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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).

22 Jun 2012

Positive results from Amgen Sensipar/Mimpara Phase 3 trial for HPT, CKD

Amgen today announced top-line results of the Phase 3 EVOLVE (EValuation Of Cinacalcet HCl Therapy to Lower CardioVascular Events) trial, which evaluated Sensipar/Mimpara (cinacalcet) for the reduction of the risk of mortality and cardiovascular (CV) events among 3,883 patients with secondary hyperparathyroidism (HPT) and chronic kidney disease (CKD) receiving dialysis.

8 Jun 2012

EMA CHMP adopts positive opinion for Pfizer’s axitinib to treat advanced renal cell carcinoma

Pfizer announced today that the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion regarding the marketing authorization of axitinib in the European Union (EU), for the treatment of adult patients with advanced renal cell carcinoma (RCC), a type of advanced kidney cancer, after failure of prior treatment with sunitinib or a cytokine.

25 May 2012

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.

22 May 2012

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.

4 May 2012

FDA issues Complete Response Letter to Amgen’s sBLA for XGEVA

Amgen today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the supplemental Biologics License Application (sBLA) for XGEVA (denosumab) to treat men with castration-resistant prostate cancer (CRPC) at high risk of developing bone metastases.

27 Apr 2012

FDA invites Amgen for ODAC meeting on XGEVA sBLA to treat castration-resistant prostate cancer

Amgen today announced the U.S. Food and Drug Administration has invited the Company to participate in a meeting of the Oncologic Drugs Advisory Committee (ODAC) on Feb. 8, 2012 to discuss the supplemental Biologics License Application (sBLA) for XGEVA (denosumab) to treat men with castration-resistant prostate cancer (CRPC) at high risk of developing bone metastases.

30 Dec 2011

Novartis to showcase 160 presentations on breast cancer, hematological disease drugs at SABCS and ASH

Novartis Pharmaceuticals Corporation will showcase more than one hundred and sixty presentations on data from its robust oncology portfolio at two key medical congresses this month, demonstrating significant advances for patients with cancers and hematological diseases.

3 Dec 2011

Amgen's XGEVA delays onset of bone metastases in men with prostate cancer

Amgen announced today the publication of results from a Phase 3 trial (the '147 study) that evaluated XGEVA (denosumab) for use in preventing or delaying the onset of bone metastases in men with nonmetastatic castration-resistant prostate cancer.

16 Nov 2011

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.

7 Nov 2011

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.

1 Nov 2011

Data from Amgen's XGEVA and Vectibix studies to be presented at EMCC 2011

Amgen announced today that data from XGEVA (denosumab) and Vectibix (panitumumab) studies will be presented at the 2011 European Multidisciplinary Cancer Congress, Sept. 23 - 27, 2011, in Stockholm, Sweden.

23 Sep 2011

Amgen's Prolia receives FDA approval for new indications to treat cancer patients

Amgen today announced that the U.S. Food and Drug Administration (FDA) approved two new indications for Prolia® (denosumab) as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer and as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for non-metastatic prostate cancer.

19 Sep 2011

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.

19 Sep 2011

Amgen to present data from several Prolia studies at ASBMR 2011 meeting

Amgen today announced that it will present data from several Prolia (denosumab) studies, including eight year efficacy and safety data from a Phase 2 extension study in women with postmenopausal osteoporosis with low bone mineral density (BMD), at the 2011 American Society for Bone and Mineral Research (ASBMR) Annual Meeting in San Diego, Calif. from Sept. 16-20, 2011.

19 Aug 2011

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.

3 Aug 2011

EC grants marketing authorization for Amgen's XGEVA to prevent skeletal-related events

Amgen today announced that the European Commission (EC) has granted marketing authorization for XGEVA (denosumab) for the prevention of skeletal-related events (SREs) in adults with bone metastases from solid tumors.

15 Jul 2011

Amgen files sBLA for XGEVA with FDA to treat castrate-resistant prostate cancer

Amgen today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand the indication for XGEVA (denosumab) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases.

28 Jun 2011

EMA CHMP recommends positive opinion for marketing authorization of Amgen's XGEVA

Amgen today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended a positive opinion for the marketing authorization of XGEVA (denosumab) for the prevention of skeletal-related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumors.

20 May 2011

Amgen announces primary results from XGEVA Phase 3 trial in castrate-resistant prostate cancer

Amgen today announced primary results of a pivotal Phase 3 trial demonstrating that XGEVA significantly increased bone metastasis-free survival for more than four months in men with castrate-resistant metastatic prostate cancer that has not yet spread to bone.

18 May 2011