Phase 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...

NewCardio Announces Master Services Agreement With Dedicated Phase I

SANTA CLARA, Calif., Aug. 5 /PRNewswire-FirstCall/ -- NewCardio, Inc., (OTC Bulletin Board: NWCI) a cardiac diagnostic and services company, today announced that Dedicated Phase I, an innovative, Phoenix, Arizona-based provider of clinical research services including a Core ECG...

Telik Announces Publication of Positive Phase 1 Results of a Multicenter Study of Ezatiostat Hydrochloride (TELINTRA(R), TLK199) Tablets In Patients With Myelodysplastic Syndrome

PALO ALTO, Calif., Aug. 3 /PRNewswire-FirstCall/ -- Telik, Inc. (Nasdaq: TELK ) today announced that the positive results from a Phase 1 multicenter, dose escalation study of ezatiostat hydrochloride (TELINTRA, TLK199) tablets in patients with Myelodysplastic Syndrome (MDS) have been p...

Shire Reports Positive Results From First of Three Phase III Trials of velaglucerase alfa for Type 1 Gaucher Disease and Provides Important Updates on Interactions With FDA

LEXINGTON, Massachusetts, August 3 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY ), the global specialty biopharmaceutical company, today reported positive results from the first of three Phase III studies of velaglucerase alfa, its enzyme replacement therapy in development fo...

Covance Receives Highest Level of Phase I Accreditation

PRINCETON, N.J., July 30 /PRNewswire/ -- Covance Inc. today announced that it has received standard and supplementary accreditation for the conduct of clinical pharmacology in Europe by the Medicines and Healthcare products Regulatory Agency (MHRA). This voluntary accreditation ...

European Division of Global Top 20 Pharmaceutical Company Awards Phase III Trial to DATATRAK

CLEVELAND, July 28 /PRNewswire-FirstCall/ -- DATATRAK International, Inc., a technology and services company focused on global eClinical solutions for the clinical trials industry, today announced that a European Division within a Global Top 20 Pharmaceutical organization has selected DA...

Dirucotide Does Not Meet Primary Endpoint in Phase III MAESTRO-01 Trial in Secondary Progressive Multiple Sclerosis

INDIANAPOLIS and EDMONTON, Alberta, July 27 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY ) and BioMS Medical Corp. (TSX: MS) today announced that dirucotide did not meet the primary endpoint of delaying disease progression, as measured by the Expanded Disability Status Scale (...

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...

Poniard Pharmaceuticals Announces Positive Cardiac Safety Data From Picoplatin Phase 1 Trial Supporting NDA Filing

SOUTH SAN FRANCISCO, Calif., July 21 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD ), a biopharmaceutical company focused on innovative oncology therapies, today announced results from a Phase 1 cardiac safety study of picoplatin, a new generation platinum-...

R-Tech Ueno, Ltd. Completes Phase 1 Clinical Study on RK-023

TOKYO, July 21 /PRNewswire/ -- R-Tech Ueno, Ltd. announced on July 17 that as a phase 1 clinical study on the new compound RK-023 that is being developed by our company as a therapeutic drug of androgenetic alopecia (male pattern baldness; see the note below) has been completed. The ...

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...

Cytokine PharmaSciences Initiates Phase I Study of Oral Anti-Inflammatory Agent, CPSI-2364

KING OF PRUSSIA, Pa., July 20 /PRNewswire/ -- Cytokine PharmaSciences, Inc. today announced the initiation of a Phase I study of CPSI-2364, its orally active, small-molecule inhibitor of the production of TNF-alpha and other pro-inflammatory cytokines. Results of the dose escalation and...

Human Genome Sciences and GlaxoSmithKline Announce Positive Phase 3 Study Results for BENLYSTA(TM) in Systemic Lupus Erythematosus

ROCKVILLE, Maryland and LONDON, July 20 /PRNewswire-FirstCall/ -- Human Genome Sciences, Inc. (Nasdaq: HGSI ) and GlaxoSmithKline PLC (GSK) today announced that BENLYSTA(TM) (belimumab, formerly LymphoStat-B(R)) met the primary endpoint in BLISS-52, the first of two pivotal P...

