Endocrine gland

Valbiotis publishes its annual accounts 2023

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星期五, 五月 3, 2024
FDA, Sales management, Partnership, Hypercholesterolemia, Sleep, INSIGHT, Prevalence, Insulin resistance, Inflammation, DSM-IV codes, Food, Communication, Cholecalciferol, Executive Committee, Pharmacist, Pharmacy, Volunteering, INAF, Phase, Practitioner, Incretin, EFSA, Safety, Omega-3 fatty acid, Agonal respiration, Human, LDL, Marketing, Prediabetes, NAFLD, Endocrine gland, NDI, Food and Drug Administration, Meal, Commercial, Dietary supplement, Blood pressure, Patient, Statutory auditor, Metabolism, Hypertension, Cardiovascular disease, Bank statement, Pharmaceutical industry

Sébastien PELTIER, Chairman of the Executive Committee and Co-Founder of Valbiotis, comments: ‘’2023 was one of Valbiotis' most productive years since the Company was founded just ten years ago.

Key Points: 
  • Sébastien PELTIER, Chairman of the Executive Committee and Co-Founder of Valbiotis, comments: ‘’2023 was one of Valbiotis' most productive years since the Company was founded just ten years ago.
  • By accelerating its structuring, Valbiotis also laid the foundations for 2024, which promises to be particularly fruitful.
  • The Company's 2023 financial statements, drawn up in accordance with IFRS, were approved by the Board of Directors on April 23, 2024.
  • They have been audited by the Statutory Auditor and are available on the Valbiotis website: www.valbiotis.com/en (investors section).

Ascendis Pharma Reports First Quarter 2024 Financial Results

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星期四, 五月 2, 2024
FDA, Endocrine gland, Hypoparathyroidism, Element, GHD, Achondroplasia, Commercial, New Drug Application, Biologics license application, Development, Prescription, ASCO, Turner syndrome, PDUFA, Patient, Society, Melanoma, Vision, Inborn errors of metabolism, Pharmaceutical industry

If approved, U.S. launch planned in Q3

Key Points: 
  • If approved, U.S. launch planned in Q3
    — SKYTROFA® Q1 revenue more than doubled year-over-year to €65 million; Q1 operating expenses fell by 20% year-over-year to €137 million
    COPENHAGEN, Denmark, May 02, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced financial results for the first quarter ended March 31, 2024, and provided a business update.
  • Plan to submit a supplemental Biologics License Application to FDA for adult growth hormone deficiency (GHD), in the third quarter of 2024.
  • Topline results from Phase 2 trial in Turner syndrome expected in the fourth quarter of 2024.
  • In the U.S., Prescription Drug User Fee Act (PDUFA) date of May 14, 2024; if approved, U.S. commercial launch planned in the third quarter of 2024.

Royalty Pharma Reports Q4 and Full Year 2023 Results

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星期四, 二月 15, 2024
MorphoSys, Pfizer, European Commission, Recurrence, Docetaxel, Roche, Cystic fibrosis, Share repurchase, FDA, Food, Schizophrenia, Growth, Sacituzumab govitecan, PTC, Vertex, Astellas Pharma, Risdiplam, Metastasis, Projection, KarXT, Bristol Myers Squibb, PTC Therapeutics, Endocrine gland, Lung cancer, Civil service commission, JAK, Therapy, Tourette syndrome, Webcast, Patient, Cytokinetics, Eastern Time Zone, Novartis, Ruxolitinib, NDA, Pharmaceutical industry

In October 2023, Royalty Pharma drew $350 million under its existing unsecured revolving credit facility, which was repaid during the fourth quarter of 2023.

Key Points: 
  • In October 2023, Royalty Pharma drew $350 million under its existing unsecured revolving credit facility, which was repaid during the fourth quarter of 2023.
  • Royalty Pharma began repurchasing its Class A ordinary shares in April 2023 under a $1.0 billion multi-year share repurchase program.
  • During the fourth quarter of 2023, Royalty Pharma announced new transactions of up to $1.6 billion.
  • Royalty Pharma will host a conference call and simultaneous webcast to discuss its fourth quarter and full year 2023 results today at 8:00 a.m., Eastern Time.

Ascendis Pharma Reports Fourth Quarter and Full Year 2023 Results

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星期三, 二月 7, 2024
Investigational New Drug, Oncology, Endocrine gland, Research, GHD, Patient, New Drug Application, CNP, FDA, Achondroplasia, PDUFA, Turner syndrome, Webcast, Pharmaceutical industry

Topline results from Phase 2 trial in Turner syndrome expected in the fourth quarter of 2024.

Key Points: 
  • Topline results from Phase 2 trial in Turner syndrome expected in the fourth quarter of 2024.
  • During the fourth quarter of 2024, plan to submit an Investigational New Drug application or similar in adults with achondroplasia.
  • Total revenue for the fourth quarter of 2023 was €137.7 million compared to €22.9 million during the same period for 2022.
  • Ascendis Pharma will also host a conference call and webcast today at 4:30 p.m. Eastern Time (ET) to discuss 2023 financial results.

