Investigational in Medical Technology

Radius' Investigational Bone Anabolic Agent, BA058, Increased Bone Mineral Density (BMD) at Key Fracture Sites in Phase 2 Clinical Trial in Postmenopausal Osteoporosis

CAMBRIDGE, Mass., Aug. 5 /PRNewswire/ -- Radius Health ("Radius") today announced topline Phase 2 data demonstrating that in women with osteoporosis, BA058 -- the company's novel PTHrP (parathyroid hormone-related protein) analog -- significantly increased bone mineral density (BM...

Wyeth Reports Publication of Phase 3 Data for Bazedoxifene/Conjugated Estrogens, an Investigational Compound Being Studied for the Treatment of Menopausal Symptoms

COLLEGEVILLE, Pa., July 27 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE ), announced the publication in Fertility and Sterility of data from a Phase 3 clinical study that showed that the investigational compound bazedoxifene/conjugated estrogens...

Takeda Provides Update on the Investigational Fixed-Dose Combination of alogliptin and ACTOS(R) (pioglitazone HCl)

DEERFIELD, Ill., July 22, and OSAKA, Japan, July 23 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") today announced that Takeda Global Research & Development Center, Inc., a wholly owned United States (U.S.) subsidiary, received notification from the U.S. Food and Drug ...

UPDATE: US Oncology Research Network Participates in Phase III Follow-up Study to BiPar's Investigational Cancer Drug BSI-201

US Oncology Research Network Participates in Phase III Follow-up Study to BiPar's Investigational Cancer Drug BSI-201 Phase II of the trial was presented in 2009 ASCO Plenary Session US Oncology, Inc . today announced that US Oncology Research will participate...

First Patient of NOTES Investigational Device Exemption (IDE) Study Successfully Treated With Ethicon Endo-Surgery Devices

CINCINNATI, July 9 /PRNewswire/ -- Ethicon Endo-Surgery, Inc. today announced the successful treatment of the first patient of its IDE feasibility trial. The case, which was performed at The Ohio State University Center for Minimally Invasive Surgery, marks the first natural orifice translumen...

Takeda Receives FDA Complete Response Letter for Alogliptin, an Investigational Treatment for Type 2 Diabetes

DEERFIELD, Ill., June 26, and OSAKA, Japan, June 27, 2009 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") today announced that Takeda Global Research & Development Center, Inc., a wholly owned United States (U.S.) subsidiary received on June 26 (U.S. time) a complete response ...

Two-Year Data Show Investigational Drug Liraglutide More Effective at Lowering Blood Sugar Than Glimepiride: Oral 162

NEW ORLEANS, June 7 /PRNewswire-FirstCall/ -- Novo Nordisk (NVO) data presented today at the 69th Annual Scientific Sessions of the American Diabetes Association (ADA) showed that once-daily liraglutide, taken as monotherapy, leads to statistically significant and sustained reductions in blood sug...

Lilly Announces Positive Phase II Data on Investigational Medicine for Patients with Type 2 Diabetes

NEW ORLEANS, June 6 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY ) announced today new, positive Phase II study results of LY2189265, its investigational glucagon-like peptide 1 (GLP-1) analog administered subcutaneously once-weekly for the treatment of type 2 diabetes. These data ...

Intercell AG Announces First Subject Enrolled in a Phase II Trial for the Further Development of Its Investigational Vaccine Enhancement Patch to Improve Pandemic Influenza Prevention in Collaboration With U.S. Department of Health and Human Services (HHS

- Phase II clinical trial investigating the effectiveness of Intercell's Vaccine Enhancement (VE) Patch in combination with an injectable H5N1 pandemic influenza vaccine started today in the U.S. - The study is fully funded by HHS - this is the second study conducted under a 5 year USD 128 m ...

Medarex Announces Allowance of Investigational New Drug Application for Wholly-Owned Fully Human Anti-CXCR4 Antibody, MDX-1338

-Clinical study planned for relapsed / refractory acute myelogenous leukemia- PRINCETON, N.J., May 27 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX ) announced today the allowance of an investigational new drug application (IND) filed with the U.S. Food & Drug Administration (FD...

