Etanercept

Human medicines European public assessment report (EPAR): Stelara, ustekinumab, Date of authorisation: 15/01/2009, Revision: 45, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Stelara, ustekinumab, Date of authorisation: 15/01/2009, Revision: 45, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Stelara, ustekinumab, Date of authorisation: 15/01/2009, Revision: 45, Status: Authorised

Biocon Biologics Successfully Completes Integration of Viatris’ Biosimilar Business in 31 Countries in Europe

Retrieved on: 
Thursday, November 30, 2023

BENGALURU, India, Nov. 30, 2023 (GLOBE NEWSWIRE) -- Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced that the integration of the Viatris’ biosimilars business in 31 European countries has been successfully completed.

Key Points: 
  • BENGALURU, India, Nov. 30, 2023 (GLOBE NEWSWIRE) -- Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced that the integration of the Viatris’ biosimilars business in 31 European countries has been successfully completed.
  • In Europe, Biocon Biologics portfolio includes 7 biosimilars: Insulin Aspart and Insulin Glargine, Bevacizumab, Pegfilgrastim, Trastuzumab, Adalimumab, and Etanercept.
  • At a global level, Biocon Biologics has a robust pipeline of 20 assets for diabetology, oncology, immunology, ophthalmology, and bone health.
  • Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd, said: “The integration of the Viatris’ biosimilar business in Europe ahead of schedule is another important milestone for Biocon Biologics in our journey as a global biosimilars leader.

MyMD Pharmaceuticals Plans FDA-Cleared Phase 2 Clinical Trial of MYMD-1 in Rheumatoid Arthritis

Retrieved on: 
Wednesday, December 6, 2023

MyMD Pharmaceuticals, Inc.® (Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical stage biopharmaceutical company committed to developing novel therapies for age-related diseases, autoimmune and inflammatory conditions, announced today that its Investigational New Drug (IND) application for a Phase 2 clinical trial of oral MYMD-1® as a treatment for rheumatoid arthritis (RA) was recently cleared by the U.S. Food and Drug Administration (FDA), and plans are underway for trial launch in the first quarter of 2024.

Key Points: 
  • MyMD Pharmaceuticals, Inc.® (Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical stage biopharmaceutical company committed to developing novel therapies for age-related diseases, autoimmune and inflammatory conditions, announced today that its Investigational New Drug (IND) application for a Phase 2 clinical trial of oral MYMD-1® as a treatment for rheumatoid arthritis (RA) was recently cleared by the U.S. Food and Drug Administration (FDA), and plans are underway for trial launch in the first quarter of 2024.
  • “With the FDA’s recent clearance of our IND in RA, we are moving forward with plans to initiate a Phase 2 trial within the next several months.
  • Under this IND, the Phase 2 clinical trial of MYMD-1 will be a randomized placebo-controlled study that is expected to enroll approximately 60 patients with active rheumatoid arthritis.
  • Patients will receive oral MYMD-1 dosing of 1050 mg.
    Rheumatoid arthritis is a chronic, systemic inflammatory disorder that causes chronic inflammation of the joints and affects approximately 1.5 million Americans.

Global Pain Management Drugs and Devices Market Report 2023 - Rising Demand for Minimally Invasive Pain Solutions - ResearchAndMarkets.com

Retrieved on: 
Thursday, November 30, 2023

The "Global Market for Pain Management Drugs and Devices" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Market for Pain Management Drugs and Devices" report has been added to ResearchAndMarkets.com's offering.
  • The global market for pain management drugs and devices was valued at $80.9 billion in 2022.
  • In addition, technological advancements are serving as a critical factor in the pain management drugs and devices market.
  • Based on products, the global pain management drugs and devices market is segmented into pharmaceuticals and medical devices.

AMGEN TO PRESENT DATA AT ACR 2023 ACROSS EXPANDED RHEUMATOLOGY PIPELINE AND PORTFOLIO

Retrieved on: 
Wednesday, November 1, 2023

THOUSAND OAKS, Calif., Nov. 1, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of new scientific and clinical research across its expanded rheumatology pipeline and portfolio, following the recent acquisition of Horizon Therapeutics. More than 20 abstracts will be presented during the American College of Rheumatology (ACR) Convergence 2023, taking place Nov. 10-15, in San Diego.

