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FDA clears Otonomy's IND for clinical trial of OTO-104 in Meniere's disease patients

Otonomy, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted clearance of the company's Investigational New Drug (IND) application for the clinical trial of OTO-104 in patients with Meniere's disease, a debilitating disorder of the inner ear affecting balance and hearing.

17 Feb 2010

Phase 3 registration clinical trial for perifosine initiated by Keryx Biopharmaceuticals

AEterna Zentaris Inc. (the "Company"), a global biopharmaceutical company focused on oncology and endocrine therapy, today announced the initiation, by its partner Keryx Biopharmaceuticals Inc. ("Keryx") ( KERX), of a Phase 3 registration clinical trial for perifosine (KRX-0401), the Company's PI3K/Akt pathway inhibitor, in relapsed/refractory multiple myeloma patients.

16 Dec 2009

Keryx Biopharmaceuticals initiates Phase 3 registration clinical trial for perifosine

Æterna Zentaris Inc., a global biopharmaceutical company focused on oncology and endocrine therapy, today announced the initiation, by its partner Keryx Biopharmaceuticals Inc., of a Phase 3 registration clinical trial for perifosine (KRX-0401), the Company's PI3K/Akt pathway inhibitor, in relapsed/refractory multiple myeloma patients.

16 Dec 2009

AHS annual meeting focuses on myeloma, says IMF

The International Myeloma Foundation (IMF)—supporting research and providing education, advocacy and support for myeloma patients, families, researchers and physicians— says a large number of abstracts – nearly a quarter of the presentations submitted this year to the annual meeting of the American Society of Hematology (ASH) were for myeloma, with one being presented at the prestigious plenary session.

9 Dec 2009

Data evaluating combination therapy with REVLIMID and rituximab in patients with NHL presented

Celgene International Sàrl announced that investigational data evaluating combination therapy with REVLIMID (lenalidomide) and rituximab in patients with indolent non-Hodgkin’s lymphoma (NHL) were presented during the 51st American Society of Hematology’s annual meeting in New Orleans, LA.

9 Dec 2009

CombinatoRx presents encouraging results from its A2A and b2AR agonist programs for B-cell malignancies

CombinatoRx, Incorporated today announced that preclinical data from its Adenosine A2A receptor (A2A) and Beta-2 Adrenergic Receptor (b2AR) Agonist oncology programs demonstrated synergistic anti-cancer activity when combined with standard-of-care therapies in multiple myeloma and other B-cell malignancies.

8 Dec 2009

Study data of REVLIMID-dexamethasone combination therapy for high-risk smoldering multiple myeloma

Celgene International Sàrl announced that data evaluating combination therapy REVLIMID (lenalidomide) and dexamethasone in patients with high-risk smoldering multiple myeloma were presented during the American Society of Hematology’s annual meeting in New Orleans, LA. The landmark study demonstrated REVLIMID and dexamethasone prolonged time to progression, including complete responses, with manageable toxicity.

8 Dec 2009

Study results comparing REVLIMID regimen to stem cell transplant in multiple myeloma patients

Celgene International Sàrl announced clinical data from an investigational study of patients with multiple myeloma who were younger than 65 years old and received either REVLIMID (lenalidomide), melphalan and prednisone (MPR) or melphalan plus autologous stem cell transplant (MEL200) following an induction treatment of REVLIMID plus low-dose dexamethasone (Rd) were presented during the 51st American Society of Hematology’s annual meeting in New Orleans, LA.

8 Dec 2009

Potentially promising data from Phase I/II study of elotuzumab presented at ASH 2009

Facet Biotech Corporation and Bristol-Myers Squibb Company announced that potentially promising data from a Phase I/II study of elotuzumab, an investigational humanized antibody being studied for the treatment of relapsed multiple myeloma (MM), were presented today at the American Society of Hematology (ASH) 2009 Annual Meeting in New Orleans.

8 Dec 2009

Data from two phase Ib clinical trials of dacetuzumab for DLBCL reported

Seattle Genetics, Inc. today reported data from two phase Ib clinical trials of dacetuzumab, one in combination with Rituxan® (rituximab) and Gemzar® (gemcitabine) for diffuse large B-cell lymphoma (DLBCL), and the other in combination with Revlimid® (lenalidomide) for multiple myeloma.

8 Dec 2009

Study data of Perifosine + Bortezomib combination in multiple myeloma patients presented

Æterna Zentaris Inc., a global biopharmaceutical company focused on endocrine therapy and oncology, today announced that its partner Keryx Biopharmaceuticals Inc. reported updated efficacy and safety data as well as new survival data on the clinical activity of perifosine (KRX-0401) in combination with bortezomib (Velcade(R)) (+/- dexamethasone) in patients with relapsed/refractory multiple myeloma.

7 Dec 2009

New three-drug combination may be effective for treating patients with bone cancer

A new three-drug combination has shown in a phase 1/2 clinical trial that it is a "highly effective regimen" in the treatment of patients newly diagnosed with multiple myeloma, a cancer of white blood cells in bone marrow, say researchers from Dana-Farber Cancer Institute.

