Nieuws en video's - MALLINCKRODT PLC - Pagina 3

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 U.S. data on HRS and AKI in patients with liver disease may help advance kidney health PR Newswire DUBLIN, Nov. 16, 2020 DUBLIN , Nov. 16, 2020 /PRNewswire/ -- Mallinckrodt plc , a global biopharmaceutical...

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 PR Newswire DUBLIN, Nov. 16, 2020 DUBLIN , Nov. 16, 2020 /PRNewswire/ -- Mallinckrodt plc , a global biopharmaceutical company, today...

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 - PR Newswire DUBLIN, Nov. 10, 2020 DUBLIN , Nov. 10, 2020 /PRNewswire/ -- Mallinckrodt plc , a global biopharmaceutical company, today announced initiation of a retrospective chart review study,...

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 PR Newswire DUBLIN, Oct. 29, 2020 DUBLIN , Oct. 29, 2020 /PRNewswire/ -- Mallinckrodt plc , a global biopharmaceutical company,...

Mallinckrodt Secures Broad Consensus with Key Stakeholders on Comprehensive Chapter 11 Restructuring 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 Agreement in Principle to Resolve Various Acthar® Gel-Related Matters Proposed Capital Structure...

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 PR Newswire DUBLIN, Sept. 14, 2020 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...

Mallinckrodt's Hobart, N.Y. Site Recognized With Two Manufacturing Leadership Awards PR Newswire ST. LOUIS, Aug. 24, 2020 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 Manufacturers (NAM). The Specialty Generics business' Hobart, N.Y. manufacturing...

...

Mallinckrodt Announces U.S. FDA Filing Acceptance of Biologics License Application for StrataGraft® Regenerative Skin Tissue for Treatment of Adults with Deep Partial-thickness Thermal Burns - StrataGraft® Skin Tissue, If Approved, Could Reduce or Eliminate the Need for Autografting of Healthy Skin to Treat Burn Wounds - PR Newswire STAINES-UPON-THAMES, United Kingdom, Aug. 10, 2020 STAINES-UPON-THAMES, United Kingdom , Aug. 10, 2020 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a global...

Mallinckrodt plc Reports Earnings for the Second Quarter 2020 and Highlights Pipeline Advancements PR Newswire DUBLIN, Aug. 4, 2020 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 on certain products Diluted loss per share of $11.04 with adjusted...

...

Mallinckrodt Announces U.S. Food and Drug Administration (FDA) Advisory Committee Voted to Recommend Terlipressin for Approval to Treat Patients with Hepatorenal Syndrome Type 1 (HRS-1) - 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 - PR Newswire DUBLIN, July 15, 2020 DUBLIN , July 15, 2020 /PRNewswire/ --...

Mallinckrodt to Report Earnings Results for Second Quarter 2020 PR Newswire STAINES-UPON-THAMES, United Kingdom, July 9, 2020 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. 4 , 2020. A conference call for investors will begin at 8:30 a.m. Eastern Time. The call can be accessed in three...

Mallinckrodt Confirms that U.S. Food and Drug Administration (FDA) Will Convene an Advisory Committee to Review Terlipressin for the Treatment of Patients with Hepatorenal Syndrome Type 1 (HRS-1) - Advisory committee meeting scheduled for July 15, 2020 - PR Newswire STAINES-UPON-THAMES, United Kingdom, July 7, 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...

Mallinckrodt to Present at the BMO Prescriptions for Success Healthcare Conference PR Newswire STAINES-UPON-THAMES, United Kingdom, June 17, 2020 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 Reasons , Executive Vice President and Chief Financial...

Mallinckrodt to Proceed with Appeal Despite Appellate Court Decision Denying Temporary Injunction in Ongoing Acthar Gel Medicaid Drug Rebate Dispute with the Centers for Medicare and Medicaid Services (CMS) -- 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...

Mallinckrodt to Present Phase 3 StrataGraft® Regenerative Skin Tissue Clinical Trial Results on Severe Burns During the Virtual American Burn Association 52nd Annual Meeting -- Phase 3 Clinical Trial Selected Among "Top Five Abstracts" -- -- Additional Abstracts on Health Economics and Outcomes Research and Other Data Accepted as Poster Presentations -- PR Newswire STAINES-UPON-THAMES, United Kingdom, June 15, 2020 STAINES-UPON-THAMES, United Kingdom , June 15, 2020 /PRNewswire/ -- Mallinckrodt...

Real-World Data of Terlipressin in Hospitalized Patients in U.K. with Hepatorenal Syndrome Type 1 (HRS-1) Published in Alimentary Pharmacology and Therapeutics - 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 - PR Newswire STAINES-UPON-THAMES, United Kingdom, June 11, 2020 STAINES-UPON-THAMES, United Kingdom , June 11, 2020 /PRNewswire/ -- Mallinckrodt plc...

Mallinckrodt Completes Rolling Submission of Biologics License Application for StrataGraft® Regenerative Skin Tissue to U.S. Food and Drug Administration - StrataGraft® Skin Tissue is in Development as Potential New Treatment Option for Patients with Deep Partial-thickness Thermal Burns - PR Newswire STAINES-UPON-THAMES, United Kingdom, June 9, 2020 STAINES-UPON-THAMES, United Kingdom , June 9, 2020 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today...

Mallinckrodt Will Appeal District Court Ruling in Case Involving Ongoing Acthar Medicaid Drug Rebate Dispute with the Centers for Medicare and Medicaid Services (CMS) -- 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 action during appellate process -- PR...