Key Points: 
  • Abstract #2161, Poster Session C: RA – Treatments Poster III, Tuesday, Nov. 14 from 9-11am PST
    Outcomes in Patients With Rheumatoid Arthritis Initiating Therapy With Etanercept, Adalimumab, or Janus Kinase Inhibitors
    Abstract #0441, Poster Session A: RA – Treatments Poster I, Sunday, Nov. 12 from 9-11am PST
    Treatment-Emergent Major Adverse Cardiovascular and Thromboembolic Events Were Infrequent During Pegloticase Therapy: Pooled Clinical Trial Findings
    Abstract #0236, Poster Session A: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster I, Sunday, Nov. 12 from 9-11am PST
    Oral Urate-Lowering Therapy Use and Efficacy Following Pegloticase Treatment: Findings from a Rheumatology Network Database
    Abstract #0237, Poster Session A: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster I, Sunday, Nov. 12 from 9-11am PST
    Abstract #0239, Poster Session A: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster I, Sunday, Nov. 12 from 9-11am PST
    Abstract #0242, Poster Session A: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster I, Sunday, Nov. 12 from 9-11am PST
    Finding Lost-to-Care Gout Patients in a Large Community Rheumatology Network: Patient Re-engagement Initiative with Metrics (PRIME)
    Abstract #1102, Poster Session B: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster II, Monday, Nov. 13 from 9-11am PST
    Abstract #1103, Poster Session B: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster II, Monday, Nov. 13 from 9-11am PST
    Abstract #1107, Poster Session B: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster II, Monday, Nov. 13 from 9-11am PST
    Abstract #1108, Poster Session B: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster II, Monday, Nov. 13 from 9-11am PST
    Real-world Trends in the Use of Immunomodulation as Co-Therapy to Pegloticase: Claims-Based Findings Since 2016
    Abstract #1123, Poster Session B: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster II, Monday, Nov. 13 from 9-11am PST
    Abstract #1145, Poster Session B: Miscellaneous Rheumatic & Inflammatory Diseases Poster II, Monday, Nov. 13 from 9-11am PST
    Understanding Community Perspectives on Disease Management: A Social Media Analysis of Gout Care Strategies
    Abstract #1691, Oral Abstract Session: Spondyloarthritis Including Psoriatic Arthritis – Treatment II: PsA, Monday Nov. 13 from 5-5:10pm PST
    Apremilast Reduces Inflammation as Measured by MRI of the Hand in Patients With Psoriatic Arthritis: Primary Results from the Phase 4 MOSAIC Study
    Abstract #1690, Oral Abstract Session: Spondyloarthritis Including Psoriatic Arthritis – Treatment II: PsA, Monday Nov. 13 from 4:45-4:55pm PST
    Abstract #0966, Poster Session B: Epidemiology & Public Health Poster II, Monday Nov. 13 from 9-11am PST
    Abstract #1041, Poster Session B: Imaging of Rheumatic Diseases Poster I, Monday Nov. 13 from 9-11am PST
    Effect of Apremilast Treatment on the Domains of MDA-Joints in Patients With Early Oligoarticular Psoriatic Arthritis: 16-Week Results From FOREMOST
    Abstract #1413, Poster Session B: Spondyloarthritis Including Psoriatic Arthritis – Treatment Poster II: SpA, Monday Nov. 13 from 9-11am PST
