Adrenocorticotropic hormone (medication)

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

Retrieved on: 
Monday, March 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 Completes Financial Restructuring and Irish Examinership Proceedings and Emerges From Chapter 11

Retrieved on: 
Tuesday, November 14, 2023
EBITDA, Food and Drug Administration, Corporation, Independent monitoring board, Food, New Board, LLP, Chairperson, Silver Point Capital, Patient, FDA, Specialty, Trust, Latham & Watkins, Growth, Guggenheim Partners, The Company, Adrenocorticotropic hormone (medication), AlixPartners, Alpha Metallurgical Resources, Pharmaceutical industry, Management, Mallinckrodt, Ajman Specialty General Hospital

DUBLIN, Nov. 14, 2023 /PRNewswire/ -- Mallinckrodt plc ("Mallinckrodt" or the "Company"), a global specialty pharmaceutical company, today announced that it has completed its financial restructuring, emerged from Chapter 11 following an expedited court-supervised process and completed the Irish Examinership Proceedings.

Key Points: 
  • DUBLIN, Nov. 14, 2023 /PRNewswire/ -- Mallinckrodt plc ("Mallinckrodt" or the "Company"), a global specialty pharmaceutical company, today announced that it has completed its financial restructuring, emerged from Chapter 11 following an expedited court-supervised process and completed the Irish Examinership Proceedings.
  • Supported by an enhanced capital structure, Mallinckrodt will continue to focus on advancing its business across its portfolio and executing on recent and planned product launches.
  • The Company's Specialty Generics segment benefits from vertical integration and high-quality U.S.-based manufacturing plants that have supported strong growth.
  • Latham & Watkins LLP, Wachtell, Lipton, Rosen & Katz, Arthur Cox LLP, Richards, Layton & Finger PA, and Hogan Lovells US LLP served as Mallinckrodt's counsel.

Mallinckrodt Completes Financial Restructuring and Irish Examinership Proceedings and Emerges From Chapter 11

Retrieved on: 
Tuesday, November 14, 2023
EBITDA, Food and Drug Administration, Corporation, Independent monitoring board, Food, New Board, LLP, Chairperson, Silver Point Capital, Patient, FDA, Specialty, Trust, Latham & Watkins, Growth, Guggenheim Partners, The Company, Adrenocorticotropic hormone (medication), AlixPartners, Alpha Metallurgical Resources, Pharmaceutical industry, Management, Mallinckrodt, Ajman Specialty General Hospital

DUBLIN, Nov. 14, 2023 /PRNewswire/ -- Mallinckrodt plc ("Mallinckrodt" or the "Company"), a global specialty pharmaceutical company, today announced that it has completed its financial restructuring, emerged from Chapter 11 following an expedited court-supervised process and completed the Irish Examinership Proceedings.

Key Points: 
  • DUBLIN, Nov. 14, 2023 /PRNewswire/ -- Mallinckrodt plc ("Mallinckrodt" or the "Company"), a global specialty pharmaceutical company, today announced that it has completed its financial restructuring, emerged from Chapter 11 following an expedited court-supervised process and completed the Irish Examinership Proceedings.
  • Supported by an enhanced capital structure, Mallinckrodt will continue to focus on advancing its business across its portfolio and executing on recent and planned product launches.
  • The Company's Specialty Generics segment benefits from vertical integration and high-quality U.S.-based manufacturing plants that have supported strong growth.
  • Latham & Watkins LLP, Wachtell, Lipton, Rosen & Katz, Arthur Cox LLP, Richards, Layton & Finger PA, and Hogan Lovells US LLP served as Mallinckrodt's counsel.

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

Retrieved on: 
Thursday, October 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.

Mallinckrodt Announces Publication of Two Journal Manuscripts with Clinical and Economic Evidence for Acthar® Gel (Repository Corticotropin Injection)

Retrieved on: 
Tuesday, October 10, 2023
Narrative, RA, Adrenocorticotropic hormone, Health, Literature review, Food, Polymyositis, Dermatomyositis, MS, Abstract, Autoimmunity, Length of stay, Spasm, Clinical, Manuscript, Copyright in Historical Perspective, MOA, Nephrotic syndrome, Rheumatoid arthritis, FDA, Proteinuria, RCI, Patient, ClinicoEconomics and Outcomes Research, History, Literature, Lupus, Multiple sclerosis, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Sarcoidosis, Outcomes research, Inflammation, SLE, Pharmaceutical industry, Medical device, Mallinckrodt, Adrenocorticotropic hormone (medication)

DUBLIN, Oct. 10, 2023 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKTQ), a global specialty pharmaceutical company, today announced the publication of two journal manuscripts reinforcing the clinical and economic evidence supporting the efficacy, safety profile, continued use, and cost-effectiveness of Acthar Gel for appropriate patients across a range of FDA-approved autoimmune and inflammatory disease indications.1,2 

Key Points: 
  • Mallinckrodt's health economics manuscript titled "Acthar Gel (RCI): A Narrative Literature Review of Clinical and Economic Evidence" was published on June 24, 2023 in ClinicoEconomics and Outcomes Research.
  • Acthar is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides.
  • Acthar Gel is approved by the U.S. Food and Drug Administration (FDA) for the treatment of several autoimmune disorders and medical conditions known to cause inflammation.3
    Please see indications and Important Safety Information below.
  • Outcomes may be influenced by therapies not evaluated in the study and the clinical outcomes may not be solely attributable to Acthar.

