Rheumatoid arthritis

Alvotech and Teva Announce U.S. Approval of SIMLANDI® (adalimumab-ryvk) injection, the first interchangeable high-concentration, citrate-free biosimilar to Humira®

Retrieved on: 
Saturday, February 24, 2024
Biotechnology, FDA, Health, Pharmaceutical, Managed Care, Pharmacy, Ulcerative colitis, Psoriasis, Uveitis, Ankylosing spondylitis, Multimedia, TEVA, Marketing, Teva, Partnership, Food, Teva Pharmaceuticals, Volunteering, Biosimilar, IC, Safety, Juvenile idiopathic arthritis, Rheumatoid arthritis, Hidradenitis suppurativa, Patient, Prescription, Environment, Generic drug

Teva is Alvotech’s strategic partner for the exclusive commercialization of SIMLANDI in the United States.

Key Points: 
  • Teva is Alvotech’s strategic partner for the exclusive commercialization of SIMLANDI in the United States.
  • An interchangeable biosimilar may be substituted at the pharmacy without consulting the prescriber, much like generic drugs are routinely substituted for brand name drugs.
  • As the only interchangeable adalimumab biosimilar with the high-concentration formulation, SIMLANDI can be substituted for Humira at the pharmacy level, subject to state pharmacy laws.
  • Alvotech handles development and manufacturing, and Teva is responsible for U.S. commercialization, which leverages Teva’s extensive experience and sales and marketing infrastructure.

Organon Announces HADLIMA™ (adalimumab-bwwd) Has Been Exclusively Selected by the US Department of Veterans Affairs (VA), Replacing HUMIRA on Its National Formulary

Retrieved on: 
Tuesday, February 20, 2024
FDA, Health, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, Certification, Sepsis, Psoriasis, Adolescence, Infection, Adalimumab, Hospital, Intuition, Public sector, TB, Risk, Safety, Arthritis, Rheumatoid arthritis, Hidradenitis suppurativa, Death, Autoimmunity, Patient, Lymphoma, Tuberculosis, Malignancy, TNF, OGN, Pharmaceutical industry

Organon (NYSE: OGN), a global healthcare company with a dedicated commitment to biosimilars, announced that the US Department of Veterans Affairs (VA) has exclusively selected HADLIMA in replacement of HUMIRA (adalimumab) for the VA National Formulary.

Key Points: 
  • Organon (NYSE: OGN), a global healthcare company with a dedicated commitment to biosimilars, announced that the US Department of Veterans Affairs (VA) has exclusively selected HADLIMA in replacement of HUMIRA (adalimumab) for the VA National Formulary.
  • "America’s veterans deserve access to quality medicines at a lower cost.
  • “We applaud the VA for its leadership in championing biosimilars and including all three of Organon’s biosimilars available in the US on its formulary."
  • HADLIMA was launched in the US to offer patients a more affordable option without compromising on safety and efficacy.

"Double Life" of Key Immune Protein Reveals New Strategies for Treating Cancer and Autoimmune Diseases

Retrieved on: 
Friday, March 8, 2024
Bangladesh Technical Education Board, University of Oslo, Cancer, University, The central science, Immune system, Research, Doctor of Philosophy, Science Immunology, National Institutes of Health, MD, Moses Austin, Neoplasm, Inflammation, Wang, Wellcome Trust, Rheumatology, Lupus, PD-1, Bristol Myers Squibb, Howard Hughes Medical Institute, Biochemistry, NYU, Autoimmunity, Perlmutter, Rheumatoid arthritis, Pathology, Ligand, Pharmacology, NYU Langone Health, Patient, Hanmi Pharmaceutical, Internal medicine, Biomedical sciences, Funding of science, Columbia University, Mouse, Vaccine

The same findings also support experimental treatment strategies for autoimmune diseases, in which the immune system attacks the body, because stimulating the action of PD-1, as opposed to restricting it, can potentially block an overactive immune response.

