Mallinckrodt Pharmaceuticals
386 articles about Mallinckrodt Pharmaceuticals
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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
3/11/2024
Mallinckrodt plc announced the publication of findings from a retrospective chart review of Acthar® Gel treatment outcomes for African American and non-African American patients with symptomatic sarcoidosis – including treatment patterns, co-medication use, and overall health outcomes.
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Mallinckrodt Announces Appointment of Paul O'Neill as Executive Vice President, Quality & Operations, Specialty Brands
3/4/2024
Mallinckrodt plc, a global specialty pharmaceutical company, announced that Paul O'Neill has been appointed Executive Vice President, Quality & Operations, Specialty Brands, effective immediately.
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Mallinckrodt Announces U.S. FDA Approval of Supplemental New Drug Application for Acthar® Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector
3/1/2024
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.
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A new packaging and labeling manufacturing facility has derailed the potential approval of Malinckrodt’s investigational hepatorenal syndrome (HRS) treatment, terlipressin.
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Mallinckrodt Announces Publication of Phase 3 STRATA2016 Study in Burns
7/7/2021
Mallinckrodt plc, a global biopharmaceutical company, announced publication of results from the pivotal Phase 3 STRATA2016 clinical trial of StrataGraft®, which is approved for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated.
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Mallinckrodt Announces U.S. FDA Approval of StrataGraft® (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen - dsat)
6/16/2021
Mallinckrodt today announced that the U.S. Food and Drug Administration (FDA) has approved StrataGraft
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The StrataGraft is designed to help heal patients who have received thermal burns that would ultimately require a skin graft. Here's everything about it.
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Mallinckrodt Presents Data Evaluating Acthar® Gel (Repository Corticotropin Injection) for the Treatment of Severe Keratitis at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting
5/3/2021
Phase 4 open-label study showed clinically important improvement in the patient-reported Impact of Dry Eye on Everyday Life (IDEEL) symptom bother score, the study's primary outcome measure
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National Association of Manufacturers Selects Mallinckrodt for Two Prestigious Manufacturing Leadership Awards
3/29/2021
Mallinckrodt's Specialty Generics division honored with Collaborative Innovation Leadership Award for its COVID-19 pandemic response
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Mallinckrodt Supports Healthcare Businesswomen's Association as Two Employees Honored with Prominent Awards
3/24/2021
Mallinckrodt plc announced that employees Tanya Hill, Executive Director, Commercial Strategy and Brand Planning, will be honored as a Luminary; and Megan Roberts, Director, SEC Reporting, Technical Accounting, and Global Consolidations, will be honored as a Rising Star by the Healthcare Businesswomen's Association at its 32nd Annual Woman of the Year virtual event, on May 6, 2021.
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Mallinckrodt Gains Support for Its Restructuring Support Agreement from Lenders Holding Approximately $1.3 Billion of Its First Lien Term Loans
3/10/2021
Mallinckrodt plc announced that it has reached agreement with an ad hoc group of first lien term lenders holding approximately $1.3 billion of its outstanding First Lien Term Loans to support the Company's previously announced restructuring support agreement.
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Mallinckrodt Provides Regulatory Update on StrataGraft®
2/12/2021
Mallinckrodt plc , a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that it is deferring action (pending a site inspection) on the Stratatech Biologics License Application (BLA) for StrataGraft ® , an investigational allogeneic cellularized scaffold product
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February is kicking off with a number of PDUFA dates for the U.S. FDA as well as a cancer advisory committee meeting. Here’s a look.
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Mallinckrodt Earns Top Marks in Human Rights Campaign's 2021 Corporate Equality Index
1/29/2021
Mallinckrodt plc, a global biopharmaceutical company, announced that it received a score of 100 on the Human Rights Campaign Foundation's 2021 Corporate Equality Index, the nation's foremost benchmarking survey and report measuring corporate policies and practices related to LGBTQ workplace equality.
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Mallinckrodt Announces Real World Data on Hepatorenal Syndrome (HRS) and Acute Kidney Injury (AKI) in Patients with Liver Disease at The Liver Meeting Digital Experience
11/16/2020
Advancing American kidney health has been identified as a key public health priority by a 2019 Presidential Executive Order
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Mallinckrodt Announces Data from a Multicenter Post Hoc Analysis of Terlipressin in Patients with Hepatorenal Syndrome-Acute Kidney Injury (HRS-AKI) at The Liver Meeting Digital Experience
11/16/2020
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
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Mallinckrodt Initiates Retrospective Study of the Use of Inhaled Nitric Oxide in COVID-19 Patients
11/10/2020
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
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Mallinckrodt Announces Data at Kidney Week 2020 Reimagined that Showed A Potential for Reduced Need for Renal Replacement (RRT) Therapy for Patients with Hepatorenal Syndrome Type 1 (HRS-1) Treated with Terlipressin
10/29/2020
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
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Pharmaceutical Giant Mallinckrodt Bankruptcy Threatens Lawsuit Filed by Local Unions and Delaware Valley Health Care Coalition, Worth Hundreds of Millions of Dollars
10/22/2020
In response to the pharmaceutical giant Mallinckrodt’s bankruptcy filing last week, Delaware Valley Health Care Coalition, Inc. (DVHCC) President John Heenan said, “Its crucial for our members to have a seat at the table for the bankruptcy proceedings.” The DVHCC is a non-profit voluntary association comprised of multi-employer trust funds, governmental entities, labor unions, schools and school districts in ov
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Mallinckrodt Receives Court Approval of "First Day" Motions to Support Business Operations
10/15/2020
Mallinckrodt plc 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, 2020.