News Releases

DateTitle 
11/16/20
Advancing American kidney health has been identified as a key public health priority by a 2019 Presidential Executive Order   U.S. data on HRS and AKI in patients with liver disease may help advance kidney health DUBLIN , Nov. 16, 2020 /PRNewswire/ --  Mallinckrodt plc , a global biopharmaceutical
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11/16/20
U.K. retrospective chart review examined potential predictors of treatment response including age, baseline AKI severity and concomitant use of albumin in patients with HRS-AKI DUBLIN , Nov. 16, 2020 /PRNewswire/ --  Mallinckrodt plc , a global biopharmaceutical company, today announced results
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11/13/20
DUBLIN – November 13, 2020 –  Mallinckrodt plc , a global biopharmaceutical company, today announced that the Company recently participated in an end of review meeting with the U.S. Food and Drug Administration (FDA) to discuss the Complete Response Letter issued on September 11, 2020 for the
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11/10/20
- Chart review is expected to collect real-world data on patients with respiratory complications associated with COVID-19 who received INOmax® (nitric oxide) gas, for inhalation in a hospital setting - DUBLIN , Nov. 10, 2020 /PRNewswire/ --  Mallinckrodt plc , a global biopharmaceutical company,
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10/29/20
Post-hoc, pooled analyses of three Phase 3 trials found HRS-1 patients treated with terlipressin was associated with less RRT up to Day 90 versus placebo DUBLIN , Oct. 29, 2020 /PRNewswire/ --  Mallinckrodt plc , a global biopharmaceutical company, today announced results from two post-hoc studies
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10/14/20
DUBLIN, Ireland, October 14, 2020 – Mallinckrodt plc (“Mallinckrodt” or the “Company”) today announced that it has received approvals from the U.S. Bankruptcy Court for the District of Delaware for its “First Day” motions related to the Company’ s voluntary Chapter 11 petitions filed on October 12,
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10/12/20
Enters a Restructuring Support Agreement with Guaranteed Unsecured Noteholders and Certain Governmental Opioid Plaintiffs, Including 50 States and Territories, and a Court-Appointed Plaintiff's Executive Committee Representing the Interests of Thousands of Opioid Plaintiffs; Includes Support for an
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09/14/20
Company remains committed to working with FDA toward an approval for this important potential therapy DUBLIN , Sept. 14, 2020 /PRNewswire/ --  Mallinckrodt plc  (NYSE: MNK), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete
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08/31/20
-- €50,000 award goes to University Hospital of Lille in France to fund research into the potential impact of Extracorporeal Photopheresis (ECP) on fibrosing processes -- DUBLIN, August 31, 2020 -- Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today announced the recipient of
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08/24/20
ST. LOUIS , Aug. 24, 2020 /PRNewswire/ --  Mallinckrodt Pharmaceuticals  (NYSE: MNK), a global biopharmaceutical company, today announced that its Specialty Generics business has been recognized as a Manufacturing Leadership Award winner for outstanding achievement by the National Association of
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08/10/20
- StrataGraft® Skin Tissue, If Approved, Could Reduce or Eliminate the Need for Autografting of Healthy Skin to Treat Burn Wounds - STAINES-UPON-THAMES, United Kingdom , Aug. 10, 2020 /PRNewswire/ --  Mallinckrodt plc  (NYSE: MNK), a global biopharmaceutical company, today announced that the U.S.
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08/04/20
DUBLIN , Aug. 4, 2020 /PRNewswire/ --     Second quarter net sales of $166.5 million net of the retrospective one-time Acthar ® Gel Medicaid liability; adjusted net sales of $700.9 million , a decline of 14.9%, due primarily to demand impacts related to COVID-19 and competitive and payer pressures
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07/15/20
- If approved, terlipressin would be the first FDA-approved treatment in the United States for adult patients with HRS-1, a life-threatening condition -   - Prescription Drug User Fee Act (PDUFA) target action date is September 12 - DUBLIN , July 15, 2020 /PRNewswire/ -- Mallinckrodt plc  (NYSE:
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07/12/20
– In a rare dual-review process, two independent advisory committees to the Australian Minister for Health recommend reimbursement based on a favorable clinical and cost-effectiveness comparison – STAINES-UPON-THAMES, United Kingdom and LAKEWOOD, Colo. USA – July 13, 2020 –  Mallinckrodt plc
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07/09/20
STAINES-UPON-THAMES, United Kingdom , July 9, 2020 /PRNewswire/ -- Mallinckrodt plc  (NYSE: MNK), a global biopharmaceutical company, announced today that it will report second quarter 2020 earnings results for the period ended June 26, 2020 on Tuesday, Aug.
