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Acucela to present data on ACU-4429 oral visual cycle modulator for dry AMD at Retina International meeting

Acucela, a clinical-stage biotechnology company focused on developing new treatments for blinding eye diseases, announced today that Ryo Kubota, M.D., Ph.D., Acucela's chairman, president and chief executive officer, has been invited to participate in Retina International's annual Scientific & Medical Advisory Board meeting being held in Fort Lauderdale, Florida on May 3, 2010.

3 May 2010

Targacept, AstraZeneca expand TC-5619 development program to include ADHD, Alzheimer's disease

Targacept, Inc., a clinical-stage biopharmaceutical company developing novel NNR Therapeutics (TM), today announced an amendment to its 2005 collaboration agreement with AstraZeneca expanding the TC-5619 development program. In addition to the current development of TC-5619 in cognitive dysfunction in schizophrenia (CDS), the amended terms provide for parallel development in attention deficit/hyperactivity disorder (ADHD) and potentially Alzheimer's disease.

3 May 2010

ImmunoCellular Therapeutics seeks FDA orphan drug status for ICT-107 dendritic-cell based vaccine for GBM

ImmunoCellular Therapeutics announced today it has filed an orphan drug application with the U.S. Food and Drug Administration (FDA) for its cancer treatment candidate ICT-107. ICT-107 is a dendritic-cell based cancer vaccine product which targets glioblastoma multiforme (GBM), the most prevalent, aggressive and malignant form of primary brain tumors.

3 May 2010

Curis completes enrollment in Phase I clinical trial of CUDC-101 HDAC, EGFR and HER2 inhibitor

Curis, Inc., a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that it has successfully completed enrollment and treatment of the last patient in its Phase I clinical trial of CUDC-101, Curis' first-in-class HDAC, EGFR and HER2 inhibitor.

3 May 2010

BioSante Pharmaceuticals reinitiates GVAX Prostate Cancer Vaccine development

BioSante Pharmaceuticals, Inc. today announced that development of its GVAX Prostate Cancer Vaccine (GVAX Prostate) for the treatment of prostate cancer has been reinitiated. Manufacturing of new GVAX Prostate is in process, regulatory steps to lift the GVAX Prostate clinical hold prior to trial initiation are being taken, and prostate cancer patients are expected to be treated in a Phase II human clinical trial beginning in the fourth quarter of 2010 at Johns Hopkins Sidney Kimmel Comprehensive Cancer Center.

3 May 2010

Penwest Pharmaceuticals reports net income of $3.9 million for first-quarter 2010

Penwest Pharmaceuticals Co. today announced its financial results for the first quarter ended March 31, 2010. Compared with the first quarter of 2009, first quarter 2010 revenues increased sharply to $8.8 million, and operating expenses decreased by 20%. The Company had net income of $0.12 per share for the first quarter of 2010.

3 May 2010

AVANIR Pharmaceuticals reports net loss of $6.4 million for second-quarter fiscal 2010

AVANIR Pharmaceuticals, Inc. today reported unaudited financial results for the three and six months ended March 31, 2010.

3 May 2010

Omeros announces additional data from Phase 2 trial of OMS103HP for arthroscopic meniscectomy surgery

Omeros Corporation today announced additional data from a Phase 2 trial of OMS103HP, its PharmacoSurgery™ product candidate for arthroscopy, showing that patients treated with OMS103HP during arthroscopic meniscectomy surgery achieved statistically significant clinical benefits.

3 May 2010

Santen licenses Clinical Data's ATL313 agonist compound for development of ophthalmic treatments

Clinical Data, Inc., and Santen Pharmaceutical Co., Ltd., today announced that Santen has exercised its option to license Clinical Data's highly selective adenosine A2A agonist compound, ATL313, for the development of topical treatments for certain ophthalmic diseases, including glaucoma. ATL313, a promising late-stage preclinical compound, has shown significant pharmacological effects in vivo and has been nominated as a clinical candidate.

From Santen Pharmaceutical Co., Ltd. 3 May 2010

TGRD presents positive results from Phase 3 studies of azilsartan medoxomil for lowering SBP at 25th ASH

Takeda Global Research & Development Center, Inc., U.S., (TGRD U.S.) today announced results from pivotal phase 3 studies of azilsartan medoxomil (development code: TAK-491), an angiotensin II receptor blocker (ARB), demonstrating greater 24-hour systolic blood pressure (SBP) reduction compared to commonly prescribed ARBs olmesartan medoxomil and valsartan.

3 May 2010

SARcode presents positive results from Phase 2 study of SAR 1118 ophthalmic solution at Dry Eye Summit

SARcode Corporation, a privately-held biotechnology company focused on developing a novel class of lymphocyte function-associated antigen-1 (LFA-1) antagonists, today announced results of a 230 patient Phase 2 proof-of-concept study evaluating topical SAR 1118 ophthalmic solution in the treatment of aqueous deficient dry eye (keratoconjunctivitis sicca).

3 May 2010

Raptor Pharmaceutical presents positive results from Phase 2a trial of DR cysteamine bitartrate for NASH

Raptor Pharmaceutical Corp., announced positive Phase 2a clinical trial results from its pilot study of delayed-release cysteamine bitartrate in 11 adolescent patients with non-alcoholic steatohepatitis, a progressive form of liver disease believed to affect 5% to 11% of the U.S. population. The results were presented at the Digestive Disease Week 2010 conference in New Orleans, LA on May 2, 2010.

