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    Mallinckrodt Pharmaceuticals is a multibillion dollar specialty biopharmaceutical company focused on our mission: Managing Complexity. Improving Lives. We provide medicines to address unmet patient needs, steming from nearly 150 years of using our unique strengths, experience and expertise to help improve people’s lives. Discover how our rich history of innovation and patient-centered solutions has helped influence our visio...
    Mallinckrodt Pharmaceuticals is a multibillion dollar specialty biopharmaceutical company focused on our mission: Managing Complexity. Improving Lives. We provide medicines to address unmet patient needs, steming from nearly 150 years of using our unique strengths, experience and expertise to help improve people’s lives. Discover how our rich history of innovation and patient-centered solutions has helped influence our vision for the future. Our strong ability to master and manage complexity is the key component in making high-quality products that provide value for patients.

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    INTERVIEW #SpeakPharma

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    “Our unmatched efficiency and track record of faster DMF filings give our customers a critical competitive advantage”

    “Our unmatched efficiency and track record of faster DMF filings give our customers a critical competitive advantage”

    This week, SpeakPharma interviews Pete Werth III, the new president of ChemWerth, a company that has been at the forefront of the generic pharmaceutical industry for over four decades. He shares his vision for ChemWerth, which includes his commitment to strengthening global manufacturing relationships, and enhancing supply chain resilience. Additionally, he highlights the key aspects of a successful drug master file (DMF). HIGHLIGHTS// Pete Werth III, the new president of ChemWerth/ vision for ChemWerth/ commitment to strengthening global manufacturing relationships/ key aspects of a successful drug master file Your father, Peter J. Werth, is recognized as one of the founders of the generic pharmaceutical industry, having built ChemWerth from the ground up over four decades ago. How do you view his legacy? As you take the helm, what key lessons or principles from his leadership do you intend to carry forward? My father, Peter J. Werth, is a true pioneer in the generic pharmaceutical industry. Over his 42‐year tenure, he not only built ChemWerth from a humble garage startup into a global leader in generic API development but also established standards that many in our industry now take for granted. Under his leadership, we filed our very first DMF in 1987 and have since achieved more than 500 DMF filings. With an average review cycle of just 0.79, we have been far outperforming the industry average of 2.5 cycles. His focus on quality, regulatory excellence, and a relentless commitment to customers’ success set the foundation for our reputation as a trusted supplier of over 500 APIs sourced from more than 30 cGMP-certified facilities worldwide. Equally inspiring is his dedication to nurture long-term, mutually beneficial relationships with manufacturing partners across the US, Europe, India, and China, as well as his passion for giving back to the community through philanthropic initiatives. As I take the helm, I intend to build on his guiding principles — sustaining our high standards of quality and compliance while pursuing innovation in regulatory strategy, diversifying our supply chain, and embracing new technologies and approaches to remain competitive in an evolving market. I will also strive to continue his legacy of mentorship, ensuring that our company culture remains rooted in integrity and diligence, with an unyielding focus on making safe, affordable medicines available worldwide. HIGHLIGHTS// trusted supplier of over 500 APIs/ 30 cGMP-certified facilities worldwide/ embracing new technologies and approaches to remain competitive What are your top priorities as the new president of ChemWerth? How do you plan to strengthen and expand relationships with manufacturers worldwide? My immediate priorities as the new president are twofold: to enhance the value we deliver to our customers and, to deepen our relationships with our manufacturing partners worldwide. We will further diversify our supply chain and broaden our product portfolio. Our expansion plans include upgrading equipment, and hiring additional highly skilled scientists, engineers, and GMP auditors. We will also leverage our proprietary product selection and regulatory submission processes. These processes help us get the regulatory filing right the first time, and allows us to be approved 44 percent faster than the industry average. This helps our customers gain a competitive edge in the market. In essence, by strengthening operational excellence and expanding our global network, we intend to continue the company’s long-standing commitment to customer success and process innovation. We plan to reinforce our long-standing relationships with our manufacturers — especially those in strategic markets like China and