FDA Accepts sNDA for Alternative Dosing Regimen for Dacogen(R) (decitabine for injection) to Treat Patients with Myelodysplastic Syndromes (MDS)

WOODCLIFF LAKE, N.J., July 8 /PRNewswire/ -- Eisai Corporation of North America today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's supplemental new drug application (sNDA) for an alternative five-day dosing regimen for Dacogen(R) (decitabine for ...

Innocoll Announces Dosing of Last Patient in Second US Phase 3 Clinical Trial to Investigate GENTAMICIN SURGICAL IMPLANT for Prevention of Surgical Site Infections in Colorectal Surgery Patients

ASHBURN, Va., March 19 /PRNewswire/ -- Innocoll, Inc., a privately-held biopharmaceutical company, announced that the last patient has been dosed in the second of two ongoing U.S. phase 3 clinical trials sponsored by its wholly owned subsidiary, Innocoll Technologies Ltd, to investigate CollaRx(R)...

Innocoll Announces Dosing of Last Patient in US Phase 3 Clinical Trial to Investigate GENTAMICIN SURGICAL IMPLANT for Prevention of Surgical Site Infections in Cardiac Surgery Patients

ASHBURN, Va., March 16 /PRNewswire/ -- Innocoll, Inc., a privately-held biopharmaceutical company, announced that the last patient has been dosed in the first of two ongoing U.S. phase 3 clinical trials sponsored by its wholly owned subsidiary, Innocoll Technologies Ltd, to investigate CollaRx(R) ...

Quark Pharmaceuticals Announces Dosing of the First Patient in Phase I/II Clinical Trial for Systemically Delivered siRNA Drug Candidate for Delayed Graft Function

Kidney transplantation to be Quark's second indication with clinical-stage, systemically administered siRNA product candidate FREMONT, Calif., Jan. 8 /PRNewswire/ -- Quark Pharmaceuticals, Inc., a development-stage pharmaceutical company discovering and developing novel RNA interference (RNA...

Synvista Therapeutics Announces First Dosing of SYI-2074 in Clinical Trial for Psoriasis

MONTVALE, N.J., Dec. 15 /PRNewswire-FirstCall/ -- Synvista Therapeutics, Inc. (NYSE Alternext US : SYI) has dosed the first patient in a 30-patient Phase 2 clinical trial of its proprietary topical GPx-mimetic, SYI-2074, in patients with psoriasis. The trial is planned to be a 28-day multi-ce...

SCOLR Pharma Announces Completion of Patient Enrollment and Dosing for Pivotal Clinical Trial Evaluating Extended Release Ibuprofen

Top Line Clinical Results Expected in November 2008 BOTHELL, Wash., Oct. 9 /PRNewswire-FirstCall/ -- SCOLR Pharma, Inc. (Amex: DDD ) announced today the completion of patient enrollment and dosing for the third of its three pivotal trials to evaluate the safety and efficacy of its formulati...

Innocoll Announces Dosing of Last Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) BUPIVACAINE SURGICAL IMPLANT for the Management of Post-Operative Pain

ASHBURN, Va., Aug. 8 /PRNewswire/ -- Innocoll, Inc., a privately-held biopharmaceutical company, announced that the last patient has been dosed in the first of three ongoing phase 2 clinical trials sponsored by its wholly owned subsidiary, Innocoll Technologies Ltd, to investigate CollaRx(R) B...

Tolerx Initiates Dosing of Otelixizumab, a Novel Type 1 Diabetes Agent, in DEFEND, a Phase 3 Clinical Trial

Milestone achievement triggers $15 million payment from collaborator GlaxoSmithKline CAMBRIDGE, Mass., Aug. 6 /PRNewswire/ -- Tolerx, Inc., a biopharmaceutical company engaged in the discovery and development of novel therapies for immune-mediated diseases, today a...

Nile Therapeutics Announces Dosing in Second Phase Ib Study of CD-NP in Heart Failure Patients

SAN FRANCISCO, July 30 /PRNewswire-FirstCall/ -- Nile Therapeutics, Inc. (Nasdaq: NLTX ), today announced that Mayo Clinic has initiated a Phase Ib, double-blind, placebo-controlled clinical study of CD-NP, a novel chimeric natriuretic peptide, in development for the treatment of acute decomp...

