Adrenocorticotropic hormone

Neurocrine Biosciences Presents CAHtalyst™ Adult Study Baseline Characteristics and Data on Impact of Supraphysiologic Glucocorticoid Therapy at AACE 2024

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星期四, 五月 9, 2024
Disorder, Common, Risk, GC, Overweight, Trial of the century, Adrenocorticotropic hormone, Hyperlipidemia, Associate, Deficit spending, Hydrocortisone, Neurocrine Biosciences, White matter, Food, Oklahoma State University–Stillwater, Cognition, Psychology, Testosterone, Male, Literature, Brain, DSM-IV codes, A4, SAN, GCS, CAH, Acne, Safety, Glucocorticoid, Research, Depression, Congenital adrenal hyperplasia, Osteopenia, Anxiety, Division, Hirsutism, Androstenedione, Psychiatry, Psychosis, Hypertension, Metabolism, Poster, Pharmaceutical industry

The CAHtalyst Adult study baseline data demonstrate the potential long-term consequences of current CAH treatments, with many patients in young adulthood experiencing disorders found more commonly in people decades older, including osteopenia, hypertension and hyperlipidemia.

Key Points: 
  • The CAHtalyst Adult study baseline data demonstrate the potential long-term consequences of current CAH treatments, with many patients in young adulthood experiencing disorders found more commonly in people decades older, including osteopenia, hypertension and hyperlipidemia.
  • These new data were presented at oral presentations and poster sessions at the American Association of Clinical Endocrinology 2024 Annual Meeting in New Orleans.
  • Despite supraphysiologic GC dosing, levels of adrenocorticotropic hormone, 17-hydroxyprogesterone and androstenedione (A4) were elevated at baseline, with levels of testosterone (females) and A4/testosterone (males) also elevated.
  • The data from both studies supported two New Drug Applications submitted to the U.S. Food and Drug Administration in April 2024.

Neurocrine Biosciences to Present Phase 3 Baseline Characteristics Data from the CAHtalyst™ Program of Crinecerfont in CAH, and Data for Modified-Release Hydrocortisone in Primary Adrenal Insufficiency and CAH Studies at ECE 2024

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星期二, 五月 7, 2024
Safety, Patient, Neurocrine Biosciences, CAH, Abstract, Hydrocortisone, Congenital adrenal hyperplasia, ECE, Adrenal crisis, Treatment, Adrenocorticotropic hormone, Capsule, SAN, Incidence, Pharmaceutical industry

SAN DIEGO, May 7, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that it will present key information from its neuroendocrinology pipeline, including baseline characteristics data from its CAHtalyst™ Program of crinecerfont in congenital adrenal hyperplasia (CAH), as well as data from its modified-release hydrocortisone studies in primary adrenal insufficiency and CAH, at the European Congress of Endocrinology 2024 meeting in Sweden, May 11–14.

Key Points: 
  • SAN DIEGO, May 7, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that it will present key information from its neuroendocrinology pipeline, including baseline characteristics data from its CAHtalyst™ Program of crinecerfont in congenital adrenal hyperplasia (CAH), as well as data from its modified-release hydrocortisone studies in primary adrenal insufficiency and CAH, at the European Congress of Endocrinology 2024 meeting in Sweden, May 11–14.
  • Neurocrine Biosciences will be presenting several abstracts and posters at ECE 2024, including:
    Baseline Characteristics of Children and Adolescents with Classic Congenital Adrenal Hyperplasia Enrolled in CAHtalyst Pediatric, a Phase 3 Study of Crinecerfont, a Corticotropin-Releasing Factor Type 1 Receptor Antagonist
    Baseline Characteristics of Adults with Classic Congenital Adrenal Hyperplasia Enrolled in CAHtalyst Adult, a Phase 3 Study of Crinecerfont, a Corticotropin-Releasing Factor Type 1 Receptor Antagonist
    CHAMPAIN study: Initial Results from a Phase II Study of Efficacy, Safety and Tolerability of Modified-Release Hydrocortisones: Chronocort® (Efmody®) versus Plenadren, in Primary Adrenal Insufficiency,
    Biochemical Control with Dose Reduction in Chronic Glucocorticoid Therapy over 4 Years: A Phase III Extension Study of Chronocort (Efmody®) in the Treatment of Congenital Adrenal Hyperplasia (CAH)
    Incidence of Adrenal Crisis in Congenital Adrena Hyperplasia (CAH) Patients During a Prospective Monitored Long-Term study of Modified-Release Hydrocortisone (MRHC) Capsules, (Efmody)

