Cushing's syndrome

Sterne Kessler Secures Non-Infringement Win for Teva Pharmaceuticals

Retrieved on: 
Friday, January 5, 2024
Orange Book, Teva, Syndrome, FDA, The Orange Book, Therapy, Cushing's syndrome, Mifepristone, Type, Corcept Therapeutics, Teva Pharmaceuticals, Patient, Prediabetes, Generic drug

WASHINGTON, Jan. 5, 2024 /PRNewswire/ -- Sterne, Kessler, Goldstein & Fox secured a victory on behalf of Teva Pharmaceuticals in the U.S. Court District Court for the District of New Jersey in a case involving a patent-infringement suit filed by Corcept Therapeutics.

Key Points: 
  • WASHINGTON, Jan. 5, 2024 /PRNewswire/ -- Sterne, Kessler, Goldstein & Fox secured a victory on behalf of Teva Pharmaceuticals in the U.S. Court District Court for the District of New Jersey in a case involving a patent-infringement suit filed by Corcept Therapeutics.
  • On December 29, 2023, the district court held that Teva does not infringe the two patents asserted at trial, finding that Corcept had failed to show that direct infringement is likely or that Teva's label would induce infringement.
  • Teva Pharmaceuticals USA, Inc. is a leading manufacturer of generic and proprietary drug products.
  • Corcept Therapeutics, Inc., the holder of the Korlym NDA, filed a Hatch-Waxman lawsuit against Teva alleging infringement of two patents listed in the Orange Book for Korlym.

Human medicines European public assessment report (EPAR): Agamree, Vamorolone, Date of authorisation: 14/12/2023, Status: Authorised

Retrieved on: 
Friday, January 5, 2024
Medical Subject Headings, Marketing, Cushing's syndrome, Cytokine, Agency, Health, INN, Risk, EMA, Muscular dystrophy, International, Duchenne muscular dystrophy, Adrenal crisis, Ageing, Language, Mouth, Inflammation, Vamorolone, European Medicines Agency, DMD, Face, Growth, Select, Patient, Bruise, Safety, Vomiting, IIA, Medical device

Human medicines European public assessment report (EPAR): Agamree, Vamorolone, Date of authorisation: 14/12/2023, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Agamree, Vamorolone, Date of authorisation: 14/12/2023, Status: Authorised

NORTH AMERICAN MENOPAUSE SOCIETY PUBLISHES REBALANCE HEALTH IRB STUDY CITING AN 80% EFFICACY IN THE REDUCTION OF HOT FLASHES

Retrieved on: 
Wednesday, November 22, 2023
Participation, Sleep, Woman, Brain, Hot, Hormone, IRB, Nail, Serum, North American Menopause Society, Menopause (journal), Health, Cushing's syndrome, Hormone replacement therapy, Skin, Libido, NAMS, Birth control, Pharmaceutical industry, Dietary supplement

DENVER, Nov. 22, 2023 /PRNewswire/ -- Today, health and wellness company, Rebalance Health announced preliminary results, from an IRB-approved open label study that was 70% completed at the time the abstract was written citing significant reduction in menopausal symptoms in the North American Menopause Society's Menopause Journal and full study outcomes will be released in Q1. Rebalance Health's products affect cortisol levels through a proprietary delivery system that allows the body to rebalance naturally without the use of hormone replacement therapy. Taken 3 times a day, each dose is formulated in accordance to how the body metabolizes the active ingredients for the most enhanced and effective outcome to help the body achieve the optimal cortisol levels based on the time of day.

Key Points: 
  • Rebalance Health's products affect cortisol levels through a proprietary delivery system that allows the body to rebalance naturally without the use of hormone replacement therapy.
  • The participants were given a 90-day supply of The Hot Flash System, consisting of three lozenges per day.
  • They reported the number of hot flashes and provided feedback on a daily questionnaire.
  • In Q1 2024, Rebalance Health is anticipating the full study to be published by a leading medical publication, with unprecedented data not released in the NAMS abstract.

Corcept Therapeutics Announces Second Quarter Financial Results and Provides Corporate Update

Retrieved on: 
Wednesday, August 2, 2023
Journal of Clinical Oncology, Doctor of Pharmacy, Depression, University, Prevalence, NASH, Diabetes, Anxiety, NDA, Syndrome, Neck, Corcept Therapeutics, PIN, Metabolism, MD, Investment, Physician, Cushing's syndrome, Patient, CORT, Liver, Growth, Ageing, American Association of Clinical Endocrinologists, Irritability, ALS, Fatigue, Prostate cancer, Pharmaceutical industry, Cryptocurrency

Corcept’s second quarter 2023 revenue was $117.7 million, compared to $103.4 million in the second quarter of 2022.

