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Cumberland Pharmaceuticals reports 9% increase in second quarter 2010 net revenue

Cumberland Pharmaceuticals Inc. ,a specialty pharmaceutical company focused on the hospital acute care and gastroenterology markets, today announces financial results for the second quarter ending June 30, 2010, and provides revenue guidance for full year 2010.

17 Aug 2010

FDA accepts to review sNDA for SPRYCEL for treating adult patients with CML

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration has accepted for filing and review the supplemental New Drug Application for SPRYCEL (dasatinib) for the treatment of adult patients with newly diagnosed chronic myeloid leukemia in chronic phase.

12 Jul 2010

CHMP adopts positive opinion on pending MAA for SYCREST sublingual tablets

Merck announced that the Committee for Medicinal Products for Human Use adopted a positive opinion on the pending Marketing Authorization Application for SYCREST (asenapine) sublingual tablets. The CHMP has recommended that the European Commission grant a marketing authorization for SYCREST for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. The CHMP did not support an indication for the treatment of schizophrenia.

25 Jun 2010

Merck proposes to initiate Phase II proof-of-concept clinical study of posaconazole for chronic Chagas disease

Merck today announced plans to initiate a Phase II investigational proof-of-concept clinical study to evaluate its oral antifungal agent posaconazole for the treatment of chronic Chagas disease. Chagas disease results from infection with the parasite Trypanosoma cruzi that is spread by biting insects. The disease is estimated to affect approximately eight million people in Latin America, of whom approximately 30-40 percent will develop serious cardiac disease, digestive disease, or both as a result of this infection.

24 Jun 2010

Merck's DULERA Inhalation Aerosol for asthma receives FDA approval

Merck today announced that the U.S. Food and Drug Administration (FDA) has approved DULERA® (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol, a new fixed-dose combination asthma treatment for patients 12 years of age and older. DULERA is not indicated for the relief of acute bronchospasm. DULERA combines an inhaled corticosteroid (mometasone furoate) with a long-acting beta2-agonist (formoterol fumarate).

24 Jun 2010

Pfizer to discontinue commercial availability of Mylotarg for AML in U.S.

Pfizer Inc. announced today that based on discussions with the U.S. Food and Drug Administration (FDA), it will be discontinuing commercial availability of Mylotarg® (gemtuzumab ozogamicin for Injection) (used for the treatment of relapsed acute myeloid leukemia (AML)) in the United States and that it will be voluntarily withdrawing the new drug application (NDA) for Mylotarg effective October 15, 2010.

22 Jun 2010

Four-year follow-up results from SPRYCEL Phase 3 study in CML-CP presented at ASCO

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced four-year follow-up results from a Phase 3 randomized, open-label, dose-optimization study of SPRYCEL® (dasatinib) in chronic-phase chronic myeloid leukemia (CML-CP) patients resistant or intolerant to Gleevec®* (imatinib mesylate). At four years, for all patients administered SPRYCEL 100 mg once daily, overall survival was 82% (95% CI: 76%-88%) and progression-free survival was 66% (95% CI: 57%-74%).

9 Jun 2010

Clinical trials of four investigational compounds in solid tumors presented at ASCO Annual Meeting

Millennium: The Takeda Oncology Company today announced data from clinical trials of four investigational compounds in solid tumors presented at the Annual Meeting of the American Society of Clinical Oncology, held in Chicago, Illinois, June 4-8, 2010. These data include an oral presentation on MLN8237, the Company's selective Aurora A kinase inhibitor.

9 Jun 2010

$Phase 2 Study: NKTR-102 holds great therapeutic potential for women with platinum-resistant/refractory ovarian cancer$

Phase 2 Study: NKTR-102 holds great therapeutic potential for women with platinum-resistant/refractory ovarian cancer

Nektar Therapeutics today announced positive results from a Phase 2 clinical study evaluating single-agent NKTR-102 in women with platinum-resistant/refractory ovarian cancer. A total of 68 patients were enrolled with platinum-resistant disease, half of whom were platinum refractory. All 68 patients were evaluable for the primary endpoint of objective response rate using Gynecologic Cancer InterGroup criteria, which is a combination of response by tumor imaging (RECIST) and/or ovarian cancer biomarker (CA-125) criteria.

8 Jun 2010

AMG 386 demonstrates antitumor activity in Phase 2 trial involving patients with recurrent ovarian cancer

Amgen today announced that AMG 386, combined with paclitaxel, demonstrated antitumor activity in a randomized Phase 2 trial involving 161 patients with recurrent ovarian cancer. The results are being presented for the first time in an oral presentation at the 2010 American Society of Clinical Oncology Annual Meeting.