7 Dec 2009

More than 80 abstracts highlighting Bristol-Myers Squibb's oncology compound to be presented

Bristol-Myers Squibb Company today announced that more than 80 abstracts highlighting compounds from the company’s oncology portfolio will be presented at the 51st Annual Meeting of the American Society of Hematology (ASH) to be held December 5-8 in New Orleans.

3 Dec 2009

FDA grants Fast Track designation for Keryx Biopharmaceuticals' KRX-0401

Keryx Biopharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for KRX-0401 (perifosine), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits the phosphoinositide 3-kinase (PI3K)/Akt pathway, for the treatment of relapsed/refractory multiple myeloma.

3 Dec 2009

FDA grants Fast Track designation for AEterna Zentaris' perifosine

AEterna Zentaris Inc., a global biopharmaceutical company focused on endocrine therapy and oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company's PI3K/Akt pathway inhibitor compound, perifosine (KRX-0401), for the treatment of relapsed/refractory multiple myeloma.

2 Dec 2009

Data from brentuximab vedotin and dacetuzumab programs to be presented by Seattle Genetics

Seattle Genetics, Inc. today announced that data from its brentuximab vedotin (SGN-35) and dacetuzumab (SGN-40) programs will be reported at the upcoming 51st American Society of Hematology (ASH) 2009 Meeting and Exposition being held December 5-8, 2009 in New Orleans, Louisiana.

2 Dec 2009

Keryx Biopharmaceuticals to present KRX-0401 Phase 1/2 clinical trial data at the ASH meeting

Keryx Biopharmaceuticals, Inc. today announced that data from its Phase 1/2 clinical trial of KRX-0401 (perifosine) in combination with bortezomib (+/- dexamethasone) has been selected for poster presentation at the upcoming 51st Annual Meeting of the American Society of Hematology (ASH), to be held in New Orleans from December 5-8, 2009.

12 Nov 2009

Onyx Pharmaceuticals to present data on carfilzomib and ONX 0803 at the 51st ASH Annual Meeting

Onyx Pharmaceuticals, Inc. today announced nearly 20 presentations evaluating carfilzomib and ONX 0803 (SB 1518) in hematological cancers at the 51st American Society of Hematology (ASH) Annual Meeting December 5-8, 2009 in New Orleans, LA. Among the data presentations are four oral and seven poster presentations highlighting data from the carfilzomib development program in patients with relapsed and refractory multiple myeloma.

11 Nov 2009

Steroid-induced osteoporosis can now be treated with Teriparatide

A recent study determined glucocorticoid-induced osteoporosis (OP) is now treatable with Teriparatide, a synthetic form of the human parathyroid hormone. Researchers found patients with glucocorticoid-induced OP who were treated with teriparatide for 36 months had a greater increase in bone mineral density (BMD) and fewer new vertebral fractures than those treated with alendronate.

29 Oct 2009

Celgene announces fiscal 2009 third-quarter results

Celgene Corporation announced non-GAAP (Generally Accepted Accounting Principles) net income of $259.8 million, or non-GAAP earnings per diluted share of $0.56 for the quarter ended September 30, 2009. Non-GAAP net income for the third quarter of 2008 was $185.9 million, or non-GAAP earnings per diluted share of $0.40.

22 Oct 2009

Dexamethasone News and Research

FDA clears Otonomy's IND for clinical trial of OTO-104 in Meniere's disease patients

Phase 3 registration clinical trial for perifosine initiated by Keryx Biopharmaceuticals

Keryx Biopharmaceuticals initiates Phase 3 registration clinical trial for perifosine

AHS annual meeting focuses on myeloma, says IMF

Data evaluating combination therapy with REVLIMID and rituximab in patients with NHL presented

CombinatoRx presents encouraging results from its A2A and b2AR agonist programs for B-cell malignancies

Study data of REVLIMID-dexamethasone combination therapy for high-risk smoldering multiple myeloma

Study results comparing REVLIMID regimen to stem cell transplant in multiple myeloma patients

Potentially promising data from Phase I/II study of elotuzumab presented at ASH 2009

Data from two phase Ib clinical trials of dacetuzumab for DLBCL reported

Study data of Perifosine + Bortezomib combination in multiple myeloma patients presented

New three-drug combination may be effective for treating patients with bone cancer

More than 80 abstracts highlighting Bristol-Myers Squibb's oncology compound to be presented

FDA grants Fast Track designation for Keryx Biopharmaceuticals' KRX-0401

FDA grants Fast Track designation for AEterna Zentaris' perifosine

Data from brentuximab vedotin and dacetuzumab programs to be presented by Seattle Genetics

Keryx Biopharmaceuticals to present KRX-0401 Phase 1/2 clinical trial data at the ASH meeting

Onyx Pharmaceuticals to present data on carfilzomib and ONX 0803 at the 51st ASH Annual Meeting

Steroid-induced osteoporosis can now be treated with Teriparatide

Celgene announces fiscal 2009 third-quarter results

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