Quark Pharmaceuticals Announces First Patient Dosing by Pfizer in Phase II Trial of RNAi Therapy in Diabetic Macular Edema

Clinical Program Leverages Quark's RNAi Technology FREMONT, Calif., July 30 /PRNewswire/ -- Quark Pharmaceuticals, Inc., a development-stage pharmaceutical company discovering and developing novel RNA interference (RNAi)-based therapeutics, today announced that its partner, Pfizer Inc, initi...

Newly Published Study Results Showed That Two Mealtime Insulin Dosing Algorithms Were Effective for Patients with Type 2 Diabetes

Two Regimens Including Lantus(R) and Apidra(R) Resulted in Significant Reductions in A1C in Patients with Type 2 Diabetes, Whatever the Algorithm Used BRIDGEWATER, N.J., July 22 /PRNewswire/ -- Results from the "Adjust to Target in Type 2 Diabetes: Comparison...

Nile Therapeutics Announces Dosing in Phase IIa Study of CD-NP in Heart Failure Patients

SAN FRANCISCO, July 11 /PRNewswire-FirstCall/ -- Nile Therapeutics, Inc. (Nasdaq: NLTX ), today announced that it has dosed the first acute setting heart failure patient in its Phase IIa, multi-center, open-label, ascending dose clinical study of the company's lead product candidate, CD-NP, a...

NeurogesX Initiates Dosing in Phase 1 Clinical Trial for NGX-1998 Capsaicin Liquid Formulation

SAN MATEO, Calif., July 11 /PRNewswire-FirstCall/ -- NeurogesX, Inc. (Nasdaq: NGSX ), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced the initiation of its Phase 1 clinical trial (study C203) of NGX-1998. The product candidate i...

Cimzia(R) Provides Long-Term Efficacy with Stable Dosing in Crohn's Disease

Data on Newly-Approved Cimzia(R) Presented at Digestive Disease Week (DDW) SAN DIEGO, May 20 /PRNewswire/ -- UCB announced today that data presented at Digestive Disease Week reaffirm the long-term, sustainable efficacy and safety of Cimzia(R) (certolizumab pegol) at stable doses in treating pa...

Ikaria Completes Dosing of Phase 1a Clinical Study for IK-1001 (Sodium Sulfide) for Injection

CLINTON, N.J., May 19 /PRNewswire/ -- Ikaria Holdings, Inc., a fully integrated critical care biotherapeutics company, announced today that it has completed dosing of its Phase 1a trial for its drug candidate, IK-1001 (sodium sulfide) for injection. The study was a Phase 1, randomized, singl...

Neurobiological Technologies, Inc. Presents Dosing Rationale for Viprinex(TM) (ancrod) at the European Stroke Conference

NICE, France, May 14 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc. (NTI(R)) (Nasdaq: NTII ) reported for the first time at the European Stroke Conference detailed analyses supporting the dosing regimen in NTI's two ongoing Phase 3 studies of Viprinex(TM) (ancrod) for ischemic s...

Pharmasset Commences Dosing R7128 Cohorts 3 and 4 for the Treatment of Chronic Hepatitis C

- Two 4-week cohorts will evaluate R7128 1000mg BID in HCV genotype 1 treatment-naive patients and R7128 1500mg BID in HCV genotypes 2 or 3 treatment-experienced patients - PRINCETON, N.J., May 14 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS ) has commenced ...

Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) GENTAMICIN TOPICAL for the Prevention of Diabetic Foot Infections

ASHBURN, Va., April 30 /PRNewswire/ -- Innocoll, Inc., a privately-held biopharmaceutical company, announced that the last of three planned phase 2 clinical trials sponsored by its wholly owned subsidiary, Innocoll Technologies Ltd, to investigate CollaRx(R) GENTAMICIN TOPICAL for the treatmen...

Novel Xeloda(R) Dosing Schedule May Offer Well-Tolerated Alternative for Treatment of Advanced Breast Cancer

- Investigational Study Results Published in Journal of Clinical Oncology Pave Way for Phase II Efficacy Trial - NUTLEY, N.J., April 18 /PRNewswire/ -- A novel biweekly dosing schedule of Xeloda(R) (capecitabine) enabled safe delivery of higher daily doses in the treatment of ad...

Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) GENTAMICIN TOPICAL for the Treatment of Moderately Infected Diabetic Foot Ulcers

ASHBURN, Va., April 17 /PRNewswire/ -- Innocoll, Inc., a privately-held biopharmaceutical company, announced that the second of three planned phase 2 clinical trials sponsored by its wholly owned subsidiary, Innocoll Technologies Ltd, to investigate CollaRx(R) GENTAMICIN TOPICAL for the treatm...