Orexigen(R) Therapeutics Schedules July 20, 2009 Teleconference and Webcast Discussion of Contrave(R) Phase 3 Results

SAN DIEGO, July 17 /PRNewswire-FirstCall/ -- Orexigen(R) Therapeutics, Inc. (Nasdaq: OREX ), a biopharmaceutical company focused on the treatment of obesity, plans to announce the results of the three remaining Phase 3 clinical trials in the Contrave program on Monday, July 20, 2009 be...

BioCryst Pharmaceuticals Reports Positive Results of Shionogi & Co. Sponsored Phase 3 Studies of i.v. Peramivir for Influenza

BIRMINGHAM, Ala., July 17 /PRNewswire-FirstCall/ -- BioCryst Pharmaceuticals (Nasdaq: BCRX ) today announced positive results from two Phase 3 studies of intravenous (i.v.) peramivir in patients with seasonal influenza. The studies were sponsored by BioCryst's partner Shionogi & Co.,...

Schering-Plough Expands Vicriviroc Phase II Study in Treatment-Naive Patients With HIV

KENILWORTH, N.J., July 15 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP ) today announced that it has extended to stage two an ongoing Phase II clinical study with vicriviroc, its investigational CCR5 antagonist, for use in first-line therapy of adult ...

Analysis of Edoxaban Phase II Data Provides Insight Into Reduced Bleeding Events Seen in Once-Daily Dosing

BOSTON and EDISON, N.J., July 15 /PRNewswire/ -- A sub-analysis of a Phase IIb multinational study(1) with edoxaban(2) - an investigational oral Factor Xa inhibitor - provides insights into why patients with non-valvular atrial fibrillation (AF) receiving edoxaban once daily (QD) experie...

Keryx Biopharmaceuticals, Inc. Commences Phase 1 Study of KRX-0401 (Perifosine) in Recurrent Pediatric Solid Tumors at Memorial Sloan-Kettering Cancer Center

NEW YORK, July 14 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX ) announced today the initiation of a Phase 1 clinical study to evaluate KRX-0401 (perifosine) as a single agent treatment for recurrent solid tumors in pediatric patients. This Phase 1 study is now ope...

Iontophoretic Drug Delivery System (IDDS) Containing Lidocaine and Epinephrine is Effective in Reducing Pain Associated With Insertion of an Intravenous Catheter in a Phase 2 Clinical Trial

SEATTLE, July 9 /PRNewswire/ -- Dharma Therapeutics, Inc., ("Dharma") Seattle, WA (a subsidiary of the Transcu Group Limited, a company listed on the Singapore Exchange Limited) announced that its improved active transdermal delivery technology, which administers lidocaine and epinephrine through ...

Rigel's R788 Significantly Improves Rheumatoid Arthritis in Phase 2b Clinical Trial

SOUTH SAN FRANCISCO, Calif., July 9 /PRNewswire-FirstCall/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL ) today announced that R788 (fostamatinib disodium) produced significant clinical improvement in rheumatoid arthritis (RA) patients in the recently completed TASKi2 Phase 2b clinical trial of ...

Rigel to Host Conference Call to Discuss Results of Its Phase 2b TASKi2 Clinical Trial of R788 in Rheumatoid Arthritis

SOUTH SAN FRANCISCO, Calif., July 8 /PRNewswire-FirstCall/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL ) today announced that the Company plans to host a conference call on Thursday, July 9, 2009 at 8:00 am EDT (5:00 am PDT). Members of Rigel's senior management team and the principal investig...

Denosumab Demonstrates Superiority Over Zometa(R) in Pivotal Phase 3 Head-to-Head Trial in Breast Cancer Patients With Bone Metastases

THOUSAND OAKS, Calif., July 7 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN ) today announced that a pivotal, Phase 3, head-to-head trial evaluating denosumab versus Zometa(R) (zoledronic acid) in the treatment of bone metastases in 2,049 patients with advanced breast cancer met its primary and ...