India — by helping our partners meet the highest standards of regulatory compliance and current good manufacturing practice (cGMP) quality. This balanced approach of strengthening existing partnerships while pioneering new ones is key to maintaining and growing our competitive edge. HIGHLIGHTS// diversify our supply chain and broaden our product portfolio/ commitment to customer success and process innovation/ filings approved 44 percent faster than the industry average When ChemWerth last spoke to PharmaCompass, there was a mention of investing millions of dollars in expanding manufacturing partnerships in China and India. Can you elaborate on the success of these partnerships, and how have they contributed to ChemWerth’s overall growth? Our strategic, multimillion-dollar investments in manufacturing partnerships are a cornerstone of our growth strategy. Over the past few years, these joint ventures have proven their worth by diversifying our supply base and mitigating the risk of global supply chain disruptions — a lesson that became all too clear during the Covid-19 pandemic. These investments are already paying dividends. They help us support manufacturers producing steroids, hormones, veterinary products, and large-volume APIs, while also accelerating the development of small-molecule inhibitors and new generic APIs. We have ensured that our partners are equipped with the latest equipment and trained personnel to meet cGMP standards. By partnering with facilities in these markets, we now have access to state-of-the-art production capabilities that enable us to produce a wider range of APIs at competitive costs. The success of these partnerships is evident in our ability to consistently file DMFs rapidly — often on the first cycle — and deliver affordable, high-quality medicines to patients worldwide. This supports our clients’ growth trajectory and has helped us expand into new markets. This strategy has reinforced our global footprint — supporting our presence in 38 countries with over 100 products — and positioned us well to capitalize on a global generic drug market projected to grow at a compounded annual growth rate of 5.4 percent from 2022 to 2030, to reach a size of US$ 671 billion by 2030. HIGHLIGHTS// strategic multimillion-dollar investments/ support manufacturers producing steroid, hormone, veterinary products/ development of small-molecule inhibitors and new generic APIs/ ensured partners are equipped with the latest equipment and trained personnel ChemWerth has an impressive track record, and an over 40-year relationship with the US Food and Drug Administration (FDA). What are the key aspects of a successful DMF? Are there specific challenges manufacturers face in preparing DMFs, and how does ChemWerth help them overcome these hurdles? ChemWerth’s record of filing over 500 DMFs in 38 countries reflects our commitment to excellence in regulatory compliance and quality management. A successful DMF is built on comprehensive documentation that rigorously follows cGMP guidelines, robust analytical validation, and detailed tracking of every step. Every DMF we file meticulously details the entire manufacturing process — from raw material acquisition to final batch production. This comprehensive approach ensures that our submissions meet the rigorous quality, safety, and efficacy standards expected by the FDA. Our team stays continuously updated on the evolving guidelines and protocols, which allows us to file DMFs that align with current FDA practices. We recognize that many manufacturers face challenges such as complex regulatory requirements, lengthy review cycles, and the need for precise coordination between various production stages. ChemWerth helps them overcome these hurdles by offering end-to-end regulatory support, detailed internal audits, and continuous training on cGMP and FDA requirements. Our efficiency is a critical competitive advantage. By receiving approvals 44 percent faster than the industry average, we help our customers get their products to market faster, resulting in larger market share and increased profits. HIGHLIGHTS// over 500 DMFs in 38 countries/ robust analytical validation/ end-to-end regulatory support What is your vision for ChemWerth over the next few years? How do you plan to navigate the challenges and opportunities in the generic pharmaceutical industry? I plan to continue to add value for our customers, and look for innovative ways to compete in today’s generic pharmaceutical landscape. At ChemWerth, our vision for the future is rooted in both our proud legacy and our relentless drive for innovation. We will further diversify our supply chain and expand our product portfolio. We have begun leveraging our expertise to supply APIs for biosimilars and new drug applications (NDAs), while maintaining our reputation for rapid regulatory approvals. With unwavering determination, we uphold our “First to Quality. Fast to Market.” approach — delivering high-quality APIs to customers worldwide while leveraging our expertise to give them a competitive edge in their markets. HIGHLIGHTS// supply APIs for biosimilars and NDAs/ give customers a competitive edge in their markets 

