Lenalidomide

Legend Biotech Reports Third Quarter 2023 Results and Recent Highlights

Retrieved on: 
Monday, November 20, 2023
Oncology, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Webcast, Research, Carcinoma, Investment, Exercise, Patient, Nature, Collaboration, DLL3, Bortezomib, Investigational New Drug, Novartis, Janssen, Drug discovery, ASCT, Pharmaceutical industry, Cryptocurrency, Lenalidomide, Dexamethasone

Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, today reported its unaudited financial results for the three and nine months ended September 30, 2023 and key corporate highlights.

Key Points: 
  • Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, today reported its unaudited financial results for the three and nine months ended September 30, 2023 and key corporate highlights.
  • Legend Biotech shared the latest updates from its portfolio and pipeline, alongside its financial performance, including detailing Legend Biotech’s license agreement with Novartis.
  • Available at: https://classic.clinicaltrials.gov/ct2/show/NCT05257083
    Financial Results for Quarter Ended September 30, 2023
    As of September 30, 2023, Legend Biotech had approximately $1.4 billion of cash and cash equivalents, time deposits, and short-term investments.
  • License revenue for the three months ended September 30, 2023 was $20.1 million compared to no license revenue for the three months ended September 30, 2022.

Human medicines European public assessment report (EPAR): Pomalidomide Viatris, pomalidomide, Status: Opinion

Retrieved on: 
Monday, December 18, 2023
Dexamethasone, Medicine, Multiple myeloma, Anatomy, ATC, Lenalidomide, European Commission, International, INN, EMA, Civil service commission, Patient, Medication package insert, Marketing, CHMP, Bortezomib, Committee, Medical Subject Headings, Physician, HIV disease progression rates, Instrumentation, Vaccine, Generic drug, Pharmaceutical industry, Medicinal plants, Pomalidomide

Pomalidomide Viatris will be available as 1 mg, 2 mg, 3 mg and 4 mg hard capsules.

Key Points: 
  • Pomalidomide Viatris will be available as 1 mg, 2 mg, 3 mg and 4 mg hard capsules.
  • Pomalidomide Viatris is a generic of Imnovid, which has been authorised in the EU since 05 August 2013.
  • Studies have demonstrated the satisfactory quality of Pomalidomide Viatris and its bioequivalence to the reference product Imnovid.
  • Treatment with Pomalidomide Viatris should be carried out under the supervision of physicians experienced in the treatment of multiple myeloma.

Florida Cancer Specialists & Research Institute Contributing to Cutting-Edge Advancements in Hematology Science

Retrieved on: 
Wednesday, December 13, 2023
Annual Reviews (publisher), ASH, BTK, Research, Bortezomib, Omicron, Conference, Bangladesh Technical Education Board, Poster, Mantle cell lymphoma, SLL, Risk, Science, Abstract, Drug development, Tyrosine kinase, Society, B-cell lymphoma, FACP, Rituximab, Reversibility, Delta, Phase, Nivolumab, Hospital, Safety, DRD, MCL, FCS, FDA, Lymphocytosis, Pivotal trial, Chronic lymphocytic leukemia, Meta-analysis, Artery, Bias, Coronary thrombosis, NHL, CLL, Pharmaceutical industry, Dietary supplement, Vaccine, Birth control, Incidence, Patient, Dexamethasone, Lenalidomide, Hematology, Relapse, Dacarbazine, MD, Doxorubicin

FORT MYERS, Fla., Dec. 13, 2023 /PRNewswire/ -- Research conducted at Florida Cancer Specialists & Research Institute, LLC (FCS) was presented in the cutting-edge advancements being shared at the American Society of Hematology (ASH) 65th Annual Meeting and Exposition in San Diego on Dec. 9 - 12, 2023. Scientific abstracts submitted by FCS hematologists and medical oncologists were among the 7,000 accepted submissions selected through an extensive peer review process.

Key Points: 
  • FORT MYERS, Fla., Dec. 13, 2023 /PRNewswire/ -- Research conducted at Florida Cancer Specialists & Research Institute, LLC (FCS) was presented in the cutting-edge advancements being shared at the American Society of Hematology (ASH) 65th Annual Meeting and Exposition in San Diego on Dec. 9 - 12, 2023.
  • Scientific abstracts submitted by FCS hematologists and medical oncologists were among the 7,000 accepted submissions selected through an extensive peer review process.
  • Pirtobrutinib has also been approved for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
  • Once again, FCS is proud to have a strong presence, sharing the latest and most promising research and science that is moving the field forward."

DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based quadruplet therapy regimen shows significant improvement in outcomes for patients with transplant-eligible newly diagnosed multiple myeloma

Retrieved on: 
Tuesday, December 12, 2023
Dexamethasone, Multiple myeloma, TE, Johnson & Johnson, SAN, Lenalidomide, Progression-free survival, ASH, Risk, Abstract, PFS, MRD, Hyaluronidase, Bortezomib, Daratumumab, Death, Society, Confidence interval, HIV disease progression rates, Pharmaceutical industry, Vaccine

SAN DIEGO, Dec. 12, 2023 /PRNewswire/ -- Johnson & Johnson announced today the first data from the Phase 3 PERSEUS study highlighting significant clinical improvement with a DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based quadruplet induction, consolidation regimen and doublet maintenance regimen in the treatment of transplant-eligible (TE) newly diagnosed multiple myeloma (NDMM). The data, showing an unrivaled progression-free survival (PFS) in a Phase 3 study evaluating TE NDMM and clinically significant improvement of rates of overall complete response (CR) or better and minimal residual disease (MRD) negativity over the comparator arm, were featured as a late-breaking oral presentation at the 2023 American Society of Hematology (ASH) Annual Meeting (Abstract #LBA-1). The data were published simultaneously in The New England Journal of Medicine.

Key Points: 
  • The data were published simultaneously in The New England Journal of Medicine .
  • Overall MRD negativity rates (10–5) were higher with D-VRd vs VRd (75.2 percent vs 47.5 percent; P
  • Overall survival (OS) data are not yet mature but trending favorably for the D-VRd arm compared to VRd.
  • "We will continue to advance innovative regimens and approaches with DARZALEX to deliver on our commitment of transforming outcomes for patients with multiple myeloma."

AMGEN HIGHLIGHTS HEMATOLOGY PORTFOLIO AT ASH 2023

Retrieved on: 
Friday, December 8, 2023
Bone marrow, Prednisone, Daratumumab, Consolidation, National Cancer Institute, ASH, NCI, Research and development, Measure (mathematics), VMP, Acute lymphoblastic leukemia, Ageing, Exposition, ECOG, Phase, Society, Relapse, Bangladesh Technical Education Board, AMGN, Amgen, Pharmaceutical industry, Nursing, Flour, Medical imaging, Veterinary medicine, Communications satellite, Blinatumomab, Research, Lenalidomide, Patient, Dexamethasone, Carfilzomib

THOUSAND OAKS, Calif., Dec. 8, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of new data from its blood cancer portfolio and pipeline at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition, taking place from Dec. 9-12 in San Diego.

Key Points: 
  • THOUSAND OAKS, Calif., Dec. 8, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of new data from its blood cancer portfolio and pipeline at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition, taking place from Dec. 9-12 in San Diego.
  • "Data at this year's ASH meeting illustrate the expanding potential of our innovative hematology medicines, BLINCYTO and KYPROLIS, as well as our commitment to providing additional treatment options with our biosimilar eculizumab," said David M. Reese, M.D., executive vice president of Research and Development at Amgen.
  • "As the pioneer of T-cell engager technology and building on nearly a decade of real-world experience, we continue to advance our first-in-class BiTE® molecule, BLINCYTO, into earlier lines of treatment where we have seen encouraging data in patients living with acute lymphoblastic leukemia."
  • Preliminary Results of the Gimema ALLL2820 Trial
    Abstract # 4249 , Session #614, Monday, December 11 from 6:00 - 8:00 p.m. PT
    *E1910 is sponsored by National Cancer Institute (NCI), part of the National Institutes of Health, and conducted by the NCI Funded National Clinical Trial Network.

Lucio N. Gordan, MD is Lead Author of First Real-World Study Comparing Preferred Treatments for Multiple Myeloma

Retrieved on: 
Wednesday, November 22, 2023
Bone marrow, End organ damage, Immune system, Food, Multiple myeloma, DRD, Progression-free survival, Risk, FCS, Clinical trial, TIE, Patient, PFS, Lenalidomide, Death, HIV disease progression rates, Vaccine, Pharmaceutical industry, Dexamethasone, ScienceDirect

FORT MYERS, Fla., Nov. 22, 2023 /PRNewswire/ -- Medical oncologist Lucio N. Gordan MD, president and managing physician of Florida Cancer Specialists & Research Institute, LLC (FCS), is lead author of the first real-world study comparing the two preferred regimens recommended for the primary treatment of non-transplant patients with newly-diagnosed multiple myeloma, published recently in Science Direct. Results of the study to assess optimal clinical treatment strategies were reported in the article entitled, "Progression-Free Survival of Daratumumab (DRd) Versus Bortezomib Triplet Combination With Lenalidomide and Dexamethasone (VRd) in Transplant Ineligible Patients (TIE) With Newly Diagnosed Multiple Myeloma (NDMM): TAURUS Chart Review Study."

Key Points: 
  • Results of the study to assess optimal clinical treatment strategies were reported in the article entitled, "Progression-Free Survival of Daratumumab (DRd) Versus Bortezomib Triplet Combination With Lenalidomide and Dexamethasone (VRd) in Transplant Ineligible Patients (TIE) With Newly Diagnosed Multiple Myeloma (NDMM): TAURUS Chart Review Study."
  • However, previous to the TAURUS study, no direct head-to-head clinical trial had been conducted to compare the efficacy of the two regimens.
  • Cancerous tumors can weaken the body's immune system, damage bones and lead to end-organ damage.
  • MM is the second most common hematologic malignancy in the U.S. Two thirds of newly diagnosed patients are 65 years or older.

CARsgen Announces Formation of its Clinical Advisory Board

Retrieved on: 
Monday, November 20, 2023
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SHANGHAI, Nov. 20, 2023 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces the formation of its Clinical Advisory Board.

