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Amgen's Vectibix (panitumumab) receives EC approval for treatment patients with WT RAS mCRC

Amgen's Vectibix (panitumumab) receives EC approval for treatment patients with WT RAS mCRC

Amgen today announced that the European Commission approved a new use of Vectibix (panitumumab) as first-line treatment in combination with FOLFIRI for the treatment of adult patients with wild-type (WT) RAS metastatic colorectal cancer (mCRC). [More]
Shire announces availability of Natpara (parathyroid hormone) for injection in U.S.

Shire announces availability of Natpara (parathyroid hormone) for injection in U.S.

Shire plc today announced that Natpara (parathyroid hormone) for injection is now available in the United States. The U.S. Food and Drug Administration approved Natpara as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism on January 23, 2015. [More]
United Therapeutics announces FDA approval of dinutuximab for treatment of high-risk neuroblastoma

United Therapeutics announces FDA approval of dinutuximab for treatment of high-risk neuroblastoma

United Therapeutics Corporation announced today that the United States Food and Drug Administration has approved Unituxin (dinutuximab) Injection (formerly called ch14.18), in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. [More]
Eisai announces FDA approval of LENVIMA (lenvatinib) for treatment of RAI-refractory DTC

Eisai announces FDA approval of LENVIMA (lenvatinib) for treatment of RAI-refractory DTC

Eisai Inc. announced today that the U.S. Food and Drug Administration approved the company's receptor tyrosine kinase inhibitor LENVIMA (lenvatinib) for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (RAI-R DTC). [More]
Amgen's XGEVA (denosumab) receives FDA approval for treatment of hypercalcemia of malignancy

Amgen's XGEVA (denosumab) receives FDA approval for treatment of hypercalcemia of malignancy

Amgen today announced that the U.S. Food and Drug Administration has approved a new indication for XGEVA (denosumab) for the treatment of hypercalcemia of malignancy (HCM) refractory to bisphosphonate therapy. [More]
Viewpoints: 'Blunders' on Ebola; McConnell's strange logic on Obamacare; temporary victory for Texas women

Viewpoints: 'Blunders' on Ebola; McConnell's strange logic on Obamacare; temporary victory for Texas women

The point of this is not to flog Presbyterian, though a few lashes might help snap [Daniel] Varga and other administrators back to reality. [More]
Study on widespread vitamin D deficiency among patients who undergo thyroidectomy

Study on widespread vitamin D deficiency among patients who undergo thyroidectomy

A new study from researchers at Henry Ford Hospital in Detroit finds widespread vitamin D deficiency among patients who undergo a thyroidectomy, potentially putting them at greater risk for developing dangerously low blood calcium levels after surgery. [More]
Amgen’s AMG 416 Phase 3 placebo-controlled study meets primary and secondary endpoints

Amgen’s AMG 416 Phase 3 placebo-controlled study meets primary and secondary endpoints

Amgen (NASDAQ: AMGN) today announced that a second placebo-controlled Phase 3 study evaluating AMG 416 for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD), receiving hemodialysis, met its primary and all secondary endpoints. [More]
Phase 3 trial: NEXAVAR tablets fail to meet primary endpoint in HER2-negative breast cancer patients

Phase 3 trial: NEXAVAR tablets fail to meet primary endpoint in HER2-negative breast cancer patients

Bayer HealthCare and Onyx Pharmaceuticals Inc., an Amgen subsidiary, today announced that an investigational Phase 3 trial of NEXAVAR (sorafenib) tablets in patients with advanced breast cancer did not meet its primary endpoint of improving progression-free survival (PFS). [More]
Denosumab increases bone density for postmenopausal women with osteoporosis

Denosumab increases bone density for postmenopausal women with osteoporosis

Postmenopausal women with osteoporosis who take denosumab long-term have increased bone density, sustained low rate of fractures, and a favorable benefit/risk profile, a new multinational study finds. [More]
Amgen presents extended analysis of PEAK study data at ASCO