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    12 Mar 2025
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    CDMO Activity Tracker: Axplora enhances ADC capacities, Quotient beefs up HPAPI capabilities; Evonik, EUROAPI forge deals

    CDMO Activity Tracker: Axplora enhances ADC capacities, Quotient beefs up HPAPI capabilities; Evonik, EUROAPI forge deals

    The contract development and manufacturing organization (CDMO) sector witnessed significant activity in the first quarter (Q1) of 2025, characterized by strategic investments, facility expansions, and collaborative partnerships.The quarter saw some significant deals. WuXi Biologics agreed to sell its vaccine manufacturing facility in Dundalk, Ireland, to Merck for € 500 million (US$  521 million). Quadria Capital announced the acquisition of a 10 percent stake in Aragen for US$ 100 million. This investment will help Aragen accelerate its research and development efforts.Some CDMOs, like India-based Syngene International and Belgium-based Ardena expanded their presence in the US market. Syngene completed the acquisition of its first US biologics facility that it had purchased from Emergent Manufacturing Operations Baltimore for US$ 36.5 million. And, leading nanomedicine developer Ardena purchased a drug manufacturing unit in New Jersey from Catalent.  View CDMO Activity Tracker for Q1 2025 (Free Excel Available) Axplora expands its ADC capacities; Quotient Sciences wraps up HPAPI unit upgradeThe antibody-drug conjugate (ADC) market saw considerable investments by CDMOs. Axplora expanded its commercial payload production capabilities at its Le Mans site in France, reinforcing its position as a leading player in ADC manufacturing. This expansion is part of the France 2030 program and builds on Axplora’s track record of supplying 40 percent of the world’s marketed ADCs and 50 percent of ADCs approved by the US Food and Drug Administration (FDA).Samsung Biologics said it will support a series of LigaChem Biosciences’ ADC programs at its new dedicated ADC facility. Similarly, Cerbios-Pharma announced significant enhancements to its ADC production capabilities. Cerbios also announced the expansion of its high potency active pharmaceutical ingredients (HPAPIs) production capabilities. On March 31, Cerbios-Pharma got acquired by Healthcare Advanced Synthesis, a leading developer of APIs, HPAPIs and anticancer compounds. Both these global players are based in Switzerland. Overall, HPAPIs saw significant investments. Quotient Sciences made headlines with the successful completion of a US$ 1.4 million project designed to improve high potency handling capabilities at its Philadelphia (US) facility. The initiative focused on upgrading infrastructure and implementing advanced safety protocols to manage HPAPIs more effectively.Polfa Tarchomin achieved significant milestones in enhancing its pharmaceutical manufacturing capabilities. The company successfully completed the site acceptance test (SAT) for its vial filling and packaging line at the Center for Development and Production of Highly Potent Drugs, ensuring full functionality and compliance with good manufacturing practice (GMP) standards.Additionally, Polfa Tarchomin is installing a high-tech, high-containment robotic ONCO LINE designed for aseptic production of highly potent pharmaceutical products, including lyophilisates and liquid formulations in vials and pre-filled syringes. Developed in collaboration with leading global suppliers, this line supports multiple packaging formats and comes with advanced systems. With an annual production capacity of up to 6 million units, this line will set a new benchmark in pharmaceutical manufacturing.In a significant development for analytical testing, SK Pharmteco launched an enhanced laboratory specifically designed for HPAPIs. The new facility is in California (US).  