Ascendis Pharma Introduces Vision 2030

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星期日, 一月 7, 2024
Growth hormone, Vision 2030, Patient, Endocrine gland, Hypoparathyroidism, Conference, Achondroplasia, Turner syndrome, FDA, GHD, PDUFA, Globalization, Investigational New Drug, New Drug Application, Transgender hormone therapy, J. P. Morgan, Ophthalmology, CNP, HNSCC, Growth, CTA, Pharmaceutical industry

COPENHAGEN, Denmark, Jan. 07, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today introduced selected 2024 corporate milestones and Vision 2030, its strategic roadmap through 2030. Ascendis President and CEO Jan Mikkelsen will present the update tomorrow, January 8, at the 42nd Annual J.P. Morgan Healthcare Conference.

Key Points: 
  • COPENHAGEN, Denmark, Jan. 07, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today introduced selected 2024 corporate milestones and Vision 2030, its strategic roadmap through 2030.
  • Ascendis President and CEO Jan Mikkelsen will present the update tomorrow, January 8, at the 42nd Annual J.P. Morgan Healthcare Conference.
  • Topline results from Phase 2 trial in Turner syndrome expected in the fourth quarter of 2024.
  • The Company’s slides from the J.P. Morgan presentation will be available on the same Investor Relations website at https://investors.ascendispharma.com .

TransCon™ hGH (lonapegsomatropin) Achieved Statistically Superior Outcomes Compared to Placebo in Phase 3 foresiGHt Trial of Adults with Growth Hormone Deficiency

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星期二, 十二月 19, 2023
Growth hormone, Endocrine gland, GHD, Ageing, Tissue, Biologics license application, Week, Patient, Safety, SDS, Dietary supplement

COPENHAGEN, Denmark, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced positive topline results from foresiGHt, its Phase 3 randomized, parallel-arm, placebo-controlled (double-blind) and active-controlled (open-label) trial to compare the efficacy and safety of TransCon hGH (lonapegsomatropin) with placebo and daily hGH (human growth hormone, somatropin) in adults with growth hormone deficiency (GHD).

Key Points: 
  • The foresiGHt Trial evaluated 259 adults with GHD aged 23 to 80 years old, randomized 1:1:1, titrated to receive a target fixed dose of TransCon hGH, placebo, or daily hGH based on age and oral estrogen intake with approximately equivalent hGH mg/week for TransCon hGH and daily hGH.
  • For patients with IGF-1 SDS levels ≤ 1.75 at Week 38:
    Change from baseline in trunk percent fat (TransCon hGH -2.42% vs. daily hGH -2.59%)
    TransCon hGH was generally safe and well tolerated, with no discontinuations related to study drug and with comparable safety and tolerability to daily hGH.
  • “TransCon hGH, our once-weekly growth hormone, is designed to deliver unmodified somatropin, thereby preserving the same overall endocrine benefits inherent in endogenous and daily hGH,” said Jan Mikkelsen, Ascendis Pharma’s President and CEO.
  • “Next year, we plan to submit a supplemental Biologics License Application to the U.S. FDA for the adult GHD indication and look forward to reporting data from our Phase 2 program in Turner syndrome.”

Ascendis Pharma Announces Strategic Partnership with Teijin Limited in Japan

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星期三, 十一月 29, 2023
Endocrine gland, Partnership, Teijin, Endocrinology, CNP, Patient, Pharmaceutical industry

COPENHAGEN, Denmark, Nov. 29, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the company has entered into an exclusive license agreement with Teijin Limited for the further development and commercialization of TransCon hGH, TransCon PTH, and TransCon CNP for endocrinology rare disease in Japan.

Key Points: 
  • –   Teijin to receive exclusive license to further develop and commercialize TransCon™ hGH, TransCon™ PTH, and TransCon™ CNP in Japan
    –   Ascendis Pharma is eligible to receive $70 million upfront, development/regulatory milestones of up to $175 million, transfer pricing, and commercial milestones
    –   Ascendis Pharma is also eligible to receive royalties on net sales in Japan, of up to mid-20’s percent,
    COPENHAGEN, Denmark, Nov. 29, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the company has entered into an exclusive license agreement with Teijin Limited for the further development and commercialization of TransCon hGH, TransCon PTH, and TransCon CNP for endocrinology rare disease in Japan.
  • “We are pleased to partner with Teijin Pharma given their track record of navigating regulatory approval and commercialization of rare disease and endocrinology product candidates in Japan, and commitment to providing best-in-class therapies,” said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer.
  • “We believe this collaboration is a major step in our journey to achieve global reach for our current Endocrinology Rare Disease portfolio by helping to address unmet medical needs of patients in Japan.”
    “Ascendis has leveraged its innovative TransCon technology platform to create a suite of highly differentiated product candidates with best-in-class potential that complement our existing pharmaceutical portfolio,” said Akimoto Uchikawa, Teijin Limited’s President and Chief Executive Officer.
  • In addition, Ascendis Pharma is eligible to receive royalties on net sales in Japan, of up to mid-20’s percent, varying by product.

