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Clinical Trial News

Purdue Pharma Secures $7.4 Billion Opioid Settlement Support from 55 States and Territories

  • Purdue Pharma and the Sackler family have secured support from 55 U.S. states and territories for a $7.4 billion settlement to resolve thousands of opioid lawsuits related to OxyContin.
  • The settlement includes approximately $6.5 billion from the Sackler family and $900 million from Purdue Pharma, with payouts beginning after creditor approval of the Chapter 11 reorganization plan.
  • Unlike a previous rejected settlement, this agreement does not provide the Sacklers with broad immunity from future opioid-related civil lawsuits.
  • The funds will be distributed to individuals, state and local governments, and Native American tribes over 15 years to address the opioid crisis that has caused over 850,000 deaths since 1999.

FDA Approves CSL's ANDEMBRY for Hereditary Angioedema Prevention with Novel Factor XIIa Targeting

Drug ApprovalMonoclonal AntibodyRare Disease
  • The FDA approved ANDEMBRY (garadacimab-gxii), the first and only prophylactic HAE treatment targeting factor XIIa, offering once-monthly dosing for patients 12 years and older.
  • Phase 3 VANGUARD trial data showed ANDEMBRY reduced HAE attacks by a median of more than 99% and a least squares mean of 89.2% compared to placebo, with 62% of patients remaining attack-free.
  • ANDEMBRY represents a breakthrough approach by inhibiting the top of the HAE cascade through factor XIIa targeting, providing sustained protection with convenient subcutaneous self-injection in 15 seconds or less.
  • CSL will launch ANDEMBRY commercially immediately with availability before the end of June, expanding treatment options for the approximately 1 in 50,000 people affected by this rare genetic disorder.

CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks

NCT04656418CompletedPhase 3
CSL Behring
Posted 1/27/2021

Biogen's Leqembi Shows Accelerating Growth with 58% Global Sales Increase Despite Slow Market Adoption

Monoclonal Antibody
  • Biogen reported Leqembi generated $160 million in global sales for Q2 2024, representing a 58% increase, with U.S. sales rising 20% to $63 million despite ongoing market adoption challenges.
  • The Alzheimer's drug maintains a 70% market share against competitor Eli Lilly's Kisunla, with biomarker testing improvements helping to remove diagnostic bottlenecks and accelerate patient identification.
  • Biogen raised full-year revenue guidance to $15.50-16 billion, driven by strong performance across multiple franchises including multiple sclerosis products and post-partum depression drug Zurzuvae.
  • CEO Chris Viehbacher emphasized plans to restock the early-stage pipeline through strategic partnerships and acquisitions, citing the successful $1.8 billion HI-BIO acquisition as a model for future deals.

Blood Test Detects Early Liver Transplant Rejection Using Cell-Free DNA Analysis

  • Georgetown University and MedStar Health researchers developed a blood test that uses circulating cell-free DNA fragments to detect early signs of liver transplant rejection and complications.
  • The technology analyzes DNA methylation patterns to identify the specific cellular origin of organ damage, enabling more targeted treatment approaches.
  • This liquid biopsy approach could replace invasive liver biopsies and provide continuous monitoring of transplant recipients with greater accuracy.
  • The research, funded by a $2.5 million NIH grant, represents a major advancement in post-transplant care and has potential applications in other organ transplants and cancer treatment.

Digital Inhaler Technology Shows Promise for Early COPD Exacerbation Detection

  • Digital inhalers can detect significant physiologic changes up to two weeks before COPD exacerbations occur, potentially enabling earlier clinical intervention.
  • The ProAir Digihaler captured three key metrics that changed significantly before acute exacerbations: inhalation volume, inhalation duration, and time to peak inhalation.
  • These physiologic changes preceded the typical increase in rescue inhaler use, suggesting patients may perceive symptoms after lung function deterioration begins.
  • The pilot study involved 40 current smokers with COPD and recorded 23 acute exacerbation events, demonstrating the technology's potential for remote patient monitoring.