Alcon Commences Phase 2 Clinical Trial of NovaBay's NVC-422 for Viral Conjunctivitis

EMERYVILLE, Calif. and HUENENBERG, Switzerland, July 5 /PRNewswire-FirstCall/ -- Alcon, Inc. (NYSE: ACL ) and its partner, NovaBay Pharmaceuticals, Inc. (NYSE-AMEX: NBY ), announced today that Alcon has begun treating patients in a Phase 2 clinical trial of NovaBay's patented lead Aganocide(R)...

BioCis Pharma Reports Positive Phase IIa Clinical Results in Atopic Dermatitis

TURKU, Finland, July 3 /PRNewswire/ -- BioCis Pharma Ltd., a privately held drug development company with its headquarters in Turku, Finland, announced positive results from its Phase IIa clinical trial of ProtoCure(TM) emulsion cream, the company's novel topical drug for dermatology. This dou...

ThromboGenics and BioInvent Start Recruitment of Second 100 Patient Cohort in Phase II DVT Prophylaxis Study With TB-402

LEUVEN, Belgium and LUND, Sweden, July 3 /PRNewswire-FirstCall/ -- ThromboGenics NV (Euronext Brussels: THR) and co-development partner BioInvent International (OMXS: BINV) announce that they have started recruitment of a second cohort of patients for their Phase II trial of TB-402. This follo...

Calixa Therapeutics Announces Initiation of Phase 2 Clinical Trial of Its Antibiotic, CXA-101, in Patients with Complicated Urinary Tract Infections

SAN DIEGO, June 30 /PRNewswire/ -- Calixa Therapeutics Inc. today announced the initiation of a Phase 2 clinical trial of CXA-101 in patients with complicated urinary tract infections. CXA-101 is a new broad-spectrum, parenteral cephalosporin antibiotic with excellent in vitro and in vivo act...

AcelRx Announces Positive Phase 2 Results from a Study of ARX-01 Sufentanil NanoTabs in Treating Post-Operative Pain

Study in major abdominal surgery patients achieved primary and secondary endpoints REDWOOD CITY, Calif., June 29 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. today announced positive results from the second Phase 2 clinical study evaluating the safety and efficacy of its ARX-01 Sufentanil Nan...

Vantia Therapeutics' Lead Candidate VA106483 Demonstrates Positive Anti-diuretic Effect in Phase IIa Trial in Nocturia

SOUTHAMPTON, England, June 29 /PRNewswire/ -- Vantia Therapeutics, an emerging pharmaceutical company developing novel, small molecule drugs targeting large, underserved medical markets, announces positive results from a Phase IIa clinical trial of its lead development compound VA106483 for no...

Sosei and Vectura Announce Start of Phase III Clinical Study With NVA237

CHIPPENHAM, England and TOKYO, June 29 /PRNewswire/ -- - Study Triggers $7.5m Milestones for Both Companies Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565) and Vectura Group plc ("Vectura"; LSE: VEC) announce the commencement of a Phase III clinical study by Novartis, ...

ThromboGenics' Microplasmin Phase III Program Progressing According to Schedule

LEUVEN, Belgium, June 25 /PRNewswire-FirstCall/ -- - Recruitment on Track for ThromboGenics' Lead Product for the Non-Surgical Treatment of Eye Disease With No Reported Safety Issues ThromboGenics NV (Euronext Brussels: THR), a biotechnology company focused on the discovery and d...

Jazz Pharmaceuticals and UCB Announce Second Phase III Study of Sodium Oxybate in Patients With Fibromyalgia Meets Primary Endpoints

Preliminary top-line results of second Phase III study show highly significant decreases in pain and fatigue and improved daily function in fibromyalgia patients and confirm results from the first Phase III study PALO ALTO, Calif., and BRUSSELS, June 24 /PRNewswire-FirstCall/ -- press releas...