View CDMO Activity Tracker for Q1 2025 (Free Excel Available) Evonik expands RNA portfolio; Catalent to support Galapagos’ CAR-T therapy trialsThe success of mRNA vaccines and the growing interest in RNA therapeutics is luring CDMOs to rapidly expand their capabilities in this emerging area. Evonik, in collaboration with ST Pharm, announced plans to expand its portfolio of RNA and nucleic acid therapeutic services during Q1. The partnership enables Evonik to provide customized nucleic acids from ST Pharm alongside its portfolio of lipid and lipid nanoparticle (LNP) drug product development services.ReciBioPharm secured a grant from the Bill & Melinda Gates Foundation to advance RNA manufacturing technologies that meet FDA standards with a focus on improving access to RNA therapeutics in low- and middle-income countries.The cell and gene therapy sector also witnessed remarkable activity in Q1 2025. Catalent announced it will support Galapagos’ decentralized CAR T therapy trials for GLPG5101 for relapsed/refractory non-Hodgkin lymphoma indications.Similarly, AGC Biologics announced it will manufacture and supply lentiviral vectors for Adaptimmune’s solid tumor cell therapy initiatives. And, Genenta and AGC Biologics strengthened their cell therapy manufacturing pact through a collaboration agreement. This grants Genenta access to the exclusive GMP suite at the AGC Biologics Cell and Gene Center of Excellence in Milan, dedicated to manufacturing cell therapy products.  View CDMO Activity Tracker for Q1 2025 (Free Excel Available) EUROAPI, StrainChem join hands to develop peptides; Fermion expands flow chemistry capabilitiesEven traditional therapeutics like peptides and small molecules saw considerable investments by CDMOs. For instance, EUROAPI and StrainChem announced a collaborative venture to develop liquid phase peptides. The partnership aims to harness advanced synthesis techniques and innovative technologies for more efficient peptide manufacturing. Through this collaboration, EUROAPI and StrainChem will offer their customers a one-stop shop solution for peptides. In one of the most ambitious expansions announced this quarter, CordenPharma unveiled plans to invest over € 1 billion (US$ 1.10 billion) over the next three years in building and expanding small, medium, and large peptide manufacturing facilities across Europe and the US. That includes a new greenfield facility for peptide manufacturing in the Basel region of Switzerland, valued at over € 500 million (US$ 553 million).In obesity treatments, Viking Therapeutics agreed to pay US$ 150 million to CordenPharma for the production of its dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) agonist VK2735.In a show of confidence, Indian CDMO Neuland Labs’ board approved a ₹ 3.42 billion (approximately US$ 42 million) capital expenditure plan. The approved capex is earmarked for enhancing the company’s peptide synthesizer reactor capacity and building additional capacity to meet growing demand.In the small molecule space, Fermion announced a strategic investment to expand its flow chemistry capabilities, aiming to enhance processes and sustainability by integrating continuous flow techniques into manufacturing. This technology offers advantages in scalability, process control, and safety, positioning Fermion at the forefront of pharmaceutical innovation.Recipharm announced a major expansion of its aseptic filling capabilities, encompassing process development, pilot-scale production, and clinical supply operations. Similarly, Curia announced significant expansions to its global network of sterile fill-finish sites, aiming to enhance production capacity, streamline supply chains, and improve overall quality in sterile pharmaceutical manufacturing.  View CDMO Activity Tracker for Q1 2025 (Free Excel Available) Our viewDuring Q1 2025, the CDMO sector continued to evolve towards higher-value and more complex services. This only underscores the crucial role CDMOs are playing in supporting growth and innovation in the pharmaceutical industry.With the Trump administration in the US triggering a global tariff war, drugmakers have no option but to reshape their supply chains. And this means more business for CDMOs that manufacture drugs in the US. In the coming quarter, we expect strong dealmaking and increased focus on innovation in the CDMO sector. 
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    10 Apr 2025
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    NEWS #PharmaBuzz