D-Pharm Submits Investigational New Drug Application and Special Protocol Assessment to the FDA for Phase III Trial of DP-b99 in Acute Stroke Patients

REHOVOT, Israel, May 6 /PRNewswire/ -- D-Pharm announced today that it has submitted IND and Special Protocol Assessment (SPA) packages to the US Food and Drug Administration (FDA), for its pivotal Phase III clinical trial of DP-b99 in acute ischemic stroke patients. D-Pharm plans to initiate ...

Glycotex' Investigational Compound GLYC-101 Achieves Accelerated Wound Closure Based on Interim Analysis

ROCKVILLE, Md., April 7 /PRNewswire/ -- Glycotex, Inc. today announced the completion of a scheduled interim analysis in a Phase II study evaluating the effect of investigational GLYC-101 gel on complete wound closure and cosmetic outcomes in cosmetic surgery patients undergoing carbon dioxide las...

Premier Research Announces Milestone Investigational New Drug Application

PHILADELPHIA, April 7 /PRNewswire/ -- Premier Research Group Limited, the international pharmaceutical services company, is pleased to announce that it has submitted an Investigational New Drug Application which represents the 50th IND under management. The milestone IND was submitted to the FDA's...

Rib-X Pharmaceuticals Novel Antibiotic Delafloxacin Named One of R&D Directions 100 Great Investigational Drugs of 2009

NEW HAVEN, Conn., April 2 /PRNewswire/ -- Rib-X Pharmaceuticals, Inc. ("Rib-X" or the "Company"), a development-stage company focused on the discovery and development of novel antibiotics for the treatment of antibiotic-resistant infections, today announced that its lead compound, delafloxacin, ha...

Phase III Trial Showed Investigational Compound Arzoxifene Was Superior to Evista(R) (raloxifene HCl) in Increasing BMD in Postmenopausal Women with Osteoporosis

Results from the "NEXT" Study Also Showed Arzoxifene Significantly Suppressed Bone Turnover Markers versus Raloxifene in Postmenopausal Women with Osteoporosis ATHENS, Greece, March 23 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY ) presented new data showing arzoxifene, an inv...

Schering-Plough's Investigational Oral Thrombin Receptor Antagonist Meets Primary Endpoint in a Newly Published Study

A Phase II Study Published in The Lancet of Fast-Tracked Antiplatelet Agent Showed No Increase in TIMI Major and Minor Bleeding and was Well Tolerated When Given With Standard Platelet Therapy KENILWORTH, N.J., March 12 /PRNewswire-FirstCall/ -- Results of a Schering-Plough Corporation (NYSE:...

ImQuest Submits Investigational New Product Application to the Food and Drug Administration to Initiate HIV Therapeutic Clinical Trials with IQP-0410

FREDERICK, Md., Jan. 7 /PRNewswire/ -- ImQuest Life Sciences announced today the successful submission of an IND application to the Food and Drug Administration to initiate human clinical trials for their lead pyrimidinedione HIV inhibitor IQP-0410. ImQuest anticipates initiating their Phase 1 stu...

Daiichi Sankyo Initiates Phase III Trial of Its Investigational Factor Xa Inhibitor, DU-176b, in Patients With Atrial Fibrillation

TOKYO and EDISON, N.J., Dec. 7 /PRNewswire-FirstCall/ -- Daiichi Sankyo Company, Limited (TSE: 4568), announced today that it has initiated its pivotal Phase III trial for DU-176b, an investigational oral Factor Xa inhibitor, in patients with atrial fibrillation. DU-176b is being developed solely...

Vical Receives Milestone Payment from Merck & Co., Inc. Triggered by Planned Initiation of Investigational Cancer DNA Vaccine Trial

SAN DIEGO, Dec. 1 /PRNewswire-FirstCall/ -- Vical Incorporated (Nasdaq: VICL ) announced today the receipt of a $1.0 million milestone payment from Merck & Co., Inc. based on Merck's planned initiation of a Phase I clinical trial of an investigational plasmid DNA (pDNA) cancer vaccine. The c...

Miami Jewish Home and Hospital, Berma Research Group and Segal Institute for Clinical Research Enrolling Local Patients in Study of Investigational Therapy to Treat Alzheimer's Disease

MIAMI, Nov. 12 /PRNewswire/ -- The Miami Jewish Home and Hospital, Berma Research Group, and Segal Institute for Clinical Research today announced that they are actively enrolling patients in the CONNECTION study, a Phase 3 clinical trial that is evaluating the safety and efficacy of the inves...