3 May 2010

Belatacept preserves kidney function in transplant recipients better than cyclosporine, says study

Two-year results from phase III clinical trials show the experimental immunosuppressive drug belatacept can better preserve kidney function in kidney transplant recipients while preventing graft rejection when compared with the standard immunosuppressive drug cyclosporine.

3 May 2010

Triple combination therapy with OM, AML, HCTZ more effective at lowering blood pressure

Results of a new study found that the investigational triple combination therapy of olmesartan medoxomil (OM), amlodipine besylate (AML), and hydrochlorothiazide (HCTZ) demonstrated significantly greater mean reductions at week 12 in blood pressure (37.1/21.8 mm Hg versus 27.5 to 30.0/15.1-18.0 mm Hg LS Mean Reductions, P< 0.0001), as compared to corresponding dual combination therapy (dual components).

3 May 2010

Advaxis advances lead prostate cancer immunotherapeutic toward clinical trials

Advaxis, the live, attenuated Listeria monocytogenes (Lm) immunotherapy company, is advancing the clinical development of its lead prostate cancer immunotherapeutic toward clinical trials.

3 May 2010

Results from VeriStrat biomarker analysis of Phase III trial presented at European Lung Cancer Conference

Results from the VeriStrat biomarker analysis of a multicenter Phase III trial were presented today at the 2nd European Lung Cancer Conference currently being held in Geneva, Switzerland. Results showed that the VeriStrat test identified patients who were likely to have a survival benefit from treatment with erlotinib, a commonly prescribed oral therapy for advanced non-small cell lung cancer.

3 May 2010

FDA approves continuation of Phase IIb clinical trial for superficial bladder cancer

Tikcro Technologies Ltd. today announced that BioCancell Therapeutics, Inc., concluded the first 18 patient group treated pursuant to a Phase IIb clinical trial of the drug candidate BC-819 for use in superficial bladder cancer. These patients had not responded to conventional treatment.

3 May 2010

GeNOsys sponsors Phase I safety trial in collaboration with Nitric Solutions

GeNOsys, Inc. today announced they are sponsoring a Phase I safety trial in collaboration with Nitric Solutions Inc. GeNOsys will be testing their patented nitric oxide generator and nitric oxide producing formula for safety and effectiveness in treating disease. In a parallel study Nitric Solutions will be testing the efficacy of their prophilactic nitric oxide producing formula Nitrisol.

30 Apr 2010

Pieris AG announces preclinical data for proprietary PRS-110 Anticalin compound

Pieris AG announced today preclinical data for its proprietary PRS-110 Anticalin compound, which targets the c-Met receptor, demonstrating a dose-dependant reduction of tumor growth in a xenograft mouse model.

30 Apr 2010

Celtic Pharma commences enrolment in Phase III trial of TDT 067 for onychomycosis

Celtic Pharmaceutical Holdings L.P., the global private equity firm focused on the biotechnology and pharmaceutical industries, announced today the enrolment of the first patient into its Phase III trial of TDT 067, terbinafine in Transfersomes®, for the topical treatment of onychomycosis (also known as a fungal nail infection).

30 Apr 2010

Drug Trial News

Acucela to present data on ACU-4429 oral visual cycle modulator for dry AMD at Retina International meeting

Targacept, AstraZeneca expand TC-5619 development program to include ADHD, Alzheimer's disease

ImmunoCellular Therapeutics seeks FDA orphan drug status for ICT-107 dendritic-cell based vaccine for GBM

Curis completes enrollment in Phase I clinical trial of CUDC-101 HDAC, EGFR and HER2 inhibitor

BioSante Pharmaceuticals reinitiates GVAX Prostate Cancer Vaccine development

Penwest Pharmaceuticals reports net income of $3.9 million for first-quarter 2010

AVANIR Pharmaceuticals reports net loss of $6.4 million for second-quarter fiscal 2010

Omeros announces additional data from Phase 2 trial of OMS103HP for arthroscopic meniscectomy surgery

Santen licenses Clinical Data's ATL313 agonist compound for development of ophthalmic treatments

TGRD presents positive results from Phase 3 studies of azilsartan medoxomil for lowering SBP at 25th ASH

SARcode presents positive results from Phase 2 study of SAR 1118 ophthalmic solution at Dry Eye Summit

Raptor Pharmaceutical presents positive results from Phase 2a trial of DR cysteamine bitartrate for NASH

Belatacept preserves kidney function in transplant recipients better than cyclosporine, says study

Triple combination therapy with OM, AML, HCTZ more effective at lowering blood pressure

Advaxis advances lead prostate cancer immunotherapeutic toward clinical trials

Results from VeriStrat biomarker analysis of Phase III trial presented at European Lung Cancer Conference

FDA approves continuation of Phase IIb clinical trial for superficial bladder cancer

GeNOsys sponsors Phase I safety trial in collaboration with Nitric Solutions

Pieris AG announces preclinical data for proprietary PRS-110 Anticalin compound

Celtic Pharma commences enrolment in Phase III trial of TDT 067 for onychomycosis

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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