Neurocrine Biosciences Presented CAHtalyst™ Pediatric Study Baseline Characteristics and CAHtalog™ Registry Data at PES 2024

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星期五, 五月 3, 2024
Weill Cornell Medical Center, Hyperplasia, Weill Cornell Medicine, Patient, Neurocrine Biosciences, Clinical Pediatrics, CAH, Safety, GC, Androstenedione, Food, Male, Congenital adrenal hyperplasia, Observation, Obesity, Disease, D.O, Hirsutism, Diagnosis, Poster, Associate, Adrenocorticotropic hormone, Natural history, SAN, Pharmaceutical industry

SAN DIEGO, May 3, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX), today presented the CAHtalyst™ Pediatric Phase 3 clinical study baseline characteristics data for children and adolescents with congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency enrolled in the study, along with CAHtalog™ Registry data assessing glucocorticoid treatment patterns in pediatric and adult patients with CAH.

Key Points: 
  • SAN DIEGO, May 3, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX), today presented the CAHtalyst™ Pediatric Phase 3 clinical study baseline characteristics data for children and adolescents with congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency enrolled in the study, along with CAHtalog™ Registry data assessing glucocorticoid treatment patterns in pediatric and adult patients with CAH.
  • These new data were presented at the Pediatric Endocrine Society 2024 Annual Meeting in Chicago.
  • Baseline characteristics of the subjects who enrolled in the CAHtalyst Pediatric Phase 3 study were presented (Poster# 56).
  • Neurocrine Biosciences also presented glucocorticoid treatment patterns from a recent cohort of pediatric and adult patients participating in the CAHtalog Registry (Poster# 51).

IMFINZI® (durvalumab) significantly improved overall survival and progression-free survival for patients with limited-stage small cell lung cancer in ADRIATIC Phase III trial

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星期五, 四月 5, 2024
Research, FDA, Clinical Trials, Biometrics, Health, Pharmaceutical, General Health, Science, Oncology, Lung cancer, Chemoradiotherapy, CRT, Small-cell carcinoma, Radiation, AstraZeneca, Survival, NSCLC, Immunotherapy, Disease, Infection, Carcinoma, Incidence, Progression-free survival, Patient, Warning, Doctor of Philosophy, Prednisone, Adrenocorticotropic hormone, Creatinine, Prognosis, PFS, Recurrence, ACTH, Administration, Pneumonitis, SCLC, Vaccine

Immune‑mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions.

Key Points: 
  • Immune‑mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions.
  • Immune-mediated colitis occurred in 2% (37/1889) of patients receiving IMFINZI, including Grade 4 (
  • Immune‑mediated colitis or diarrhea occurred in 6% (23/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (3.6%) adverse reactions.
  • Immune-mediated adrenal insufficiency occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.

Mallinckrodt Announces Journal Publication of Real-World Data on Acthar® Gel (repository corticotropin injection) to Treat Symptomatic Sarcoidosis in African American and Non-African American Patients

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星期一, 三月 11, 2024
African Americans, Conference, Sarcoidosis, Disease, Adrenocorticotropic hormone (medication), Inflammation, Patient, Research, Manuscript, Adrenocorticotropic hormone, Respiratory disease, Therapy, FDA, Food, Pharmaceutical industry

DUBLIN, March 11, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced the publication of findings from a retrospective chart review of Acthar® Gel (repository corticotropin injection) treatment outcomes for African American and non-African American patients with symptomatic sarcoidosis – including treatment patterns, co-medication use, and overall health outcomes.1 This analysis suggested that Acthar Gel treatment was associated with similar improvements in health outcomes, a reduction in symptoms, and reduced co-medication use in both African Americans and non-African Americans with symptomatic sarcoidosis.1 The manuscript was recently published online in Therapeutics & Clinical Risk Management.