Key Points: 
  • Corcept’s second quarter 2023 revenue was $117.7 million, compared to $103.4 million in the second quarter of 2022.
  • Second quarter operating expenses were $88.1 million, compared to $72.0 million in the second quarter of 2022, due to increased spending on our development programs and to support the expansion of our clinical development and commercial teams.
  • Net income was $27.5 million in the second quarter of 2023 compared to $27.4 million in the same period last year.
  • In April 2023, Corcept purchased 6.6 million shares of its common stock for $145.4 million.

Corcept Therapeutics Announces First Quarter Financial Results and Provides Corporate Update

Retrieved on: 
Wednesday, May 3, 2023
Doctor of Pharmacy, Depression, Prevalence, NASH, Diabetes, Marketing, Anxiety, NDA, Type 2 diabetes, Syndrome, Neck, Corcept Therapeutics, PIN, MD, Investment, Patient, Cushing's syndrome, Physician, CORT, Liver, Growth, Ageing, Irritability, ALS, Fatigue, Pharmaceutical industry, Cryptocurrency, Nursing

Net income was $15.9 million in the first quarter of 2023 compared to $22.8 million in the same period last year.

Key Points: 
  • Net income was $15.9 million in the first quarter of 2023 compared to $22.8 million in the same period last year.
  • In April 2023, Corcept purchased 6.6 million shares of its common stock for $145.4 million.
  • “Korlym is an excellent treatment for patients with Cushing’s syndrome and there are many eligible patients who have yet to receive it.
  • Corcept holds patents directed to the composition of relacorilant and the use of cortisol modulators, including Korlym, in the treatment of patients with hypercortisolism.

Corcept Therapeutics Announces Fourth Quarter and Full-Year 2022 Audited Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, February 28, 2023
CORT, Diabetes, Neck, MD, Depression, Anxiety, Disease, Syndrome, Irritability, Investment, Patient, NDA, Corcept Therapeutics, Growth, Cushing's syndrome, Doctor of Pharmacy, NASH, Atrophy, Fatigue, Neuroinflammation, GRACE, Woman, Prevalence, Ageing, ALS, Pharmaceutical industry, Video game, Cryptocurrency

Net income was $16.6 million in the fourth quarter of 2022, compared to $32.1 million in the fourth quarter of 2021.

Key Points: 
  • Net income was $16.6 million in the fourth quarter of 2022, compared to $32.1 million in the fourth quarter of 2021.
  • Cash and investments of $436.6 million at December 31, 2022 compared to $335.8 million at December 31, 2021.
  • We are providing 2023 revenue guidance of $430 - $450 million,” said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer.
  • Corcept holds patents directed to the composition of relacorilant and the use of cortisol modulators, including Korlym, in the treatment of patients with hypercortisolism.

Xeris Biopharma Announces FDA Grants Orphan-drug Exclusivity for Recorlev®

Retrieved on: 
Monday, January 30, 2023
FDA, Pharmaceutical, Health, Clinical Trials, Levoketoconazole, Caregiver, Patent, Diagnosis, Patient, ODE, Food, Orphan, Cushing's syndrome, Disease, Education, Food and Drug Administration Amendments Act of 2007, Pharmaceutical industry

As the first approval of levoketoconazole (Recorlev) for Cushing’s syndrome, Xeris is entitled to seven years of orphan-drug market exclusivity from its FDA approval date of December 30, 2021.

Key Points: 
  • As the first approval of levoketoconazole (Recorlev) for Cushing’s syndrome, Xeris is entitled to seven years of orphan-drug market exclusivity from its FDA approval date of December 30, 2021.
  • This regulatory exclusivity is in addition to the patent exclusivity under Xeris’ U.S. patents covering Recorlev and its therapeutic use, which extends to at least March 2040.
  • Xeris has created Xeris CareConnection™ to provide a comprehensive program for patients and their caregivers throughout the treatment journey, including financial assistance, one-on-one support, and educational resources.
  • For more information visit our website ( www.recorlev.com ) or contact Xeris CareConnection (available Monday–Friday from 8 a.m–7 p.m ET) at 1-844-444-RCLV (7258).

