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Globe and Mail
15-05-2025
- Business
- Globe and Mail
Hodgkin's Lymphoma Pipeline Appears Robust With 15+ Key Pharma Companies Actively Working in the Therapeutics Segment
DelveInsight's, 'Hodgkin's Lymphoma Pipeline Insight 2025' report provides comprehensive insights about 15+ companies and 20+ pipeline drugs in Hodgkin's Lymphoma pipeline landscape. It covers the Hodgkin's Lymphoma pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Hodgkin's Lymphoma pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Discover the latest drugs and treatment options in the Hodgkin's Lymphoma Pipeline. Dive into DelveInsight's comprehensive report today! @ Hodgkin's Lymphoma Pipeline Outlook Key Takeaways from the Hodgkin's Lymphoma Pipeline Report In May 2025, Celgene announced a phase II study to Evaluate the Safety and Efficacy of Single-Agent Lenalidomide (Revlimid®, CC-5013) in Subjects With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma. In May 2025, Hoffmann-La Roche conducted a Phase I/II study designed to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of a novel T-Cell bispecific (TCB), glofitamab, administered by intravenous (IV) infusion as a single agent and in combination with obinutuzumab, following pre-treatment with a one-time, fixed dose of obinutuzumab. In May 2025, Bristol-Myers Squibb organized a study is to assess the safety, tolerability, drug levels, and preliminary efficacy of relatlimab plus nivolumab in pediatric and young adult participants with recurrent or refractory classical Hodgkin lymphoma and non-Hodgkin lymphoma. DelveInsight's Hodgkin's Lymphoma Pipeline report depicts a robust space with 15+ active players working to develop 20+ pipeline therapies for Hodgkin's Lymphoma treatment. The leading Hodgkin's Lymphoma Companies such as Merck Sharp & Dohme LLC, Affimed Therapeutics, Aurigene Oncology, AstraZeneca, Novartis Pharmaceuticals, Bristol-Myers Squibb, Italfarmaco, ADC Therapeutics and others. Promising Hodgkin's Lymphoma Pipeline Therapies such as HCD122, Resminostat (4SC-201), Ruxolitinib, AK105, ITF2357, Panobinostat, Obatoclax mesylate (GX15-070MS) and others. Stay ahead with the most recent pipeline outlook for Hodgkin's Lymphoma. Get insights into clinical trials, emerging therapies, and leading companies with DelveInsight @ Hodgkin's Lymphoma Treatment Drugs Hodgkin's Lymphoma Emerging Drugs Profile AFM 13: Affimed Therapeutics AFM13 is a first-in-class innate cell engager (ICE®) that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. AFM13 induces specific and selective killing of CD30-positive tumor cells, leveraging the power of the innate immune system by engaging and activating natural killer (NK) cells and macrophages. AFM13 is most advanced ICE® clinical program and was evaluated as monotherapy in a Phase IIB trial in patients with relapsed/refractory peripheral T cell lymphoma (REDIRECT). The study achieved an ORR of 32.4% demonstrating anti-tumor activity with a DOR of 2.3 months and a well-managed safety profile. AFM13 is a tetravalent bispecific innate cell engager designed to act as a bridge between the innate immune cells and the tumor creating the necessary proximity for the innate immune cells to specifically destroy the tumor cells. Currently it is in Phase II stage of clinical trial evaluation to treat Hodgkin's Lymphoma. AUR105 : Aurigene Oncology AUR105 is a small molecule that acts by targeting protein arginine methyltransferase 5 (PRMT5). The drug candidate is also under development for other indications like solid tumor, non-Hodgkin lymphoma, leukemia or Hodgkin lymphoma. The drug candidate is administered through oral route. Currently the drug is being evaluated in Phase I for the treatment of Hodgkin's Lymphoma. The Hodgkin's Lymphoma Pipeline Report Provides Insights into The report provides detailed insights about companies that are developing therapies for the treatment of Hodgkin's Lymphoma with aggregate therapies developed by each company for the same. It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Hodgkin's Lymphoma Treatment. Hodgkin's Lymphoma Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects. Hodgkin's Lymphoma Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Hodgkin's Lymphoma market Explore groundbreaking therapies and clinical trials in the Hodgkin's Lymphoma