Update From Mipomersen Extended Dosing Study Continues to Show That Mipomersen Is Well Tolerated and Maintains Activity in Patients Treated for Up to 16 Months

Isis Will Host a Conference Call on Monday, April 14, at 8:30 a.m. E.T. at http://www.isispharm.com CARLSBAD, Calif., April 14 /PRNewswire-FirstCall/ -- Isis Pharmaceuticals, Inc. (Nasdaq: ISIS ) announced additional results from its ongoing Phase 2 open-label extensio...

EntreMed Commences Continuous Dosing Clinical Trial For MKC-1

Phase 1 Study to be Conducted in Advanced Cancer Patients ROCKVILLE, Md., April 2, 2008 /PRNewswire-FirstCall/ -- EntreMed, Inc. (Nasdaq: ENMD ), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced that ...

Tailored Clopidogrel Dosing Improves PCI Outcomes

Blood test monitors each patient's response to anti-clotting drug CHICAGO, March 29 /PRNewswire/ -- Using a simple blood test to individualize the loading dose of a medication that prevents blood clotting significantly reduces the risk of major cardiovascular complications after percutaneou...

Nventa Enrolls and Initiates Dosing of Final Cohort in HspE7 Phase 1 Cervical Dysplasia Trial

SAN DIEGO, March 11 /PRNewswire-FirstCall/ -- Nventa Biopharmaceuticals Corporation (TSX: NVN) today announced that the Company has completed enrollment and initiated dosing of the fourth and final cohort of patients in its Phase 1 dose escalation trial. This study examines the safety of its l...

Innocoll Announces Dosing of First Patient in Second US Phase 3 Clinical Trial to Investigate CollaRx(R) GENTAMICIN SURGICAL IMPLANT for the Prevention of Surgical Site Infections

ASHBURN, Va., Feb. 19 /PRNewswire/ -- Innocoll, Inc., a privately-held specialty pharmaceutical company, announced that the second of two phase 3 clinical trials sponsored by its wholly owned subsidiary, Innocoll Technologies Ltd, to investigate CollaRx(R) GENTAMICIN SURGICAL IMPLANT for the p...

Human Genome Sciences Modifies Dosing in Achieve Trials of Albuferon(R)

ROCKVILLE, Md., Jan. 23 /PRNewswire-FirstCall/ -- Human Genome Sciences Inc. (Nasdaq: HGSI ) announced today that it will modify the dosing in one arm of each of its ACHIEVE clinical trials of Albuferon(R) (albinterferon alfa-2b) for chronic hepatitis C. Patients in the Phase 3 trials who hav...

Genaera Begins Dosing Second Phase 1 Trial of Type 2 Diabetes and Obesity Compound Trodusquemine (MSI-1436)

Study in Overweight and Obese Type 2 Diabetics to Assess Safety and Pharmacokinetics in addition to Specialized Secondary Endpoints PLYMOUTH MEETING, Pa., Jan. 17 /PRNewswire-FirstCall/ -- Genaera Corporation (Nasdaq: GENR ) today announced that dosing of subjects has begun in study MSI-...

Sangart, Inc. Initiates Dosing in Phase II Study of Hemospan(R) in Chronic Critical Limb Ischemia

SAN DIEGO, Jan. 7 /PRNewswire/ -- Sangart, Inc., a privately held biopharmaceutical company focused on the research, development and commercialization of oxygen transport agents, announced today that it has started testing its lead product, Hemospan(R), in a Phase II clinical study involving c...

Alexion Commences Dosing in AEGIS Registration Study of Soliris(R) (eculizumab) in Patients with PNH in Japan

CHESHIRE, Conn., Jan. 7 /PRNewswire-FirstCall/ -- Alexion Pharmaceuticals, Inc. (the "Company," Nasdaq: ALXN) today announced that it has commenced dosing in the AEGIS study, a single registration study to evaluate the safety, efficacy, and pharmacology of Soliris(R) (eculizumab) as a treatmen...

Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) BUPIVACAINE SURGICAL IMPLANT for the Management of Post-operative Pain

ASHBURN, Va., Jan. 4 /PRNewswire/ -- Innocoll, Inc., a privately-held specialty pharmaceutical company, announced that the first of a series of planned phase 2 clinical trials sponsored by its wholly owned subsidiary, Innocoll Technologies Ltd, to investigate CollaRx(R) BUPIVACAINE SURGICAL IM...

