Calcifediol

OPKO Health to Present New Clinical Data on Rayaldee (ER Calcifediol) at Kidney Week 2023

Retrieved on: 
Wednesday, October 25, 2023

MIAMI, Oct. 25, 2023 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) will present late-breaking clinical data on RAYALDEE® extended-release calcifediol (ERC) at the American Society of Nephrology (ASN) Kidney Week in Philadelphia on Thursday, November 2, 2023.

Key Points: 
  • MIAMI, Oct. 25, 2023 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) will present late-breaking clinical data on RAYALDEE® extended-release calcifediol (ERC) at the American Society of Nephrology (ASN) Kidney Week in Philadelphia on Thursday, November 2, 2023.
  • OPKO Health will present two other posters at ASN Kidney Week summarizing additional new clinical data on RAYALDEE.
  • The data demonstrate that effective control of SHPT has been achieved with RAYALDEE treatment in both randomized clinical trials and in a real-world clinical experience trial.
  • Data from these trials support early initiation of SHPT treatment with RAYALDEE in order to delay disease progression.

Should I be getting my vitamin D levels checked?

Retrieved on: 
Monday, October 2, 2023

Australia has seen a surge in vitamin D testing of children, with similar trends reported for adults around the world. GPs are now being urged not to test for vitamin D unnecessarily. So when is low vitamin D a potential concern? And when might you need to get your levels tested?How much vitamin D do we need?Vitamin D also has many other roles, including helping our immune defences and contributing to DNA repair and cell differentiation.

Key Points: 


Australia has seen a surge in vitamin D testing of children, with similar trends reported for adults around the world. GPs are now being urged not to test for vitamin D unnecessarily. So when is low vitamin D a potential concern? And when might you need to get your levels tested?

How much vitamin D do we need?

    • Vitamin D also has many other roles, including helping our immune defences and contributing to DNA repair and cell differentiation.
    • We can thank the sun for most of our vitamin D. A chemical in our skin called 7-dehydrocholesterol is converted to vitamin D after contact with UVB radiation from the sun.
    • While we get some vitamin D also through our diet, this makes a relatively small contribution.
    • It’s difficult to get much more than one-third of our daily vitamin D requirement from diet without supplementation.

Why avoid vitamin D deficiency?

    • Prolonged, severe vitamin D deficiency will lead to softening of bone tissue and cause diseases such as rickets (children) and osteomalacia (adults).
    • However, avoiding low concentrations is likely to be good for many aspects of health, with consistent evidence suggesting benefits for infectious diseases and autoimmune conditions such as multiple sclerosis.

Who is at risk of deficiency?

    • The two main reasons for vitamin D deficiency typically relate to: 1. not getting (enough) vitamin D through sun exposure.
    • Deficiency risk can be high for anyone who is housebound, such as older or disabled people in residential care.
    • The risk of deficiency increases if we always cover our skin carefully by modest cultural dress, and also dark skin pigmentation is known to reduce vitamin D synthesis.

Am I getting enough sun exposure?

    • In Australia, it is possible to get enough vitamin D from the sun throughout the year.
    • Read more:
      Why you need more Vitamin D in the winter

      During winter, catching enough sun can be difficult, especially if you spend your days confined indoors.

    • This is because sunlight exposure can only help produce vitamin D if the UVB rays reach us at the correct angle.

Why does excess vitamin D testing matter?

    • Excessive testing is also a waste of health-care resources, with one single test costing about the same as a years’ worth of vitamin D supplementation.
    • Very often, we can make relatively small changes to our lifestyles to reduce the risks of vitamin D deficiency.

Global Calcifediol Market Report 2022: Increasing Expenditures on Advanced Pharmaceutical Ingredients in Emerging Economies Fueling Growth - ResearchAndMarkets.com

Retrieved on: 
Tuesday, September 13, 2022

The "Calcifediol Market - Forecasts from 2022 to 2027" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Calcifediol Market - Forecasts from 2022 to 2027" report has been added to ResearchAndMarkets.com's offering.
  • Increasing expenditures on advanced pharmaceutical ingredients (API) manufacturing in emerging economies such as China and India is expected to keep the calcifediol monohydrate market growing.
  • Furthermore, the global prevalence of chronic kidney disease (CKD) is increasing as a result of changing dietary patterns and a fast-paced work environment, which is boosting the demand for calcifediol monohydrate-based medications.
  • The largest market, Asia Pacific, accounts for a considerable portion of the global calcifediol monohydrate market.

RAYALDEE® Launched in Germany by OPKO Health’s Licensee, VFMCRP

Retrieved on: 
Thursday, February 3, 2022

VFMCRP has received marketing authorizations for RAYALDEE in 11 European countries and expects to launch in additional markets later this year.

Key Points: 
  • VFMCRP has received marketing authorizations for RAYALDEE in 11 European countries and expects to launch in additional markets later this year.
  • The launch of RAYALDEE in Germany is a significant commercial milestone with more European countries expected to come on board, beginning with Switzerland in early March.
  • Europe represents a large market opportunity for RAYALDEE with an estimated 26 million people suffering from stage 3 or 4 CKD, said Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO.
  • VFMCRP has significant expertise in nephrology and we are confident in their ability to market RAYALDEE successfully in Germany and other licensed territories.

OPKO Health Announces Topline Results from Phase 2 Trial Evaluating RAYALDEE to Treat Symptomatic COVID-19 Outpatients

Retrieved on: 
Thursday, December 23, 2021

MIAMI, Dec. 23, 2021 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) announces preliminary topline results from its Phase 2 trial with RAYALDEE to treat mild-to-moderate COVID-19.