Key Points: 
  • The same findings also support experimental treatment strategies for autoimmune diseases, in which the immune system attacks the body, because stimulating the action of PD-1, as opposed to restricting it, can potentially block an overactive immune response.
  • The study results revolve around the body's immune system, which is primed to attack virally infected and cancerous cells while leaving normal cells alone.
  • The immune system recognizes tumors as abnormal, but cancer cells can hijack checkpoints to turn off immune responses.
  • At the same time, PD-1 signaling is slowed in autoimmune diseases like rheumatoid arthritis, lupus, and type 1 diabetes, such that the action of unchecked immune cells creates inflammation that can damage tissues.

Cloud Peritus and Junction Health Forge Strategic Salesforce Partnership

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Monday, March 4, 2024
Cloud, SAN, Crohn's disease, SVP, Health, Data management, Growth, Multiple sclerosis, Salesforce, Rheumatoid arthritis, CRM, Haemophilia, Patient, Partnership, Nursing

SAN RAMON, Calif., March 4, 2024 /PRNewswire/ -- Cloud Peritus, a renowned expert in cloud technology announces an exciting collaboration with Junction Health, a leading provider of healthcare infusion services.

Key Points: 
  • SAN RAMON, Calif., March 4, 2024 /PRNewswire/ -- Cloud Peritus, a renowned expert in cloud technology announces an exciting collaboration with Junction Health, a leading provider of healthcare infusion services.
  • Cloud Peritus will be instrumental in helping Junction Health develop a strategic roadmap of Salesforce CRM capabilities, and optimizing the value of their investment in the platform.
  • "We're thrilled to work with Cloud Peritus to leverage a host of integrated solutions on the Salesforce platform.
  • Together, Junction Health and Cloud Peritus are poised to deliver unparalleled value to patient and provider stakeholders and drive sustainable growth for its community health center partners.

Mallinckrodt Announces U.S. FDA Approval of Supplemental New Drug Application for Acthar® Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector

Retrieved on: 
Friday, March 1, 2024
Chorioretinitis, Natural history, Caregiver, New Drug Application, Ankylosing spondylitis, Optic neuritis, Education, FDA, Food, Adnexa, Shanda, Uveitis, Eye, Adrenocorticotropic hormone, Multiple sclerosis, Condylar resorption, Safety, Rheumatoid arthritis, Patient, Sclerosis, Disease, Keratitis, MRCP, Insurance, Pharmaceutical industry

DUBLIN, March 1, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Mallinckrodt's supplemental New Drug Application (sNDA) for the Acthar® Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector (herein referred to as "SelfJect"), a new delivery device for Acthar Gel for appropriate patients with a range of chronic and acute inflammatory and autoimmune conditions.2 SelfJect is intended to provide the appropriate subcutaneous dose of Acthar Gel, as prescribed by a healthcare professional, and is designed to help give patients control of their administration.1,3

Key Points: 
  • "We're excited to bring this innovation to U.S. patients with chronic and acute inflammatory and autoimmune conditions.
  • Mallinckrodt also offers a team of field-based experts who provide education for healthcare professionals on the reimbursement process as well as tools available for patients.
  • Acthar Gel will continue to be available as an injection with a vial and syringe.
  • Controlled clinical trials have shown Acthar to be effective in speeding the resolution of acute exacerbations of multiple sclerosis.

Dynamic Access Launches Dynamic Infusion, a Specialty Home Infusion Nursing Provider

Retrieved on: 
Wednesday, February 28, 2024
Multiple sclerosis, Patient, Crohn's disease, Organization, Pharmacy, Haemophilia, Rheumatoid arthritis

DALLAS, Feb. 28, 2024 /PRNewswire/ -- Dynamic Access, LLC (Dynamic Access), a leading provider of vascular access solutions, has announced the launch of a new affiliate brand, Dynamic Infusion, which will provide home infusion nursing services for patients with chronic conditions such as autoimmune disorders, hemophilia, Crohn's disease, rheumatoid arthritis, multiple sclerosis and more.