Spherix Announces Positive Phase 2 Study Results

Preliminary Data Demonstrates Reduction of HbA1c Levels With Doses an Order of Magnitude Lower than the Dose Used in the Current Phase 3 Trial. BETHESDA, Md., June 24 /PRNewswire-FirstCall/ -- Spherix Incorporated (Nasdaq CM: SPEX), an innovator in biotechnology for diabetes therapy, and a pr...

Conatus Pharmaceuticals Initiates a Second Phase 2 Clinical Trial for the Treatment of Hepatitis

SAN DIEGO, June 24 /PRNewswire/ -- Conatus Pharmaceuticals Inc. announced today the initiation of a second Phase 2 clinical trial with a novel drug candidate for the treatment of liver disease associated with Hepatitis C Virus (HCV) infection. The trial will enroll patients for whom treatment with...

Amicus Therapeutics Commences Phase 3 Trial Evaluating Amigal(TM) for the Treatment of Fabry Disease

- FDA Agreement Reached on Phase 3 Study Design, Primary Endpoint and Histological Methodology - CRANBURY, N.J., June 22 /PRNewswire-FirstCall/ -- Amicus Therapeutics (Nasdaq: FOLD ) today announced it has commenced the U.S. registration Phase 3 trial with its investigational drug, Amigal...

Responses After Completion of Therapy Increase Pixantrone Complete Remission (CR)/Unconfirmed Complete Remission (CRu) Rate to 24% and Overall Response Rate (ORR) to 40% Compared to 7% and 14% for Comparator Agents in Phase III EXTEND Trial in 3rd Line Th

SEATTLE, June 22 /PRNewswire-FirstCall/ -- Updated follow-up phase III EXTEND (PIX 301) clinical trial data enhances previously reported superior response rates for pixantrone over comparator including in high risk patient subgroups Additional Clinical Studies Also Highlighted at Pan ...

ProFibrix Initiates Phase II Clinical Trial of its Lead Topical Hemostat Product Fibrocaps(TM)

SEATTLE, Washington, and LEIDEN, The Netherlands, June 18 /PRNewswire/ -- ProFibrix B.V. today announced the start of the company's Phase II clinical trial for Fibrocaps(TM), the company's lead topical Hemostat product, with the successful treatment of the first patients for mild to moderate b...

CuraGen Announces Expansion of CR011-vcMMAE Phase II Trial in Advanced Breast Cancer

- 12 week progression free rate supports advancement into second stage of Simon 2-Stage designed trial - BRANFORD, Conn., June 17 /PRNewswire-FirstCall/ -- CuraGen Corporation (Nasdaq: CRGN ) announced today that its Phase I/II Trial evaluating CR011-vcMMAE for the treatment of patients w...

HEALTHPOINT-Sponsored Venous Leg Ulcer Clinical Trial Enrolls First Subject for Second Phase II Study

Multi-Center, Randomized Trial to Test Unique Delivery System Using Living Cells to Enhance Wound Healing Marks Milestone for Fort Worth, Texas-based Specialty Biopharmaceutical Company FORT WORTH, Texas, June 16 /PRNewswire/ -- HEALTHPOINT, Ltd. today announced that it has enrolled the f...

MacroGenics and Lilly Achieve Targeted Patient Enrollment in PROTEGE, a Global Phase 2/3 Clinical Trial of Teplizumab in Type 1 Diabetes

Phase 3 PROTEGE ENCORE Clinical Trial Initiated ROCKVILLE, Md. and INDIANAPOLIS, June 16 /PRNewswire/ -- MacroGenics, Inc. and Eli Lilly and Company (NYSE: LLY ) today announced that the PROTEGE trial achieved its targeted patient enrollment. The trial is a pivotal Phase 2/3 clinical study...

VIA Pharmaceuticals Meets With FDA to Discuss Next Steps For VIA-2291 and Phase 3 Outcome Trial in Cardiovascular Disease

Safety and Biologic Activity Data Reviewed in End of Phase 2a Meeting SAN FRANCISCO, June 11 /PRNewswire-FirstCall/ -- VIA Pharmaceuticals, Inc. (Nasdaq: VIAP ), a biotechnology company focused on the development of compounds for the treatment of cardiovascular and metabolic disease, annou...