    Abstract #1414, Poster Session B: Spondyloarthritis Including Psoriatic Arthritis – Treatment Poster II: SpA, Monday Nov. 13 from 9-11am PST
    Current Trends in the Risk of Subsequent Fracture After Initial Fracture, and Post-Fracture Treatment Among Commercially Insured Postmenopausal Women in the United States
    Abstract #2528, Oral Abstract Session: Osteoporosis & Metabolic Bone Disease – Basic & Clinical Science, Tuesday, Nov. 14 from 4:15-4:25pm PST
    Comparative Effectiveness of Denosumab versus Zoledronic Acid Among Postmenopausal Women with Osteoporosis in the U.S. Medicare Program
    Abstract #2529, Oral Abstract Session: Osteoporosis & Metabolic Bone Disease – Basic & Clinical Science, Tuesday, Nov. 14 from 4:30-4:40pm PST
    Comparative Effectiveness of Denosumab versus Alendronate among Postmenopausal Women with Osteoporosis in the U.S. Medicare Program
    Abstract #2008, Poster Session C: Osteoporosis & Metabolic Bone Disease – Basic & Clinical Science Poster, Tuesday, Nov. 14 from 9-11am PST
    Abstract #0683, Poster Session A: Vasculitis – ANCA-Associated Poster I: Treatment Outcomes, Sunday, Nov. 12 from 9-11am PST
    Abstract #0684, Poster Session A: Vasculitis – ANCA-Associated Poster I: Treatment Outcomes, Sunday, Nov. 12 from 9-11am PST
    Abstract #0685, Poster Session A: Vasculitis – ANCA-Associated Poster I: Treatment Outcomes, Sunday, Nov. 12 from 9-11am PST
    Abstract #0686, Poster Session A: Vasculitis – ANCA-Associated Poster I: Treatment Outcomes, Sunday, Nov. 12 from 9-11am PST
    Abstract #2379, Poster Session C: Vasculitis – ANCA-Associated Poster III: Biomarkers & Renal Outcomes, Tuesday, Nov. 14 from 9-11am PST
    Abstract #0171, Poster Session A: Health Services Research Poster I, Sunday, Nov. 12 from 9-11am PST
    Dazodalibep, a CD40L Antagonist, in Subjects with Sjögren's Having Moderate-to-Severe Systemic Disease Activity: Full Crossover Results from a Phase 2, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study
    Abstract #1636, Oral Abstract Session: Sjögren's Syndrome – Basic & Clinical Science, Monday, Nov. 13 from 2-3:30pm PST
    Abstract #1638, Oral Abstract Session: Sjögren's Syndrome – Basic & Clinical Science, Monday, Nov. 13 from 2-3:30pm PST
    Treatment Patterns and Drivers of Biologic Prescriptions in Patients with Primary Sjögren's Disease: Results from a Multinational, Real-World Survey
    Abstract #1369, Poster Session B: Sjögren's Syndrome – Basic & Clinical Science Poster I, Monday, Nov. 13 from 9-11am PST
    Population Pharmacokinetic/Pharmacodynamic Modeling of Dazodalibep, a CD40L Antagonist, in Healthy Volunteers and Patients with Rheumatoid Arthritis and Sjögren's Syndrome
    Abstract #1379, Poster Session B: Sjögren's Syndrome – Basic & Clinical Science Poster I, Monday, Nov. 13 from 9-11am PST
    Disease Burden of Patients with Primary Sjögren's Disease: Results from a Multinational Real-World Survey
    Abstract #2179, Poster Session C: Sjögren's Syndrome – Basic & Clinical Science Poster II, Tuesday, Nov. 14 from 9-11am PST
    Osteoporosis Treatment Attributes and Levels for an Online Decision-Making Tool for Patients: Findings from Adaptive Choice-Based Conjoint Analysis
    Abstract #0688, Poster Session A: Vasculitis – ANCA-Associated Poster I: Treatment Outcomes, Sunday, Nov. 12 from 9-11am PST

