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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

FDA approves Protalix, Pfizer’s ELELYSO for treatment of type 1 Gaucher disease

Pfizer Inc. and Protalix BioTherapeutics, Inc. announced today that the United States (U.S.) Food and Drug Administration (FDA) approved ELELYSO (taliglucerase alfa) for injection, an enzyme replacement therapy (ERT) for the long-term treatment of adults with a confirmed diagnosis of type 1 Gaucher disease.

2 May 2012

FDA denies AstraZeneca Citizen Petitions on SEROQUEL labeling

AstraZeneca today announced that on March 7, 2012, the Food and Drug Administration denied Citizen Petitions requesting that the FDA withhold finally approving any generic quetiapine product with labeling that omits certain hyperglycemia warning language that the FDA required AstraZeneca to include in the labeling for SEROQUEL (quetiapine fumarate) tablets and SEROQUEL XR (quetiapine fumarate) extended-release tablets.

12 Mar 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

FDA approves changes to REMS for Nplate and Promacta

The approval of changes to the Risk Evaluation and Mitigation Strategies (REMS) for both Nplate (romiplostim) and Promacta (eltrombopag) was announced by the U.S. Food and Drug Administration.

7 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

Sore throat among young adults taking antibiotics for acne: Study

A new study reveals that young adults who take oral antibiotics for acne may be more likely to get sore throats. The reason behind this is unclear say researchers. However they add that long-term use of antibiotics might change the balance of bacteria in the throat. In principle, that could allow infection-causing strains to multiply.

22 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

Merck's NEXPLANON 68 mg now available in the U.S.

Merck today announced that NEXPLANON (etonogestrel implant) 68 mg, a long-acting, progestin-only single-rod hormonal contraceptive, is now available in the United States.

10 Nov 2011

Human Genome Sciences to present abstracts regarding BENLYSTA, SLE at ACR/ARHP meeting

Human Genome Sciences, Inc. announced today that several abstracts related to BENLYSTA (belimumab) and systemic lupus erythematosus will be presented at the annual meeting of the American College of Rheumatology/ Association of Rheumatology Health Professionals, being held in Chicago, IL from November 4 to November 9, 2011.

5 Nov 2011

Teva reports data from QNASL studies on seasonal and perennial allergic rhinitis

Teva Pharmaceutical Industries Ltd. today announced that data from four late-stage studies examining QNASL (beclomethasone dipropionate [BDP]) HFA, a nasal aerosol corticosteroid in development for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) symptoms, will be presented at the 2011 Annual Meeting of the American College of Allergy, Asthma and Immunology (ACAAI) in Boston, Mass., November 3-8, 2011.

1 Nov 2011

EC approves Lilly's ALIMTA as continuation maintenance therapy for NSCLC

Eli Lilly and Company announced today that the European Commission has granted approval for the use of ALIMTA (pemetrexed for injection) as a single agent for continuation maintenance therapy in patients with a particular type of lung cancer, called advanced nonsquamous non-small cell lung cancer

29 Oct 2011

FDA approves NDA for Edgemont's Fluoxetine 60 mg tablet

Edgemont Pharmaceuticals, LLC, a neuroscience focused company, today announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Fluoxetine Tablets 60 mg.

12 Oct 2011

Boehringer Ingelheim receives FDA approval for COMBIVENT RESPIMAT to treat COPD

Boehringer Ingelheim Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved COMBIVENT RESPIMAT, a new, propellant-free inhaler product that uses a slow-moving mist to deliver the same active ingredients of COMBIVENT Inhalation Aerosol in a metered dose inhaler.

10 Oct 2011

Vaxent, PREVENT sign license agreement to develop and commercialize Strep-A vaccine

An international collaboration between Vaxent, a Memphis-based early stage vaccine development company in the Memphis Bioworks Foundation Incubator, and The Pan-Provincial Vaccine Enterprise Inc. (PREVENT), a Centre of Excellence for Commercialization and Research (CECR) in Saskatchewan, has put a vaccine for group A streptococcus (Strep-A) back on the path for potential commercialization.

26 Sep 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

African Americans more likely than Caucasians to develop and die from lung cancer

Lung cancer, the leading cause of cancer death in the U.S., takes a particularly heavy toll on African Americans. Despite their lower smoking rates, African Americans are more likely than Caucasians to develop and die from lung cancer.

21 Sep 2011