Osteomalacia News and Research

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Upsher-Smith announces FDA approval of sNDA for Qudexy XR extended-release capsules

Upsher-Smith Laboratories, Inc. announced that it has received U.S. Food and Drug Administration approval of a supplemental new drug application (sNDA) for Qudexy XR (topiramate) extended-release capsules for use as initial monotherapy in patients two years of age and older who are experiencing partial-onset seizures (POS) or primary generalized tonic-clonic seizures.

2 Jun 2015

Upsher-Smith presents favorable data from PREVAIL OLE study of Qudexy XR capsules

Upsher-Smith Laboratories, Inc. presented data from a 52-week, open-label extension study (PREVAIL OLE) showing that Qudexy XR (topiramate) extended-release capsules offered a long-term adjunctive treatment option with a favorable tolerability profile for a high proportion of patients with refractory partial-onset seizures (POS).

21 Apr 2015

Researchers find link between vitamin D deficiency and seasonal affective disorder

Vitamin D deficiency is not just harmful to physical health--it also might impact mental health, according to a team of researchers that has found a link between seasonal affective disorder, or SAD, and a lack of sunlight.

3 Dec 2014

Hypocalcaemic seizure surveillance highlights UK public health policy failings

The occurrence of 91 confirmed or probable hypocalcaemic seizures in children with vitamin D deficiency over a 2-year period in the UK highlights a failure to promote appropriate supplementation.

30 Oct 2014

Chemclin's Vitamin D assay helps in quantitative determination of 25-OH Vitamin D in human serum

Chemclin's new Vitamin D assay provides components for in-vitro quantitative determination of 25-Hydroxy Vitamin D (25-OH Vitamin D) in human serum by a competitive chemiluminescent assay method.

22 Jul 2014

Gilead Sciences gets FDA approval for once-daily single tablet HIV-1 regimen Complera

Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration has approved the single tablet HIV-1 regimen Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) for use in certain virologically-suppressed (HIV RNA <50 copies/mL) adult patients on a stable antiretroviral regimen in order to replace their current antiretroviral treatment regimen. Complera was first approved in 2011 for patients new to therapy and is now one of the most widely-prescribed HIV regimens in the United States.

13 Dec 2013

OPKO Health completes patient enrollment in first phase 3 trial of Rayaldy for SHPT treatment

OPKO Health, Inc., has completed patient recruitment in the first phase 3 trial of Rayaldy to treat patients with secondary hyperparathyroidism, stage 3 or 4 chronic kidney disease and vitamin D insufficiency.

16 Nov 2013

New systematic review analyzes patterns of vitamin D status worldwide

A new systematic review published in the British Journal of Nutrition, is one of the first to focus on patterns of vitamin D status worldwide and in key population subgroups, using continuous values for 25(OH)D to improve comparisons.

5 Sep 2013

Qualigen's FastPack Vitamin D Immunoassay receives FDA clearance

Qualigen, Inc., a privately owned company that provides rapid, easy to use, fully quantitative diagnostic testing solutions, announced today that it has received 510(k) clearance from the United States Food and Drug Administration for its FastPack Vitamin D Immunoassay for use on its proprietary FastPack System for the rapid determination of vitamin D status.

16 Jul 2013

Study links vitamin D deficiency to accelerated aging of bones

Everyone knows that as we grow older our bones become more fragile. Now a team of U.S. and German scientists led by researchers with the U.S. Department of Energy (DOE)'s Lawrence Berkeley National Laboratory (Berkeley Lab) and the University of California (UC) Berkeley has shown that this bone-aging process can be significantly accelerated through deficiency of vitamin D - the sunshine vitamin.

11 Jul 2013

OPKO reports more than 50% enrollment in phase 3 trial of Rayaldy for treatment of secondary hyperparathyroidism

OPKO Health, Inc., has surpassed 50% enrollment in the first phase 3 trial of RayaldyTM to treat patients with secondary hyperparathyroidism (SHPT), stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.

24 May 2013

Eating mushrooms can help increase, maintain vitamin D levels, find BUSM researchers

Researchers from Boston University School of Medicine have discovered that eating mushrooms containing Vitamin D2 can be as effective at increasing and maintaining vitamin D levels (25-hydroxyvitamin D) as taking supplemental vitamin D2 or vitamin D3.

23 Apr 2013

OPKO Health acquires Cytochroma

OPKO Health, Inc. announced that it has completed the acquisition of Cytochroma Inc. Cytochroma's lead products include CTAP101 Capsules, a vitamin D prohormone to treat secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency, and Fermagate Tablets, a new and potent non-absorbed phosphate binder to treat hyperphosphatemia in CKD patients on chronic hemodialysis.

4 Mar 2013

Osteopontin plays a role in X-linked hypophosphatemia

Diagnosed in toddlers, X-linked hypophosphatemia (XLH) is the most common form of heritable rickets, in which soft bones bend and deform, and tooth abscesses develop because infections penetrate soft teeth that are not properly calcified. Researchers at McGill University and the Federal University of Sao Paulo have identified that osteopontin, a major bone and tooth substrate protein, plays a role in XLH. Their discovery may pave the way to effectively treating this rare disease.

21 Feb 2013

African-American and Caucasian women absorb, metabolize vitamin D at same rate

African-American women battling vitamin D deficiencies need the same dose as Caucasian women to treat the condition, according to a recent study accepted for publication in The Endocrine Society's Journal of Clinical Endocrinology & Metabolism (JCEM).

13 Feb 2013

Vitamin D deficiency: an interview with Kellie Bilinski

We know that vitamin D is important in keeping bones strong. In the last 30-40 years it has also been realized that vitamin D has a lot of other roles in the body. Vitamin D essentially has a role in any cell in the body that has a vitamin D receptor.

5 Nov 2012

What are vitamins?

Most people have heard of vitamin C and its effects upon the body; but how much do you know about other vitamins? How many even are there? And what do they all do?

8 Jun 2012

Studies show vitamin D may benefit cardiovascular, skin and metabolic disorders

The Endocrine Society's new scientific statement published online today represents the first comprehensive evaluation of both the basic and clinical evidence related to the non-skeletal effects of vitamin D. The statement addresses current research regarding the associations of vitamin D with immune function, hypertension, stroke, skin conditions and maternal/fetal health.

19 May 2012

Experts recommend vitamin D supplementation for menopausal women

A group of experts has prepared a report on vitamin D supplementation for menopausal women after it was revealed that Europeans have suffered an alarming decrease in their levels of this vitamin. In their opinion, the ideal would be to maintain blood levels above 30 ng/ml. Vitamin D is essential to the immune system and processes such as calcium absorption.

11 Jan 2012

Many spinal fusion surgery patients have low levels of vitamin D

A new study indicates that many patients undergoing spine surgery have low levels of vitamin D, which may delay their recovery. In a study of 313 patients undergoing spinal fusion surgery, orthopaedic surgeons at Washington University School of Medicine in St. Louis found that more than half had inadequate levels of vitamin D, including one-fourth who were more severely deficient.

3 Nov 2011