Data From Investigational Use of PROCRIT(R) (Epoetin alfa) Presented at American Society of Nephrology Annual Meeting

PHILADELPHIA, Nov. 7 /PRNewswire/ -- Data from an investigational, open-label, randomized study assessing extended dosing regimens of PROCRIT(R) (Epoetin alfa) in treating anemia in subjects with Stages 3 - 4 chronic kidney disease (CKD) were presented today at the American Society of Nephrolo...

Medarex Receives Milestone Payment for Investigational Antibody Targeting Integrin Receptors

PRINCETON, N.J., Nov. 5 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX ) today announced that it has received a milestone payment of an undisclosed amount from its licensing partner, Centocor R&D Inc., for the completion of a Phase 2 trial of CNTO 95, a fully human antibody targeting t...

Tibotec Presents Interim Findings for TMC435, an Investigational Genotype 1 Hepatitis C Treatment, at the AASLD Liver Meeting 2008

Nearly 90 percent of patients achieve undetectable viral load in Phase IIa trial within 28 days of combined treatment with standard of care SAN FRANCISCO, Nov. 1 /PRNewswire/ -- New clinical data show antiviral activity of TMC435, an investigational protease inhibitor (PI) being developed by...

Sequella Presents Data on Synergy Between Investigational New TB Drugs SQ109 and TMC207

Study results to be presented at 2008 ICAAC/IDSA Joint Meeting ROCKVILLE, Md., Oct. 28 /PRNewswire/ -- Sequella, Inc., a clinical-stage biopharmaceutical company focused on commercializing products to treat infectious diseases of epidemic potential, announces the successful demonstration of ...

Sequoia Pharmaceuticals Presents In Vitro and First-in-Human Data Supporting Further Development of SPI-256, a Novel Investigational Protease Inhibitor

WASHINGTON, Oct. 26 /PRNewswire/ -- Sequoia Pharmaceuticals presented positive results today from two studies on SPI-256, a novel investigational HIV protease inhibitor (PI). One study based on an in vitro analysis demonstrates that the mode of interaction of SPI-256 with HIV protease provides...

Millennium Presents New Data on Investigational Drugs for Novel Cancer Targets at EORTC-NCI-AACR Symposium

CAMBRIDGE, Mass., Oct. 22 /PRNewswire/ -- Millennium: The Takeda Oncology Company today announced new data from early non-clinical studies of Millennium/Takeda-discovered pipeline molecules highlighting novel therapeutic pathways in oncology. MLN4924 data build on the growing body of evidence ...

Berlin Heart's EXCOR(R) Pediatric Receives Unconditional Investigational Device Exemption (IDE) Approval

BERLIN, October 16 /PRNewswire/ -- Berlin Heart Inc. today announced its EXCOR(R) Pediatric ventricular assist device (VAD) has received unconditional approval for the ongoing IDE clinical trial in the United States of America. The U.S Food and Drug Administration (FDA) has fully approved the ...

Takeda's Investigational PPI TAK-390MR Demonstrated Higher Healing Rates Compared to Lansoprazole as the Severity of Erosive Esophagitis Grade Increased, a New Integrated Analysis Showed

TAK-390MR Data Presented at the American College of Gastroenterology Annual Meeting ORLANDO, Fla., Oct. 6 /PRNewswire/ -- Combined results from two Phase 3 studies presented at the American College of Gastroenterology Annual Scientific Meeting (ACG) in Orlando, Fla...

Lilly Announces Initiation of Second Global Phase III Trial of Investigational Alzheimer's Disease Compound

Pivotal Study to Provide Real-World Dosing Simulation of Lilly's Gamma-Secretase Inhibitor INDIANAPOLIS, Oct. 1 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY ) today announced it will begin enrolling patients in a second Phase III study of LY450139, a ga...

Forest Laboratories, Inc. and Gedeon Richter Plc Announce Positive Phase II Results with the Investigational Antipsychotic Cariprazine in Patients with Acute Mania Associated with Bipolar I Disorder

NEW YORK and BUDAPEST, Hungary, Sept. 30 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX ) and Gedeon Richter Plc today announced preliminary top-line results from a phase II clinical trial of cariprazine (RGH-188), an investigational antipsychotic, in patients with acute mania...