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    Mallinckrodt plc to Report Q1 2025 Earnings
    Mallinckrodt plc to Report Q1 2025 Earnings

    10 Apr 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/mallinckrodt-plc-to-report-earnings-results-for-first-quarter-2025-302424998.html

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    Mallinckrodt and Endo get a bump from tariffs in $6.7 billion merger
    Mallinckrodt and Endo get a bump from tariffs in $6.7 billion merger

    14 Mar 2025

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/drugmakers-mallinckrodt-endo-merge-nearly-7-billion-deal-2025-03-13/

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    14 Mar 2025
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    Mallinckrodt plc Reports Q4 and FY 2024 Results, 2025 Guidance
    Mallinckrodt plc Reports Q4 and FY 2024 Results, 2025 Guidance

    13 Mar 2025

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    https://www.prnewswire.com/news-releases/mallinckrodt-plc-reports-fourth-quarter-and-fiscal-year-2024-financial-results-and-provides-2025-guidance-302400719.html

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    13 Mar 2025
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    Mallinckrodt plc Reschedules Q4 & FY 2024 Results to March 13
    Mallinckrodt plc Reschedules Q4 & FY 2024 Results to March 13

    10 Mar 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/mallinckrodt-plc-reschedules-release-of-fourth-quarter-and-fiscal-year-2024-financial-results-to-thursday-march-13-2025-302397490.html

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    10 Mar 2025
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    CVC Completes Acquisition of Therakos from Mallinckrodt
    CVC Completes Acquisition of Therakos from Mallinckrodt

    02 Dec 2024

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20241202409570/en

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    02 Dec 2024
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    Mallinckrodt Completes Divestiture of Therakos® Business
    Mallinckrodt Completes Divestiture of Therakos® Business

    02 Dec 2024

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/mallinckrodt-completes-divestiture-of-therakos-business-302319183.html

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    02 Dec 2024
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    Drugs in Development

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    Mallinckrodt Reaches Agreement to Sell Therakos® Business to CVC for $925 Million

    Details:

    Through the acquisition, CVC will leverage the Company's Therakos Uvadex (methoxsalen), a fully integrated ECP delivery system for skin manifestations of Cutaneous T-cell lymphoma.


    Lead Product(s): Methoxsalen

    Therapeutic Area: Oncology Brand Name: Uvadex

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: CVC Capital Partners

    Deal Size: $925.0 million Upfront Cash: Undisclosed

    Deal Type: Acquisition May 08, 2024

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    Lead Product(s) : Methoxsalen

    Therapeutic Area : Oncology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : CVC Capital Partners

    Deal Size : $925.0 million

    Deal Type : Acquisition

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    Mallinckrodt Reaches Agreement to Sell Therakos® Business to CVC for $925 Million

    Details : Through the acquisition, CVC will leverage the Company's Therakos Uvadex (methoxsalen), a fully integrated ECP delivery system for skin manifestations of Cutaneous T-cell lymphoma.

    Product Name : Uvadex

    Product Type : Other Small Molecule

    Upfront Cash : Undisclosed

    May 08, 2024

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    Mallinckrodt Gets FDA Approval for Acthar® Gel Single-Dose Pre-filled Injector

    Details:

    SelfJect (repository corticotropin) is an ACTH analogue indicated as monotherapy for infantile spasms in children under 2 and exacerbations of multiple sclerosis in adults.


    Lead Product(s): Corticotropin

    Therapeutic Area: Neurology Brand Name: Acthar

    Study Phase: Approved FDFProduct Type: Hormone

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable January 03, 2024

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    Lead Product(s) : Corticotropin

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

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    Mallinckrodt Gets FDA Approval for Acthar® Gel Single-Dose Pre-filled Injector

    Details : SelfJect (repository corticotropin) is an ACTH analogue indicated as monotherapy for infantile spasms in children under 2 and exacerbations of multiple sclerosis in adults.

    Product Name : Acthar

    Product Type : Hormone

    Upfront Cash : Inapplicable

    January 03, 2024

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    Mallinckrodt Receives U.S. FDA Approval for Lisdexamfetamine Dimesylate Capsules and Launches Product Used to Treat Attention-Deficit/Hyperactivity Diso...

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    Lisdexamfetamine Dimesylate Capsules are a federally controlled substance (CII) used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) and other indications and currently are on the FDA's drug shortage list.


    Lead Product(s): Lisdexamfetamine Dimesylate

    Therapeutic Area: Psychiatry/Psychology Brand Name: Vyvanse-Generic

    Study Phase: Approved FDFProduct Type: Controlled Substance

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 31, 2023

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    Lead Product(s) : Lisdexamfetamine Dimesylate

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

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    Mallinckrodt Receives U.S. FDA Approval for Lisdexamfetamine Dimesylate Capsules and Launches Prod...

