Glucocorticoid

EQS-News: Grünenthal reports strong 2023 results with record revenue and continued investments in R&D and acquisitions

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Wednesday, April 10, 2024
Trigeminal neuralgia, Knee, Growth, Rheumatoid arthritis, Neuropathic pain, Pain, GRM, DPN, ESG, Patient, Prednisolone, Research, Sustainalytics, Breakthrough, Glucocorticoid, Quality of life, PSNP, Research and development, Investment, Diabetic neuropathy, NOP, Kyowa Kirin, Osteoarthritis, RTX, Food, FDA, Corporation, Pharmaceutical industry

In 2023, Grünenthal generated €1.8 billion in revenues, an increase of 10 percent over the prior year.

Key Points: 
  • In 2023, Grünenthal generated €1.8 billion in revenues, an increase of 10 percent over the prior year.
  • Grünenthal owns 51 percent of the new enterprise Grünenthal Meds and intends to acquire the remaining share in 2026.
  • Aachen, Germany, 25 March 2024 – Grünenthal, the leading pharmaceutical company in pain research and management, released its 2023 full-year results, announcing a double-digit revenue growth.
  • The 2023 results were driven by strong business performance in the United States, Latin America and Europe.

InnoCare Releases 2023 Results and Business Highlights

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Thursday, March 28, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical Trials, QD, Tafasitamab, Patient, B-cell lymphoma, NDA, SLE, POC, IND, Clinical trial, Bone marrow, IKZF1, Phase, Therapy, IGA, MCD, Dexamethasone, MCL, Neuromyelitis optica spectrum disorder, IKZF3, AML, NMOSD, Outline of health sciences, DLT, Cancer, Autoimmune disease, Safety, TYK2, HSA, NRDL, BLA, Follicular lymphoma, Food, GC, Development, Multiple sclerosis, PD, CRBN, Public, Gordon Ramsay's Bank Balance, Multiple myeloma, ITP, BCL2, Leukemia, Cmax, Gadolinium, HKEX, SRI, AAD, Proteinuria, DLBCL, Glucocorticoid, IVIG, Loss, European Hematology Association, American Academy, EHA, Lenalidomide, NHL, Non-Hodgkin lymphoma, CCR8, US FDA, BTK, NRS, Pharmaceutical industry

InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, today announced the 2023 annual results as of 31 December 2023.

Key Points: 
  • InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, today announced the 2023 annual results as of 31 December 2023.
  • In 2023, InnoCare has continued to advance its robust pipeline across various clinical stages, continuously unleashing the power of innovation to meet unmet medical needs.
  • In June 2023, the ITP Phase II result was orally presented at the European Hematology Association (EHA) 2023 Hybrid Congress.
  • InnoCare was approved by the Hong Kong Stock Exchange to remove "B" from the stock code from May 12, 2023.

Sudden Hearing Loss: Recent Clinical Trial HODOKORT Questions Benefits of Glucocorticoid Treatment

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Tuesday, March 12, 2024
Health, General Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Speech, Glucocorticoid, Hearing loss, Patient, NEJM, Human, Trial of the century, Huber loss, Clinical trial, Multimedia, Steroid, Pharmaceutical industry

High-dose glucocorticoids are no more effective than the standard-dose in treating patients with sudden hearing loss.

Key Points: 
  • High-dose glucocorticoids are no more effective than the standard-dose in treating patients with sudden hearing loss.
  • This clinical study, led by Prof. Stefan Plontke from the University Medicine Halle, evaluated the efficacy of different doses of glucocorticoids in over 300 sudden hearing loss patients and is published in NEJM Evidence .
  • However, there is no convincing mode-of-action for the treatment of sudden hearing loss with steroids, as our own research has shown," says Dr. Reimar Schlingensiepen, CEO of AudioCure Pharma.
  • After 50 years of treating sudden hearing loss with glucocorticoids, a new and effective drug for this condition would represent a much-needed paradigm shift.

