Hypocalcemia News and Research

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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.

7 Jan 2014

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.

3 Jan 2014

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.

3 Jan 2014

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.

11 Dec 2013

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).

4 Dec 2013

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.

31 Oct 2013

Study explores advantages of minimally invasive parathyroidectomy for treating hyperparathyroidism

An open surgical procedure called bilateral neck exploration has been the gold standard operation for treating patients with primary hyperparathyroidism. But the development of a minimally invasive procedure to remove the parathyroid gland now offers a new option.

17 Oct 2013

Amgen presents data from several romosozumab and Prolia at ASBMR 2013 Annual Meeting

Amgen today announced that it will present data from several romosozumab and Prolia® (denosumab) studies at the American Society for Bone and Mineral Research (ASBMR) 2013 Annual Meeting in Baltimore from Oct. 4-7, 2013.

5 Oct 2013

NPS Pharmaceuticals president receives Ernst & Young Entrepreneur Award in Life Sciences category

NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), a biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases worldwide, today announced that president and chief executive officer Francois Nader, M.D. has received the Ernst & Young Entrepreneur Of The Year® 2013 Award in the Life Sciences category in New Jersey. Dr. Nader was presented with the award at a special gala event on June 13 at the Hyatt Regency New Brunswick, New Jersey.

15 Jun 2013

Exelixis starts phase 3 pivotal trial of cabozantinib for treatment of metastatic renal cell carcinoma

Exelixis, Inc. today announced it has initiated METEOR, a phase 3 pivotal trial comparing cabozantinib to everolimus in patients with metastatic renal cell carcinoma who have experienced disease progression following treatment with at least one prior VEGFR tyrosine kinase inhibitor.

31 May 2013

Chelation therapy with drug disodium EDTA reduces risk of heart attack

Although chelation therapy with the drug disodium EDTA has been used for many years with limited evidence of efficacy for the treatment of coronary disease, a randomized trial that included patients with a prior heart attack found that use of a chelation regimen modestly reduced the risk of a composite of adverse cardiovascular outcomes.

27 Mar 2013

Study: Controversial treatment for autism spectrum disorder may be harmful

A controversial treatment for autism spectrum disorder (ASD) is not only ineffective but may be harmful, according to a study conducted by Baylor University researchers.

30 Nov 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

Exelixis announces FDA approval of COMETRIQ for treatment of medullary thyroid cancer

Exelixis, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved COMETRIQ (cabozantinib) for the treatment of progressive, metastatic medullary thyroid cancer (MTC).

30 Nov 2012

European Medicines Agency accepts Exelixis’ COMETRIQ MAA for review

Exelixis, Inc. today announced the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for COMETRIQ (cabozantinib) for the proposed indication of treatment of progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC).

29 Nov 2012

Phase 3 study of INLYTA fails to meet primary endpoint in treatment-naïve patients with RCC

Pfizer Inc. announced today that a Phase 3 study of INLYTA (axitinib) did not meet its primary endpoint of demonstrating statistically significantly longer progression-free survival, versus sorafenib, in treatment-naïve patients with advanced renal cell carcinoma.

18 Oct 2012

Amgen receives FDA approval for Prolia to treat bone loss in men with osteoporosis

Amgen today announced the U.S. Food and Drug Administration (FDA) approved a new indication for Prolia (denosumab) as a treatment to increase bone mass in men with osteoporosis at high risk for fracture.

21 Sep 2012

EC grants European market authorization for Revestive to treat short bowel syndrome

Takeda Pharmaceutical Company Limited and NPS Pharmaceuticals, Inc., jointly announced today that the European Commission has granted European market authorization for the medicinal product teduglutide (trade name in Europe: Revestive) as a once-daily treatment for adult patients with short bowel syndrome.

5 Sep 2012

FDA committee to review NPS’ Gattex NDA in October

NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing therapeutics for rare gastrointestinal and endocrine disorders, today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that its New Drug Application (NDA) for Gattex (teduglutide) will be discussed at the Gastrointestinal Drugs Advisory Committee meeting scheduled for October 16, 2012.

22 Aug 2012

FDA extends PDUFA action date for NPS Gattex NDA

NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing therapeutics for rare gastrointestinal and endocrine disorders, today announced that it has received a communication from the U.S. Food and Drug Administration extending the Prescription Drug User Fee Act action date for its New Drug Application for Gattex (teduglutide) by three months to December 30, 2012.

13 Aug 2012

Hypocalcemia News and Research

FDA accepts NPS Pharmaceuticals' Natpara BLA for review

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

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

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

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

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

Study explores advantages of minimally invasive parathyroidectomy for treating hyperparathyroidism

Amgen presents data from several romosozumab and Prolia at ASBMR 2013 Annual Meeting

NPS Pharmaceuticals president receives Ernst & Young Entrepreneur Award in Life Sciences category

Exelixis starts phase 3 pivotal trial of cabozantinib for treatment of metastatic renal cell carcinoma

Chelation therapy with drug disodium EDTA reduces risk of heart attack

Study: Controversial treatment for autism spectrum disorder may be harmful

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

Exelixis announces FDA approval of COMETRIQ for treatment of medullary thyroid cancer

European Medicines Agency accepts Exelixis’ COMETRIQ MAA for review

Phase 3 study of INLYTA fails to meet primary endpoint in treatment-naïve patients with RCC

Amgen receives FDA approval for Prolia to treat bone loss in men with osteoporosis

EC grants European market authorization for Revestive to treat short bowel syndrome

FDA committee to review NPS’ Gattex NDA in October

FDA extends PDUFA action date for NPS Gattex NDA

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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