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Alnylam receives Portuguese, Swedish, British approvals to initiate ALN-TTR01 Phase I study in ATTR

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that its applications for ALN-TTR01 have been given clearance by Portuguese, Swedish, and British regulatory authorities to begin clinical testing. The trial will begin enrolling patients shortly in a blinded, randomized, placebo-controlled, multicenter Phase I study.

29 Jun 2010

Chelsea initiates NORTHERA Phase III trial for symptomatic NOH associated with PD

Chelsea Therapeutics International, Ltd. announced the initiation of Study 306, a pivotal Phase III trial evaluating the efficacy of NORTHERA™, an oral synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) associated with Parkinson's disease.

29 Jun 2010

International symposium to highlight current and future applications of MR-guided ultrasound

Leading research and clinical experts from around the world are scheduled to speak at the 2nd International Symposium for MR-guided Focused Ultrasound, which will be held October 17 to 20 in the Washington, D.C. area.

From Elekta 29 Jun 2010

Avila's AVL-292 demonstrates disease-modifying effects in prophylactic, therapeutic models of rheumatoid arthritis

Avila Therapeutics™, Inc., a biotechnology company developing targeted covalent drugs that treat diseases through protein silencing, today announced results of preclinical studies demonstrating that its clinical candidate, AVL-292, potently inhibits B cell receptor signaling, and demonstrates efficacy in a rodent model of rheumatoid arthritis. These new data were presented Saturday, June 26, 2010 at the Federation of Clinical Immunology Societies (FOCIS) 2010 annual meeting in Boston, MA.

29 Jun 2010

Marcadia, Eli Lilly sign development, license agreement for short-acting glucagon program

Marcadia Biotech, Inc. and Eli Lilly and Company today announced that the companies have signed a development and exclusive license agreement for Marcadia's short-acting glucagon program, covering glucagon analogs that may provide greater convenience and ease-of-use than the current recombinant glucagon for the treatment of severe hypoglycemia. The program includes MAR531, a glucagon analog that is in preclinical development at Marcadia, as well as related backup compounds.

29 Jun 2010

MGH, Iacocca Foundation complete Phase I BCG clinical trial in type 1 diabetes

Massachusetts General Hospital (MGH) and the Iacocca Foundation announce today the completion of the Phase I BCG clinical trial in type 1 diabetes, as well as the submission of all safety reports to the U.S. Food and Drug Administration (FDA) and the MGH data safety monitoring boards. Plans for the Phase II clinical study, which will continue the investigation of bacillus Calmette-Guerin (BCG) vaccination as a treatment for people with existing type 1 diabetes, are actively underway.

29 Jun 2010

World's leading pharma services industry events to held at Frankfurt in 2011

Leading events organiser UBM International Media today announced that its flagship CPhI Worldwide tradeshow will return to Frankfurt, Germany for 2011. Along with co-hosted events - P-MEC Europe for equipment, machinery and technology; ICSE for contract services and packaging; and BioPh Europe for the biopharma sector - the world's leading pharma services industry events will be held at Messe Frankfurt, from Tuesday 25 to Thursday 27 October.

28 Jun 2010

Eisai, Morphotek receive clearance for MORAb-022 Phase I clinical trial for rheumatoid arthritis

Eisai Inc. and Morphotek®, Inc. announced today that the Medical Ethical Review Committee and Central Committee on Research Involving Human Subjects of the Netherlands cleared its Clinical Trial Application to test the investigational new drug MORAb-022 in a Phase I clinical trial that will include both normal healthy volunteers and subjects diagnosed with rheumatoid arthritis.

28 Jun 2010

MorphoSys, Xencor sign worldwide exclusive license, collaboration agreement for XmAb5574 antibody program

MorphoSys AG and US-based biopharmaceutical company Xencor, Inc., announced today the signing of a worldwide exclusive license and collaboration agreement for an antibody in Phase 1 clinical development. The agreement provides MorphoSys with an exclusive worldwide license to XmAb5574, a high potency monoclonal antibody developed by Xencor for the treatment of B-cell malignancies.

28 Jun 2010

Aestus Therapeutics announces license agreement with Astellas Pharma

Aestus Therapeutics, Inc. announced today a license agreement with Astellas Pharma Inc. (Astellas; Tokyo, Japan) to provide Aestus with exclusive, world-wide rights to the Astellas product FK614. Aestus will develop the product as ATx08-001, a novel, first-in-class therapeutic for the treatment of neuropathic pain. The first clinical trial will start later this year.

28 Jun 2010

Tolerx presents preclinical data on TRX518 anti-GITR immunotherapy for cancer

Tolerx, Inc., a biopharmaceutical company developing novel therapies to treat autoimmune diseases and cancer by modulating T cell activity, presented results from preclinical studies with TRX518, an early-stage agent Tolerx is developing as a treatment for cancer. TRX518 is a monoclonal antibody to glucocorticoid-induced tumor necrosis factor receptor (GITR) and is designed to enhance the immune system's ability to attack tumors by activating and rendering T effector cells resistant to T regulatory cell suppression.

28 Jun 2010

TRL commences operations at San Diego facility with focus on biological drugs for autoimmune diseases

Tanabe Research Labs USA, Inc. (TRL) today announced commencement of its new operations at the TRL facility in San Diego with a focus on biological drugs for the treatment of autoimmune diseases. TRL began its new activities in May with the appointment of three new senior executives: Masaki Yamada, Ph.D., Chief Executive Officer; Toshihiro Hosaka, Ph.D., Senior Vice President, and Roland Newman, Ph.D., VP and Chief Scientific Officer.

