Nephrology and Urology Drugs in the Pipeline

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Drugs in the Pipeline

Phase 3 Study of Simponi for Ulcerative Colitis

May 21, 2012

New Phase 3 study findings show that subcutaneous induction regimens of Simponi (golimumab; Janssen Biotech, Inc.) induced clinical response in a majority of patients with moderately to severely active ulcerative colitis (UC) who had previously failed or were intolerant to conventional agents.

Phase 3 Study Update of Tivozanib for First-Line Advanced Renal Cell Carcinoma

May 17, 2012

AVEO and Astellas announced detailed data from TIVO-1 (Tivozanib Versus Sorafenib in 1st line Advanced Renal Cell Carcionma [RCC]).

Phase 2 Trial Update of Tivantinib for Hepatocellular Carcinoma

May 17, 2012

ArQule and Daiichi Sankyo announced Phase 2 trial data with tivantinib as a single agent investigational second-line treatment in hepatocellular carcinoma (HCC).

Phase 2 Study Update of Rilotumumab (AMG 102) for Gastric and Gastroesophageal Cancer

May 17, 2012

Amgen announced results from an exploratory biomarker analysis evaluating MET expression as a predictor of clinical response to rilotumumab (AMG 102) conducted on a previously reported Phase 2 study of rilotumumab in patients with locally advanced or metastatic gastric or gastroesophageal cancer.

Phase 2 Study Update of Blinatumomab (AMG 103) for Relapsed or Refractory Acute Lymphoblastic Leukemia

May 17, 2012

Amgen announced updated results from a Phase 2 study that showed treatment with blinatumomab (AMG 103) helped achieve a high-rate of complete response (CR) in 72% of adult patients with relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL) treated in the study.

Phase 3 Trial Update of NVA237 for COPD

May 17, 2012

Sosei Group Corporation confirmed the information released today by Novartis that results from the pivotal Phase 3 GLOW2 study demonstrated that once-daily 50mcg NVA237 (glycopyrronium bromide) was superior to placebo in improving lung function, symptom relief and quality of life, and reducing exacerbations over a one-year period in patients with chronic obstructive pulmonary disease (COPD).

Phase 3 Trial of Vedolizumab for Crohn's Disease

May 11, 2012

Takeda announced results from the GEMINI II Phase 3 trial evaluating vedolizumab in patients with moderately to severely active Crohn's disease who have failed at least one conventional therapy, including TNFα antagonists.

Phase 2 Trial Update of Adcetris for Relapsed Cutaneous T-Cell Lymphoma

May 10, 2012

Seattle Genetics announced interim results from an investigator-sponsored Phase 2 clinical trial of Adcetris (brentuximab vedotin) in patients with relapsed cutaneous T-cell lymphoma (CTCL).

NDA Accepted for BG-12 for Multiple Sclerosis

May 10, 2012

Biogen Idec announced that the FDA has accepted for filing the company's New Drug Application (NDA) for BG-12 (dimethyl fumarate) for the treatment of multiple sclerosis (MS).

sNDA Submitted for Xarelto for Reduction of the Risk of Stent Thrombosis in Patients with Acute Coronary Syndrome

May 09, 2012

Janssen Research & Development announced that it has submitted a supplemental New Drug Application (sNDA) to the FDA seeking approval for the use of Xarelto (rivaroxaban) to reduce the risk of stent thrombosis in patients with Acute Coronary Syndrome (ACS).

Phase 3 Study of Aripiprazole Intramuscular Depot for the Maintenance Treatment of Schizophrenia

May 07, 2012

Otsuka and Lundbeck announced results from a Phase 3 clinical trial evaluating the efficacy, safety and tolerability of once-monthly aripiprazole intramuscular (IM) depot formulation for the maintenance treatment of adults with schizophrenia.

FDA Issues Complete Response Letter to NDA for Adasuve

May 07, 2012

Alexza Pharmaceuticals announced that it has received a complete response letter from the FDA regarding its New Drug Application (NDA) for Adasuve (Staccato loxapine) inhalation powder, 5mg and 10mg, for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

Phase 3 Trial Update of Latuda for Bipolar I Depression

May 07, 2012

Dainippon Sumitomo Pharma announced results from two Phase 3 clinical trials designed to evaluate the efficacy and safety of Latuda (lurasidone; Sunovion) as adjunctive therapy and monotherapy, respectively, in patients with bipolar I depression (PREVAIL 1 and PREVAIL 2; PRogram to EValuate the Antidepressant Impact of Lurasidone).

Phase 3 Study Update of 4-Factor Prothrombin Complex Concentrate for Hemostasis

May 04, 2012

CSL Behring announced results of a Phase 3b study that showed that a balanced, human 4-factor prothrombin complex concentrate (PCC) is as effective as the current standard of treatment in stopping bleeding in patients receiving vitamin K antagonist therapy (eg, warfarin).

Phase 3 Study Update of Gattex for Adult Short Bowel Syndrome

May 03, 2012

NPS Pharmaceuticals reported that four additional patients have successfully achieved independence from parenteral nutrition (PN) and intravenous (IV) fluids while on long-term Gattex (teduglutide) therapy in STEPS 2, a 24-month open-label study in adult short bowel syndrome (SBS).

Phase 2 Study of Ficlatuzumab and Gefitinib in Advanced Lung Cancer

May 02, 2012

AVEO Pharmaceuticals announced preliminary data from the exploratory, randomized Phase 2 study comparing the combination of ficlatuzumab and gefitinib (Iressa; AstraZeneca Pharmaceuticals), to gefitinib monotherapy in previously untreated Asian subjects with non-small cell lung cancer (NSCLC), a population with a high prevalence of EGFR sensitizing mutations (SM+).

sNDAs Submitted for Xarelto for Treatment and Prevention of Recurrent Venous Thromboembolism

May 02, 2012

Janssen Research & Development announced that it has submitted supplemental New Drug Applications (sNDAs) to the FDA seeking approval for the use of Xarelto (rivaroxaban) to treat patients with deep vein thrombosis (DVT) or pulmonary embolism (PE) and prevention of recurrent venous thromboembolism (VTE).

NDA Submitted for Zohydro for Treatment of Chronic Pain

May 02, 2012

Zogenix announced that it has submitted a New Drug Application (NDA) to the FDA for Zohydro (hydrocodone bitartrate extended-release capsules), an investigational product candidate for the treatment of chronic pain.

Phase 3 Study Update of Quadrivalent Influenza Vaccine in Pediatric Population

May 01, 2012

Sanofi Pasteur, the vaccines division of Sanofi Aventis, announced new Phase 3 data for its investigational quadrivalent influenza vaccine (QIV) in children.

FDA Issues Complete Response Letter to sBLA for Xgeva

April 27, 2012

Amgen announced that it received a complete response letter from the FDA for it supplemental Biologics License Application (sBLA) for Xgeva (denosumab) injection for the treatment of men with castration-resistant prostate cancer (CRPC) at high risk of developing bone metastases.

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