Rare Disease Genetic Testing Market Report 2022: Advancements Such as NGS and Microarray Testing Drive Sector - ResearchAndMarkets.com

Retrieved on: 
Tuesday, December 6, 2022
Genetics, Health, Medical Devices, NIH, Degenerative disease, Cushing's syndrome, Disorder, NGS, Revenue, Projection, Disease, Diagnosis, Patient, Prevalence, Rare Diseases Clinical Research Network, Research, Data collection, Cros, Government, Growth, Genetic testing, RDCRN, USD, Registry, Agriculture, Pharmaceutical industry, Antibiotics, Vaccine

The "Rare Disease Genetic Testing Market Share, Size, Trends, Industry Analysis Report, By Specialty; By Technology; By Disease Type; By End-Use; By Region; Segment Forecast, 2022-2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Rare Disease Genetic Testing Market Share, Size, Trends, Industry Analysis Report, By Specialty; By Technology; By Disease Type; By End-Use; By Region; Segment Forecast, 2022-2030" report has been added to ResearchAndMarkets.com's offering.
  • The global rare disease genetic testing market size is expected to reach USD 2,414.90 million by 2030 according to a new study.
  • The report gives a detailed insight into current market dynamics and provides analysis on future market growth.
  • The publisher has segmented the rare disease genetic testing market report based on disease type, technology, specialty, end-use, and regions:
    Rare Disease Genetic Testing, Disease Type Outlook (Revenue - USD Million, 2018 - 2030)

Corcept Therapeutics Announces Third Quarter Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, November 3, 2022
Progression-free survival, Exercise, Weight gain, Fatigue, Neck, Investment, Ageing, CORT, Food, Doctor of Pharmacy, Cushing's syndrome, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, GLOBE, Irritability, Muscle, Investor, Intellectual property, NASH, Safety, Neuroinflammation, COVID-19, PIN, Marketing, Intention, Income, Ovary, NDA, Life expectancy, Physician, GRACE, ALS, Prostate, Clinical trial, Depression, Liver disease, NASDAQ, Microdeletion syndrome, Acquisition, Woman, Anxiety, Diabetes, Goal, Wilms' tumor, Insurance, Enrollment, SEC, Patient, MD, Pharmaceutical industry, Corcept Therapeutics

Net income was $34.6 million in the third quarter of 2022, compared to $30.5 million in the third quarter of 2021.

Key Points: 
  • Net income was $34.6 million in the third quarter of 2022, compared to $30.5 million in the third quarter of 2021.
  • Diagnosing and treating patients with a complex disease such as Cushings syndrome requires frequent in-person contact with physicians.
  • Our revenue in the third quarter was affected by fewer than expected in-person interactions as many physician practices have not returned to pre-pandemic patterns of activity.
  • Korlym is an excellent treatment for patients with Cushings syndrome and there are many eligible patients who have yet to receive it.

Recordati Rare Diseases Announce Publication of Long-term Outcomes From the Extension to the Phase III LINC 3 Study of Isturisa® (Osilodrostat) in Patients With Cushing’s Disease in the European Journal of Endocrinology

Retrieved on: 
Wednesday, August 31, 2022
Research, Managed Care, General Health, Pharmaceutical, Oncology, Hospitals, Science, Surgery, Cardiology, Nursing, Health, Diabetes, Consensus, AES, Safety, Research, Hirsutism, Guru Angad Dev Veterinary and Animal Sciences University, Conditional sentence, Maintenance, Adrenocorticotropic hormone, CYP11B1, Meta-analysis, Osilodrostat, European Journal, Cushing's syndrome, Adult, Endocrinology, Risk, Patient, ISIN, Female, Degenerative disease, OR, Disorder, Manuscript, Oregon Health Plan, Consensus decision-making, Advertising, Pituitary adenoma, EMEA, Reuters, Rare, Neurosurgery, David Ferrier, Quality of life, LINC, Cushing's disease, European Commission, Marketing, Nature, Microdeletion syndrome, Oregon Health & Science University, Phase, Royal commission, Manchester, ULN, The Lancet, III, Uncertainty, Pharmaceutical industry, Silviculture, EU, Diagnosis

Median duration of exposure to Isturisa from core study baseline to end of the extension was 130 weeks (range 1245).

Key Points: 
  • Median duration of exposure to Isturisa from core study baseline to end of the extension was 130 weeks (range 1245).
  • Recordati Rare Diseases is committed to improving the lives of patients with this rare, debilitating and life-threatening condition.
  • Long-term outcomes of osilodrostat in Cushings disease: LINC 3 study extension The European Journal of Endocrinology 2022.
  • Efficacy and safety of osilodrostat in patients with Cushing's disease (LINC 3): a multicentre phase III study with a double-blind, randomised withdrawal phase.