Samsung Bioepis Presents Two Abstracts at EADV 2023 Congress, Highlighting Continuous Dedication in Dermatology

Retrieved on: 
Wednesday, October 11, 2023

The study demonstrated biosimilarity of SB17 to UST through equivalent efficacy and comparable safety and PK up to Week 28.

Key Points: 
  • The study demonstrated biosimilarity of SB17 to UST through equivalent efficacy and comparable safety and PK up to Week 28.
  • SB17 is Samsung Bioepis’ fourth candidate in immunology pipeline, following SB4 (etanercept), SB2 (infliximab) and SB5 (adalimumab).
  • Samsung Bioepis’ and Biogen’s anti-TNF treatment products have helped nearly 256,0003 patients in Europe.
  • Details of the Samsung Bioepis’ abstracts are as follows:

Samsung Bioepis Partners with Sandoz to Commercialize Ustekinumab Biosimilar Candidate

Retrieved on: 
Monday, September 11, 2023

Enters into a commercialization agreement for SB17, ustekinumab biosimilar candidate, in Europe and North America

Key Points: 
  • Enters into a commercialization agreement for SB17, ustekinumab biosimilar candidate, in Europe and North America
    INCHEON, Korea, Sept. 11, 2023 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today announced that it has entered into a commercialization agreement with Sandoz for SB17, a proposed biosimilar to Stelarai (ustekinumab), marking a step forward in strengthening access to Samsung Bioepis’ immunology portfolio in the United States (US), Canada, European Economic Area (EEA), Switzerland and United Kingdom (UK).
  • “This agreement is a testament to Samsung Bioepis’ strong track record in the field of immunology, demonstrating a potential value that our biosimilars could deliver for widening access to biologic medicines.” said Sang-Jin Pak, Executive Vice President and Head of Commercial Division, at Samsung Bioepis.
  • SB17, a proposed biosimilar to Stelara (ustekinumab), is Samsung Bioepis’ fourth candidate in its immunology pipeline, following SB4 (etanercept), SB2 (infliximab) and SB5 (adalimumab).
  • Samsung Bioepis has a more than 5-year track record of supplying over 48 million units of immunology biosimilars in nearly 40 markets across the world.

Tonix Pharmaceuticals Initiates Phase 1 Trial of TNX-1500 (Fc-modified humanized anti-CD40L mAb) in Healthy Volunteers

Retrieved on: 
Wednesday, August 16, 2023

CHATHAM, N.J., Aug. 16, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the initiation of a Phase 1 single ascending dose escalation study of TNX-1500 (Fc-modified humanized anti-CD40L monoclonal antibody or mAb) in healthy volunteers. The primary objectives of the study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous (IV) TNX-1500.

Key Points: 
  • The primary objectives of the study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous (IV) TNX-1500.
  • TNX-1500 is in development for the prevention of kidney transplant rejection and other potential transplant and autoimmune disorder indications.
  • Initiation of this first-in-human study is intended to support dosing in a planned Phase 2 trial in kidney transplant recipients.
  • Our ability to develop and advance protein therapeutics is facilitated by our Research and Development Center (RDC) in Frederick, Md.

FTC Sues to Block Biopharmaceutical Giant Amgen from Acquisition That Would Entrench Monopoly Drugs Used to Treat Two Serious Illnesses

Retrieved on: 
Tuesday, May 16, 2023

The Federal Trade Commission is seeking to block biopharmaceutical giant Amgen Inc. from acquiring Horizon Therapeutics plc, saying the deal would allow Amgen to leverage its portfolio of blockbuster drugs to entrench the monopoly positions of Horizon medications used to treat two serious conditions, thyroid eye disease and chronic refractory gout.

Key Points: 
  • The Federal Trade Commission is seeking to block biopharmaceutical giant Amgen Inc. from acquiring Horizon Therapeutics plc, saying the deal would allow Amgen to leverage its portfolio of blockbuster drugs to entrench the monopoly positions of Horizon medications used to treat two serious conditions, thyroid eye disease and chronic refractory gout.
  • Neither of these treatments have any competition in the pharmaceutical marketplace.
  • Amgen has for years built its pharmaceutical portfolio through acquisitions, thereby increasing its leverage with the insurers and PBMs that negotiate reimbursement for its products.
  • Amgen has a history of leveraging its broad portfolio of blockbuster drugs to gain advantages over potential rivals.
  • The Commission vote to authorize staff to seek a temporary restraining order and preliminary injunction was 3-0.