535 Science Drive
383 articles with Mallinckrodt Pharmaceuticals
It’s entirely possible that what we will be seeing most from the U.S. Food and Drug Administration for the month of September is related to treatments and vaccines for COVID-19.
Mallinckrodt Pharmaceuticals, a global biopharmaceutical company, announced that its Specialty Generics business has been recognized as a Manufacturing Leadership Award winner for outstanding achievement by the National Association of Manufacturers.
8/13/2020Biopharma and life sciences companies from across the globe provide updates on their business and pipelines.
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
Shares of Mallinckrodt climbed after the company announced the Cardiovascular and Renal Drugs Advisory Committee of the U.S. Food and Drug Administration voted to recommend approval for its investigational agent terlipressin to treat adults with hepatorenal syndrome type 1.
Mallinckrodt plc, a global biopharmaceutical company, announced that it will report second quarter 2020 earnings results for the period ended June 26, 2020 on Tuesday, Aug. 4, 2020.
Mallinckrodt plc, a global biopharmaceutical company, will present on Tuesday, June 23, 2020 at the BMO Prescriptions for Success Healthcare Conference.
Mallinckrodt to Present Phase 3 StrataGraft® Regenerative Skin Tissue Clinical Trial Results on Severe Burns During the Virtual American Burn Association 52nd Annual Meeting
Additional Abstracts on Health Economics and Outcomes Research and Other Data Accepted as Poster Presentations
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
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
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
Mallinckrodt plcMallinckrodt plc, a global biopharmaceutical company, reported results for the three months ended March 27, 2020.
Mallinckrodt Announces Positive Findings in INOmax® (Nitric Oxide) Gas, for Inhalation Phase 4 Observational Registry in Neonates with Pulmonary Hypertension; Ends Trial Early
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
Mallinckrodt and Massachusetts General Hospital teamed up to evaluate the potential benefits of inhaled nitric oxide as a treatment for pulmonary complications in patients infected with COVID-19.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 1, 2020.
Mallinckrodt Supports Investigator-Initiated Study at Massachusetts General Hospital to Assess Effectiveness of Inhaled Nitric Oxide in Patients with Severe Acute Respiratory Distress Syndrome Due to COVID-19
More than 170 U.S. hospitals have reported using INOmax® (nitric oxide) gas, for inhalation, to treat COVID-19 lung complications
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)
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
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.
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
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
Mallinckrodt Initiates Rolling Submission of Biologics License Application for StrataGraft® Regenerative Skin Tissue to U.S. Food and Drug Administration
Application is Supported by Data from Pivotal Phase 3 Study for the Treatment of Deep Partial-Thickness Thermal Burns