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Galderma's Phase III OLYMPIA 1 Trial Results Show Nemolizumab Significantly Improves Prurigo Nodularis Symptoms

Monoclonal AntibodyDrug Approval
• Newly published results in JAMA Dermatology demonstrate nemolizumab monotherapy significantly improved itch intensity and skin lesions in patients with moderate-to-severe prurigo nodularis compared to placebo.
• The OLYMPIA 1 trial showed rapid response as early as Week 4, with over six times more nemolizumab-treated patients achieving itch response and twenty times more reaching an itch-free or nearly itch-free state compared to placebo.
• Based on the OLYMPIA clinical trial program, nemolizumab (Nemluvio®) received FDA approval for adult prurigo nodularis in August 2024, with additional regulatory reviews ongoing worldwide.

A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

NCT04501679CompletedPhase 3
Galderma R&D
Posted 8/11/2020

Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

NCT04501666CompletedPhase 3
Galderma R&D
Posted 9/11/2020

FDA Considers Revoking Pfizer COVID-19 Vaccine Authorization for Healthy Children Under 5

Drug Approval
  • The FDA is weighing whether to revoke Pfizer's emergency use authorization for its COVID-19 vaccine in healthy children aged 6 months to 4 years, potentially limiting vaccination options for parents ahead of the 2025-2026 respiratory virus season.
  • Moderna's COVID-19 vaccine received full FDA approval in July for children 6 months to 11 years old, but only for those at increased risk of severe COVID-19, leaving healthy young children without official vaccination options if Pfizer's authorization is withdrawn.
  • The potential revocation follows policy changes under HHS Secretary Robert F. Kennedy Jr., who removed COVID-19 vaccines for healthy children from the CDC's immunization schedule in May 2025, citing lack of evidence that healthy kids need vaccination.
  • Pediatric advocates warn that losing Pfizer's authorization would create significant access barriers, forcing parents to drive hours for vaccines and potentially requiring off-label use of Moderna's vaccine without insurance coverage guarantees.

Roche's PiaSky Approved in EU as First Monthly Self-Administered Treatment for Paroxysmal Nocturnal Haemoglobinuria

Monoclonal AntibodyRare DiseaseDrug Approval
  • The European Commission has approved PiaSky (crovalimab), the first monthly subcutaneous treatment for paroxysmal nocturnal haemoglobinuria (PNH), offering patients the option to self-administer following training.
  • PiaSky utilizes innovative recycling antibody technology developed by Chugai Pharmaceutical, allowing it to bind to C5 protein multiple times and remain effective longer with a small volume of medicine.
  • Clinical trials demonstrated PiaSky's non-inferiority to eculizumab, the current standard of care, while potentially reducing treatment burden through less frequent administration and eliminating the need for regular clinic visits.

A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors

NCT04432584Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 9/30/2020

A Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors

NCT04434092Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 10/8/2020

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)

NCT04861259Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 10/22/2021

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Participants With Atypical Hemolytic Uremic Syndrome (aHUS)

NCT04958265Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 11/17/2021

Federal Circuit Reverses Patent Invalidation for Allergan's IBS-D Drug Viberzi in Landmark Double Patenting Case

Drug Approval
  • The Federal Circuit reversed a district court's invalidation of Allergan's patent claims for eluxadoline (Viberzi®), used to treat irritable bowel syndrome with diarrhea, clarifying key principles in obviousness-type double patenting doctrine.
  • The court held that a first-filed, first-issued patent cannot be invalidated by later-filed, later-issued patents from the same family simply because they expire earlier due to Patent Term Adjustment differences.
  • The decision also reversed findings on written description requirements, ruling that patent specifications need not explicitly label every component as "optional" if a skilled person would understand the invention as disclosed.
  • This ruling provides important protections for patentees who receive Patent Term Adjustment on first-filed applications, preventing invalidation based solely on expiration date comparisons with related patents.

PTAB Invalidates Multiple Regeneron EYLEA Patents as Biosimilar Competition Intensifies

Drug Approval
  • The Patent Trial and Appeal Board (PTAB) has issued multiple final written decisions finding Regeneron's aflibercept-dosing patents for EYLEA unpatentable, with Regeneron voluntarily dismissing several Federal Circuit appeals.
  • Samsung Bioepis's EYLEA biosimilar Opuviz received FDA approval as an interchangeable biosimilar on May 20, 2024, but faces a preliminary injunction preventing commercial launch.
  • The patent invalidations affect key intellectual property protecting EYLEA, which generated $5.89 billion in sales for Regeneron in 2023, signaling potential increased biosimilar competition.

