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Lilly receives FDA approval for CYRAMZA (ramucirumab)

Eli Lilly and Company has received its third U.S. Food and Drug Administration approval for CYRAMZA (ramucirumab).

16 Dec 2014

Endo announces acquisition of rights to Natesto (testosterone nasal gel)

Endo International plc, announced today the acquisition of rights to Natesto (testosterone nasal gel), the first and only testosterone nasal gel for replacement therapy in adult males diagnosed with hypogonadism, from Trimel BioPharma SRL, a wholly-owned subsidiary of Trimel Pharmaceuticals Corporation.

24 Nov 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

Sanofi, Regeneron report positive Phase 2 study of dupilumab in patients with CSwNP

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi (EURONEXT: SAN and NYSE: SNY) today announced that a Phase 2a proof-of-concept study of dupilumab, an investigational therapy that blocks IL-4 and IL-13 signaling, met all primary and secondary endpoints in patients with moderate-to-severe chronic sinusitis with nasal polyps (CSwNP) who did not respond to intranasal corticosteroids.

30 Sep 2014

Ramucirumab Phase III study meets primary endpoint in patients with metastatic colorectal cancer

Eli Lilly and Company today announced that the RAISE trial, a Phase III study of ramucirumab (CYRAMZA) in combination with chemotherapy in patients with metastatic colorectal cancer (mCRC), met its primary endpoint of overall survival.

15 Sep 2014

FDA approves Trimel’s Natesto nasal gel to treat adult males with low testosterone

Trimel Pharmaceuticals Corporation announced today that the United States Food and Drug Administration (FDA) has approved Natesto (testosterone), formerly CompleoTRT, the first and only testosterone nasal gel for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.

29 May 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

CHMP adopts positive opinion for ABRAXANE with gemcitabine for treatment of metastatic pancreas

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation, today announced that the European Medicines Agency's: Committee for Medicinal Products for Human Use has adopted a positive opinion 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.

25 Nov 2013

New England publishes results of phase III clinical trial of ABRAXANE for metastatic pancreatic cancer

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation , today announced the results of the MPACT phase III clinical trial of ABRAXANE® in combination with gemcitabine were published online in the October 16th edition of the New England Journal of Medicine.

17 Oct 2013

Bayer HealthCare receives FDA approval for Adempas tablets

Bayer HealthCare announced today that the United States Food and Drug Administration has approved Adempas (riociguat) tablets for: (i) the treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (WHO Group 4) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class; and (ii) the treatment of adults with pulmonary arterial hypertension (WHO Group 1) to improve exercise capacity, improve WHO functional class and delay clinical worsening.

9 Oct 2013

Researchers develop therapeutic algorithm to study outcomes in epistaxis management

Approximately 60 percent of people experience epistaxis, commonly known as nosebleed, at least once in their lifetime. Of those who experience nosebleed, six percent require medical treatment. A study in the September 2013 issue of Otolaryngology-Head and Neck Surgery, explores which nosebleed treatment options demonstrate the best outcomes.

27 Aug 2013

Celgene to discontinue treatment with REVLIMID in phase III ORIGIN trial

Celgene Corporation today announced that after consultation with the U.S. Food and Drug Administration Celgene will discontinue treatment with REVLIMID (lenalidomide) in the open-label, phase III ORIGIN trial, which enrolled 450 patients in over 100 sites in 26 countries.

18 Jul 2013

Phase III study: REVLIMID meets primary endpoint in patients newly diagnosed with multiple myeloma

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation, today announced that its phase III study (MM-020/IFM 07-01) of REVLIMID (lenalidomide) in combination with dexamethasone in patients newly diagnosed with multiple myeloma met its primary endpoint of progression-free survival.

11 Jul 2013

European Commission amends marketing authorisation for Celgene's REVLIMID

Celgene International Sàrl was today notified that the European Commission has amended the marketing authorisation for REVLIMID. This decision means that REVLIMID is now approved to treat patients with transfusion-dependent anaemia due to low or intermediate-1 risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

17 Jun 2013

FDA gives Priority Review to Celgene's ABRAXANE sNDA for advanced pancreatic cancer

Celgene International Sàrl, a subsidiary of Celgene Corporation today announced that the U.S. Food and Drug Administration has assigned a Priority Review designation to the supplemental New Drug Application for the use of ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine for the first-line treatment of patients with advanced pancreatic cancer.

23 May 2013

Celgene announces results from REVLIMID plus VIDAZA phase II study on AML

Celgene International Sàrl today announced that results from a study evaluating the combination of REVLIMID (lenalidomide) plus VIDAZA (azacitidine) in patients 60 years or older with untreated acute myeloid leukemia (AML) were presented at the American Society of Hematology annual meeting in Atlanta, GA.

11 Dec 2012

Pfizer, Bristol-Myers Squibb receive EC approval for ELIQUIS to prevent NVAF-related stroke

Bristol-Myers Squibb and Pfizer announced today that the European Commission has approved ELIQUIS (apixaban) for prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors.

21 Nov 2012

FDA approves Acton’s AEROSPAN sNDA to treat asthma

Acton Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved the sNDA (Supplemental New Drug Application) for AEROSPAN (flunisolide HFA, 80 mcg) Inhalation Aerosol, a hydrofluoroalkane (HFA) orally inhaled corticosteroid indicated for the maintenance treatment of asthma as a prophylactic therapy in adult and pediatric patients 6 years of age and older.

21 Sep 2012

EC grants marketing authorization for Pfizer’s INLYTA to treat renal cell carcinoma

Pfizer Inc. announced today that the European Commission (EC) has granted marketing authorization for INLYTA (axitinib) for the treatment of adult patients with advanced renal cell carcinoma (RCC), a type of kidney cancer, after failure of prior treatment with sunitinib or a cytokine.

4 Sep 2012