7 Jun 2010

Low potassium levels increase risk of death in patients with heart failure and CKD

New research from the University of Alabama at Birmingham (UAB) says low potassium levels produce an increased risk of death or hospitalization in patients with heart failure and chronic kidney disease (CKD).

10 Feb 2010

Low potassium levels increase risk of death in patients with heart failure and CKD

9 Feb 2010

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

Positive interim data from the multicenter randomized Phase II trial of palifosfamide presented

ZIOPHARM Oncology, Inc. presented today at the 15th Annual Connective Tissue Oncology Society (CTOS) Meeting, positive interim data from the multicenter randomized Phase II trial of palifosfamide (ZymafosTM, ZIO-201) treating patients with unresectable or metastatic soft tissue sarcoma.

6 Nov 2009

Positive data from ZIOPHARM's palifosfamide sarcoma Phase II trial

ZIOPHARM Oncology, Inc. announced today positive top line interim data from the multicenter randomized Phase II trial of palifosfamide (ZymafosTM, ZIO-201) treating patients with unresectable or metastatic soft tissue sarcoma. The analysis evaluated 62 patients treated as of the end of September, with 58 being analyzed.

14 Oct 2009

Wake Forest University School of Medicine honours researchers

Wake Forest University School of Medicine honored eight of its researchers with awards for excellence at the 13th Annual Research Awards Day Oct. 1.

12 Oct 2009

FDA: Randomized clinical trial necessary to better interpret Clolar’s efficacy and safety in adult AML

Genzyme Corporation (Nasdaq: GENZ) announced today that the FDA’s Oncologic Drugs Advisory Committee voted 9 to 3 that a randomized, controlled trial is needed to support the currently proposed label expansion for Clolar® (clofarabine) in adult myeloid leukemia (AML). The committee found that the single-arm clinical study results submitted to support the label expansion showed Clolar was an active agent in acute AML patients, but concluded that a randomized clinical trial should be necessary to better interpret Clolar’s efficacy and safety in the proposed patient population.

2 Sep 2009

New data on ZOLINZA (vorinostat) in combination with Bortezomib

Results from two Phase 1 studies of ZOLINZA (vorinostat), Merck's oral histone deacetylase (HDAC) inhibitor, administered in combination with bortezomib, showed early anti-tumor activity in patients with relapsed and/or refractory multiple myeloma, including those previously treated with and no longer responding to bortezomib.

10 Dec 2008

Levosimendan compared to dobutamine for decompensated heart failure

The drug levosimendan did not improve survival for patients with decompensated heart failure when compared with a more widely-used treatment for this condition, dobutamine, according to a study in the May 2 issue of JAMA.

2 May 2007

Gatorade appears effective in correcting dehydration and improving bowel symptoms

A double-blind trial of oral rehydration solutions for children with diarrhea and vomiting related to acute viral gastroenteritis found that Gatorade is as effective as Pedialyte in correcting dehydration and improving bowel symptoms.

1 Nov 2005

Hypokalemia News and Research

Cumberland Pharmaceuticals reports 9% increase in second quarter 2010 net revenue

FDA accepts to review sNDA for SPRYCEL for treating adult patients with CML

CHMP adopts positive opinion on pending MAA for SYCREST sublingual tablets

Merck proposes to initiate Phase II proof-of-concept clinical study of posaconazole for chronic Chagas disease

Merck's DULERA Inhalation Aerosol for asthma receives FDA approval

Pfizer to discontinue commercial availability of Mylotarg for AML in U.S.

Four-year follow-up results from SPRYCEL Phase 3 study in CML-CP presented at ASCO

Clinical trials of four investigational compounds in solid tumors presented at ASCO Annual Meeting

Phase 2 Study: NKTR-102 holds great therapeutic potential for women with platinum-resistant/refractory ovarian cancer

AMG 386 demonstrates antitumor activity in Phase 2 trial involving patients with recurrent ovarian cancer

Low potassium levels increase risk of death in patients with heart failure and CKD

Low potassium levels increase risk of death in patients with heart failure and CKD

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

Positive interim data from the multicenter randomized Phase II trial of palifosfamide presented

Positive data from ZIOPHARM's palifosfamide sarcoma Phase II trial

Wake Forest University School of Medicine honours researchers

FDA: Randomized clinical trial necessary to better interpret Clolar’s efficacy and safety in adult AML

New data on ZOLINZA (vorinostat) in combination with Bortezomib

Levosimendan compared to dobutamine for decompensated heart failure

Gatorade appears effective in correcting dehydration and improving bowel symptoms

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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