IASO Bio Secures FDA Approval for BCMA CAR-T Therapy in Multiple Autoimmune Diseases

CAR-TDrug Approval
  • IASO Bio received FDA IND approval for Equecabtagene Autoleucel (Eque-cel) to treat multiple sclerosis, marking the second autoimmune indication approved in 2024.
  • The fully human anti-BCMA CAR-T therapy has now secured five total IND approvals across China and the US for various autoimmune diseases including lupus and myasthenia gravis.
  • Multiple sclerosis affects approximately 3.07 million patients worldwide with 400,000 in the US, representing a significant unmet medical need in neuroinflammatory diseases.
  • The therapy targets BCMA-expressing B cells and plasma cells to reduce pathogenic autoantibodies and suppress autoimmune inflammation across multiple disease indications.

NHS England Approves First CRISPR Gene-Editing Therapy for Beta Thalassaemia Treatment

Gene EditingDrug ApprovalRare Disease
  • NHS England has approved Casgevy, the first CRISPR gene-editing therapy, for treating severe beta thalassaemia in patients aged 12 and older, making it among the first healthcare systems globally to offer this treatment.
  • Clinical trials demonstrated that 93% of beta thalassaemia patients did not require blood transfusions for at least a year after receiving the one-time gene therapy, offering potential lifetime cure for a condition that typically requires transfusions every 3-5 weeks.
  • The therapy will be available at seven specialist NHS centres within weeks, with an estimated 460 patients in England potentially eligible for the treatment that uses Nobel Prize-winning CRISPR technology to edit bone marrow stem cells.

FDA Accepts sBLA for Susvimo in Diabetic Eye Diseases Following Promising Phase 3 Results

Drug Approval
• The FDA has accepted Roche's supplemental Biologics License Application for Susvimo to treat diabetic macular edema and diabetic retinopathy, based on successful Phase 3 trial results.
• Susvimo, a refillable ocular implant that continuously delivers ranibizumab, demonstrated non-inferior visual gains compared to monthly injections in DME patients, with 95% requiring no additional treatment during the study period.
• The treatment recently returned to the US market for wet AMD after addressing quality issues, potentially offering a paradigm shift in diabetic eye disease management by reducing the need for frequent injections.

A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DME

NCT04108156RecruitingPhase 3
Hoffmann-La Roche
Posted 9/30/2019

A Multicenter, Randomized Study in Participants With Diabetic Retinopathy Without Center-involved Diabetic Macular Edema To Evaluate the Efficacy, Safety, and Pharmacokinetics of Ranibizumab Delivered Via the Port Delivery System Relative to the Comparator Arm

NCT04503551Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 8/10/2020

FDA Approves First Generic Methimazole Solution for Feline Hyperthyroidism Treatment

Drug Approval
  • The FDA has approved Felanorm, the first generic methimazole oral solution for treating hyperthyroidism in cats, manufactured by Norbrook Laboratories.
  • Felanorm contains the same active ingredient as the brand name Felimazole and is available only by prescription from licensed veterinarians.
  • Hyperthyroidism is the most common endocrine disease in middle-aged and older cats, causing symptoms like weight loss, vomiting, and hyperactivity.
  • The medication requires careful dosing in 2.5 mg increments every 12 hours with a maximum daily dose of 20 mg, and ongoing veterinary monitoring is essential.

Global Breast Cancer Therapeutics Market Expected to Reach $78.61 Billion by 2033

OncologyTargeted TherapyMonoclonal AntibodyAIPrecision MedicineDrug Approval
• The global breast cancer therapeutics market, valued at $32.93 billion in 2023, is projected to reach $78.61 billion by 2033, growing at a CAGR of 9.09% over the next decade.
• North America dominates the market with a 38.61% revenue share, driven by high breast cancer prevalence and presence of key pharmaceutical companies including Pfizer, Roche, and Novartis.
• Targeted therapies hold the largest market segment at 64.85%, with hormone receptor-positive treatments accounting for 66.97% of the market as precision medicine approaches gain traction.

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