Medarex Receives Milestone Payment from Pfizer for Investigational New Drug Application Filing

PRINCETON, N.J., Sept. 8 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX ) today announced that it received a milestone payment for an undisclosed amount from its licensing partner, Pfizer Inc. (NYSE: PFE ). This payment is a result of the submission of an Investigational New Drug (IND...

Volcano's VH(R) IVUS Technology Used in Imaging Study of GlaxoSmithKline's Novel Investigational Compound, Darapladib

IBIS-2 (Integrated Biomarker and Imaging Study) Results Demonstrate Benefits of VH(R) IVUS in Drug Development SAN DIEGO, Calif., Sept. 2 /PRNewswire-FirstCall/ -- Volcano Corporation (Nasdaq: VOLC ) [ESC Booth # A2-D403], a leading manufacturer of intravascular ultrasound (IV...

Intercell Announces Initiation of Further Phase II Clinical Trial of V710 an Investigational Vaccine to Prevent S. aureus Infection

VIENNA, Austria, Aug. 28 /PRNewswire/ -- Intercell AG (VSE: ICLL) today announced that its collaborator Merck & Co., Inc. has initiated a Phase II clinical trial of V710, an investigational vaccine for the prevention of Staphylococcus aureus (S. aureus) infections. This randomized double blind...

Ninety-Six Week Data on Tibotec Investigational NNRTI, TMC278, Presented at AIDS 2008

- Phase IIb study examines efficacy and safety of once-daily TMC278 in treatment-naive adults with HIV-1 - MEXICO CITY, Aug. 5 /PRNewswire/ -- New phase IIb data from Tibotec Pharmaceuticals Ltd. provides additional information on the safety and efficacy of TMC278, the compan...

Medarex Announces Allowance of Investigational New Drug Application for Wholly-Owned Fully Human Anti-PD-L1 Antibody, MDX-1105

Clinical study planned for advanced or recurrent solid tumors PRINCETON, N.J., Aug. 5 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX ) announced today the allowance of an investigational new drug application (IND) filed with the U.S. Food & Drug Administration (FDA) for MDX-1105, ...

Meditrina Pharmaceuticals, Inc. Opens Investigational New Drug (IND) Application for Phase IIb Clinical Trial With MPI-676 in Endometriosis

- Approval of Second IND Marks Major Corporate Milestone and Advances Clinical Program - ANN ARBOR, Mich., July 17 /PRNewswire/ -- Meditrina Pharmaceuticals, Inc. today announced the approval of its second investigational new drug (IND) application for a Phase IIb do...

Roche Moves Investigational Diabetes Drug, Taspoglutide, Into Phase III Clinical Trials

- Positive Phase II Results of Roche and Ipsen's First Once-Weekly Human GLP-1 Presented at the American Diabetes Association Meeting - NUTLEY, N.J., June 10 /PRNewswire/ -- Roche and Ipsen's investigational type 2 diabetes drug taspoglutide (R1583) has been shown to provide significant im...

Banner Alzheimer's Institute and Sun Health Research Institute Enrolling Local Patients in Study of Investigational Therapy to Treat Alzheimer's Disease

- Data from Pivotal Study Highlighted at Recent Arizona Alzheimer's Consortium Annual Conference in Phoenix - PHOENIX and SUN CITY, Ariz., June 9 /PRNewswire/ -- Banner Alzheimer's Institute and Sun Health Research Institute today announced that they are actively enrolling pati...

Abbott's Phase III Sub-Group Analysis Shows Investigational TriLipix(TM) in Combination with CRESTOR(R) Improves Key Lipids in Patients with Mixed Dyslipidemia and Type 2 Diabetes

TriLipix in Combination with CRESTOR (rosuvastatin calcium) Demonstrates Similar Lipid Effects in Patients with Diabetes and Overall Study Population SAN FRANCISCO, June 7 /PRNewswire-FirstCall/ -- New data from a sub-group analysis of patients with mixed dyslip...

Type 2 Diabetes Patients Taking Exenatide Once Weekly, a Phase 3 Investigational Diabetes Therapy, Showed Improvements in Glycemic Control, Weight

DURATION-1 Data Presented at the 68th Annual Scientific Sessions of the American Diabetes Association SAN FRANCISCO, June 7 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN ), Eli Lilly and Company (NYSE: LLY ), and Alkermes, Inc. (Nasdaq: ALKS ) anno...