Key Points: 
  • DALLAS, Feb. 28, 2024 /PRNewswire/ -- Dynamic Access, LLC (Dynamic Access), a leading provider of vascular access solutions, has announced the launch of a new affiliate brand, Dynamic Infusion, which will provide home infusion nursing services for patients with chronic conditions such as autoimmune disorders, hemophilia, Crohn's disease, rheumatoid arthritis, multiple sclerosis and more.
  • The Dynamic Infusion brand will support the operations of two legacy companies, each with more than a decade of experience delivering home infusion nursing services to patients throughout the Northeast: Infusion Ventures in New England, and NursePro in the Mid-Atlantic.
  • Peter Harris, CEO of Dynamic Access will also serve as CEO of Dynamic Infusion.
  • "The recent addition of NursePro expands our portfolio of specialty nursing solutions, expands our geographical footprint, and expands the number of lives we serve with life-changing care."

Coeptis Therapeutics Adds Autoimmune Indications to Exclusive License Agreement with University of Pittsburgh for SNAP-CAR T and SNAP-CAR NK

Retrieved on: 
Monday, February 26, 2024
Division, Woman, Autoimmune disease, Assistant, Pain, CD19, Multiple sclerosis, University, Therapy, Rheumatoid arthritis, Immunology, Death, Patient, Autoimmunity, NK, Nature Communications, Infection, University of Pittsburgh, Research, Cancer, Vaccine

WEXFORD, Pa., Feb. 26, 2024 /PRNewswire/ -- Coeptis Therapeutics Holdings, Inc. (NASDAQ: COEP) (the "Company" or "Coeptis"), a biopharmaceutical company developing innovative cell therapy platforms for cancer, autoimmune, and infectious diseases, today announced that it has expanded its exclusive license agreement with the University of Pittsburgh to include autoimmune indications as part of its ongoing development of SNAP-CAR T and SNAP-CAR NK.   This amended agreement builds upon the original exclusive license agreement with the University of Pittsburgh for SNAP-CAR T Cells, a "universal" CAR T technology platform designed to target multiple antigens simultaneously and potentially address a range of hematologic and solid tumors, and a recent amendment to the agreement for SNAP-CAR NK, an allogeneic natural killer (NK) cell therapy platform.

Key Points: 
  • WEXFORD, Pa., Feb. 26, 2024 /PRNewswire/ -- Coeptis Therapeutics Holdings, Inc. (NASDAQ: COEP) (the "Company" or "Coeptis"), a biopharmaceutical company developing innovative cell therapy platforms for cancer, autoimmune, and infectious diseases, today announced that it has expanded its exclusive license agreement with the University of Pittsburgh to include autoimmune indications as part of its ongoing development of SNAP-CAR T and SNAP-CAR NK.
  • Autoimmune diseases, including systemic lupus erythematosus, rheumatoid arthritis, and multiple sclerosis, are known to result from autoreactive B cells.
  • "We are again excited to expand our license with Coeptis," said Jason Lohmueller, Ph.D., Assistant Professor of Surgery and Immunology in the Division of Surgical Oncology Research, University of Pittsburgh.
  • According American Autoimmune Related Disease Association , there are more than 100 autoimmune diseases impacting 1 in every 5 Americans, 75% of whom are women.

Eisai: Metoject Subcutaneous Injection Pen (Methotrexate) Pen-Type Autoinjector Approved in Japan

Retrieved on: 
Friday, February 16, 2024
Arthritis, Marketing, Eisai, MHLW, Skin, Gesellschaft mit beschränkter Haftung, Medac, Safety, Gemeinschaft and Gesellschaft, Rheumatoid arthritis, Patient, Pharmaceutical industry

TOKYO, Feb 16, 2024 - (JCN Newswire) - Eisai Co., Ltd. and nippon medac Co., Ltd., a subsidiary of medac Gesellschaft fur klinische Spezialpraparate mbH announced that they have obtained manufacturing and marketing approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the additional formulation of Metoject Subcutaneous Injection for the anti-rheumatic agent, pen-type autoinjector "Metoject Subcutaneous Injection 7.5mg Pen 0.15mL, 10mg Pen 0.20mL, 12.5mg Pen 0.25mL and 15mg Pen 0.30mL" (methotrexate).