Key Points: 
  • DUBLIN, March 11, 2024 /PRNewswire/ -- Mallinckrodt plc , a global specialty pharmaceutical company, today announced the publication of findings from a retrospective chart review of Acthar® Gel (repository corticotropin injection) treatment outcomes for African American and non-African American patients with symptomatic sarcoidosis – including treatment patterns, co-medication use, and overall health outcomes.1 This analysis suggested that Acthar Gel treatment was associated with similar improvements in health outcomes, a reduction in symptoms, and reduced co-medication use in both African Americans and non-African Americans with symptomatic sarcoidosis.1 The manuscript was recently published online in Therapeutics & Clinical Risk Management.
  • "The results of this retrospective medical chart review highlight unmet needs that exist for African American patients with symptomatic sarcoidosis, who are disproportionately affected by the disease, and reinforce Acthar Gel's potential to help improve health outcomes for appropriate patients,"1,4,5 said George Wan, Ph.D., M.P.H., Vice President, Evidence Generation and Data Sciences, Mallinckrodt.
  • "This research reflects Mallinckrodt's commitment to collecting real-world data on the relationship between patient characteristics, treatment patterns, and outcomes to support clinicians' treatment decisions and address disparities in symptomatic sarcoidosis care.
  • "1

Mallinckrodt Announces U.S. FDA Approval of Supplemental New Drug Application for Acthar® Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector

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星期五, 三月 1, 2024
Chorioretinitis, Natural history, Caregiver, New Drug Application, Ankylosing spondylitis, Optic neuritis, Education, FDA, Food, Adnexa, Shanda, Uveitis, Eye, Adrenocorticotropic hormone, Multiple sclerosis, Condylar resorption, Safety, Rheumatoid arthritis, Patient, Sclerosis, Disease, Keratitis, MRCP, Insurance, Pharmaceutical industry

DUBLIN, March 1, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Mallinckrodt's supplemental New Drug Application (sNDA) for the Acthar® Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector (herein referred to as "SelfJect"), a new delivery device for Acthar Gel for appropriate patients with a range of chronic and acute inflammatory and autoimmune conditions.2 SelfJect is intended to provide the appropriate subcutaneous dose of Acthar Gel, as prescribed by a healthcare professional, and is designed to help give patients control of their administration.1,3

Key Points: 
  • "We're excited to bring this innovation to U.S. patients with chronic and acute inflammatory and autoimmune conditions.
  • Mallinckrodt also offers a team of field-based experts who provide education for healthcare professionals on the reimbursement process as well as tools available for patients.
  • Acthar Gel will continue to be available as an injection with a vial and syringe.
  • Controlled clinical trials have shown Acthar to be effective in speeding the resolution of acute exacerbations of multiple sclerosis.

Pharmactive's Saffron Extract improves Resilience to Occasional Stress

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星期三, 一月 24, 2024
DSM-IV codes, Hypothalamus, Arginine, Iterative method, Pituitary gland, Research, Overalls, Manager, Food, Health, Brain-derived neurotrophic factor, HPA, Hormone, Survival, Communication, History, Nutrient, Anxiety, Pandemic, Human, Gland, Doctor of Philosophy, Rat, Anhedonia, ACTH, Adrenocorticotropic hormone, CRF, Brain, Motivation, Glucocorticoid, BDNF, Depression, Growth

MADRID, Jan. 24, 2024 /PRNewswire/ -- A new in vitro study sheds light to the stress relief effect of saffron (Crocus sativus L). The research highlights the ability of affron®, a standardized extract of saffron developed by Pharmactive Biotech Products to enhance resilience to occasional stress.

