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CDSCO Approves AstraZeneca's Protocol Amendments for Durvalumab-Tremelimumab Combination in Advanced Liver Cancer

Monoclonal AntibodyOncology
  • India's CDSCO expert committee has approved AstraZeneca's protocol amendment for a Phase III trial evaluating durvalumab and tremelimumab combination as first-line treatment for advanced hepatocellular carcinoma.
  • The approval follows AstraZeneca's presentation of protocol amendment version 8.0 dated June 17, 2024, allowing the company to proceed with modifications to their ongoing clinical investigation.
  • This development comes alongside CDSCO's separate approval of AstraZeneca's protocol amendment for AZD0901, an antibody-drug conjugate being studied in advanced gastric cancer expressing claudin18.2.

EL1SSAR Trial Confirms Efficacy of Atezolizumab Plus Nab-Paclitaxel in PD-L1-Positive Advanced TNBC

OncologyMonoclonal Antibody
  • The phase IIIb EL1SSAR trial demonstrates that atezolizumab plus nab-paclitaxel provides significant clinical benefit in PD-L1-positive advanced triple-negative breast cancer, with median overall survival reaching 27 months in the overall population.
  • Patients with centrally confirmed PD-L1-positive tumors showed superior outcomes, with median progression-free survival of 11.1 months and overall survival not yet reached, highlighting the importance of accurate biomarker testing.
  • The safety profile was consistent with previous findings from the IMpassion130 trial, with 47% of patients experiencing grade ≥3 adverse events and 12% developing grade ≥2 immune-mediated adverse events, with no treatment-related deaths reported.

A Study of Atezolizumab Plus Nab-Paclitaxel in the Treatment of Unresectable Locally Advanced or Metastatic PD-L1-Positive Triple-Negative Breast Cancer

NCT04148911CompletedPhase 3
Hoffmann-La Roche
Posted 12/17/2019

Acquired Hemophilia A Pipeline Expands with 10+ Novel Therapies in Development

Monoclonal AntibodyRare Disease
  • Global Acquired Hemophilia A pipeline comprises over 10 companies developing innovative therapies across various clinical stages, according to DelveInsight's 2025 report.
  • Recent clinical advances include promising results for rituximab as a potential first-line therapy and Pfizer's positive Phase 3 AFFINE trial results for giroctocogene fitelparvovec gene therapy.
  • Key pharmaceutical players including Novo Nordisk, Sanofi, Pfizer, and Belief Biomed are advancing treatments ranging from gene therapies to monoclonal antibodies targeting this rare autoimmune bleeding disorder.

BeCoMe-9: A Clinical Study of BE-101 for the Treatment of Adults With Moderately Severe or Severe Hemophilia B

NCT06611436RecruitingPhase 1
Be Biopharma
Posted 12/4/2024

Study to Evaluate the Efficacy and Safety of PF-07055480 / Giroctocogene Fitelparvovec Gene Therapy in Moderately Severe to Severe Hemophilia A Adults

NCT04370054Active, Not RecruitingPhase 3
Pfizer
Posted 8/18/2020

Riliprubart Shows Promise in CIDP Treatment with Significant Neurofilament Light Reduction

NeurologyMonoclonal Antibody
  • Phase 2 study results reveal that Sanofi's investigational riliprubart reduced plasma neurofilament light levels by 31% in patients with chronic inflammatory demyelinating polyneuropathy.
  • Greater reductions in neurofilament light levels correlated with higher treatment response rates, with up to 69% of patients showing improvement in disability scores.
  • Riliprubart, a selective inhibitor of the classical complement pathway, is now being evaluated in two global Phase 3 trials (MOBILIZE and VITALIZE) across 28 countries.

A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

NCT06290141RecruitingPhase 3
Sanofi
Posted 8/21/2024

Study to Evaluate Safety and Efficacy of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly (Radiculo) Neuropathy

NCT02638207CompletedPhase 3
Octapharma
Posted 9/27/2017

A Study to Assess the Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)

NCT04281472CompletedPhase 2
argenx
Posted 4/15/2020

A Study to Test the Effects and Safety of Riliprubart in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) for Which the Usual Treatments do Not Work

NCT06290128RecruitingPhase 3
Sanofi
Posted 7/12/2024

Regeneron Wins $407 Million in Landmark Antitrust Case Against Amgen Over PCSK9 Drug Market

PCSK9 InhibitorsMonoclonal Antibody
  • A federal jury awarded Regeneron $407 million in damages after finding Amgen violated antitrust laws by using cross-therapeutic bundled rebates to block Praluent from competing with Repatha in the PCSK9 inhibitor market.
  • The verdict includes $135.6 million in compensatory damages and $271.2 million in punitive damages, signaling a strong deterrent against anticompetitive bundling practices in pharmaceutical markets.
  • Amgen was found to have leveraged its blockbuster drugs Enbrel and Otezla to force pharmacy benefit managers to exclude Praluent, creating an uneven playing field not based on clinical merit or price.

