Nephrology and Urology Drugs in the Pipeline

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Drugs in the Pipeline

Orphan-Drug Designation for AR-42 for Central-Nervous-System Tumors

February 21, 2012

Arno Therapeutics, Inc. announced that the FDA has granted its request for orphan drug designation for AR-42 for the treatment of meningioma and schwannoma of the central nervous system.

Priority Review Granted for SecreFlo for Detection of Pancreatic Duct Abnormalities

February 21, 2012

Repligen announced that the FDA has accepted for filing and granted Priority Review to the Company's new drug application (NDA) for SecreFlo for the improved detection of pancreatic duct abnormalities in patients with pancreatitis.

Phase 3 Trial of Vedolizumab for Ulcerative Colitis

February 21, 2012

Takeda announced results from the GEMINI I Phase 3 trial evaluating vedolizumab in patients with moderately to severely active ulcerative colitis who have failed at least one conventional therapy, including TNFα antagonists.

NDA Accepted for Oral Treprostinil for Pulmonary Arterial Hypertension

February 21, 2012

United Therapeutics Corp. announced that the FDA has accepted for review its new drug application (NDA) for treprostinil diethanolamine sustained release tablets (oral treprostinil) for the treatment of pulmonary arterial hypertension.

Orphan Drug Designation for rVIIa-FP for Hemophilia A and Hemophilia B

February 16, 2012

CSL Behring announced that the FDA has granted its request for orphan drug designation for recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP) for treatment and prophylaxis of bleeding episodes in patients with congenital hemophilia and inhibitors to coagulation factor VIII or IX.

NDA Accepted for Tafamidis Meglumine for Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP)

February 15, 2012

Pfizer Inc. announced that the FDA has accepted its New Drug Application (NDA) for tafamidis meglumine for the treatment of Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP).

NDA Accepted for Uceris for Ulcerative Colitis

February 15, 2012

Santarus, Inc. announced that the FDA has accepted its New Drug Application (NDA) for Uceris (budesonide) tablets 9mg for the induction of remission of mild to moderate active ulcerative colitis.

Orphan Drug Designation for Digoxin Immune Fab (Ovine) for Severe Preeclampsia and Eclampsia

February 14, 2012

Glenveigh Medical announced that the FDA has granted its request for orphan drug designation for digoxin immune fab (ovine) to treat severe preeclampsia and eclampsia.

Priority Review Granted for Truvada for Reducing the Risk of Acquiring HIV Infection

February 14, 2012

Gilead Sciences announced that the FDA has accepted the supplemental New Drug Application (sNDA) and granted a six-month Priority Review for once-daily Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection among uninfected adults.

Phase 2 Study Update of Arikace for Non-Tuberculous Mycobacteria Lung Disease

February 10, 2012

Insmed announced that it is proceeding with a Phase 2 clinical trial of Arikace (liposomal amikacin for inhalation) in patients with non-tuberculous mycobacteria (NTM) lung disease.

Phase 3 Study Update of LibiGel for Female Sexual Dysfunction

February 09, 2012

BioSante announced positive safety data from ongoing Phase 3 trials of LibiGel (testosterone) for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women.

Phase 2 Trial Update of Eliglustat for the Treatment of Gaucher Disease

February 08, 2012

Genzyme announced four-year follow-up data from its Phase 2 clinical trial of eliglustat tartrate for the treatment of Gaucher disease type 1.

Phase 3 Study Update of Cariprazine for Acute Mania in Bipolar I Disorder

February 08, 2012

Forest Laboratories and Gedeon Richter Plc announced preliminary results from a Phase 3 trial of cariprazine (RGH-188) in patients with acute mania associated with bipolar I disorder.

Phase 3 Study of AVP-923 for Diabetic Neuropathic Pain

February 08, 2012

Avanir Pharmaceuticals announced results of a Phase 3 randomized controlled trial of AVP-923 in the treatment of diabetic neuropathic pain.

Priority Review Granted for Pertuzumab for Previously Untreated HER2+ Metastatic Breast Cancer

February 07, 2012

Genentech announced that the FDA has accepted the company's Biologics License Application (BLA) for pertuzumab and granted Priority Review for use in combination with Herceptin (trastuzumab; Genentech) and docetaxel chemotherapy for people with HER2+ metastatic or locally recurrent, unresectable breast cancer, who have not received previous treatment or whose disease has relapsed after adjuvant therapy.

Priority Review Granted for Crofelemer for HIV-Associated Diarrhea

February 07, 2012

Salix announced that the FDA has granted priority review designation of its New Drug Application (NDA) for crofelemer 125mg tablets for the control and symptomatic relief of diarrhea in patients with HIV/AIDS on anti-retroviral therapy (ART).

Phase 2 Trial of OGX-427 for Metastatic Castrate-Resistant Prostate Cancer

February 02, 2012

OncoGenex announced preliminary results from a Phase 2 study of OGX-427 in chemotherapy-naive patients with metastatic castrate-resistant prostate cancer (mCRPC). More patients treated with OGX-427 plus prednisone were without disease progression at 12 weeks versus those treated with prednisone alone.

Phase 2 Trial of Captisol-Enabled, Propylene Glycol-Free Melphalan for Multiple Myeloma Patients Undergoing Autologous Transplantation

February 02, 2012

Ligand Pharmaceuticals announced results from a Phase 2 study of Captisol-enabled, propylene glycol-free (PG-free) melphalan in multiple myeloma patients undergoing autologous transplantation.

Phase 3 Trial Update of Lubiprostone for Opioid-Induced Bowel Dysfunction (OBD)

February 02, 2012

Sucampo and Takeda Pharmaceuticals announced that lubiprostone met the primary endpoint in a Phase 3 clinical trial for the treatment of opioid-induced bowel dysfunction (OBD) in patients with chronic, non-cancer pain, excluding those taking methadone.

Phase 2 Trial of AGS-003 with Sunitinib for Advanced Renal Cell Carcinoma

January 31, 2012

Argos Therapeutics announced results from AGS-003-006, a Phase 2 study of AGS-003 in combination with sunitinib in patients with advanced renal cell carcinoma (RCC). The results showed a statistically significant correlation between anti-tumor memory T cell responses and overall survival.

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