Pipeline. Access DelveInsight's detailed report now! @ New Hodgkin's Lymphoma Drugs Hodgkin's Lymphoma Companies Merck Sharp & Dohme LLC, Affimed Therapeutics, Aurigene Oncology, AstraZeneca, Novartis Pharmaceuticals, Bristol-Myers Squibb, Italfarmaco, ADC Therapeutics and others. Hodgkin's Lymphoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Oral Parenteral intravenous Subcutaneous Topical Hodgkin's Lymphoma Products have been categorized under various Molecule types such as Monoclonal Antibody Peptides Polymer Small molecule Gene therapy Unveil the future of Hodgkin's Lymphoma Treatment. Learn about new drugs, pipeline developments, and key companies with DelveInsight's expert analysis @ Hodgkin's Lymphoma Market Drivers and Barriers Scope of the Hodgkin's Lymphoma Pipeline Report Coverage- Global Hodgkin's Lymphoma Companies- Merck Sharp & Dohme LLC, Affimed Therapeutics, Aurigene Oncology, AstraZeneca, Novartis Pharmaceuticals, Bristol-Myers Squibb, Italfarmaco, ADC Therapeutics and others. Hodgkin's Lymphoma Pipeline Therapies- HCD122, Resminostat (4SC-201), Ruxolitinib, AK105, ITF2357, Panobinostat, Obatoclax mesylate (GX15-070MS) and others. Hodgkin's Lymphoma Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination Hodgkin's Lymphoma Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Get the latest on Hodgkin's Lymphoma Therapies and clinical trials. Download DelveInsight's in-depth pipeline report today! @ Hodgkin's Lymphoma Companies, Key Products and Unmet Needs Table of Contents Introduction Executive Summary Hodgkin's Lymphoma: Overview Pipeline Therapeutics Therapeutic Assessment Hodgkin's Lymphoma – DelveInsight's Analytical Perspective Late Stage Products (Phase III) Drug Name: Company Name Drug profiles in the detailed report….. Mid-Stage Products (Phase II) AFM13: Affimed Therapeutics Drug profiles in the detailed report….. Early Stage Products (Phase I) AUR105 : Aurigene Oncology Drug profiles in the detailed report….. Preclinical and Discovery Stage Products Drug Name: Company Name Drug profiles in the detailed report….. Inactive Products Hodgkin's Lymphoma Key Companies Hodgkin's Lymphoma Key Products Hodgkin's Lymphoma- Unmet Needs Hodgkin's Lymphoma- Market Drivers and Barriers Hodgkin's Lymphoma- Future Perspectives and Conclusion Hodgkin's Lymphoma Analyst Views Hodgkin's Lymphoma Key Companies Appendix About Us DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Yash Bhardwaj Email: Send Email Phone: 09650213330 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: NV Country: United States Website:
Reuters
08-04-2025
- Business
- Reuters
Bristol Myers wins dismissal of lawsuit alleging Pomalyst monopoly
NEW YORK, April 8 (Reuters) - Bristol Myers Squibb (BMY.N), opens new tab won the dismissal of a proposed class action accusing it of fraudulently obtaining patents and filing sham patent lawsuits to maintain an illegal monopoly on its blockbuster blood cancer drug Pomalyst, keeping cheaper generic versions off the market. In a 70-page decision made public on Tuesday, U.S. District Judge Edgardo Ramos in Manhattan said the health insurer Blue Cross Blue Shield of Louisiana and other Pomalyst purchasers failed to show that Bristol Myers and the former Celgene Corp violated the federal Sherman antitrust law. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. Ramos said the plaintiff purchasers failed to establish fraud in the procurement of six patents related to Pomalyst. He also said they failed to show how nine lawsuits that Celgene filed between 2017 and 2020 against generic drug producers such as Teva ( opens new tab and Mylan (VTRS.O), opens new tab were "objectively baseless" and led to fraudulent settlements. Lawyers for the plaintiffs did not immediately respond to requests for comment. The plaintiffs claimed they were overcharged for Pomalyst since at least October 2020, when generic versions of the multiple myeloma treatment allegedly could have been launched but for the defendants' alleged illegal scheme. Pomalyst sales totaled $3.55 billion in 2024, or about 7.3% of Bristol Myers' $48.3 billion of overall revenue. The drug was developed by Celgene, which Bristol Myers bought in 2019. Bristol Myers is based in Princeton, New Jersey. The case is Louisiana Health Service & Indemnity Co et al v Celgene Corp et al, U.S. District Court, Southern District of New York, No. 23-07871.