Key Points: 
  • TOKYO, Feb 16, 2024 - (JCN Newswire) - Eisai Co., Ltd. and nippon medac Co., Ltd., a subsidiary of medac Gesellschaft fur klinische Spezialpraparate mbH announced that they have obtained manufacturing and marketing approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the additional formulation of Metoject Subcutaneous Injection for the anti-rheumatic agent, pen-type autoinjector "Metoject Subcutaneous Injection 7.5mg Pen 0.15mL, 10mg Pen 0.20mL, 12.5mg Pen 0.25mL and 15mg Pen 0.30mL" (methotrexate).
  • Based on the license agreement signed by Eisai and medac GmbH in May 2019, nippon medac will hold the marketing authorization of Metoject, while Eisai will be responsible for product distribution of Metoject in Japan.
  • This formulation incorporates the previously MHLW-approved Metoject Subcutaneous Injection pre-filled syringe formulation in a pen-type autoinjector and was developed to reduce the burden on patients and improve safety during self-injection.
  • The drug can be self-injected in two steps (1- removing the cap, 2- pressing the pen against the skin).

Nurix Therapeutics Reports Fourth Quarter and Fiscal Year 2023 Financial Results and Provides a Corporate Update

Retrieved on: 
Thursday, February 15, 2024
Fast Track, BTK, MCL, Research, B-cell lymphoma, ASH, NHL, Inflammation, FDA, CLL, Calendar, Mantle cell lymphoma, Manuscript, Medicinal chemistry, Lymphocytosis, BCL2, Lymphoma, Society, Chronic lymphocytic leukemia, Therapy, Pharmacology, Accelerated approval (FDA), Rheumatoid arthritis, Lymphoid leukemia, Paclitaxel, Non-Hodgkin lymphoma, Patient, Journal, Clinical trial, Science, IND, Publication, Trial of the century, DLBCL, Cancer, Priority review, Pharmaceutical industry

NX-2127 exhibited dose-dependent PK, leading to robust and sustained degradation of BTK and biologically relevant degradation of IKZF1 (Ikaros).

Key Points: 
  • NX-2127 exhibited dose-dependent PK, leading to robust and sustained degradation of BTK and biologically relevant degradation of IKZF1 (Ikaros).
  • NX-2127 had a manageable safety profile that was consistent with previous reports for BTK-targeted and immunomodulatory therapies.
  • During the year ended November 30, 2023, Nurix achieved research milestones under its collaborations with Gilead and Sanofi totaling $12.5 million and $7.0 million, respectively.
  • Cash, cash equivalents and marketable securities was $295.3 million as of November 30, 2023, compared to $268.7 million as of August 31, 2023.

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against VNET, Assertio, Cummins, and Brooge and Encourages Investors to Contact the Firm

Retrieved on: 
Wednesday, February 14, 2024
Complaint, Acquisition, Spectrum, FDA, News, Food, BIA, Sale, Fraud, CMI, Adjustment, Risk, Cayman, Suppository, Rheumatoid arthritis, Executive, Spectrum Pharmaceuticals, Patient, ASRT, Security (finance), Facility, EPS, Defendant, Learning, P.C

Stockholders have until the deadlines below to petition the court to serve as lead plaintiff.

Key Points: 
  • Stockholders have until the deadlines below to petition the court to serve as lead plaintiff.
  • On this news, the Company’s share price fell $0.20, or 3.2% on February 13, 2023, on unusually heavy trading volume.
  • According to the complaint, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and prospects.
  • For more information on the Brooge class action go to: https://bespc.com/cases/BROG