    Details : Lisdexamfetamine Dimesylate Capsules are a federally controlled substance (CII) used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) and other indications and currently are on the FDA's drug shortage list.

    Product Name : Vyvanse-Generic

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    August 31, 2023

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    Mallinckrodt Announces FDA Clearance of the INOmax® EVOLVE™ DS Delivery System and Approval of the INOmax® (nitric oxide) Mini-Cylinder

    Details:

    INOmax® EVOLVE™ DS delivery system has been cleared by the U.S. Food and Drug Administration for the delivery of INOmax® (nitric oxide) gas, for inhalation, for the treating neonatal patients with hypoxic respiratory failure


    Lead Product(s): Nitric Oxide

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: INOmax

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable July 12, 2023

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    Lead Product(s) : Nitric Oxide

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

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    Mallinckrodt Announces FDA Clearance of the INOmax® EVOLVE™ DS Delivery System and Approval of ...

    Details : INOmax® EVOLVE™ DS delivery system has been cleared by the U.S. Food and Drug Administration for the delivery of INOmax® (nitric oxide) gas, for inhalation, for the treating neonatal patients with hypoxic respiratory failure

    Product Name : INOmax

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    July 12, 2023

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    Silence Therapeutics to Buyback siRNA Complement Assets

    Details:

    Silence will gain rights back to 2 undisclosed complement targets. SLN501, the C3 targeting program will remain under the agreement. Silence’s proprietary mRNAi GOLD™ platform can be used to create siRNAs that precisely target and silence disease-associated genes in the liver.


    Lead Product(s): Undisclosed

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

    Study Phase: IND EnablingProduct Type: Other Large Molecule

    Sponsor: Silence Therapeutics

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement March 28, 2023

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    05

    Mallinckrodt Pharmaceuticals

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    Lead Product(s) : Undisclosed

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : IND Enabling

    Partner/Sponsor/Collaborator : Silence Therapeutics

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Silence Therapeutics to Buyback siRNA Complement Assets

    Details : Silence will gain rights back to 2 undisclosed complement targets. SLN501, the C3 targeting program will remain under the agreement. Silence’s proprietary mRNAi GOLD™ platform can be used to create siRNAs that precisely target and silence disease-ass...

    Product Name : Undisclosed

    Product Type : Other Large Molecule

    Upfront Cash : Undisclosed

    March 28, 2023

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    Mallinckrodt to Present Data on TERLIVAZ® (terlipressin) for Injection in Adult Patients with Hepatorenal Syndrome (HRS) at the American College of Gas...

    Details:

    TERLIVAZ (terlipressin) is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function, an acute and life-threatening condition requiring hospitalization.


    Lead Product(s): Terlipressin Acetate

    Therapeutic Area: Nephrology Brand Name: Terlivaz

    Study Phase: Approved FDFProduct Type: Other Large Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 24, 2022

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    06

    Mallinckrodt Pharmaceuticals

    Ireland
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    Mallinckrodt Pharmaceuticals

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    Lead Product(s) : Terlipressin Acetate

    Therapeutic Area : Nephrology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Mallinckrodt to Present Data on TERLIVAZ® (terlipressin) for Injection in Adult Patients with Hep...

    Details : TERLIVAZ (terlipressin) is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function, an acute and life-threatening condition requiring hospitalization.

    Product Name : Terlivaz

    Product Type : Other Large Molecule

    Upfront Cash : Inapplicable

    October 24, 2022

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    Mallinckrodt Announces Submission of 510(k) to the U.S. FDA for Inhaled Nitric Oxide Delivery System

    Details:

    INOmax® (nitric oxide) gas, for inhalation, is an FDA-approved treatment that is indicated to improve oxygenation and reduce need for extracorporeal membrane oxygenation in term and near-term neonates with hypoxic respiratory failure associated.