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07/07/20
- Advisory committee meeting scheduled for July 15, 2020 - STAINES-UPON-THAMES, United Kingdom , July 7, 2020 /PRNewswire/ --  Mallinckrodt plc  (NYSE: MNK), a global biopharmaceutical company, today announced that the Cardiovascular and Renal Drugs Advisory Committee of the U.S.
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06/17/20
STAINES-UPON-THAMES, United Kingdom , June 17, 2020 /PRNewswire/ --  Mallinckrodt plc  (NYSE: MNK), a global biopharmaceutical company, will present on Tuesday, June 23, 2020 at the BMO Prescriptions for Success Healthcare Conference . Mark Trudeau , President and Chief Executive Officer, and Bryan
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06/15/20
-- Company remains committed to opioid settlement in principle but says allowing District Court ruling to stand could adversely impact settlement completion -   --Appeals Court sets expedited briefing and oral argument schedule--   -- Company continues to explore all options to address its
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06/15/20
-- Phase 3 Clinical Trial Selected Among "Top Five Abstracts" --   -- Additional Abstracts on Health Economics and Outcomes Research and Other Data Accepted as Poster Presentations -- STAINES-UPON-THAMES, United Kingdom , June 15, 2020 /PRNewswire/ --  Mallinckrodt plc  (NYSE: MNK), a global
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06/11/20
- U.K. medical chart study showed an association between patients treated with terlipressin and an improvement in kidney function in 73 percent of hospitalized adult patients with HRS-1 - STAINES-UPON-THAMES, United Kingdom , June 11, 2020 /PRNewswire/ --  Mallinckrodt plc  (NYSE: MNK), a global
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06/09/20
- StrataGraft® Skin Tissue is in Development as Potential New Treatment Option for Patients with Deep Partial-thickness Thermal Burns - STAINES-UPON-THAMES, United Kingdom , June 9, 2020 /PRNewswire/ --  Mallinckrodt plc  (NYSE: MNK), a global biopharmaceutical company, today announced that
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06/01/20
-- Company believes District Court decision misinterprets federal law and fails to address important legal requirements of the Administrative Procedure Act --   -- Company will immediately appeal to the U.S. Court of Appeals for the D.C. Circuit to overturn District Court decision and block CMS
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05/05/20
STAINES-UPON-THAMES, United Kingdom , May 5, 2020 /PRNewswire/ -- First quarter net sales of $665.8 million , with diluted loss per share of $0.60 , with results impacted in part by competitive and payer pressures in certain products and a decline in demand due to COVID-19 Adjusted diluted earnings
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05/04/20
- Company ends Phase 4 observational registry early as data achieved statistical significance for non-inferiority in premature neonates compared to term and near-term neonates at planned interim analysis - STAINES-UPON-THAMES, United Kingdom , May 4, 2020 /PRNewswire/ --  Mallinckrodt plc  (NYSE:
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04/30/20
- More than 170 U.S. hospitals have reported using INOmax® (nitric oxide) gas, for inhalation, to treat COVID-19 lung complications - STAINES-UPON-THAMES, United Kingdom , April 30, 2020 /PRNewswire/ --  Mallinckrodt plc  (NYSE: MNK), a global biopharmaceutical company, announced today that it is
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04/22/20
- Terlipressin would be the first FDA-approved treatment option in the United States for adult patients with HRS-1, a life-threatening condition, if approved - STAINES-UPON-THAMES, United Kingdom , April 22, 2020 /PRNewswire/ -- Mallinckrodt plc  (NYSE: MNK), a global biopharmaceutical company,
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04/16/20
STAINES-UPON-THAMES, United Kingdom , April 16, 2020 /PRNewswire/ -- Mallinckrodt plc  (NYSE: MNK), a global biopharmaceutical company, announced today that it will report first quarter 2020 earnings results for the period ended March 27, 2020 on Tuesday, May 5, 2020 .  A conference call for
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04/15/20
-- The two-part multicenter study of 259 enrolled subjects showed >60 percent of patients achieved low disease activity (LDA) at week 12 with open-label therapy, an effect that was maintained in a proportion of patients with 12 additional weeks of treatment in the double-blind phase --
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04/06/20
- Application is Supported by Data from Pivotal Phase 3 Study for the Treatment of Deep Partial-Thickness Thermal Burns - - StrataGraft Skin Tissue Could be a Potential New Treatment Option for Deep Partial-Thickness Thermal Burns, if Approved - STAINES-UPON-THAMES, United Kingdom , April 6, 2020
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04/01/20
-- Study to investigate antiviral activity and improvement in oxygenation and pulmonary arterial pressure in patients suffering from COVID-19 -- STAINES-UPON-THAMES, United Kingdom and GARDEN GROVE, Calif. , April 1, 2020 /PRNewswire/ -- Mallinckrodt plc  (NYSE: MNK), a global biopharmaceutical
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03/20/20
Mar. 20, 2020-- Mallinckrodt Pharmaceuticals , a global biopharmaceutical company, has been monitoring the development of the novel coronavirus (COVID-19) outbreak using our resources in conjunction with the appropriate global health and security agencies.
