Mallinckrodt Pharmaceuticals
387 articles about Mallinckrodt Pharmaceuticals
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Mallinckrodt Announces U.S. Food and Drug Administration (FDA) Filing Acceptance of New Drug Application for Terlipressin for Treatment of Hepatorenal Syndrome Type 1 (HRS-1)
4/22/2020
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
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Mallinckrodt to Report Earnings Results for First Quarter 2020
4/16/2020
Mallinckrodt plc, a global biopharmaceutical company, announced that it will report first quarter 2020 earnings results for the period ended March 27, 2020 on Tuesday, May 5, 2020.
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Mallinckrodt Announces Publication of Data on Acthar® Gel (Repository Corticotropin Injection) from its Randomized, Double-Blind, Placebo-Controlled Phase 4 Study in Rheumatoid Arthritis (RA) in Rheumatology and Therapy
4/15/2020
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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Mallinckrodt Initiates Rolling Submission of Biologics License Application for StrataGraft® Regenerative Skin Tissue to U.S. Food and Drug Administration
4/6/2020
Application is Supported by Data from Pivotal Phase 3 Study for the Treatment of Deep Partial-Thickness Thermal Burns
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Mallinckrodt and Novoteris Receive Clearance from Health Canada to Start Pilot Trial of High-Dose Inhaled Nitric Oxide Therapy for COVID-19 Infection and Associated Lung Complications
4/1/2020
Study to investigate antiviral activity and improvement in oxygenation and pulmonary arterial pressure in patients suffering from COVID-19
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Mallinckrodt Completes Rolling Submission of New Drug Application to the U.S. Food and Drug Administration (FDA) for Terlipressin for the Treatment of Patients with Hepatorenal Syndrome Type 1 (HRS-1)
3/17/2020
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
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Mallinckrodt Confirms Court Decision in Lawsuit Against HHS and CMS and Provides Update Related to Global Opioid Settlement and Present Financing Activities
3/16/2020
Mallinckrodt plc confirmed that its subsidiary, Mallinckrodt ARD LLC, received a decision from the U.S. District Court for the District of Columbia in its suit against U.S. Department of Health and Human Services and Centers for Medicare and Medicaid Services regarding the company's calculation of Medicaid drug rebates for Acthar® Gel.
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Mallinckrodt Evaluates the Potential Role for Inhaled Nitric Oxide to Treat COVID-19 Associated Lung Complications, Engages with Scientific, Governmental and Regulatory Agencies
3/12/2020
Mallinckrodt plc today commented that it is currently evaluating the limited published evidence suggesting a potential role for inhaled nitric oxide ("iNO") as a supportive measure in treating those patients infected with coronavirus (SARS-CoV-2) and having as
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Mallinckrodt Provides Update on Proposed Global Opioid Settlement
3/11/2020
New York State Attorney General Supports Company's Proposed Global Opioid Settlement; Joining 47 Other State and U.S. Territory Attorneys General
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Mallinckrodt Announces Publication of New Data on Acthar® Gel (Repository Corticotropin Injection) in Rheumatoid Arthritis, Systemic Lupus Erythematosus and Dermatomyositis/Polymyositis Published in Open Access Rheumatology: Research and Reviews
3/4/2020
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
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Mallinckrodt plc Reports Strong Fourth Quarter and 2019 Results
2/25/2020
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
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Mallinckrodt Announces Agreement in Principle for Global Opioid Settlement and Associated Debt Refinancing Activities
2/25/2020
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
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Mallinckrodt Files Chapter 11 for its Generics Business as it Reaches $1.6 Billion Opioid Settlement
2/25/2020
In addition to the settlement and bankruptcy, Mallinckrodt entered into a debt refinancing agreement, including an $800 million loan that will be used to repay some outstanding debt and acquire some outstanding stocks. -
These prices refer to the company’s list price. Most patients will not pay that price because of various forms of health insurance or patient assistance programs.
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Mallinckrodt Recognized as one of the "2020 Best Places to Work for LGBTQ Equality"
1/30/2020
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
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First Patient Enrolled in Mallinckrodt Phase 4 Trial of Acthar® Gel (Repository Corticotropin Injection) for Severe Keratitis
12/16/2019
The Phase 4 clinical study is titled "A Multicenter, Open-Label Study to Assess the Efficacy and Safety of Acthar Gel in Subjects with Severe Keratitis."
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Mallinckrodt Announces Plans to Update Its Incentive Compensation Clawback Policy and Create Opioid Report
12/10/2019
Actions taken in response to approval of shareholder proposals presented at the Company's 2019 Annual General Meeting
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Mallinckrodt Presents Data on a Novel Predictive Model to Identify Infants at Risk for Infantile Spasms (IS) at the 2019 Annual Meeting of the American Epilepsy Society (AES)
12/7/2019
Predictive model based on claims data from 10.8 million infant patients and input from IS medical experts finds strongest predictors for identifying infants at risk for IS include presence of at least two symptoms and a moderate or high severity emergency department visit
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Mallinckrodt Moves Date and Time of Its Fireside Chat at Piper Jaffray Annual Healthcare Conference
12/3/2019
Mallinckrodt plc, a global biopharmaceutical company, announced that the Company now will present at the Piper Jaffray Annual Healthcare Conference on Wednesday, Dec. 4, 2019 at 12:30 p.m. Eastern..
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Following Civil Settlements, Opioid Drugmakers and Distributors Could Face Criminal Charges
11/27/2019
The companies are facing questions in a criminal probe regarding their marketing distribution practices related to the sale of opioids.