FDA Issues Second Complete Response Letter for Odronextamab in Relapsed/Refractory Follicular Lymphoma

Drug Approval
  • The FDA has issued a second complete response letter (CRL) for odronextamab's biologics license application, this time related to observations from an FDA site inspection at Catalent Indiana, LLC manufacturing facility.
  • Updated ELM-2 trial data with 28.3 months median follow-up demonstrate sustained efficacy with 80.5% overall response rate and 74.2% complete response rate in heavily pretreated follicular lymphoma patients.
  • The bispecific antibody received European Union approval in August 2024 for relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma after at least 2 prior therapies.
  • Safety profile remains consistent with previous reports, dominated by manageable cytokine release syndrome and infection-related adverse events requiring careful patient monitoring and prophylaxis.

A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Adult Patients With B-cell Non-Hodgkin Lymphoma Who Have Been Previously Treated With Other Cancer Therapies

NCT03888105RecruitingPhase 2
Regeneron Pharmaceuticals
Posted 11/13/2019

Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies

NCT02290951Active, Not RecruitingPhase 1
Regeneron Pharmaceuticals
Posted 1/9/2015

A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Participants With Follicular Lymphoma

NCT06091254RecruitingPhase 3
Regeneron Pharmaceuticals
Posted 12/12/2023

TRUST Trial Shows Primary Surgery Improves Progression-Free Survival in Advanced Ovarian Cancer Despite Missing Overall Survival Endpoint

  • The TRUST trial, the first phase III randomized study comparing surgical timing in advanced ovarian cancer, demonstrated statistically significant improvement in progression-free survival with primary cytoreductive surgery versus interval surgery (22.1 vs 19.7 months, HR=0.80, P=.018).
  • Despite improved progression-free survival, the study failed to meet its primary endpoint of overall survival, with median overall survival of 54.3 months for upfront surgery versus 48.3 months for interval surgery (HR=0.89, P=.24).
  • The trial enrolled 796 patients with FIGO stage IIIB/C or IVA/B ovarian cancer at high-volume centers performing at least 36 primary cytoreductive surgeries annually with complete resection rates of at least 50%.
  • Complete gross tumor resection was achieved in 70% of primary surgery patients versus 85% of interval surgery patients, with low morbidity rates of 18% and 12% respectively and 30-day mortality rates under 1%.

Mabion and NovalGen Partner to Advance Novel T-Cell Engager NVG-222 for Cancer Treatment

  • Mabion and NovalGen have formed a strategic partnership to bring NVG-222, a bispecific T-cell engager targeting ROR1 and CD3, to phase one clinical trials scheduled for the second half of 2025.
  • NVG-222 is the first therapeutic to utilize NovalGen's proprietary AutoRegulation technology, designed to mitigate toxicity and improve efficacy in T-cell engager therapies for both blood cancers and solid tumors.
  • The partnership marks a significant milestone with the successful release of the first clinical batch, demonstrating Mabion's transformation into a world-class CDMO and providing a platform for future collaboration on NovalGen's pipeline.
  • This collaboration represents a potential paradigm shift in immuno-oncology therapies, offering safer and more effective treatment options for cancer patients with high unmet medical needs.

Enzene Expands New Jersey Biomanufacturing Facility by 26,000 Square Feet Ahead of Opening

Monoclonal Antibody
  • Enzene has expanded its Hopewell, New Jersey biologics manufacturing facility by an additional 26,000 square feet before its official opening later this year.
  • The expansion includes drug substance manufacturing suites, laboratories, storage, dispensing and warehousing facilities to meet strong demand from U.S.-based small and medium-sized innovators.
  • The facility will utilize Enzene's EnzeneX 2.0 platform featuring fully-connected continuous manufacturing technology that enables clinical phase GMP supply from 30-liter scale with improved efficiency.
  • The company is already producing non-GMP batches at the site and aims to reduce monoclonal antibody production costs to below $40 per gram by 2025.

EDX Medical Partners with Spire Healthcare to Advance Diagnostic Innovation for Cancer and Cardiovascular Disease

  • EDX Medical Group has entered into a memorandum of understanding with Spire Healthcare Group to advance diagnostic innovations for major diseases including cancer, cardiovascular and infectious conditions.
  • The partnership will explore applications of EDX Medical's "super tests" for prostate, bowel and testicular cancer, along with molecular profiling cancer tests and tumor response assessment platforms.
  • The collaboration aims to enhance patient referral pathways and develop joint healthcare propositions based on improved understanding of patient biology and disease risk across Spire's network.
  • EDX Medical shares rose 4.2% to 12.50 pence on the Aquis Exchange following the announcement, while Spire Healthcare shares increased 1.0% to 210.50 pence in London.

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