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383 articles with Mallinckrodt Pharmaceuticals
A new packaging and labeling manufacturing facility has derailed the potential approval of Malinckrodt’s investigational hepatorenal syndrome (HRS) treatment, terlipressin.
Mallinckrodt Announces Publication of Phase 3 STRATA2016 Study in Burns
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.
Mallinckrodt Announces U.S. FDA Approval of StrataGraft® (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen - dsat)
Mallinckrodt today announced that the U.S. Food and Drug Administration (FDA) has approved StrataGraft
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.
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
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
National Association of Manufacturers Selects Mallinckrodt for Two Prestigious Manufacturing Leadership Awards
Mallinckrodt's Specialty Generics division honored with Collaborative Innovation Leadership Award for its COVID-19 pandemic response
Mallinckrodt Supports Healthcare Businesswomen's Association as Two Employees Honored with Prominent Awards
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.
Mallinckrodt Gains Support for Its Restructuring Support Agreement from Lenders Holding Approximately $1.3 Billion of Its First Lien Term Loans
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.
Mallinckrodt Provides Regulatory Update on StrataGraft®
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
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.
Mallinckrodt Earns Top Marks in Human Rights Campaign's 2021 Corporate Equality Index
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.
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
Advancing American kidney health has been identified as a key public health priority by a 2019 Presidential Executive Order
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
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
Mallinckrodt Initiates Retrospective Study of the Use of Inhaled Nitric Oxide in COVID-19 Patients
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
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
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
Pharmaceutical Giant Mallinckrodt Bankruptcy Threatens Lawsuit Filed by Local Unions and Delaware Valley Health Care Coalition, Worth Hundreds of Millions of Dollars
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
Mallinckrodt Receives Court Approval of "First Day" Motions to Support Business Operations
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.
Mallinckrodt has filed for Chapter 11 bankruptcy amid growing lawsuits that allege the company has participated in fueling the opioid epidemic in the United States.
Mallinckrodt Secures Broad Consensus with Key Stakeholders on Comprehensive Chapter 11 Restructuring
Mallinckrodt plc announced that it has voluntarily initiated Chapter 11 proceedings in the U.S. Bankruptcy Court for the District of Delaware to modify its capital structure, including restructuring portions of its debt, and resolve several billion dollars of otherwise unmanageable potential legal liabilities.
Mallinckrodt Receives a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for Terlipressin for the Treatment of Hepatorenal Syndrome Type 1 (HRS-1)
Company remains committed to working with FDA toward an approval for this important potential therapy