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Study provides new insights into molecular basis of CaSR-related human diseases

Study provides new insights into molecular basis of CaSR-related human diseases

A study led by researchers at Georgia State University provides new insights into the molecular basis of human diseases resulting from mutations in the calcium-sensing receptor (CaSR), a protein found in cell membranes. [More]
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]
Romosozumab for postmenopausal women with osteoporosis meets co-primary endpoints in Phase 3 study

Romosozumab for postmenopausal women with osteoporosis meets co-primary endpoints in Phase 3 study

Amgen and UCB today announced top-line results from the Phase 3 placebo-controlled FRActure study in postmenopausal woMen with ostEoporosis (FRAME). [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]
Standardized treatment approach makes outpatient thyroid surgery a safe option for elderly patients

Standardized treatment approach makes outpatient thyroid surgery a safe option for elderly patients

A standardized treatment approach that starts with good screening and ends with patients going home to well-prepared caregivers, means outpatient thyroid surgery is safe for the vast majority of patients, including the elderly and super-elderly, physician-scientists say. [More]
Latest ENT research to be presented at AAO-HNSF's annual meeting

Latest ENT research to be presented at AAO-HNSF's annual meeting

The latest research on hearing loss, head and neck cancers, sleep apnea and other otolaryngic topics will be presented in Dallas, TX, September 27-30, at the 2015 Annual Meeting & OTO EXPO? of the American Academy of Otolaryngology--Head and Neck Surgery Foundation (AAO-HNSF), the largest annual meeting of ear, nose, throat, head and neck physicians in the world. [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]
Lenvatinib-everolimus combination extends PFS in patients with mRCC versus everolimus alone

Lenvatinib-everolimus combination extends PFS in patients with mRCC versus everolimus alone

Eisai Inc. announced today results from an investigational Phase 2 trial which showed that lenvatinib, when used in combination with everolimus, significantly extended progression-free survival (PFS) in patients with metastatic renal cell carcinoma (mRCC) versus everolimus alone. [More]
Amgen announces AMG 416 Phase 3 results for treatment of secondary hyperparathyroidism in CKD patients

Amgen announces AMG 416 Phase 3 results for treatment of secondary hyperparathyroidism in CKD patients

Amgen today announced pooled data from two pivotal Phase 3, global, randomized, placebo-controlled trials evaluating AMG 416, a novel calcimimetic, for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease (CKD) receiving hemodialysis. [More]
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]
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