Human Growth Hormone Market Size, Share & Trends Analysis Report 2023 - ResearchAndMarkets.com

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星期二, 十二月 12, 2023
Health, Pharmaceutical, Growth hormone, Global health, Distribution, HGH, Research, Hospital pharmacy, Acquisition, Organization, Food, Incidence, Investment, Application, Dwarfism, Patient, FDA, OPKO Health, USD, Endocrine gland, Pfizer, Novartis, Lilly, Diagnosis, Partnership, Growth, Merck & Co., Parent, Quality of life, Pharmaceutical industry

The "Human Growth Hormone Market Size, Share & Trends Analysis Report By Distribution Channel (Hospital Pharmacy, Retail Pharmacy), By Application, By Product, By Region, And Segment Forecasts, 2023 - 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Human Growth Hormone Market Size, Share & Trends Analysis Report By Distribution Channel (Hospital Pharmacy, Retail Pharmacy), By Application, By Product, By Region, And Segment Forecasts, 2023 - 2030" report has been added to ResearchAndMarkets.com's offering.
  • The global human growth hormone market size is expected to reach USD 14.28 billion by 2030, growing at a CAGR of 12.3% from 2023 to 2030
    The market is witnessing growth due to an increase in the incidence of growth hormone deficiency and other growth-related disorders.
  • In addition, market growth is being driven by intense competition among key players striving to develop innovative and cost-effective treatment options.
  • The increasing parental concerns regarding the growth of their children are contributing to the rising demand for human growth hormone (HGH) therapy.

Global Recombinant Protein Therapeutics CDMO Market Analysis Report 2023-2030: Increasing Rate of Clinical Research to Boost Demand for Recombinant Protein Therapeutics - ResearchAndMarkets.com

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星期四, 十二月 7, 2023
Biotechnology, Pharmaceutical, Genetics, Health, Conditional sentence, Prevalence, CDMO, Investment, Sanofi, Endocrine gland, Vaccine, USD, GSK, COVID-19, Therapy, Biomedical Research, Antibody, Growth, Fine chemical, Interferon

The global recombinant protein therapeutics CDMO market size is expected to reach USD 51.95 billion by 2030, expected to grow at a CAGR of 13.9% from 2023 to 2030.

Key Points: 
  • The global recombinant protein therapeutics CDMO market size is expected to reach USD 51.95 billion by 2030, expected to grow at a CAGR of 13.9% from 2023 to 2030.
  • Increasing prevalence of chronic diseases, advancements in biotechnology, the rising prominence of personalized medicine, and increasing biomedical research and development investments are the key factors driving the growth of the market.
  • The growing demand for recombinant protein therapeutics has increased investment in biopharmaceutical manufacturing infrastructure and facilities.
  • The expanded manufacturing capacity enables greater production of recombinant protein therapeutics, thereby augmenting the market growth.

UT Health San Antonio launches Center for Global and Community Oral Health

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星期五, 十二月 1, 2023
School, Global health, Gingivitis, Health literacy, Research, Oral hygiene, SAN, Foreign policy, Canadian International Council, University, Dean (education), Workforce, Dentist, Plaque, History, Student, Patient, University of Texas System, Radioactive decay, Endocrine gland, UCLA School of Dentistry, MBA, MPH, Endodontics, Cancer, Pain, Doctor of Philosophy, Hospital, Diabetes, Periodontology, Education, Pharmaceutical industry, Nursing, Dentistry, DDS

SAN ANTONIO, Dec. 1, 2023 /PRNewswire-PRWeb/ -- The School of Dentistry of The University of Texas Health Science Center at San Antonio (UT Health San Antonio) has launched the Center for Global and Community Oral Health, designed to bring together various existing outreach and research programs under one umbrella to study and develop solutions to the most pressing dental challenges facing the global population.

Key Points: 
  • New Center for Global and Community Oral Health at The University of Texas Health Science Center at San Antonio will address the world's most urgent dental challenges.
  • SAN ANTONIO, Dec. 1, 2023 /PRNewswire-PRWeb/ -- The School of Dentistry of The University of Texas Health Science Center at San Antonio (UT Health San Antonio) has launched the Center for Global and Community Oral Health, designed to bring together various existing outreach and research programs under one umbrella to study and develop solutions to the most pressing dental challenges facing the global population.
  • To do this, Singh said the center will aim to increase access to oral health care to eliminate health disparities, integrate oral health care into medical care to prevent systemic disease and disseminate oral health information to increase health literacy with the ultimate goal of being a world leader in community oral health.
  • The University of Texas Health Science Center at San Antonio (UT Health San Antonio), a primary driver of San Antonio's $44.1 billion health care and biosciences sector, is the largest academic research institution in South Texas with an annual research portfolio of more than $360 million.