Hypokalemia News and Research

RSS

FDA approves new radioactive drug for treatment of rare digestive tract cancers

The U.S. Food and Drug Administration today approved Lutathera (lutetium Lu 177 dotatate) for the treatment of a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

29 Jan 2018

ACADIA Pharmaceuticals announces results from Phase II study of antipsychotic in Alzheimer's disease psychosis

ACADIA Pharmaceuticals Inc., a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system (CNS) disorders, today announced the presentation of data from the Phase II -019 Study of pimavanserin in Alzheimer's disease psychosis at the 10th Clinical Trials on Alzheimer's Disease meeting in Boston.

3 Nov 2017

Infantile spasms and multiple sclerosis relapse data presented at AAN

Mallinckrodt plc, a specialty pharmaceutical company, announced new results from two company-sponsored studies: one study on use of H.P. Acthar® Gel (repository corticotropin injection) in patients with infantile spasms (IS) and a second study on the economic burden of moderate-to-severe multiple sclerosis (MS) relapse.

2 May 2017

BCL-2 inhibitor shows promise in AML patients

Patients whose acute myelogenous leukemia (AML) had relapsed or was resistant to chemotherapy and those who were deemed unable to tolerate chemotherapy experienced responses to the selective BCL-2 inhibitor venetoclax (Venclexta), with complete remissions in some, according to phase II clinical trial data.

12 Aug 2016

European Commission approves extended indication for Amgen's Kyprolis (carfilzomib) for the treatment of relapsed multiple myeloma patients

Amgen has announced that the European Commission (EC) has approved a variation to the marketing authorization for Kyprolis® (carfilzomib) to include use in combination with dexamethasone alone for adult patients with multiple myeloma who have received at least one prior therapy. The extended indication marks the second approval for Kyprolis by the EC in less than a year.

6 Jul 2016

Health care resource use and costs of H.P. Acthar® gel for multiple sclerosis relapse

Mallinckrodt plc, a leading global specialty biopharmaceutical company, today announced new retrospective health economic data on H.P. Acthar® Gel (repository corticotropin injection; RCI), which may be an option for the management of multiple sclerosis (MS) relapses.

6 Jul 2016

Bayer-new phase 3 liver cancer data

Bayer has announced that a Phase III trial evaluating its oncology compound Stivarga® (regorafenib) tablets for the treatment of patients with unresectable hepatocellular carcinoma (HCC) has met its primary endpoint of a statistically significant improvement in overall survival. The study, called RESORCE, evaluated the efficacy and safety of regorafenib in patients with HCC whose disease has progressed after treatment with sorafenib. The safety and tolerability were generally consistent with the known profile of regorafenib. Detailed efficacy and safety analyses from this study are expected to be presented at an upcoming scientific congress.

4 May 2016

Eisai's Halaven receives FDA approval for treatment of patients with metastatic liposarcoma

Eisai Inc. announced today that the U.S. Food and Drug Administration approved Halaven (eribulin mesylate) Injection (0.5 mg per mL) for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.

29 Jan 2016

Lilly receives FDA approval for Humulin R U-500 KwikPen

The U.S. Food and Drug Administration has approved Eli Lilly and Company's Humulin R U-500 KwikPen(insulin human injection) 500 units/mL, a pre-filled device containing Humulin R U-500, a highly concentrated formulation of insulin.

21 Jan 2016

VistaPharm announces launch of Potassium Chloride Solution

VistaPharm today announced that it has launched Potassium Chloride Solution, USP, 10% in Unit Dose. The product is supplied to the market in a 50 count case of 30mL unit dose cups.

14 Dec 2015

Perrigo receives FDA approval for generic version of KlorCon extended-release tablets

Perrigo Company plc today announced it has received an AB therapeutic equivalent rating and final U.S. Food and Drug Administration approval for the generic version of KlorCon extended-release tablets (600 mg and 750 mg), manufactured by Upsher-Smith Laboratories, Inc., and marketed by Sandoz Pharmaceuticals, Inc.

10 Nov 2015

FDA grants accelerated approval to Praxbind (idarucizumab)

The U.S. Food and Drug Administration today granted accelerated approval to Praxbind (idarucizumab) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa's blood-thinning effects.

19 Oct 2015

Boehringer Ingelheim announces FDA approval of Praxbind (idarucizumab)

Boehringer Ingelheim Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration granted approval of Praxbind (idarucizumab). PRAXBIND is indicated for patients treated with Pradaxa (dabigatran etexilate mesylate), when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding.

16 Oct 2015

Clinical study data on Mallinckrodt's H.P. Acthar Gel to be presented at ACR 2015

Mallinckrodt plc, a leading specialty biopharmaceutical company, today announced that data from a pilot study for its H.P. Acthar Gel (repository corticotropin injection) will be presented at the American College of Rheumatology 2015 Annual Meeting to be held November 7-11 in San Francisco.

8 Oct 2015

Novo Nordisk announces FDA approval of Tresiba (insulin degludec injection) for diabetes treatment

Novo Nordisk, a world leader in diabetes care, today announced that the U.S. Food and Drug Administration approved the new drug application for Tresiba (insulin degludec injection), a once-daily, long-acting basal insulin. Tresiba is indicated for use alone, or in combination with oral antidiabetic medicines or bolus insulin, and is approved for glycemic control in adults with type 1 and type 2 diabetes. Tresiba provides a long duration of action beyond 42 hours.

From Novo Nordisk 26 Sep 2015

Amgen gets positive CHMP opinions for Kyprolis (carfilzomib) and BLINCYTO (blinatumomab)

"We are pleased to receive positive CHMP opinions for Kyprolis and BLINCYTO as this is an important step in providing new treatment options for patients in Europe with rare forms of cancer," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen.

25 Sep 2015

Amgen, Xencor partner to develop and commercialize new therapeutics for cancer immunotherapy, inflammation

Amgen and Xencor, Inc. announced today that the two companies have entered into a research and license agreement to develop and commercialize novel therapeutics in the areas of cancer immunotherapy and inflammation.

16 Sep 2015

FDA, EMA accept filing applications for Boehringer Ingelheim's afatinib to treat patients with advanced SCC of the lung

Boehringer Ingelheim today announced that both the U.S. Food and Drug Administration and the European Medicines Agency have accepted filing applications for afatinib for the treatment of patients with advanced squamous cell carcinoma (SCC) of the lung progressing after treatment with first-line chemotherapy.

26 Aug 2015

Eisai, Halozyme partner to evaluate eribulin and PEGPH20 in HER2-negative metastatic breast cancer

Eisai Inc. announced today that its parent company Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) and Halozyme Therapeutics, Inc. (Headquarters: San Diego, California, President and CEO: Dr. Helen Torley) have signed a clinical collaboration agreement to evaluate Eisai's agent eribulin mesylate (brand name: Halaven, "eribulin") in combination with Halozyme's investigational drug PEGPH20 (PEGylated recombinant human hyaluronidase) in first line HER2-negative metastatic breast cancer.

31 Jul 2015

Astellas reports topline results from isavuconazole Phase 3 study in candidemia and other invasive Candida infections

Astellas today announced topline results from the Phase 3 ACTIVE study evaluating the efficacy and safety of intravenous (IV) and oral isavuconazole, commercially known as CRESEMBA (isavuconazonium sulfate), under development for adults with candidemia and other invasive Candida infections.

30 Jul 2015