Peripheral Edema News and Research

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EMA accepts new IMBRUVICA (ibrutinib) application for treatment of Waldenstrom's macroglobulinemia

Pharmacyclics, Inc.today announced the acceptance of a Type II variation application for IMBRUVICA (ibrutinib) by the European Medicines Agency.

1 Dec 2014

FDA approves CYRAMZA in combination with paclitaxel for advanced adenocarcinoma

Eli Lilly and Company announced today that the U.S. Food and Drug Administration (FDA) has approved CYRAMZA (ramucirumab) in combination with paclitaxel (a type of chemotherapy) as a treatment for people with advanced or metastatic gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma whose cancer has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy.

5 Nov 2014

AstraZeneca, Pharmacyclics partner to evaluate efficacy of IMBRUVICA for solid tumors

AstraZeneca and Pharmacyclics, Inc. today announced that they have entered into a clinical trial collaboration to evaluate a novel combination therapy targeting solid tumors.

4 Nov 2014

Janssen announces submission of IMBRUVICA sNDA to FDA for WM treatment

Janssen Research & Development, LLC today announced the submission of a supplemental New Drug Application (sNDA) for IMBRUVICA (ibrutinib) to the U.S. Food and Drug Administration by its strategic partner Pharmacyclics, Inc.

20 Oct 2014

Alexion announces that FDA grants ODD to Soliris for Myasthenia Gravis treatment

Alexion Pharmaceuticals (Nasdaq:ALXN) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Soliris® (eculizumab) for the treatment of patients with Myasthenia Gravis (MG), a rare, debilitating neurologic disorder caused by uncontrolled complement activation.

17 Jun 2014

FDA accepts Pharmacyclics' IMBRUVICA sNDA for review

Pharmacyclics, Inc. today announced that the U.S. Food and Drug Administration has accepted for filing its supplemental New Drug Application (sNDA) to support the review of IMBRUVICA (ibrutinib) in the treatment of patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) who have received at least one prior therapy for a full approval.

9 Jun 2014

ARIAD reports data from Iclusig Phase 2 trial in adult patients with gastrointestinal stromal tumors

ARIAD Pharmaceuticals, Inc. today announced, for the first time, data from its Phase 2 trial of Iclusig (ponatinib) in adult patients with refractory metastatic and/or unresectable gastrointestinal stromal tumors (GIST).

2 Jun 2014

Orexo US partners with inVentiv Health to market Zubsolv sublingual tablets in the US

Orexo AB announces a new partnership between Orexo US, Inc. and inVentiv Health for the commercialization of Zubsolv in the US.

20 May 2014

FDA approves Alexion’s Soliris drug for treatment of atypical hemolytic uremic syndrome

Alexion Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's supplemental Biologics License Application (sBLA) providing regular approval for Soliris® (eculizumab) for the treatment of adult and pediatric patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA).

6 May 2014

Janssen submits supplemental New Drug Application for IMBRUVICA to the U.S. FDA

Janssen Research & Development, LLC ("Janssen") today announced the submission of a supplemental New Drug Application (sNDA) for IMBRUVICA™ (ibrutinib) to the U.S. Food and Drug Administration (FDA) by its collaboration partner Pharmacyclics, Inc.

8 Apr 2014

Astellas, Medivation submit European Marketing Authorization Application for XTANDI capsules

Astellas Pharma Inc. and Medivation Inc. today announced the submission of a variation to amend the European Marketing Authorization Application for XTANDI® (enzalutamide) capsules for the treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and in whom chemotherapy is not yet clinically indicated.

4 Apr 2014

Orexo signs multi-year agreement with OptumRx and UnitedHealth Group

Orexo AB, the manufacturer of ZUBSOLV® (buprenorphine and naloxone) sublingual tablets (CIII), announced a multi-year agreement with UnitedHealth Group® and OptumRx® providing preferred coverage and reimbursement of ZUBSOLV®.

12 Mar 2014

Pharmacyclics total revenue for fourth quarter 2013 increases 113% to $123.6 million

Pharmacyclics, Inc. today reported financial results and recent developments for the quarter and year ended December 31, 2013.

20 Feb 2014

Researchers offer new options for men whose prostate cancer has spread to bones

Dartmouth-Hitchcock Norris Cotton Cancer Center has treated three men with a recently FDA-approved treatment, which offers new options for men whose prostate cancer has spread to their bones.

13 Feb 2014

ARIAD Pharmaceuticals' Iclusig now commercially available to patients in the U.S.

ARIAD Pharmaceuticals, Inc. today announced the commercial availability of Iclusig (ponatinib) for adult patients with refractory chronic myeloid leukemia and Philadelphia-chromosome positive acute lymphoblastic leukemia in the United States. ARIAD has begun shipping Iclusig to Biologics, Inc., its exclusive specialty pharmacy, which is now filling prescriptions from physicians and distributing the cancer medicine to patients.

18 Jan 2014

Research opens door to new direction of PAH treatment

The development of new, more effective vasodilators to treat pulmonary arterial hypertension has been hampered because of their systemic toxicity and adverse side effects. An international team of investigators seeking to surmount these problems and increase drug efficacy have determined that a vascular homing peptide can selectively target hypertensive pulmonary arteries to boost the pulmonary but not systemic effects of vasodilators. Importantly for potential clinical use, this peptide retains its activity when given sublingually. The results using a rat model of PAH are published in the American Journal of Pathology.

8 Jan 2014

EC grants approval for ABRAXANE in combination with gemcitabine for metastatic pancreatic cancer

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation, today announced that the European Commission has granted approval for ABRAXANE (paclitaxel formulated as albumin bound nanoparticles, or nab-paclitaxel) in combination with gemcitabine for first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas, or metastatic pancreatic cancer.

7 Jan 2014

Celgene subsidiary presents REVLIMID study results on lymphoma at ASH annual meeting

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ:CELG) today announced that results from two studies of REVLIMID (lenalidomide) combinations in patients with diffuse large B-cell lymphoma (DLBCL) were presented at the American Society of Hematology annual meeting in New Orleans, La.

11 Dec 2013

Pharmacyclics presents ibrutinib trial data for B-cell malignancies at ASH meeting

Pharmacyclics, Inc. today announced results of 40 clinical, non-clinical and pre-clinical presentations on ibrutinib (IMBRUVICA™) at the 55TH Annual meeting of the American Society of Hematology (ASH) held in New Orleans, Dec 7 - 10, 2013.