Amgen presents extended analysis of PEAK study data at ASCO

Amgen today announced results from the Phase 2 PEAK study that reinforce the improved overall survival (OS) benefit of panitumumab (Vectibix®) when used in combination with FOLFOX, an oxaliplatin-based chemotherapy regimen, compared to bevacizumab (Avastin) plus FOLFOX as first-line treatment in patients with wild-type RAS metastatic colorectal cancer (mCRC). [More]
European Commission approves Exelixis' COMETRIQ for treatment of progressive, metastatic MTC

European Commission approves Exelixis' COMETRIQ for treatment of progressive, metastatic MTC

Exelixis, Inc. today announced that the European Commission has approved COMETRIQ (cabozantinib) for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma (MTC). [More]
NPS Pharmaceuticals reports net global product sales of $15.3 million for Q4 2013

NPS Pharmaceuticals reports net global product sales of $15.3 million for Q4 2013

NPS Pharmaceuticals, Inc., a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases worldwide, today reported financial results for 2013 and its financial outlook for 2014. [More]
Pfizer and Merck join forces to explore therapeutic potential of anti-PD-1 therapy

Pfizer and Merck join forces to explore therapeutic potential of anti-PD-1 therapy

Pfizer Inc. announced today that it has agreed with Merck & Co., Inc., known as MSD outside the United States and Canada ("Merck"), through two Merck subsidiaries, to explore the therapeutic potential of Merck's investigational anti-PD-1 therapy, MK-3475, in combination with two Pfizer oncology assets. [More]
FDA accepts NPS Pharmaceuticals' Natpara BLA for review

FDA accepts NPS Pharmaceuticals' Natpara BLA for review

NPS Pharmaceuticals, Inc., a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases worldwide, today announced that the U.S. Food and Drug Administration has accepted and filed for review the company's Biologics License Application for Natpara (recombinant human parathyroid hormone 1-84, (rhPTH[1-84])) for the treatment of hypoparathyroidism. [More]
NPS Pharmaceuticals' Natpara gets orphan drug designation for treatment of hypoparathyroidism

NPS Pharmaceuticals' Natpara gets orphan drug designation for treatment of hypoparathyroidism

NPS Pharmaceuticals, Inc., a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases, today announced that the European Commission has granted orphan drug designation to Natpara (recombinant human parathyroid hormone (rhPTH[1-84]) for the treatment of hypoparathyroidism. [More]
NPSP to conduct open-label study to evaluate teduglutide in pediatric patients with SBS

NPSP to conduct open-label study to evaluate teduglutide in pediatric patients with SBS

NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases worldwide, today announced that the company has initiated a global registration study of teduglutide in pediatric patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support. [More]
Pronai Therapeutics reports positive results from PNT2258 Phase II study on lymphoma

Pronai Therapeutics reports positive results from PNT2258 Phase II study on lymphoma

ProNAi Therapeutics, Inc., a leader in developing nucleic acid therapeutics, presented safety and efficacy data from its ongoing Phase II study yesterday at the 55th Annual Meeting of the American Society for Hematology (ASH) in New Orleans, Louisiana. [More]
Novartis to present updates on broad cancer portfolio at ASH and SABCS symposiums

Novartis to present updates on broad cancer portfolio at ASH and SABCS symposiums

Novartis will present updates on its broad cancer portfolio with more than 240 abstracts at the upcoming American Society of Hematology (ASH) annual meeting and CTRC-AACR San Antonio Breast Cancer Symposium (SABCS). [More]
Risks of developing kidney failure, calcium deficiency from zoledronic acid are extremely rare

Risks of developing kidney failure, calcium deficiency from zoledronic acid are extremely rare

The risks of developing kidney failure and a calcium deficiency from the popular osteoporosis drug zoledronic acid are extremely rare, according to researchers at Loyola University Health System. These findings were presented earlier this month at the American Society for Bone and Mineral Research's annual meeting. [More]
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