Yahoo
10-02-2025
- Business
- Yahoo
Iovance Biotherapeutics Appoints Dan Kirby as Chief Commercial Officer
SAN CARLOS, Calif., Feb. 10, 2025 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced that Dan Kirby will join the Company's executive leadership team in the newly created role of Chief Commercial Officer, effective today. 'I would like to extend a warm welcome to Dan Kirby on behalf of the entire Iovance team,' stated Frederick Vogt, Ph.D., J.D., Interim President, Chief Executive Officer and board member of Iovance. 'Dan has been instrumental in building and leading cell therapy commercial organizations since the earliest developments in the field. He is the perfect fit for Chief Commercial Officer as we grow the U.S. launch of Amtagvi and prepare to enter new markets around the world while also expanding our Proleukin sales.' Prior to joining Iovance, Mr. Kirby led global commercial strategy for an emerging cell therapy platform of products as Chief Commercial Officer of Orca Bio. From 2018 to 2020, he served as Chief Commercial Officer at Omeros Corporation, overseeing U.S. and EU launch readiness for narsoplimab, a lectin pathway inhibitor, for hematopoietic stem cell transplantation-associated thrombotic microangiopathy. Previously, he led market access, reimbursement and marketing efforts for CAR T products as Vice President and Head of US Cell and Gene at Celgene (now Bristol-Myers Squibb). He joined Celgene following the acquisition of Juno Therapeutics, where he was Vice President of Marketing and Market Access. Earlier in his career, Mr. Kirby was Head of Marketing for Medivation (now Pfizer) and held various commercial roles of increasing responsibility during a 14-year tenure at Amgen. His strengths also include market engagement, reimbursement landscape evaluation, value story creation, key opinion leader outreach, communications and advocacy. 'I am pleased to join Iovance at such an exciting time as we catalyze and expand the commercial launch of Amtagvi and growth of Proleukin within the U.S. and beyond,' said Mr. Kirby. 'As the global leader in TIL cell therapy, Iovance is strongly positioned to be the flagship cell therapy company for many thousands of patients with solid tumor cancers for decades to come.' About Iovance Biotherapeutics, Inc. Iovance Biotherapeutics, Inc. aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system's ability to recognize and destroy diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. Iovance's Amtagvi® is the first FDA-approved T cell therapy for a solid tumor indication. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information, please visit Amtagvi® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners. Forward-Looking Statements Certain matters discussed in this press release are 'forward-looking statements' of Iovance Biotherapeutics, Inc. (hereinafter referred to as the 'Company,' 'we,' 'us,' or 'our') within the meaning of the Private Securities Litigation Reform Act of 1995 (the 'PSLRA'). Without limiting the foregoing, we may, in some cases, use terms such as 'predicts,' 'believes,' 'potential,' 'continue,' 'estimates,' 'anticipates,' 'expects,' 'plans,' 'intends,' 'forecast,' 'guidance,' 'outlook,' 'may,' 'can,' 'could,' 'might,' 'will,' 'should,' or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments, and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements, and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and include, but are not limited to, the following substantial known and unknown risks and uncertainties inherent in our business: the risks related to our ability to successfully commercialize our products, including Amtagvi, for which we have obtained U.S. Food and Drug Administration ('FDA') approval, and Proleukin, for which we have obtained FDA and European Medicines Agency ('EMA') approval; the risk that the EMA or other ex-U.S. regulatory authorities may not approve or may delay approval for our marketing authorization application submission for lifileucel in metastatic melanoma; the acceptance by the market of our products, including Amtagvi and Proleukin, and their potential pricing and/or reimbursement by payors, if