Hypokalemia News and Research

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Cubist seeks FDA sNDA approval for ENTEREG to accelerate GI recovery

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that it has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) requesting approval for the use of ENTEREG® (alvimopan) to accelerate GI recovery following any surgery that includes a bowel resection with primary anastomosis; expanded from the current indication in patients requiring surgery for colorectal disease.

21 Dec 2012

FDA approves Novartis Signifor injection for treatment of Cushing's disease

Novartis announced today that the US Food and Drug Administration (FDA) has approved Signifor (pasireotide) injection for the treatment of adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative.

14 Dec 2012

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

Janssen receives FDA approval for ZYTIGA to treat metastatic castration-resistant prostate cancer

Janssen announced today that the U.S. Food and Drug Administration (FDA) has approved a broader indication for the oral, once-daily medication ZYTIGA (abiraterone acetate).

10 Dec 2012

Novartis to highlight key data from extensive oncology portfolio at SABCS and ASH meeting

Novartis will highlight more than 140 presentations on key data from its extensive oncology portfolio at the leading year-end scientific meetings devoted to hematology and breast cancer, demonstrating continued innovation in research and development efforts to advance the care of patients with cancer and rare diseases.

30 Nov 2012

ProStrakan acquires US commercial rights to Fareston for treatment of metastatic breast cancer

ProStrakan Group plc announces today that it has acquired exclusive US commercial rights to Fareston (toremifene citrate) for the treatment of metastatic breast cancer in postmenopausal women.

1 Oct 2012

Janssen receives FDA Priority Review for ZYTIGA sNDA to treat mCRPC

Janssen Research & Development, LLC, announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the supplemental New Drug Application (sNDA) for ZYTIGA (abiraterone acetate) administered in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy.

30 Aug 2012

Eplerenone shown to reduce cumulative heart failure hospitalisations

Pfizer Inc. (NYSE: PFE) announced results from a new post-hoc analysis of the EMPHASIS-HF trial showing statistically significant reductions in rates of cumulative heart failure (HF) hospitalisations in patients with HF treated with eplerenone compared with placebo on a background of standard optimal therapy.1 The results were presented at The European Society of Cardiology Congress (ESC) in Munich.

28 Aug 2012

Pendrin a possible new target for diuretic therapy

In patients with fluid overload, inhibition of the chloride-absorbing transporter pendrin and the NaCl co-transporter may provide an effective diuretic regimen without triggering hypokalemia, research suggests.

6 Aug 2012

Takeda announces updated results from orteronel phase 2 study on nmCRPC

Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited today announced updated results from a phase 2 study of orteronel, a selective oral 17,20 lyase inhibitor, dosed without prednisone in patients with non-metastatic castration resistant prostate cancer (nmCRPC) and rising prostate-specific antigen.

5 Jun 2012

Results from Janssen's ZYTIGA plus prednisone Phase 3 study on mCRPC

Results observed from pre-specified interim analyses of the randomized, placebo-controlled Phase 3 study, COU-AA-302, demonstrated that patients with metastatic castration-resistant prostate cancer (mCRPC) treated with abiraterone acetate (ZYTIGA) plus prednisone showed a statistically significant improvement in radiographic progression-free survival (rPFS) and all secondary endpoints compared to patients treated with placebo plus prednisone.

4 Jun 2012

Takeda launches EDARBYCLOR in the U.S. for treatment of hypertension

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., announced EDARBYCLOR (azilsartan medoxomil and chlorthalidone) is now available by prescription in U.S. pharmacies for the treatment of hypertension to lower blood pressure in adults.

6 Feb 2012

Two new studies focus on causes of arrhythmia and SCD

Researchers in Rhode Island Hospital's Cardiovascular Research Center have published two new studies focusing on the causes of arrhythmia and sudden cardiac death (SCD) when a genetic disorder is present.

18 Jan 2012

Takeda receives FDA approval for EDARBYCLOR to treat hypertension

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., announced that the U.S. Food and Drug Administration (FDA) approved EDARBYCLOR (azilsartan medoxomil and chlorthalidone) for the treatment of hypertension to lower blood pressure in adults.

21 Dec 2011

FDA approves modernized labeling for ViroPharma's Vancocin Capsules

ViroPharma Incorporated today announced the modernization of labeling for Vancocin (vancomycin hydrochloride, USP) Capsules made effective through the U.S. Food and Drug Administration's (FDA) approval of a supplemental new drug application.

15 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

Novartis to showcase 160 presentations on breast cancer, hematological disease drugs at SABCS and ASH

Novartis Pharmaceuticals Corporation will showcase more than one hundred and sixty presentations on data from its robust oncology portfolio at two key medical congresses this month, demonstrating significant advances for patients with cancers and hematological diseases.

3 Dec 2011

Takeda receives FDA approval for VELCADE sNDA to treat MM

Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for VELCADE (bortezomib) for Injection, which updates the label to include additional long-term overall survival (OS) data from the VISTA trial.

2 Nov 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

New clinical data on Bristol-Myers Squibb's NULOJIX to be presented at ESOT 2011 congress

Bristol-Myers Squibb Company today announced that new data on NULOJIX (belatacept) will be presented at the European Society for Organ Transplantation (ESOT) Congress on September 4 -7, 2011 in Glasgow, Scotland, United Kingdom.

2 Sep 2011