Key Points: 
  • MIAMI, Dec. 23, 2021 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) announces preliminary topline results from its Phase 2 trial with RAYALDEE to treat mild-to-moderate COVID-19.
  • COVID-19 symptoms were self-reported daily during the 42-day study using the FLU-PRO Plus questionnaire, an outcome tool validated for upper respiratory tract infections.
  • RAYALDEE is an extended-release oral formulation of calcifediol, a prohormone of calcitriol, the active form of vitamin D3.
  • Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward- looking statements.

OPKO Health Reports Transfer of Licensed Rights to RAYALDEE® in Japan to Vifor

Retrieved on: 
Monday, May 24, 2021

MIAMI, May 24, 2021 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) today announced a transfer of the licensed rights to RAYALDEE in Japan from Japan Tobacco Inc. (JT) to Vifor Fresenius Medical Care Renal Pharma (VFMCRP).

Key Points: 
  • MIAMI, May 24, 2021 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) today announced a transfer of the licensed rights to RAYALDEE in Japan from Japan Tobacco Inc. (JT) to Vifor Fresenius Medical Care Renal Pharma (VFMCRP).
  • RAYALDEE is an extended release formulation of calcifediol, a prohormone of calcitriol, the active form of vitamin D3.
  • RAYALDEE is approved to treat SHPT in adults with stage 3 or 4 CKD and vitamin D insufficiency in the U.S. and 11 European countries.
  • Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care) is part of the Vifor Pharma Group (VPG), a global pharmaceutical company.

Sian Capital Sends Letter to OPKO Health Regarding its Decision to Apparently Withhold Rayaldee From Many Patients Amidst COVID-19’s Second Wave

Retrieved on: 
Friday, November 20, 2020

As a substantial investor in OPKO, we believe the Board has not only a fiduciary duty, but a humanitarian duty to distribute Rayaldee to those in need.

Key Points: 
  • As a substantial investor in OPKO, we believe the Board has not only a fiduciary duty, but a humanitarian duty to distribute Rayaldee to those in need.
  • There is no reason that so many Americans should continue dying without having the opportunity to access potential curative drugs.
  • In this letter, we outline how Rayaldee could save countless lives while also unlocking tremendous revenues for OPKO right away.
  • Calcifediol is the active ingredient in OPKOs homegrown drug Rayaldee, which is typically used to treat Chronic Kidney Disease.

FDA Authorizes OPKO Health Clinical Trial Evaluating RAYALDEE in COVID-19 Patients

Retrieved on: 
Monday, June 1, 2020

MIAMI, June 01, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) today announced that the U.S. Food and Drug Administration (FDA) has authorized OPKO to undertake a Phase 2 trial with RAYALDEE as a treatment for patients with mild-to-moderate COVID-19.

Key Points: 
  • MIAMI, June 01, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) today announced that the U.S. Food and Drug Administration (FDA) has authorized OPKO to undertake a Phase 2 trial with RAYALDEE as a treatment for patients with mild-to-moderate COVID-19.
  • The REsCue trial will have 4 weeks of treatment with RAYALDEE or placebo and 2 weeks of follow-up.
  • COVID-19 disproportionately afflicts patients with obesity, older age, darker skin or CKD, all of which are risk factors for reduced serum 25D.
  • RAYALDEE is an extended-release oral formulation of calcifediol, a prohormone of calcitriol, the active form of vitamin D3.

Global Vitamin D Testing Market 2019-2023 | Evolving Opportunities with Abbott Laboratories and bioMérieux SA | Technavio

Retrieved on: 
Thursday, January 16, 2020
Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20200116005267/en/
    Technavio has announced its latest market research report titled global vitamin D testing market 2019-2023.
  • (Graphic: Business Wire)
    Read the 132-page report with TOC on Vitamin D Testing market research report by Product (25-hydroxyvitamin D testing and 1,25-dihydroxyvitamin D testing), Geography (Asia, Europe, North America, and ROW), and the Segment Forecasts, 2019-2023.
  • Vitamin D Testing Market Product Outlook (Revenue, USD Million, 2019-2023)
    The 25-hydroxyvitamin D testing segment is expected to grow faster than the overall market during 2019-2023.
  • Vitamin D Testing Market Regional Outlook (Revenue, USD Million, 2019-2023)
    North America will be the largest geographical segment of the global vitamin D testing market during 2019-2023.

The global vitamin D testing market at a CAGR of almost 5% during the forecast period

Retrieved on: 
Wednesday, July 24, 2019

This vitamin D testing market analysis considers sales from both 25-hydroxyvitamin D testing and 1,25-dihydroxyvitamin D testing.

Key Points: 
  • This vitamin D testing market analysis considers sales from both 25-hydroxyvitamin D testing and 1,25-dihydroxyvitamin D testing.
  • Also, our global vitamin D testing market report also looks at factors such as growing awareness on the importance of vitamin D, growing number of vitamin D deficiency-related disorders, and increasing geriatric population.
  • Global Vitamin D Testing Market: Overview
    Rickets, a disease in which bone tissue does not properly mineralize, leading to soft bones and skeletal deformities in children is caused due to vitamin D deficiency.
  • The increasing prevalence of vitamin D deficiency-related disorders due to growing life expectancy will lead to the expansion of the global vitamin D testing market at a CAGR of almost 5% during the forecast period.