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03/17/20
- Terlipressin would be the first FDA-approved treatment option in the United States for adult patients with HRS-1, a life-threatening condition, if approved - STAINES-UPON-THAMES, United Kingdom , March 17, 2020 /PRNewswire/ --  Mallinckrodt plc  (NYSE: MNK), a global biopharmaceutical company,
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03/16/20
-- Court allows CMS to change Medicaid rebate calculations for Acthar® Gel resulting in full retroactive payments -- -- Retroactive liability of approximately $650 million and prospective loss of Acthar Gel Medicaid net sales of roughly $90 million to $100 million in net sales annualized -- --
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03/12/20
STAINES-UPON-THAMES, United Kingdom , March 12, 2020 /PRNewswire/ --  Mallinckrodt plc  (NYSE: MNK), a global biopharmaceutical company, today commented that it is currently evaluating the limited published evidence suggesting a potential role for inhaled nitric oxide ("iNO") as a supportive
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03/11/20
New York State Attorney General Supports Company's Proposed Global Opioid Settlement; Joining 47 Other State and U.S. Territory Attorneys General STAINES-UPON-THAMES, United Kingdom, March 11, 2020 /PRNewswire/ --  Mallinckrodt plc (NYSE: MNK) ("Mallinckrodt" or the "Company") today announced that
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03/05/20
-- In a prospective, open-label study of 19 adult patients with biopsy-proven lgAN at high risk of progression to end-stage renal disease, treatment with Acthar Gel demonstrated a reduction in proteinuria, an effect which was sustained at 12 months -- STAINES-UPON-THAMES, United Kingdom , March 5,
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03/04/20
-- Retrospective chart review assessing Acthar Gel treatment utilization and patterns in 92 patients suggests improvement in symptoms across three disease states in a real-world setting -- STAINES-UPON-THAMES, United Kingdom , March 4, 2020 /PRNewswire/ --  Mallinckrodt plc  (NYSE: MNK), a global
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03/02/20
- Terlipressin would be the first FDA-approved treatment option in the United States for patients with HRS-1 if approved - STAINES-UPON-THAMES, United Kingdom , March 2, 2020 /PRNewswire/ --  Mallinckrodt plc  (NYSE: MNK), a global biopharmaceutical company, today announced it initiated the rolling
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02/27/20
-- Data highlights include prospective observational registry top-line results and interim baseline patient characteristics at 50 percent enrollment from randomized, double-blind, placebo-controlled OPTIONS study of Acthar Gel in MS relapse -- STAINES-UPON-THAMES, United Kingdom , Feb.
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02/25/20
- Fourth quarter net sales of $804.9 million and 2019 net sales of $3.163 billion, with strong performance across hospital products and the Specialty Generics segment, offset by declines in Acthar® Gel - Diluted loss per share of $13.76 in the fourth quarter and $11.88 in fiscal 2019; adjusted
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02/25/20
Agreement in Principle with Court-Appointed Plaintiffs' Executive Committee Representing the Interests of Thousands of Plaintiffs in the Opioid Multidistrict Litigation; Supported by a Broad-Based Group of 47 State and U.S. Territory Attorneys General Settlement Terms Include Structured Payments of
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02/14/20
STAINES-UPON-THAMES, United Kingdom , Feb. 14, 2020 /PRNewswire/ --  Mallinckrodt plc  (NYSE: MNK), a global biopharmaceutical company, announced today that it will report fourth quarter and fiscal 2019 earnings results for the period ending Dec. 27, 2019 on Tuesday, Feb.
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01/30/20
-- Company scores 100 percent on Human Rights Campaign Foundation's 18th annual Corporate Equality Index on LGBTQ Workplace Equality for Fourth Year in a Row-- STAINES-UPON-THAMES, United Kingdom , Jan. 30, 2020 /PRNewswire/ --  Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company,
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