Biopharmaceutical News and Research

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BIND Biosciences announces $12.4 million Series C-1 financing

BIND Biosciences, Inc. (BIND), a privately held biopharmaceutical company developing best in class therapeutics based on its proprietary targeted nanotechnology platform, announced today that it has secured a $12.4 Million Series C-1 financing. This financing included all of BIND's current investors (including Polaris Venture Partners, Flagship Ventures, ARCH Venture Partners, NanoDimension and DHK Investments) as well as a new venture investor, Endeavour Vision, and private investors.

29 Jun 2010

AVEO Pharmaceuticals joins Russell 2000 Index and S&P MidCap 400

AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that the company has been added to the Russell 2000® Index, as part of the annual reconstitution of the entire Russell family of indexes that took place on June 25, 2010 following the close of the market.

29 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

Tolerx presents data from otelixizumab Phase 3 DEFEND-1 clinical trial in type 1 diabetes patients

Tolerx, Inc., a biopharmaceutical company developing novel therapies to treat autoimmune diseases and cancer by modulating T cell activity, today presented an analysis of baseline data from the Phase 3 DEFEND-1 clinical trial of otelixizumab in patients with autoimmune new onset type 1 diabetes.

28 Jun 2010

Tolerx initiates confirmatory Phase 3 clinical trial to evaluate otelixizumab in new-onset type 1 diabetes

Tolerx, Inc., a biopharmaceutical company developing novel therapies to treat autoimmune diseases and cancer by modulating T cell activity, today announced the initiation of a confirmatory Phase 3 clinical trial to further evaluate otelixizumab in autoimmune new-onset type 1 diabetes. The confirmatory Phase 3 clinical trial is called DEFEND-2 (Durable-Response Therapy Evaluation For Early or New-Onset Type 1 Diabetes) and immediately follows successful completion of enrollment in the initial Phase 3 clinical trial, DEFEND-1, with results from DEFEND-1 expected in the first half of 2011.

28 Jun 2010

RiVax intradermal administration protects from mucosal, systemic ricin intoxication

Soligenix, Inc., a late-stage biopharmaceutical company, announced today the publication of an article in the June 2010 edition of Vaccine, which describes protection from mucosal and systemic ricin intoxication by intradermal administration of RiVax™, the Company's vaccine against ricin toxin.

28 Jun 2010

Roche reports results of 5 taspoglutide Phase III studies for type 2 diabetes at 70th ADA

Ipsen a global biopharmaceutical group, today announced that its partner Roche disclosed results of five Phase III 24-week studies for taspoglutide for type 2 diabetes at the American Diabetes Association's (ADA) 70th Annual Scientific Sessions. Taspoglutide, the first once weekly glucagon-like peptide-1 (GLP-1) analogue based on a human sequence, originating from Ipsen's research is developed by Roche. This compound is similar to the natural hormone GLP-1 which has a key role in blood sugar regulation.

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

Poster presentation at MASCC Conference summarizes MuGard clinical experience

ACCESS PHARMACEUTICALS, INC., a biopharmaceutical company specializing in products for cancer and supportive care, is presenting a scientific poster today at the Multinational Association of Supportive Care in Cancer Conference in Vancouver, B.C. The poster presentation, co-authored by Dr. David Nowotnik of Access Pharmaceuticals and Dr. Caroline Dumas of SpePharm Holdings, summarizes MuGard clinical experience from cancer patients globally undergoing radiotherapy and/or chemotherapy.

28 Jun 2010

VPRIV receives positive opinion from CHMP for treatment of type 1 Gaucher disease

Shire plc, the global specialty biopharmaceutical company, announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion on the marketing authorisation for VPRIV (velaglucerase alfa), the company's enzyme replacement therapy for the treatment of type 1 Gaucher disease.

28 Jun 2010

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

Biopharmaceutical News and Research

BIND Biosciences announces $12.4 million Series C-1 financing

AVEO Pharmaceuticals joins Russell 2000 Index and S&P MidCap 400

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

Tolerx presents data from otelixizumab Phase 3 DEFEND-1 clinical trial in type 1 diabetes patients

Tolerx initiates confirmatory Phase 3 clinical trial to evaluate otelixizumab in new-onset type 1 diabetes

RiVax intradermal administration protects from mucosal, systemic ricin intoxication

Roche reports results of 5 taspoglutide Phase III studies for type 2 diabetes at 70th ADA

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

Poster presentation at MASCC Conference summarizes MuGard clinical experience

VPRIV receives positive opinion from CHMP for treatment of type 1 Gaucher disease

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

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