    Lead Product(s): Nitric Oxide

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: INOmax

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 28, 2022

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    07

    Mallinckrodt Pharmaceuticals

    Ireland
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    German Wound Congress
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    Lead Product(s) : Nitric Oxide

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Mallinckrodt Announces Submission of 510(k) to the U.S. FDA for Inhaled Nitric Oxide Delivery Syst...

    Details : INOmax® (nitric oxide) gas, for inhalation, is an FDA-approved treatment that is indicated to improve oxygenation and reduce need for extracorporeal membrane oxygenation in term and near-term neonates with hypoxic respiratory failure associated.

    Product Name : INOmax

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    September 28, 2022

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    Mallinckrodt Receives U.S. FDA Approval for Terlivaz® (terlipressin) for injection for the Treatment of Hepatorenal Syndrome (HRS)

    Details:

    Terlivaz (terlipressin) is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function, an acute and life-threatening condition requiring hospitalization.


    Lead Product(s): Terlipressin Acetate

    Therapeutic Area: Nephrology Brand Name: Terlivaz

    Study Phase: Approved FDFProduct Type: Other Large Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 14, 2022

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    08

    Mallinckrodt Pharmaceuticals

    Ireland
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    German Wound Congress
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    Lead Product(s) : Terlipressin Acetate

    Therapeutic Area : Nephrology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Mallinckrodt Receives U.S. FDA Approval for Terlivaz® (terlipressin) for injection for the Treatm...

    Details : Terlivaz (terlipressin) is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function, an acute and life-threatening condition requiring hospitalization.

    Product Name : Terlivaz

    Product Type : Other Large Molecule

    Upfront Cash : Inapplicable

    September 14, 2022

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    Mallinckrodt to Present Data on Terlipressin in Adult Patients with Hepatorenal Syndrome (HRS) at the European Association for the Study of the Liver (E...

    Details:

    Teripress (Terlipressin) is an analogue of vasopressin used as a vasoactive drug in the management of hypotension which has been found to be effective when norepinephrine fails.


    Lead Product(s): Terlipressin Acetate

    Therapeutic Area: Nephrology Brand Name: Terlivaz

    Study Phase: Approved FDFProduct Type: Other Large Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 23, 2022

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    09

    Mallinckrodt Pharmaceuticals

    Ireland
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    German Wound Congress
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    Mallinckrodt Pharmaceuticals

    Ireland
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    German Wound Congress
    Not Confirmed
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    Lead Product(s) : Terlipressin Acetate

    Therapeutic Area : Nephrology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Mallinckrodt to Present Data on Terlipressin in Adult Patients with Hepatorenal Syndrome (HRS) at ...

    Details : Teripress (Terlipressin) is an analogue of vasopressin used as a vasoactive drug in the management of hypotension which has been found to be effective when norepinephrine fails.

    Product Name : Terlivaz

    Product Type : Other Large Molecule

    Upfront Cash : Inapplicable

    June 23, 2022

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    Mallinckrodt Announces Resubmission of Terlipressin to the FDA for the Treatment of Hepatorenal Syndrome

    Details:

    Teripress (Terlipressin) is an investigational agent, to treat adults with hepatorenal syndrome (HRS) involving rapid reduction in kidney function, an acute and life-threatening condition.


    Lead Product(s): Terlipressin Acetate

    Therapeutic Area: Nephrology Brand Name: Terlivaz

    Study Phase: Approved FDFProduct Type: Other Large Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 13, 2022

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    10

    Mallinckrodt Pharmaceuticals

    Ireland
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    Lead Product(s) : Terlipressin Acetate

    Therapeutic Area : Nephrology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Mallinckrodt Announces Resubmission of Terlipressin to the FDA for the Treatment of Hepatorenal Sy...

    Details : Teripress (Terlipressin) is an investigational agent, to treat adults with hepatorenal syndrome (HRS) involving rapid reduction in kidney function, an acute and life-threatening condition.

    Product Name : Terlivaz

    Product Type : Other Large Molecule

    Upfront Cash : Inapplicable

    June 13, 2022

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