IASO Bio Announces U.S. FDA Approval of Investigational New Drug Application for BCMA CAR-T Equecabtagene Autoleucel for Generalized Myasthenia Gravis

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Thursday, April 4, 2024
Vital capacity, MuSK protein, Glucocorticoid, NMPA, Hormone, GMG, Disease, Chinese, MRS, BCMA, Nervous system, Patient, SAN, Enzyme inhibitor, History, Female, Multiple myeloma, CRS, B cell, Biotechnology, IND, Phenotype, Investigational New Drug, QMG, Safety, Thymectomy, FDA, Food

The Chinese IND for this indication of Equecabtagene Autoleucel was approved by the NMPA in January this year.

Key Points: 
  • The Chinese IND for this indication of Equecabtagene Autoleucel was approved by the NMPA in January this year.
  • The 2 subjects were treated with a single infusion of Eque-cel at the doses of 1.0×106 CAR-T/Kg, respectively.
  • No immunomodulatory therapy other than low dose pyridostigmine (90 mg/day and 60 mg/day, respectively) was used during the follow-up period.
  • Anti-AChR antibodies, anti-Titin antibodies, and anti-MuSK antibodies decreased rapidly and maintained at very low levels in both subjects after infusion.

Manuscript Discussing the Benefit of SeaStar Medical’s Selective Cytopheretic Device in Patients with Heart Failure and Hyperinflammation Published in European Journal of Heart Failure

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Tuesday, February 27, 2024
Cardiorenal syndrome, Division, Inflammation, FDA, Food, SCD, Emeritus, Manuscript, Hospital, Heart failure, European Journal, University, SeaStar, Internal medicine, Glucocorticoid, Acute kidney injury, Michigan Medicine, Drug, Monocyte, FACC, Acute respiratory distress syndrome, LVAD, Mortality, Heart, Pharmaceutical industry

DENVER, Feb. 27, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces publication of a manuscript discussing the role of chronic dysregulated systemic inflammation in heart failure and the potential application of the adult Selective Cytopheretic Device, part of the Quelimmune™ product family, in enabling previously ineligible patients with severe disease to receive a left ventricular assist device (LVAD) or heart transplant in the peer-reviewed European Journal of Heart Failure February 2024, Pitt, B., Iyer, S.P.N. and Humes, H.D. (2024), Eur J Heart Fail. https://doi.org/10.1002/ejhf.3177.

Key Points: 
  • The manuscript, titled “New Opportunity for Targeting Systemic Inflammation in Patients with Heart Failure through Leukocyte Immunomodulation” cites increasing evidence of the role of chronic systemic inflammation in patients with heart failure and discusses the Adult SCD’s potential to improve hypertensive heart failure and mortality following hospitalization for acute or worsening heart failure.
  • Following treatment with the Adult SCD, this patient was effectively bridged to LVAD three days after discontinuing treatment and was subsequently discharged without further complications.
  • “Prior attempts targeting singular proinflammatory factors as well as systemic immunosuppression with glucocorticoids in patients with acute heart failure have yielded unclear results, raising the need to identify new strategies.
  • “While our manuscript discusses a positive outcome in one patient following treatment for six hours daily over six consecutive days, the results suggest that more study with Adult SCD is warranted for patients with heart failure and hyperinflammation.”

Journal of Pharmaceutical Analysis Articles Provide Novel Insights into Previously Unknown Disease Mechanisms

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Tuesday, February 27, 2024
Nerve, Central nervous system, Metabolism, PXR, Alzheimer's disease, Testosterone, PCN, Research, MSI, Diabetic cardiomyopathy, Inflammation, Pathology, Deficit spending, Pregnane X receptor, MALDI, Neurotoxicity, Dysbiosis, JPA, Hippocampus, CYP, Heart failure, DCM, Domestic airport, Phenytoin, Mass spectrometry, PHT, Triglyceride, TMAO, Transplant, Glucocorticoid, Lipid metabolism, Patient, Journal, Glucose, Heart, Mouse, Glycated hemoglobin, Brain

XI'AN, China, Feb. 27, 2024 /PRNewswire/ -- DCM is the leading cause of heart failure in patients with chronic diabetes, with unclear mechanisms and limited treatments. Another mystery is the regulation of cytochrome P450 enzymes (CYPs) in the central nervous system. Moreover, the link between the gut microbiome, microbiota-derived metabolites, and the progression of AD remains unknown. In the December issue of Journal of Pharmaceutical Analysis (JPA), three articles explore the interconnected pathologies of DCM, hippocampal neurotoxicity, and AD, offering a comprehensive insight.