28 Jun 2010

Data on MetAP2 inhibitors for treatment of obesity presented at ADA 2010

Zafgen, Inc., a pharmaceutical company pioneering novel obesity therapeutics to help the body regain and sustain a lean, healthy state by targeting imbalances in fat metabolism, today announced data on ZGN-201, a prototype methionine aminopeptidase 2 inhibitor, for the treatment of obesity. Preclinical studies demonstrate MetAP2 inhibition eliminates excess body weight through the regulation of fat metabolism and food intake, and normalizes glucose tolerance in animal models.

28 Jun 2010

New preclinical data of XOMA 052 in animal model of Type 2 diabetes to be presented at ADA 2010

XOMA Ltd., a leader in the discovery and development of therapeutic antibodies, will be presenting new preclinical data in an animal model of Type 2 diabetes in which its anti-inflammatory therapeutic antibody candidate, XOMA 052, was used as monotherapy and in combination with the marketed anti-diabetic drugs exendin-4 (Byetta) or sitagliptin (Januvia).

28 Jun 2010

Gilead Sciences signs definitive agreement to acquire CGI Pharmaceuticals

Gilead Sciences, Inc. and CGI Pharmaceuticals, Inc., a privately-held, development-stage pharmaceutical company focused on small molecule chemistry and kinase biology, today announced the signing of a definitive agreement pursuant to which Gilead will acquire CGI. Under the terms of the agreement, Gilead will acquire CGI for up to $120 million, the majority as an upfront payment and the remaining based on clinical development progress, all of which will be financed through available cash on hand.

25 Jun 2010

Athersys, CSCRM and CWRU receive $1M to advance MultiStem therapy for SCI

Athersys, Inc. and its collaborators, including the Center for Stem Cell and Regenerative Medicine and Case Western Reserve University, announced today that they have been awarded $1 million through the Ohio Third Frontier Biomedical Program to support research into the treatment of spinal cord injury with MultiStem, Athersys' proprietary stem cell product candidate.

25 Jun 2010

Quark Pharmaceuticals' siRNA drug candidates featured in two presentations at Glaucoma & Retinopathies 2010

Quark Pharmaceuticals, Inc., a world leader in the discovery and development of RNAi-based therapeutics, today announced that two of its siRNA drug candidates were featured in the following two presentations at the Glaucoma & Retinopathies 2010 conference, which was held June 21-22, 2010 in London, UK.

25 Jun 2010

Sanofi-aventis' Phase I clinical trial with SAR650984 triggers $1M milestone payment to ImmunoGen

ImmunoGen, Inc., a biotechnology company that develops targeted antibody-based anticancer products, today announced that sanofi-aventis has initiated a Phase I clinical trial with SAR650984, an investigational antibody that targets cancer cells expressing the CD38 protein antigen. This event triggers a $1 million milestone payment to ImmunoGen.

25 Jun 2010

Phase 2 clinical trial of GMI-1070 for treatment of vaso-occlusive crisis of sickle cell disease initiated

GlycoMimetics, Inc., a clinical-stage biotechnology company developing a new class of glycobiology-based therapies for a broad range of indications, today announced the commencement of a Phase 2 clinical trial of GMI-1070 for treatment of vaso-occlusive crisis of sickle cell disease. The company also announced that GMI-1070 has received Fast Track designation from the U.S. Food and Drug Administration.

25 Jun 2010

MonoSol Rx, Midatech collaborate to develop peptides for therapeutic delivery utilizing pharmaceutical films

MonoSol Rx, the developer of PharmFilm® drug delivery technology, today announced the expansion of its agreement with Midatech Group (Oxford, UK) to develop nanoparticle-based proteins and peptides for therapeutic delivery utilizing pharmaceutical films. Under the terms of the expanded agreement, MonoSol Rx has made an equity investment in Midatech and Keith Kendall, Executive Vice President and Chief Financial Officer of MonoSol Rx, will join the Midatech Board of Directors.

24 Jun 2010

Preclinical News and Research

Alnylam receives Portuguese, Swedish, British approvals to initiate ALN-TTR01 Phase I study in ATTR

Chelsea initiates NORTHERA Phase III trial for symptomatic NOH associated with PD

International symposium to highlight current and future applications of MR-guided ultrasound

Avila's AVL-292 demonstrates disease-modifying effects in prophylactic, therapeutic models of rheumatoid arthritis

Marcadia, Eli Lilly sign development, license agreement for short-acting glucagon program

MGH, Iacocca Foundation complete Phase I BCG clinical trial in type 1 diabetes

World's leading pharma services industry events to held at Frankfurt in 2011

Eisai, Morphotek receive clearance for MORAb-022 Phase I clinical trial for rheumatoid arthritis

MorphoSys, Xencor sign worldwide exclusive license, collaboration agreement for XmAb5574 antibody program

Aestus Therapeutics announces license agreement with Astellas Pharma

Tolerx presents preclinical data on TRX518 anti-GITR immunotherapy for cancer

TRL commences operations at San Diego facility with focus on biological drugs for autoimmune diseases

Data on MetAP2 inhibitors for treatment of obesity presented at ADA 2010

New preclinical data of XOMA 052 in animal model of Type 2 diabetes to be presented at ADA 2010

Gilead Sciences signs definitive agreement to acquire CGI Pharmaceuticals

Athersys, CSCRM and CWRU receive $1M to advance MultiStem therapy for SCI

Quark Pharmaceuticals' siRNA drug candidates featured in two presentations at Glaucoma & Retinopathies 2010

Sanofi-aventis' Phase I clinical trial with SAR650984 triggers $1M milestone payment to ImmunoGen

Phase 2 clinical trial of GMI-1070 for treatment of vaso-occlusive crisis of sickle cell disease initiated

MonoSol Rx, Midatech collaborate to develop peptides for therapeutic delivery utilizing pharmaceutical films

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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