Innocoll Announces Dosing of First Patient in US Phase 3 Clinical Trial to Investigate CollaRx(R) GENTAMICIN SURGICAL IMPLANT for the Prevention of Surgical Site Infections in Cardiac Surgery Patients

ASHBURN, Va., Jan. 2 /PRNewswire/ -- Innocoll, Inc., a privately-held specialty pharmaceutical company, announced that the first of two phase 3 clinical trials sponsored by its wholly owned subsidiary, Innocoll Technologies Ltd, to investigate CollaRx(R) GENTAMICIN SURGICAL IMPLANT for the pre...

Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) GENTAMICIN TOPICAL for the Treatment of Mildly Infected Diabetic Foot Ulcers

ASHBURN, Va., Dec. 18 /PRNewswire/ -- Innocoll, Inc., a privately-held specialty pharmaceutical company, announced that the first of three planned phase 2 clinical trials sponsored by its wholly owned subsidiary, Innocoll Technologies Ltd, to investigate CollaRx(R) GENTAMICIN TOPICAL for the t...

MDS Patients on Five-Day Vidaza(R) Dosing Schedules Achieve Transfusion Independence Consistent with Seven-day Schedule

Three Alternative Five-day Dosing Schedules Appear Similar to Seven-Day in Achieving Red Blood Cell Transfusion Independence, Hematologic Improvement in All MDS Patients Tested Data Presented at the 49th American Society of Hematology (ASH) Meeting ATLANTA, Dec. 11 /PRN...

VioQuest Pharmaceuticals Announces Dosing of First Patient in Phase IIa Solid Tumor Study for Lenocta(TM), a Novel Protein Tyrosine Phosphatase Inhibitor

BASKING RIDGE, N.J., Nov. 26 /PRNewswire-FirstCall/ -- VioQuest Pharmaceuticals (OTC Bulletin Board: VQPH) today announced the initiation of a Phase IIa study of Lenocta(TM) (sodium stibogluconate), a novel protein tyrosine phosphatase inhibitor, in combination with interferon alpha, an immune...

Quark Pharmaceuticals, Inc. Announces First Systemic siRNA Dosing in Humans

Commences Phase I Clinical Trial of Proprietary siRNA Molecule in Acute Renal Failure FREMONT, Calif., Nov. 19 /PRNewswire/ -- Quark Pharmaceuticals, Inc., a development-stage pharmaceutical company focused on discovering and developing novel RNA interference-based ...

Genta Completes Initial Clinical Dosing of G4544, a New Oral Drug for Bone Diseases

Safety Analysis Shows Good Tolerance with No Serious Adverse Reactions BERKELEY HEIGHTS, N.J., Nov. 15 /PRNewswire-FirstCall/ -- Genta Incorporated (Nasdaq: GNTA ) released findings from the initial clinical dosing of G4544, the Company's proprietary small molecule that is intended as a trea...

Potent Hepatitis C Virus Inhibitors Show Efficacy and Potential for Once Daily Dosing in Preclinical Studies

Data Presented at the 2nd Annual International Workshop on Hepatitis C Resistance & New Compounds WATERTOWN, Mass., Nov. 1 /PRNewswire/ -- Researchers from Enanta Pharmaceuticals today presented data on novel Hepatitis C protease inhibitors with potent antiviral activity...

Pivotal MIRCERA(R) Study First to Convert Dialysis Patients From Frequent Dosing Directly to Once Every Two Weeks or Once Every Four Weeks

- MAXIMA findings in The Lancet affirm the maintenance of hemoglobin levels with less frequent dosing - NUTLEY, N.J., Oct. 19 /PRNewswire/ -- A pivotal study published today in The Lancet has shown that dialysis patients were effectively switched from frequently-dosed anemia...

Rockwell Medical Technologies, Inc. Begins Dosing Patients for SFP Phase IIb Clinical Study

WIXOM, Mich., Oct. 3 /PRNewswire-FirstCall/ -- Rockwell Medical Technologies, Inc. (Nasdaq: RMTI ), a leading, innovative manufacturer and developer of concentrates and specialty pharmaceuticals focused on the end- stage-renal-disease market (ESRD), announced today that it has begun dosing pa...

Anthera Announces Completion of Enrollment and Dosing in Phase II Trial of A-002 for the Treatment of Cardiovascular Disease

SAN MATEO, Calif., Oct. 3 /PRNewswire/ -- Anthera Pharmaceuticals, Inc., a privately-held biopharmaceutical company developing anti-inflammatory therapeutics for chronic and acute inflammatory diseases, announced today the completion of enrollment and patient dosing in its Phase II clinical st...