approved (in the case of our product candidates), in the U.S. and other international markets and whether such acceptance is sufficient to support continued commercialization or development of our products, including Amtagvi and Proleukin, or product candidates, respectively; future competitive or other market factors may adversely affect the commercial potential for Amtagvi or Proleukin; the risk regarding our ability or inability to manufacture our therapies using third party manufacturers or at our own facility, including our ability to increase manufacturing capacity at such third party manufacturers and our own facility, may adversely affect our commercial launch; the results of clinical trials with collaborators using different manufacturing processes may not be reflected in our sponsored trials; the risk regarding the successful integration of the recent Proleukin acquisition; the risk that the successful development or commercialization of our products, including Amtagvi and Proleukin, may not generate sufficient revenue from product sales, and we may not become profitable in the near term, or at all; the risks related to the timing of and our ability to successfully develop, submit, obtain, or maintain FDA, EMA, or other regulatory authority approval of, or other action with respect to, our product candidates; whether clinical trial results from our pivotal studies and cohorts, and meetings with the FDA, EMA, or other regulatory authorities may support registrational studies and subsequent approvals by the FDA, EMA, or other regulatory authorities, including the risk that the planned single arm Phase 2 IOV-LUN-202 trial may not support registration; preliminary and interim clinical results, which may include efficacy and safety results, from ongoing clinical trials or cohorts may not be reflected in the final analyses of our ongoing clinical trials or subgroups within these trials or in other prior trials or cohorts; the risk that enrollment may need to be adjusted for our trials and cohorts within those trials based on FDA and other regulatory agency input; the risk that the changing landscape of care for cervical cancer patients may impact our clinical trials in this indication; the risk that we may be required to conduct additional clinical trials or modify ongoing or future clinical trials based on feedback from the FDA, EMA, or other regulatory authorities; the risk that our interpretation of the results of our clinical trials or communications with the FDA, EMA, or other regulatory authorities may differ from the interpretation of such results or communications by such regulatory authorities (including from our prior meetings with the FDA regarding our non-small cell lung cancer clinical trials); the risk that clinical data from ongoing clinical trials of Amtagvi will not continue or be repeated in ongoing or planned clinical trials or may not support regulatory approval or renewal of authorization; the risk that unanticipated expenses may decrease our estimated cash balances and forecasts and increase our estimated capital requirements; the risk that we may not be able to recognize revenue for our products; the risk that Proleukin revenues may not continue to serve as a leading indicator for Amtagvi revenues; the risks regarding our anticipated operating and financial performance, including our financial guidance and projections; the effects of global pandemic; the effects of global and domestic geopolitical factors; and other factors, including general economic conditions and regulatory developments, not within our control. Any financial guidance provided in this press release assumes the following: no material change in our ability to manufacture our products; no material change in payor coverage; no material change in revenue recognition policies; no new business development transactions not completed as of the period covered by this press release; and no material fluctuation in exchange rates. CONTACTS Iovance Biotherapeutics, Inc:Sara Pellegrino, IRCSenior Vice President, Investor Relations & Corporate Communications650-260-7120 ext. Jen SaundersSenior Director, Investor Relations & Corporate Communications