Key Points: 
  • SHANGHAI, Nov. 20, 2023 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces the formation of its Clinical Advisory Board.
  • This highly regarded panel of experts will provide invaluable guidance and insights for the global clinical development of company's innovative product candidates.
  • "As we embark on this exciting journey to advance our differentiated CAR T-cell therapies, I am delighted to welcome our esteemed Clinical Advisory Board members.
  • The formation of this Clinical Advisory Board marks a significant step forward for CARsgen as it continues to pioneer CAR T-cell therapies with the potential to transform cancer treatment.

Knight Therapeutics Reports Third Quarter 2023 Results

Retrieved on: 
Thursday, November 9, 2023
DLBCL, Research, MOH, ANVISA, Bank, Lenalidomide, FGFR2, S&M, Thrombocytopenia, LATAM, Health maintenance organization, Fostamatinib, EBITDA, G&A, News, R, ASCT, Hallmark-Sonali Bank Loan Scam, Growth, IAS, Marketing, ITP, USD, Investment, Patient, GBT, Lymphoma, Financial adviser, Pharmaceutical industry, Fine chemical, Bookkeeping, Cryptocurrency, Knight, Novartis, Bancolombia

Gross margin: For the quarter ended September 30, 2023, gross margin, as a percentage of revenues, was 49% compared to 42% in Q3-22.

Key Points: 
  • Gross margin: For the quarter ended September 30, 2023, gross margin, as a percentage of revenues, was 49% compared to 42% in Q3-22.
  • Selling and marketing (“S&M”): For the quarter ended September 30, 2023, S&M expenses were $11,924, a decrease of $1,532 or 11%, compared to the same period in prior year.
  • General and administrative (“G&A”): For the quarter ended September 30, 2023, G&A expenses were $11,080, an increase of $664 or 6%, compared to the same period in prior year.
  • For the quarter ended September 30, 2023, interest income was $3,055, an increase of $593 or 24%, compared to the same period in prior year.

Enterome Selected to The Leukemia & Lymphoma Society’s Therapy Acceleration Program

Retrieved on: 
Monday, October 30, 2023
Leukemia, Lenalidomide, ClinicalTrials.gov, Inflammation, Maintenance, Protein, LLS, Disease, Follicular lymphoma, Rituximab, Leukemia & Lymphoma Society, Bone marrow, Safety, Lymphoid leukemia, Patient, Acceleration, Pharmaceutical industry, Vaccine

PARIS, Oct. 30, 2023 (GLOBE NEWSWIRE) -- Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for solid and liquid malignancies and inflammatory diseases based on its unique Mimicry platform, today announced that it received a €3 million investment from The Leukemia & Lymphoma Society’s Therapy Acceleration Program® (LLS TAP). The funding will propel the Company’s ongoing Phase 2 SIDNEY study of EO2463 in indolent non-Hodgkin B-cell lymphoma (iNHL).

Key Points: 
  • PARIS, Oct. 30, 2023 (GLOBE NEWSWIRE) -- Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for solid and liquid malignancies and inflammatory diseases based on its unique Mimicry platform, today announced that it received a €3 million investment from The Leukemia & Lymphoma Society’s Therapy Acceleration Program® (LLS TAP).
  • The funding will propel the Company’s ongoing Phase 2 SIDNEY study of EO2463 in indolent non-Hodgkin B-cell lymphoma (iNHL).
  • Moreover, it could provide a key building block for the next generation of combination and maintenance therapies.”
    “We are honored to be recognized and supported by LLS’s Therapy Acceleration Program,” said Dr. Pierre Belichard, Chief Executive Officer of Enterome.
  • The study aims to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EO2463 monotherapy and combination therapy in approximately 60 patients with follicular lymphoma (FL) and marginal zone lymphoma (MZL).

Starton Therapeutics Announces Termination of Business Combination Agreement with Healthwell Acquisition Corp. I

Retrieved on: 
Friday, November 3, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Combination, Multiple myeloma, Lenalidomide, Safety, Termination, Therapy, Patient, Pharmaceutical industry

Starton Therapeutics Inc. (“Starton” or “the Company”), a clinical-stage biotechnology company focused on transforming standard-of-care therapies with proprietary continuous delivery technology, announced that it notified Healthwell Acquisition Corp.

Key Points: 
  • Starton Therapeutics Inc. (“Starton” or “the Company”), a clinical-stage biotechnology company focused on transforming standard-of-care therapies with proprietary continuous delivery technology, announced that it notified Healthwell Acquisition Corp.
  • I (NASDAQ: HWEL) (“Healthwell”) today that the Company had elected to terminate the business combination agreement among Starton, Healthwell and the other parties thereto dated as of April 27, 2023, as amended (the “Combination Agreement”), effective immediately.
  • The conditions to the closing of the initial business combination and subsequent amendments were not satisfied or waived by the outside date of November 3 2023 (the “Termination”).
  • “Over the last several months, Starton has taken significant, critical steps forward in its clinical development,” said Pedro Lichtinger, Chairman and CEO of Starton Therapeutics.