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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

Sunovion launches ZETONNA Nasal Aerosol for allergic rhinitis

Sunovion Pharmaceuticals Inc. today announced the nationwide availability of ZETONNA (ciclesonide) Nasal Aerosol, 74 mcg once-daily, for the treatment of allergic rhinitis (AR), also known as hay fever or nasal allergies. ZETONNA is a corticosteroid indicated for the treatment of symptoms associated with seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) in adults and adolescents 12 years of age and older.

30 Jul 2012

NEJM publishes results from Celgene’s REVLIMID phase III studies on MM

Celgene International Sàrl, a subsidiary of Celgene Corporation, today announced that results from three phase III studies evaluating the use of continuous REVLIMID(lenalidomide) treatment in newly diagnosed multiple myeloma (MM) patients or maintenance treatment with lenalidomide following autologous stem cell transplant were published online in the May 10, 2012 edition of the New England Journal of Medicine.

11 May 2012

Bevacizumab drug improves cardiac output in patients with HHT

In a small study that included 25 patients with hereditary hemorrhagic telangiectasia (a genetic disorder that leads to abnormalities of blood vessels) and severe liver involvement with this disease, patients who received the drug bevacizumab had improved cardiac output and a reduction in the duration and number of episodes of nose bleeds, a potentially life-threatening complication for patients with this disorder, according to a study in the March 7 issue of JAMA.

6 Mar 2012

Bacon for nosebleeds: Case report

Ian Humphreys, Sonal Saraiya, Walter Belenky and James Dworkin, at Detroit Medical Centre in Michigan proceeded to treat a four year old girl who had a rare hereditary disorder that brings prolonged bleeding, publishing their findings in the Annals of Otology, Rhinology and Laryngology.

26 Jan 2012

$Celgene reports final results from REVLIMID-rituximab combination phase II study for relapsed/refractory CLL$

Celgene reports final results from REVLIMID-rituximab combination phase II study for relapsed/refractory CLL

Celgene International Sàrl, a subsidiary of Celgene Corporation, (NASDAQ: CELG), announced final results from a phase II investigational study evaluating the combination of REVLIMID® (lenalidomide) and rituximab in 59 patients with relapsed or refractory chronic lymphocytic leukemia (CLL). These data were presented at the 53rd Annual Meeting of the American Society of Hematology in San Diego, CA.

14 Dec 2011

Celgene announces data from REVLIMID Phase III study on high-risk asymptomatic smoldering MM

Celgene International Sàrl, a subsidiary of Celgene Corporation, announced that updated data evaluating continuous treatment with REVLIMID (lenalidomide) in patients with high-risk asymptomatic smoldering multiple myeloma were presented at the 53rd Annual Meeting of the American Society of Hematology.

14 Dec 2011

Celgene reports final results from REVLIMID plus VIDAZA phase II study on higher-risk MDS

Celgene International Sàrl, a subsidiary of Celgene Corporation, today reported final results from the phase II portion of a multi-center phase I/II study evaluating combination therapy with REVLIMID (lenalidomide) and VIDAZA (azacitidine) in patients with higher-risk myelodysplastic syndromes (MDS) not previously treated with either drug.

13 Dec 2011

Celgene announces interim results of REVLIMID study on CLL

Celgene International Sàrl, a subsidiary of Celgene Corporation, announced interim results of CLL-009, a study evaluating three starting doses of REVLIMID (lenalidomide), followed by step-wise dose escalation as tolerated in patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.

12 Dec 2011

Celgene to discontinue docetaxel and prednisone plus lenalidomide Phase III trial on CRPC

Celgene International Sàrl, a subsidiary of Celgene Corporation, announced that based on the recommendation from the Data Monitoring Committee (DMC) it will discontinue its pivotal double-blinded Phase III MAINSAIL trial that was designed to evaluate the efficacy and safety of docetaxel and prednisone with or without lenalidomide in patients with castrate-resistant prostate cancer.

23 Nov 2011

Swissmedic approves REVLIMID for treatment of myelodysplastic syndromes

Celgene International Sàrl, a subsidiary of Celgene Corporation, today announced that REVLIMID (lenalidomide) has been granted approval by the Swiss agency for Therapeutic Products (Swissmedic) for use in patients with transfusion-dependent anemia due to low-or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenic abnormality with or without additional cytogenic abnormalities.

21 Nov 2011

Sunovion reports positive results from ciclesonide nasal aerosol Phase III study for perennial allergic rhinitis

Sunovion Pharmaceuticals Inc. today announced results from a large Phase III clinical study of ciclesonide nasal aerosol, a corticosteroid formulated with a hydrofluoroalkane (HFA) propellant, intended for the treatment of allergic rhinitis.

5 Nov 2011

E.U. CHMP issues positive opinion for use of Celgene's REVLIMID/dexamethasone MM drug

Celgene International Sàrl was notified today that the E.U. Committee for Medicinal Products for Human Use (CHMP), on behalf of the European Medicines Agency (EMA) has concluded an Article 20 review of REVLIMID and issued a positive opinion for the use of REVLIMID in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

23 Sep 2011

Celgene announces data from REVLIMID plus rituximab Phase II study on malignant lymphomas

Celgene International Sàrl announced that clinical data from a Phase II study, conducted by investigators from the MD Anderson Cancer Center in Houston, TX, evaluating the combination regimen of REVLIMID plus rituximab (R2) in untreated, advanced stage, indolent B-cell non-Hodgkin's lymphomas, were presented at the 11th International Conference on Malignant Lymphoma in Lugano, Switzerland.

18 Jun 2011