Key Points: 
  • The research highlights the ability of affron®, a standardized extract of saffron developed by Pharmactive Biotech Products to enhance resilience to occasional stress.
  • Results demonstrated significant improvements following repeated oral administration of the extract in stress model animal subjects.
  • The HPA axis is a vital brain signaling system involved in orchestrating responses to stress.
  • We are realizing these extend beyond influencing serotonin expression but actually demonstrates a potential to boost resilience to occasional stress and prevent its detrimental impact on overall mental and physical health."

Mallinckrodt Presents Latest Health Economics Data on Acthar® Gel (Repository Corticotropin Injection) at the Academy of Managed Care Pharmacy (AMCP) Nexus 2023

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星期四, 十月 26, 2023
Nexus, Patient, FDA, Academy of Managed Care Pharmacy, Research, Standard of care, Cyclophosphamide, Food, Outcomes research, ClinicoEconomics and Outcomes Research, Treatment, NS, Adrenocorticotropic hormone (medication), Regulation of food and dietary supplements by the U.S. Food and Drug Administration, D20, QALY, Poster, Nephrotic syndrome, Congenital nephrotic syndrome, Adrenocorticotropic hormone, Sarcoidosis, Chlorambucil, Rituximab, Symphony, ICER, SOC, Calcineurin, AMCP, Azathioprine, Diagnosis, Proteinuria, Pharmaceutical industry, Medical imaging, Mallinckrodt

DUBLIN, Oct. 26, 2023 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKTQ), a global specialty pharmaceutical company, recently shared findings from Mallinckrodt's latest health economics outcomes research on Acthar® Gel (repository corticotropin injection) for patients with advanced symptomatic sarcoidosis and nephrotic syndrome (NS)1,2 at the Academy of Managed Care Pharmacy (AMCP) Nexus 2023 in Orlando, FL October 16-19, 2023.

Key Points: 
  • Patients were monitored at the end of a three-month cycle for a partial or complete response.
  • The full data manuscript from this study was published in ClinicoEconomics and Outcomes Research on October 17, 2023.
  • "We are pleased to have shared our latest health economics research on Acthar Gel.
  • Outcomes may be influenced by therapies not evaluated in the study and the clinical/health economics outcomes may not be solely attributable to Acthar.

Datopotamab deruxtecan plus IMFINZI® (durvalumab) demonstrated robust and durable tumor responses in 1st-line treatment of patients with metastatic triple-negative breast cancer in BEGONIA Phase Ib/II trial

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星期日, 十月 22, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, AstraZeneca, Incidence, Pneumonitis, ESMO, Congress, Warning, ACTH, Infection, Administration, TNBC, Prednisone, Neoadjuvant therapy, Daiichi Sankyo, Adrenocorticotropic hormone, Radiation, Patient, Creatinine, Pharmaceutical industry, Vaccine

Immune‑mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions.

Key Points: 
  • Immune‑mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions.
  • Immune-mediated colitis occurred in 2% (37/1889) of patients receiving IMFINZI, including Grade 4 (
  • Immune‑mediated colitis or diarrhea occurred in 6% (23/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (3.6%) adverse reactions.
  • Immune-mediated adrenal insufficiency occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.

IMFINZI® (durvalumab) plus chemotherapy more than doubled pathologic complete response rate in resectable early-stage gastric and gastroesophageal junction cancers versus chemotherapy alone

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星期五, 十月 20, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Prednisone, Radiation, Administration, Warning, Patient, Creatinine, Adrenocorticotropic hormone, Infection, Incidence, Pneumonitis, ACTH, Vaccine

Immune‑mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions.

Key Points: 
  • Immune‑mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions.
  • Immune-mediated pneumonitis occurred in 3.5% (21/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.5%), and Grade 3 (1%) adverse reactions.
  • Immune-mediated colitis occurred in 2% (37/1889) of patients receiving IMFINZI, including Grade 4 (
  • Immune‑mediated colitis or diarrhea occurred in 6% (23/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (3.6%) adverse reactions.