Key Points: 
  • Moreover, the link between the gut microbiome, microbiota-derived metabolites, and the progression of AD remains unknown.
  • In the December issue of Journal of Pharmaceutical Analysis (JPA), three articles explore the interconnected pathologies of DCM, hippocampal neurotoxicity, and AD, offering a comprehensive insight.
  • Their findings, available online on 17 August 2023, were published in Volume 13, Issue 12 of the journal in December 2023.
  • Gut dysbiosis aggravates cognitive deficits, amyloid pathology and lipid metabolism dysregulation in a transgenic mouse model of Alzheimer's disease

Spruce Biosciences Completes Enrollment in CAHmelia-204 Study for Adult Classic Congenital Adrenal Hyperplasia

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Monday, January 22, 2024
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, A4, Glucocorticoid, Patient, CAH, Clinical trial, Food, Safety, Androstenedione, FDA

Spruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet medical need, today announced completion of enrollment in its CAHmelia-204 clinical trial of tildacerfont for the treatment of adult classic congenital adrenal hyperplasia (CAH).

Key Points: 
  • Spruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet medical need, today announced completion of enrollment in its CAHmelia-204 clinical trial of tildacerfont for the treatment of adult classic congenital adrenal hyperplasia (CAH).
  • “Completing enrollment in our CAHmelia-204 clinical trial marks a significant milestone in our adult classic CAH program.
  • This achievement reinforces the continued momentum within our tildacerfont program and positions us favorably to report topline results in the third quarter of 2024,” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce Biosciences.
  • The primary endpoint of this clinical trial is the absolute change in daily glucocorticoid dose in hydrocortisone equivalents (HCe) from baseline at week 24.

Pharmactive's Saffron Extract improves Resilience to Occasional Stress

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Wednesday, January 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."

Spruce Biosciences Provides Clinical Program Updates and Outlook for 2024

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Thursday, January 4, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Cardiology, Hyperandrogenism, CAH, A4, Public expenditure, Disclosure, Clinical trial, Pharmacokinetics, Glucocorticoid, Common, Patient, Safety, Pharmaceutical industry

“2023 was a year of exceptional clinical execution across the board, and we were pleased to reach important milestones by completing enrollment in CAHmelia-203 for adult classic CAH and CAHptain-205 for pediatric classic CAH,” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce Biosciences.

Key Points: 
  • “2023 was a year of exceptional clinical execution across the board, and we were pleased to reach important milestones by completing enrollment in CAHmelia-203 for adult classic CAH and CAHptain-205 for pediatric classic CAH,” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce Biosciences.
  • The primary endpoint of the clinical trial is the percentage change in A4 from baseline at week 12.
  • Enrollment for CAHmelia-204 Study in Adult Classic CAH to be Completed in January 2024: Enrollment in CAHmelia-204 is anticipated to be completed in January 2024, and will surpass target enrollment of 90 patients.
  • CAHptain-205 Study in Pediatric Classic CAH Completes Enrollment: Enrollment in CAHptain-205 is complete with 30 patients, surpassing target enrollment of 20 patients.

Human medicines European public assessment report (EPAR): Rixathon, rituximab, Date of authorisation: 15/06/2017, Revision: 13, Status: Authorised

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Thursday, January 4, 2024
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Human medicines European public assessment report (EPAR): Rixathon, rituximab, Date of authorisation: 15/06/2017, Revision: 13, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Rixathon, rituximab, Date of authorisation: 15/06/2017, Revision: 13, Status: Authorised