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FDA Approves GSK's Nucala for COPD Treatment, Expanding Options for "Smoker's Lung"

Monoclonal AntibodyDrug Approval
  • The FDA has approved GSK's monoclonal antibody Nucala as an add-on treatment for patients with chronic obstructive pulmonary disease (COPD), commonly known as "smoker's lung."
  • In late-stage clinical trials, Nucala reduced COPD exacerbations by 21% compared to placebo when combined with standard inhaled maintenance therapy over a 104-week period.
  • The approval expands treatment options for COPD, joining Sanofi/Regeneron's Dupixent and Verona Pharma's Ohtuvayre in addressing this condition that is the fourth leading cause of death worldwide.

Biogen Sues Neurimmune Over Rights to Novel Alzheimer's Bispecific Antibody Technology

NeurologyMonoclonal Antibody
  • Biogen has filed a lawsuit against Neurimmune seeking declaratory judgment that their 2007 Collaboration Agreement does not give Neurimmune rights to Biogen's bispecific antibody technology for Alzheimer's disease.
  • The disputed technology features a bispecific antibody that targets both the transferrin receptor on the blood-brain barrier and amyloid-beta plaques, potentially offering a novel approach to Alzheimer's treatment.
  • Biogen claims the antibody is part of their proprietary Tissue-Enhanced Delivery Platform designed to help molecules cross the blood-brain barrier, which was developed independently of their collaboration with Neurimmune.

AstraZeneca's Gremubamab Shows Promise in Reducing Pseudomonas Infection in Bronchiectasis Patients

Monoclonal Antibody
  • Phase II trial results presented at ATS 2025 demonstrate gremubamab's ability to significantly reduce Pseudomonas aeruginosa bacterial load in bronchiectasis patients, potentially offering an alternative to antibiotics.
  • The bispecific monoclonal antibody showed meaningful improvements in quality of life measures, with over 38% of treated patients achieving clinically significant improvements in respiratory questionnaire scores versus 8.3% on placebo.
  • Higher-dose gremubamab (1,500mg) significantly prolonged time to first exacerbation compared to placebo, suggesting potential clinical benefits beyond bacterial load reduction.

Vyloy Leads Claudin 18.2 Targeted Therapy Revolution with 60+ Drug Candidates in Pipeline

Monoclonal AntibodyCAR-TDrug Approval
  • Vyloy (zolbetuximab) has emerged as the first approved Claudin 18.2-targeted therapy for HER2-negative gastric and gastroesophageal junction adenocarcinoma, marking a significant milestone in precision oncology.
  • The global Claudin 18.2 therapy market is rapidly expanding with over 60 drug candidates in clinical trials, including monoclonal antibodies, bispecific antibodies, CAR-T cell therapies, and antibody-drug conjugates.
  • China has become a major innovation hub for Claudin 18.2-targeted therapies, with companies like Innovent, MabWorks, and Biotheus leading development efforts as research expands beyond gastric cancers to other solid tumors.

A Multicenter, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, HER2-negative, Gastric or Gastroesophageal Junction Adenocarcinoma

NCT06238843Enrolling by InvitationPhase 3
Innovent Biologics (Suzhou) Co. Ltd.
Posted 6/30/2024

Merck KGaA Advances Lupus Drug to Phase III Despite Mixed Clinical Results

Monoclonal Antibody
• Merck KGaA has decided to progress its experimental lupus treatment to Phase III clinical trials despite reporting mixed efficacy data from earlier studies.
• The advancement comes amid significant developments in the lupus treatment landscape, including UCB and Biogen's successful Phase III results for dapirolizumab pegol announced in September 2024.
• The lupus therapeutic area has seen recent setbacks as well, with Kezar Life Sciences discontinuing its lupus nephritis program in October 2024 following four patient deaths in their Phase IIb PALIZADE study.

India's CDSCO Approves Two Cancer Drugs with Phase IV Trial Requirements

Drug ApprovalMonoclonal AntibodyOrphan Drug
  • India's drug regulatory authority has approved Eli Lilly's selpercatinib tablets in multiple strengths for RET fusion-positive non-small cell lung cancer treatment.
  • Intas Pharmaceuticals received approval to import and market serplulimab, a PD-1 inhibitor monoclonal antibody for cancer treatment.
  • Both approvals come with mandatory Phase IV clinical trial requirements to be submitted within three months of marketing authorization.
  • The approvals reflect India's regulatory alignment with global standards for orphan cancer drugs already approved in major markets.

Alzheimer's Drug Pipeline Shows Promising Diversity as 88 Trials Recruit Patients in 2025

Monoclonal Antibody
  • The Alzheimer's drug development landscape has expanded significantly beyond anti-amyloid antibodies, with 88 different clinical trials currently recruiting patients and twelve Phase 3 trials expected to report results in 2025.
  • Several promising approaches are advancing through late-stage trials, including GLP-1 agonist semaglutide from Novo Nordisk and innovative biologics like vaccines and cell therapies targeting both disease modification and symptom management.
  • Novel therapeutic modalities are gaining traction, including brain-stimulating devices like Cognito's SPECTRIS headset and magnetic stimulation protocols that showed cognitive benefits in Phase 2 trials.

BioDlink Secures Brazil GMP Certification, Expanding Global Reach for Bevacizumab Biosimilar

Monoclonal AntibodyOncology
  • BioDlink has successfully passed its first on-site GMP inspection by Brazil's ANVISA, a PIC/S member, marking a significant regulatory milestone for the company's Suzhou manufacturing facility.
  • The inspection specifically reviewed production of Pusintin® (bevacizumab), a biosimilar antibody treating non-small cell lung cancer and metastatic colorectal cancer, receiving full approval with no observations.
  • With regulatory certifications now in five countries including Brazil, Indonesia, Egypt, Colombia, and Argentina, BioDlink aims to expand access to affordable oncology biologics across emerging markets.

Tecentriq and Avastin Combined with TACE Shows Significant Benefit in Unresectable Liver Cancer Trial

OncologyMonoclonal Antibody
  • The Phase III TALENTACE study demonstrated statistically significant improvement in TACE-progression-free survival for patients with unresectable hepatocellular carcinoma treated with Tecentriq, Avastin, and on-demand TACE.
  • This landmark trial enrolled 342 patients across China and Japan, marking the first Phase III study in Asia showing TACE PFS benefit from combining immunotherapy and targeted therapy with TACE for unresectable HCC.
  • Liver cancer remains the third leading cause of cancer-related death globally with rising mortality rates, with only 20% of patients surviving five years after diagnosis.

Sorafenib Chemoembolization Evaluation Controlled Trial

NCT01906216CompletedPhase 3
Air Force Military Medical University, China
Posted 9/1/2013

A Study of TACE Combined With Atezolizumab Plus Bevacizumab or TACE Alone in Patients With Untreated Heaptocellular Carcionma

NCT04712643Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 3/12/2021

Upstream Bio Appoints Stacy Price as Chief Technology Officer to Advance Verekitug Development

Monoclonal Antibody
  • Upstream Bio has appointed Stacy Price as Chief Technology Officer, bringing over 25 years of biotechnology experience to oversee technical operations and product development for verekitug.
  • Price will focus on chemistry, manufacturing, and controls (CMC) processes and drug delivery as Upstream Bio prepares to initiate a third clinical program for verekitug, their monoclonal antibody targeting inflammatory respiratory diseases.
  • The appointment comes at a pivotal time for Upstream Bio as they advance verekitug in Phase 2 trials for severe asthma and chronic rhinosinusitis with nasal polyps, with plans to expand into chronic obstructive pulmonary disease.

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