Welcome to the May edition of AARDEX Group’s Clinical Trials and Tribulations Newsletter – an aggregated collective of all of the industry’s hottest news and views!
Breaking News
New Pivotal Data Demonstrates the Clinical Benefit of Roche’s glofitamab, a Potential First-in-Class Bispecific Antibody for People with Aggressive Lymphoma
Roche today announced that new pivotal data on its investigational CD20XCD3 T-cell engaging bispecific antibody, glofitamab, will be presented at the American Society of Clinical Oncology Annual Meeting and the European Hematology Association Congress. Data from the Phase II NP30179 expansion study demonstrated that, after a median follow-up of more than 12 months, fixed-duration glofitamab (given for a fixed amount of time, and not taken until disease progression) induces durable complete responses (CRs) in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who had received a median of three prior therapies
China Approves Cervarix, GSK’s Two-Dose Vaccine for Girls Aged 9-14 for the prevention of Papillomavirus
GSK announced today that a two-dose schedule for its HPV vaccine, Cervarix [Human Papillomavirus bivalent (types 16,18) Vaccine, Recombinant] has been approved by China’s NMPA for girls aged 9-14. With this approval, Cervarix is the first imported two-dose HPV vaccine for girls in this age group in mainland china.
Industry Guidance
FDA Issues Draft Diversity Guidance to Improve Enrollment of Participants from Underrepresented Patient Populations
Furthering its commitment to improving diversity in clinical trials, the FDA published draft guidance, Diversity Plans to Improve the Enrolment of Participants Underrepresented Racial and Ethnic Populations in Clinical Trials, which is intended to expand on the recommendations set out in the FDA’s 2016 guidance (Collection of Race and Ethnicity Data in Clinical Trials). In this article, we discuss the Race and Ethnicity Plan in detail.
Disruptive Innovations
AstraZeneca and Oxipits Pilot Study Delivers Promising Results for Early Lung Cancer Detection
Following AstraZeneca and Oxipit’s joint pilot study, in which Oxipit’s ChestEye Quality Artificial Intelligence software was deployed in two major primary care centers in Lithuania, the companies have revealed that ChestEye Quality helped detect 82 additional clinically relevant nodule findings, potentially identifying additional early instances of lung cancer.
Fujifilm Announces Positive Study Results of FujiFilm’s AI Technology for Predicting Mild Cognitive Impairment Conversion to Alzheimers Disease
The AI Technology for AD Progression Prediction was developed by Fujifilm based on its advanced image recognition technologies and machine learning expertise. Following successful study results, Fujifilm and the National Center of Neurology and Psychiatry will further verify the technology, with the aim of applying it to a stratification of patients in clinical trials for the treatment of Alzheimers Disease
Regulatory Approvals
AstraZeneca’s COVID-19 Vaccine is Granted Approval by the EMA as a Third Dose Booster in Adults
AstraZeneca’s COVID-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]), has been granted approval in the European Union (EU) by the European Medicine Agency (EMA) as a third dose booster in adults. Healthcareprofessionals can now use Vaxzevria as a third dose booster in patients previously given a primary vaccine schedule of eitherVaxzevria or an EU-approved mRNA COVID-19 vaccine.
RapidAI Receives FDA 510(K) Clearance for Pulmonary Embolism Triage and Notifications
RapidAI, the global leader in neurovascular and vascular AI-enhanced clinical decision support and patient workflow, announced that it had received 510(k) clearance for its Rapid PE Triage & Notification product for fast identification and communication of suspected central pulmonary embolism -further strengthening RapidAI’s industry-leading clinical AI platform.
FDA Approves First Treatment for Eosinophilic Esophagitis, a Chronic Immune Disorder
The FDA has approved Regeneron’s and Sanofi’s Duxipent (dupilumab) to treat Eosinophilic Esophagitis (EoE) in adults and paediatric patients twelve years and older. This approval marks the first approval for a treatment of EoE, a chronic inflammatory disorder in which eosinophils, a type of white blood cell, are found in the tissue of the eosophagus.
FDA Approves BONESUPPORT, the First and Only Bone Graft, with Antibiotic Elution
BONESUPPORT, an emerging leader in orthobiologics for the management of bone injuries, announced that the company has received market authorization from the FDA, for the company’s antibiotic eluting product, CERAMENT, for the indication of bone infection (osteomyelitis). The approval adds significant value compared to existing treatment options by enabling natural bone healing protected by locally eluted antibiotics, in a one-stage procedure.
Indica Labs Receives CE-IVD Certification for AI-Based Prostate Cancer Detection and Gleason Grading Tool
Indica Labs, the leading provider of computational pathology software and services, announced that it has achieved CE-IVD Mark for HALO Prostate AI, a deep learning-based screening tool designed to assist pathologists in identifying and grading prostate cancer in core needle biopsies.
FDA Approves Lilly’s Mounjaro (tirzepatide) Injection, the First and Only GIP and GLP-1 Receptor Agonist for the Treatment of Adults with Type 2 Diabetes
The approval was based on results from the Phase 3 SURPASS phase 3 global clinical development program for tirzepatide, which began in late 2018 and included five global registration trials and two regional trials in Japan. These studies ranged from 40 to 52 weeks and evaluated the efficacy and safety of Mounjaro 5 mg, 10 mg and 15 mg as a monotherapy and as an add-on to various standard-of-care medications for type 2 diabetes.
Featured Content: Optimizing Study Design to Tackle Protocol Deviations in Decentralized Trials
Mergers and Acquisitions
Synexa Life Sciences Acquires Finnish CRO Synrinx Bioanalytics to Expand Bioanalysis Capabilities
Synexa Life Sciences BV, a global leader in specialist biomarker and bioanalysis research services, announced it has acquired Syrinx Bioanalytics, a bioanalytical CRO based in Turku, Finland. The move is part of Synexa’s ongoing ‘buy and build’ growth strategy, aimed at building the global market leader in specialist biomarker and bioanalytical services.
THREAD Acquires CureClick, Optimizing the Pathway from Clinical Trial Awareness to Access
THREAD, a leading technology and consulting service provider enabling electronic clinical outcome assessments (eCOA) and decentralized clinical trials (DCTs) announced that it has acquired CureClick. CureClick offers the world’s first proprietary crowdsourcing platform designed exclusively to accelerate awareness and participation in clinical trials.
ZS Acquires Bioinformatics and Systems Biology Company, Intomics
The global professional services firm, ZS, announced that it has acquired Danish bioinformatics and systems biology company, Intomics. Founded in Copenhagen, Intomics accelerates and optimizes drug discovery and development by enabling complex analysis of biomedical data, The addition of renowned scientists to the ZS team will strengthen ZS’s focus on the discovery of new medicines for all.
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