UPC Issues Landmark Ruling on Second Medical Use Patents in Cholesterol Drug Dispute

Monoclonal Antibody
  • The Unified Patent Court's Düsseldorf Local Division has issued its first-ever ruling on second medical use patent infringement in a dispute between Sanofi/Regeneron and Amgen over PCSK9 inhibitor drugs.
  • The court established a two-part test for infringement: the product must be marketed in a way that leads to the patented use, and the alleged infringer must know or should have known about such use.
  • While upholding the validity of Sanofi/Regeneron's patent for using PCSK9 inhibitors to reduce lipoprotein(a) levels, the court ruled Amgen's Repatha did not infringe as there was insufficient evidence of it being prescribed for this purpose.

Jade Biosciences Advances JADE101 Anti-APRIL Antibody for IgA Nephropathy with $300M Funding

Monoclonal Antibody
  • Jade Biosciences completed a reverse merger and raised approximately $300 million, providing financial runway through 2027 to advance its autoimmune disease pipeline.
  • The company's lead candidate JADE101, an anti-APRIL monoclonal antibody for IgA nephropathy, is expected to enter first-in-human clinical trials in the second half of 2025.
  • JADE101 targets the APRIL protein to reduce disease-driving IgA levels and preserve kidney function, with engineered half-life extension technology allowing dosing intervals of at least eight weeks.
  • The company also nominated JADE201 as a development candidate from its JADE-002 antibody discovery program, expanding its preclinical pipeline for autoimmune diseases.

Genentech Advances Prasinezumab to Phase III for Early-Stage Parkinson's Disease Following Positive Phase IIb Results

Monoclonal Antibody
  • Genentech, a Roche subsidiary, announced its decision to advance prasinezumab into Phase III development for early-stage Parkinson's disease based on encouraging Phase IIb PADOVA study results.
  • The investigational anti-alpha-synuclein antibody demonstrated clinical benefit on top of symptomatic treatment in early-stage Parkinson's disease patients during the Phase IIb trial and longer-term follow-up.
  • Prasinezumab represents a potential first-in-class treatment targeting alpha-synuclein, marking a significant milestone in Parkinson's disease drug development.

Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome

NCT04401748Active, Not RecruitingPhase 3
AbbVie
Posted 9/10/2020

A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

NCT05171647Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 4/25/2022

ATS 2025 Conference to Showcase Groundbreaking Pulmonary Research and Patient-Centered Initiatives

Monoclonal Antibody
  • The American Thoracic Society (ATS) 2025 International Conference in San Francisco will feature cutting-edge research across pulmonary, critical care, and sleep medicine, drawing over 10,000 attendees from 85 countries.
  • Key clinical trials to be presented include studies on tezepelumab for asthma and chronic rhinosinusitis, mepolizumab for COPD, sotatercept for pulmonary arterial hypertension, and tirzepatide for obstructive sleep apnea.
  • The conference will emphasize patient advocacy through dedicated panels and introduce the Respiratory Innovation Summit, fostering collaboration between scientific leaders and industry partners to advance therapeutic development.

NHIA and Roche Expand Partnership to Reduce Cancer Treatment Costs in Nigeria

Monoclonal AntibodyOncology
  • The National Health Insurance Authority and Roche have signed an expanded Memorandum of Understanding to enhance access to affordable cancer care and treatment for Nigerian patients.
  • The partnership introduces a cost-sharing model where Roche covers 50% of monoclonal medicine costs while NHIA manages patient access and coordinates financing mechanisms.
  • Since the initial 2021 partnership, the number of cancer Centers of Excellence has nearly tripled from seven to 20 facilities across Nigeria.
  • The initiative specifically targets breast cancer, which caused over 30,000 new cases in Nigeria in 2022 and remains the leading cause of death among Nigerian women.

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