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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]
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, 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]
Recombinant hormone could REPLACE calcium supplements

Recombinant hormone could REPLACE calcium supplements

Results from the phase III REPLACE trial of recombinant human parathyroid hormone (rhPTH) indicate the treatment can successfully combat the underlying deficit in hypoparathyroidism. [More]
Four new pre-clinical drug development projects at NIH develop treatment for rare disease

Four new pre-clinical drug development projects at NIH develop treatment for rare disease

Four new pre-clinical drug development projects at the National Institutes of Health will target a form of blindness and diseases characterized by cardiac problems. The projects were selected for their potential to treat specific rare diseases and to help scientists uncover new information that can be shared with other researchers. [More]

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. [More]
EC grants European market authorization for Revestive to treat short bowel syndrome

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. [More]

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. [More]

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. [More]

Investigational parathyroid hormone replacement effectively treats hypoparathyroidism

An investigational parathyroid hormone replacement effectively treated a rare disorder characterized by low calcium and high phosphate levels in the blood, a new study finds. The results will be presented Saturday at The Endocrine Society's 94th Annual Meeting in Houston. [More]

European CHMP adopts positive opinion for teduglutide to treat short bowel syndrome

Takeda Pharmaceutical Company Limited and NPS Pharmaceuticals, Inc., jointly announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product teduglutide (Revestive) as a once-daily treatment for adult patients with short bowel syndrome (SBS). [More]
Gattex may represent new treatment approach for short bowel syndrome

Gattex may represent new treatment approach for short bowel syndrome

NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, today reported the presentation of data at the Digestive Disease Week (DDW) meeting held May 19-22 in San Diego. [More]

NPS first quarter net loss increases to $10.6 million

NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing orphan therapeutics for rare gastrointestinal and endocrine disorders, today reported its results for the first quarter of 2012. [More]

Positive top-line results from NPSP558 Phase 3 study on hypoparathyroidism

NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing orphan therapeutics for rare gastrointestinal and endocrine disorders, today announced positive top-line results from REPLACE, a Phase 3 registration study of NPSP558, the company's bioengineered replica of human parathyroid hormone (rhPTH 1-84), in adult hypoparathyroidism patients. [More]
NPS announces new data from GATTEX Phase 3 study on short bowel syndrome

NPS announces new data from GATTEX Phase 3 study on short bowel syndrome

NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, today announced new data from STEPS 2, a long-term open-label study, showing that GATTEX (teduglutide) was associated with achieving and maintaining clinically meaningful reductions in parenteral nutrition (PN) and intravenous (IV) fluid volume in adult subjects with short bowel syndrome. [More]

NPS announces data about hypoparathyroidism to be presented at ASBMR 2011 meeting

NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, announced that data about hypoparathyroidism will be presented at the 2011 Annual Meeting of the American Society for Bone and Mineral Research (ASBMR) in San Diego, CA, September 16-20, 2011. [More]

NPS submits NDA CMC section to FDA for GATTEX

NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing orphan therapeutics for rare gastrointestinal and endocrine disorders, today announced that it has submitted the chemistry, manufacturing and controls (CMC) section of its new drug application (NDA) for GATTEX® (teduglutide) to the U.S. Food and Drug Administration (FDA). [More]

GSK, NPS enter agreement to evaluate ronacaleret in new indications

NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing orphan therapeutics for rare gastrointestinal and endocrine disorders, today reported that it has entered into a new agreement with GlaxoSmithKline (GSK), that terminates and replaces a prior collaborative research and license agreement between NPS and GSK from 1993, which focused on the discovery and development of small molecule antagonists of the calcium receptor that increase secretion of parathyroid hormone. [More]

GATTEX Phase 3 study results in adult short bowel syndrome presented at DDW 2011

NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, today announced that GATTEX, a novel, recombinant analog of human glucagon-like peptide 2, was found to effectively and safely reduce parenteral support volume in adult short bowel syndrome-intestinal failure patients. [More]