Hypokalemia News and Research

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Patients with chronic constipation prefer Kristalose oral solution

Cumberland Pharmaceuticals Inc. today announced the publication of a patient preference study evaluating Kristalose (lactulose) for Oral Solution, a prescription laxative packaged as a crystalline powder, compared to liquid lactulose products.

2 Dec 2010

SYMBICORT improves lung function in African American asthma patients compared to budesonide alone

AstraZeneca announced today that results from TITAN, a 12-week study of SYMBICORT® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol in African American patients with moderate to severe persistent asthma, showed significant improvement in lung function for patients taking SYMBICORT compared with those using budesonide alone.

3 Nov 2010

SPRYCEL receives FDA approval for treating adult patients with Ph+ CML in chronic phase

After receiving a priority review, Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved SPRYCEL (dasatinib) 100 mg once daily for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.

29 Oct 2010

Strativa enters amended agreement with Sobi for Nascobal Vitamin B12 Nasal Spray

Strativa Pharmaceuticals today announced that it has entered into an amended and restated license and supply agreement with Swedish Orphan Biovitrum (Sobi) covering the European development and commercialization rights of Strativa's Nascobal (cyanocobalamin) Vitamin B12 Nasal Spray. Strativa acquired the worldwide rights to Nascobal from QOL Medical, LLC in March 2009, which included a pre-existing agreement with Sobi.

26 Oct 2010

COU-AA-301 Phase 3 study demonstrates improvement in CRPC survival rate

Results from a pre-specified interim analysis of a randomized, placebo-controlled Phase 3 study, COU-AA-301, demonstrate that patients treated with the investigational agent abiraterone acetate plus low-dose prednisone/prednisolone showed a significant improvement in overall survival compared to patients treated with prednisone/prednisolone plus placebo.

11 Oct 2010

Amneal Pharmaceuticals receives FDA approval for Spironolactone HCl tablets

Amneal Pharmaceuticals, LLC is pleased to announce that it has received U.S. FDA approval to manufacture Spironolactone HCl tablets in 25 mg, 50 mg and 100 mg strengths effective July 2, 2010.

26 Aug 2010

Tasigna receives approval for chronic myeloid leukemia in Canada

Tasigna (nilotinib) capsules have been approved with conditions in Canada as a new therapy for patients with CML, in the chronic phase (first phase) of the disease. Patients must be resistant to or intolerant of at least one prior therapy, including (Pr)Gleevec (imatinib mesylate), an established standard of care.

20 Aug 2010

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

Hypokalemia News and Research

Patients with chronic constipation prefer Kristalose oral solution

SYMBICORT improves lung function in African American asthma patients compared to budesonide alone

SPRYCEL receives FDA approval for treating adult patients with Ph+ CML in chronic phase

Strativa enters amended agreement with Sobi for Nascobal Vitamin B12 Nasal Spray

COU-AA-301 Phase 3 study demonstrates improvement in CRPC survival rate

Amneal Pharmaceuticals receives FDA approval for Spironolactone HCl tablets

Tasigna receives approval for chronic myeloid leukemia in Canada

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

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