Preventing Pharmaceutical Price-Gouging: MSP Recovery Claims Proceed to Class Certification Against One of the Largest U.S. Pharmacy Benefit Managers in “Infamous” Case

Retrieved on: 
Wednesday, August 9, 2023
Legal, Parenting, Children, Baby, Maternity, Professional Services, Health, Consumer, Pharmaceutical, General Health, Clayton Antitrust Act of 1914, Sherman Antitrust Act, Spasm, Plaintiff, Pharmacy, 13th (Western) Division, MSP, Martin PBM Mariner, Hon, District court, Express Scripts, Complaint, Court, FDA, ACTH, Douglas v. U.S. District Court ex rel Talk America, Express, Pharmaceutical industry, Mallinckrodt, Adrenocorticotropic hormone (medication)

The court denied Defendants Express Scripts, Inc. et al.’s (“Express Scripts”) motion to dismiss allowing the Plaintiffs to proceed to class certification.

Key Points: 
  • The court denied Defendants Express Scripts, Inc. et al.’s (“Express Scripts”) motion to dismiss allowing the Plaintiffs to proceed to class certification.
  • Acthar’s manufacturer, Mallinckrodt, acquired the product in 2001 when Acthar sold for $40.00 per vial.
  • John H. Ruiz, CEO and Founder of MSP Recovery Inc. d/b/a LifeWallet (NASDAQ: LIFW), stated: “This is price-gouging, plain and simple.
  • No one should be forced to pay $39,000 per vial for the life-saving medicine on the market.

Whistleblower Law Collaborative LLC Wins Law360 Health Care Group of the Year

Retrieved on: 
Wednesday, March 1, 2023
Comment, Pharmacy, Health, Corporation, Corporate integrity agreement, Medicaid, Commonwealth, False Claims Act, CIA, Physician, United States v. Arthrex, Inc., AKS, Cardinal Health, OPKO Health, WLC, Medicare, Government, Anti-Kickback Statute, Mallinckrodt, Fraud, Operation Cleanslate, Adrenocorticotropic hormone (medication), Pharmaceutical industry

BOSTON, March 1, 2023 /PRNewswire/ -- Whistleblower Law Collaborative is pleased to announce it has been named a Law360 Health Care Group of the Year for 2022 .

Key Points: 
  • BOSTON, March 1, 2023 /PRNewswire/ -- Whistleblower Law Collaborative is pleased to announce it has been named a Law360 Health Care Group of the Year for 2022 .
  • Whistleblower Law Collaborative was chosen because the firm "successfully steered a host of high-stakes whistleblower suits in the health care field last year," said Law360.
  • Indeed, the award caps off an exceptional period of success for Whistleblower Law Collaborative.
  • Whistleblower Law Collaborative LLC , based in Boston, devotes its practice entirely to representing clients nationwide in bringing actions under the federal and state False Claims Acts and other whistleblower programs .

Processa Pharmaceuticals to Present at the World Orphan Drug Congress USA, July 11-13, 2022

Retrieved on: 
Tuesday, July 12, 2022
New Drug Application, SEC, Conference, EDT, UNL, Breast cancer, IND, PCSA, Congress, Company, Survival, Patient, CEO, NL, GLOBE, GI, Spasm, Nasdaq, Rare disease, Risk, FDA, Quality of life, Pancreatic cancer, Form 10-K, Pharmaceutical industry, Adrenocorticotropic hormone (medication), Processa edulis

The Processa team has successfully developed a number of drugs over the last 30 years with over 30 FDA approvals, some in Orphan indications.

Key Points: 
  • The Processa team has successfully developed a number of drugs over the last 30 years with over 30 FDA approvals, some in Orphan indications.
  • For example, while at Questcor, this team was able to successfully obtain the FDA approval for an Acthar supplemental New Drug Application for the treatment of infantile spasms, an ultra-rare orphan condition.
  • Although Processa has a pipeline of 5 drugs, 3 of which have FDA Orphan Designation, we are only developing 2 for the treatment of an orphan indication.
  • PCS499 is being developed for the treatment of the serious orphan indication, ulcerative Necrobiosis Lipoidica (uNL), and PCS3117 is being developed for the treatment of pancreatic cancer.

Mallinckrodt Agrees to Pay $234 Million to Settle False Claims Act Case Brought by Whistleblower Law Collaborative Client for Unpaid Acthar Medicaid Rebates

Retrieved on: 
Tuesday, March 8, 2022
Linda, Medicaid, Epinephrine autoinjector, Centers for Medicare & Medicaid Services, CMS, Human, False Claims Act, Mylan, AMP, New Hampshire Department of Justice, Government, Corporation, Justice, Bankruptcy, Medicare, Corporate integrity agreement, FDA, State attorney general, Medicaid Drug Rebate Program, Attorney General's Office (United Kingdom), Control, Whistleblower, State, District, Center, Department, Pharmaceutical industry, Health insurance, Mallinckrodt, Adrenocorticotropic hormone (medication)

Because of Mallinckrodt's bankruptcy, federal and state governments were not able to recoup the full amount of the unpaid rebates.

Key Points: 
  • Because of Mallinckrodt's bankruptcy, federal and state governments were not able to recoup the full amount of the unpaid rebates.
  • But individuals have a voice and the power to do something about wrongdoing, thanks to whistleblower laws like the False Claims Act."
  • This is the second major success for the Whistleblower Law Collaborative in a Medicaid rebate fraud case.
  • In 2017, Mylan paid $465 million for misclassifying EpiPen as a generic drug to avoid paying the higher rebates owed on brand name drugs.