel RNA-based treatments for Duchenne Muscular Dystrophy (DMD). The initiation of these additional programs under the terms of the existing alliance agreement is a validation of both the potential of Prosensa's "exon skipping" platform and the ongoing relationship.

23 Jun 2010

Nuon study confirms potential utility of tranilast as uricosuric agent

Nuon Therapeutics, Inc., a privately held, clinical stage biopharmaceutical company, announced that results from clinical and preclinical studies demonstrating the ability of tranilast to reduce serum uric acid levels and monosodium urate crystal-induced inflammation - two important risk factors for gout - were presented at The European League Against Rheumatism (EULAR) 2010 Annual European Congress of Rheumatology in Rome, Italy, June 16-19, 2010.

22 Jun 2010

Ricerca's Lyon facility obtains ISO 9001:2008 certification

Ricerca Biosciences, a uniquely integrated preclinical contract research drug development company providing services to the pharmaceutical industry, is pleased to announce that its Ricerca France, Lyon facility, has recently obtained the ISO 9001:2008 certification for all activities performed at the site.

22 Jun 2010

TransGenRx to produce protein-based therapeutics to support Esperion's research on HDL therapies

Esperion Therapeutics, a privately held biopharmaceutical company working to discover, develop and commercialize treatments for cardiovascular and metabolic diseases, today announced that TransGenRx, a global leader in transgenic technology, will produce protein-based therapeutics to be used in the company's research efforts targeting HDL therapies for the treatment of cardio-metabolic disease.

22 Jun 2010

OXiGENE reports encouraging data from ZYBRESTAT program at Glaucoma and Retinopathies 2010 conference

OXiGENE, Inc., a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced today that the company presented an update on its ZYBRESTAT ophthalmology program, including encouraging preclinical data showing that the company's topical formulation achieved target retina/choroid concentrations with minimal systemic exposure.

22 Jun 2010

Lexicon presents LX4211 Phase 2a clinical trial results for type 2 diabetes mellitus at ENDO 2010

Lexicon Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering breakthrough treatments for human disease, presented clinical data and analysis from its Phase 2a clinical trial of LX4211 for patients with type 2 diabetes mellitus at ENDO 2010 today. The results reported today included newly-obtained data showing a trend of increased total GLP-1 in both LX4211 treatment arms relative to placebo as measured in a post-trial analysis of blood samples.

22 Jun 2010

Celator announces expansion of research agreement with Cephalon

Celator Pharmaceuticals today announced that it has expanded its research agreement with Cephalon, Inc.. The research agreement provides for the utilization of Celator's proprietary technology in an ongoing drug development and life-cycle management program at Cephalon.

22 Jun 2010

Cadence Pharmaceuticals to acquire Incline Therapeutics

Cadence Pharmaceuticals, Inc., a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates principally for use in the hospital setting, announced today that it has signed an agreement providing Cadence with an exclusive option to acquire Incline Therapeutics, Inc., a privately held specialty pharmaceutical company.

22 Jun 2010

Results of two clinical proof-of-concept studies for CER-627 program to be presented at EAS Congress 2010

Cerenis Therapeutics SA, a privately held biopharmaceutical company developing HDL-related compounds for the treatment of cardiovascular and metabolic diseases, today announced it will present the results of two clinical proof-of-concept studies for its CER-627 program (niacin/aspirin combinations) at the 78th European Atherosclerosis Society Congress on June 20-23 in Hamburg, Germany.

21 Jun 2010

Sosei reaches agreement to acquire 100% of Activus

Sosei Group Corporation, announced today that it has reached an agreement to acquire 100% of Activus Pharma Ltd., a privately-held biopharmaceutical company based in Chiba, Japan.

21 Jun 2010

Study shows effective and efficient methods for producing recombinant proteins

A shift in the life science market has begun to steer cell culture scientists to re-evaluate their use of native transferrin and iron chelators to pursue recombinant alternatives. Transferrin regulates the uptake, transport and utilization of iron for cellular function, increasing cell growth and productivity. Native transferrin found in bovine or human serum has been widely used in cell culture for these added benefits. However, regulatory issues continue to arise with the use of native transferrin due to blood-borne pathogens.

21 Jun 2010

New phase I/IIa clinical trial of AR-42 for blood cancer at OSUCCC-James

For the second time within a year, an experimental drug invented by cancer researchers at The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC-James) is being tested on patients in a clinical trial.

19 Jun 2010

Cyclacel files Answer and Counterclaims to Celgene's declaratory judgment complaint

Cyclacel Pharmaceuticals, Inc., a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, today announced that it filed its Answer and Counterclaims to the declaratory judgment complaint filed by Celgene Corporation.

18 Jun 2010

NeoStem announces presentation on very small embryonic-like stem cells at ISSCR 2010

NeoStem, Inc., an international biopharmaceutical company with operations in the U.S. and China, announced today that a poster authored by NeoStem-affiliated scientists will be presented in a presentation at the premier stem cell research event, the International Society for Stem Cell Research (ISSCR) 8th Annual Meeting in San Francisco on June 17, 2010.

18 Jun 2010

Biopharmaceutical News and Research

FDA grants t2cure orphan drug designation for t2c001 in Buerger's Disease

AVEO receives EMA orphan medicinal product designation for tivozanib

FDA schedules Advisory Committee meeting to review Orexigen's Contrave NDA

Tikcro Technologies reports net income of $1.9 million for first-quarter 2010

Anthera commences enrollment in pivotal VISTA-16 Phase 3 clinical study of varespladib

Santaris Pharma, miRagen collaborate to develop microRNA-targeted medicines for cardiovascular disease

Prosensa, GSK initiate additional programs for DMD

Nuon study confirms potential utility of tranilast as uricosuric agent

Ricerca's Lyon facility obtains ISO 9001:2008 certification

TransGenRx to produce protein-based therapeutics to support Esperion's research on HDL therapies

OXiGENE reports encouraging data from ZYBRESTAT program at Glaucoma and Retinopathies 2010 conference

Lexicon presents LX4211 Phase 2a clinical trial results for type 2 diabetes mellitus at ENDO 2010

Celator announces expansion of research agreement with Cephalon

Cadence Pharmaceuticals to acquire Incline Therapeutics

Results of two clinical proof-of-concept studies for CER-627 program to be presented at EAS Congress 2010

Sosei reaches agreement to acquire 100% of Activus

Study shows effective and efficient methods for producing recombinant proteins

New phase I/IIa clinical trial of AR-42 for blood cancer at OSUCCC-James

Cyclacel files Answer and Counterclaims to Celgene's declaratory judgment complaint

NeoStem announces presentation on very small embryonic-like stem cells at ISSCR 2010

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How ELRIG Is Helping Mid-Career Scientists Navigate Leadership, Career Change and Redundancy

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