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Bayer-new phase 3 liver cancer data

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. [More]
Eisai's Halaven receives FDA approval for treatment of patients with metastatic liposarcoma

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. [More]
Lilly receives FDA approval for Humulin R U-500 KwikPen

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. [More]
VistaPharm announces launch of Potassium Chloride Solution

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. [More]
Perrigo receives FDA approval for generic version of KlorCon extended-release tablets

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. [More]
FDA grants accelerated approval to Praxbind (idarucizumab)

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. [More]
Boehringer Ingelheim announces FDA approval of Praxbind (idarucizumab)

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. [More]
Clinical study data on Mallinckrodt's H.P. Acthar Gel to be presented at ACR 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. [More]
Novo Nordisk announces FDA approval of Tresiba (insulin degludec injection) for diabetes treatment

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. [More]
Amgen gets positive CHMP opinions for Kyprolis (carfilzomib) and BLINCYTO (blinatumomab)

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. [More]
Amgen, Xencor partner to develop and commercialize new therapeutics for cancer immunotherapy, inflammation

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

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

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

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. [More]
New drug patiromer could improve potassium levels of patients with diabetic kidney disease

New drug patiromer could improve potassium levels of patients with diabetic kidney disease

Among patients with diabetic kidney disease and hyperkalemia (elevated potassium levels in the blood), a potentially life-threatening condition, those who received the new drug patiromer, twice daily for four weeks, had significant decreases in potassium levels which lasted through one year, according to a study in the July 14 issue of JAMA. [More]
Phase 3 study shows Vectibix meets primary endpoint in patients with chemorefractory wild-type KRAS mCRC

Phase 3 study shows Vectibix meets primary endpoint in patients with chemorefractory wild-type KRAS mCRC

Amgen today announced that a Phase 3 study evaluating Vectibix (panitumumab) and best supportive care (BSC) met its primary endpoint, demonstrating a statistically significant improvement in overall survival (OS) in patients with chemorefractory wild-type KRAS (exon 2) metastatic colorectal cancer (mCRC) compared to those patients treated with BSC alone. [More]
Boehringer announces LUX-Lung 8 data that compares efficacy of afatinib, erlotinib in patients with advanced SCC

Boehringer announces LUX-Lung 8 data that compares efficacy of afatinib, erlotinib in patients with advanced SCC

Boehringer Ingelheim today announced overall survival (OS) results from the LUX-Lung 8 trial (NCT01523587) that directly compared the efficacy and safety of two EGFR-directed treatments, afatinib and erlotinib, in patients with advanced squamous cell carcinoma (SCC) of the lung, progressing after treatment with first-line chemotherapy. Treatment with afatinib significantly reduced the risk of death by 19%, extending the survival of patients to a median of 7.9 months compared to 6.8 months on erlotinib. [More]
Eisai Phase 3 trial of eribulin meets primary endpoint in patients with advanced soft tissue sarcoma

Eisai Phase 3 trial of eribulin meets primary endpoint in patients with advanced soft tissue sarcoma

Eisai Inc. announced today the results of its Phase 3 trial (Study 309), which showed that eribulin met the study's primary endpoint evaluating overall survival in patients who had advanced leiomyosarcoma (LMS) or adipocytic sarcoma (ADI), two types of advanced soft tissue sarcoma. [More]
FDA approves Humalog 200 units/mL KwikPen to improve glycemic control in diabetic patients

FDA approves Humalog 200 units/mL KwikPen to improve glycemic control in diabetic patients

The U.S. Food and Drug Administration (FDA) has approved Humalog® 200 units/mL KwikPen® (insulin lispro 200 units/mL; U-200), a pre-filled pen containing a concentrated formulation of Lilly's rapid-acting insulin Humalog® (insulin lispro 100 units/mL) to improve glycemic control in people with type 1 and type 2 diabetes, Eli Lilly and Company announced today. Humalog U-200 KwikPen marks the first FDA approval of a concentrated mealtime insulin analog. [More]
Amgen to present clinical data on multiple blood cancer treatments at EHA 2015

Amgen to present clinical data on multiple blood cancer treatments at EHA 2015

Amgen today announced that it will present data from multiple Kyprolis (carfilzomib) for Injection, BLINCYTO (blinatumomab), oprozomib and Nplate (romiplostim)‎ studies at the 20th Congress of the European Hematology Association taking place in Vienna, June 11 - 14, 2015. [More]
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