Press Releases

Novartis to Acquire Myricx Bio in USD 1.5 Billion Deal, Strengthening Next-Generation ADC Cancer Pipeline

Novartis has agreed to acquire UK-based biotech company Myricx Bio in a deal worth up to USD 1.5 billion to strengthen its oncology pipeline. The acquisition brings Myricx's next-generation NMTi antibody-drug conjugate (ADC) platform, designed to overcome resistance to existing cancer therapies. It also adds two lead ADC candidates targeting B7-H3 and HER2, expanding Novartis' portfolio for treating solid tumors. The transaction is expected to close in the second half of 2026, subject to regulatory approvals.

VisualDx Partners with Sun River Health to Expand Access to Clinical Decision Support for Underserved Patients

FDA Clears CliniComp PACS Viewer (MIMPS), Unifying Diagnostic Imaging, Enterprise EHR, and Native AI in a Single Platform

FDA Clears CliniComp PACS Viewer (MIMPS), Unifying Diagnostic Imaging, Enterprise EHR, and Native AI in a Single Platform

ProPharma Advances Technology Enablement Strategy with AI-Assisted Capability for ANDA Submission Development

New proprietary capability enhances ProPharma’s regulatory service delivery model, helping clients accelerate submission development while maintaining the highest standards of quality and compliance.

CluePoints and Tufts CSDD Publish Peer-Reviewed Evidence Quantifying the Financial Value of RBQM

New research demonstrates RBQM-enabled trials achieve up to 23x ROI and 19% shorter phase durations, providing the industry’s first quantitative business case for risk-based oversight in clinical development

Enhanced Compliance Inc. (ECI) Appoints Taranjit S. Samra as Head of Medical Device Software Engineering, Cybersecurity and AI

ECI has announced the appointment of Taranjit S. Samra, DRSc, MSEE, RAC, as Head of Medical Device Software Engineering, Cybersecurity and AI.

Siddharth Mittal Appointed as Managing Director & CEO of Syngene International

eClinical Solutions Advances Risk-Based Quality Management Solutions, Helping Sponsors Meet ICH E6(R3) Regulatory Guidelines

Enhancements further break down silos and reduce fragmentation through integrated risk and quality management within one clinical data intelligence platform

Symeres and Axxam Appoint Russell Thomas as Chief Scientific Officer to lead their collaborative integrated discovery platform

ZoBio launches comprehensive DEL hit discovery service for challenging targets

Eli Lilly Launches National Sleep Apnea Awareness Campaign with Shaquille O'Neal and Zepbound

Eli Lilly has launched a nationwide awareness campaign featuring basketball legend Shaquille O'Neal to highlight the risks of moderate-to-severe obstructive sleep apnea (OSA). After learning that years of fatigue, loud snoring, and poor sleep were symptoms of OSA, O'Neal began treatment with Zepbound® (tirzepatide). The campaign encourages people experiencing sleep apnea symptoms to seek medical advice and explore treatment options. Zepbound is the first FDA-approved prescription medicine for adults with obesity and moderate-to-severe OSA, helping improve sleep quality and reduce breathing interruptions during sleep.

Arscience Biotherapeutics Appoints Gustavo Mahler as Chief Executive Officer

Seasoned Biopharmaceutical Leader and Board Director Steps Up to Lead the Company’s Next Phase of Growth in Customized Interleukin Therapies

Alithea Genomics Launches Early Access Program for MERCURIUS™ 1536 DRUG-seq, Bringing Transcriptomics to Compound Screening Scale

New ultra-high-throughput kit enables discovery teams to generate transcriptome-wide compound-response data directly from 1536-well plates

FDA Reopens Path for UniQure’s AMT-130: 3 Years of Gene Therapy Data Could Support Huntington’s Disease Approval

UniQure plans to submit its Huntington’s disease gene therapy, AMT-130, for FDA approval after reaching agreement with the agency on using three years of clinical data. The therapy demonstrated a 75% slowdown in disease progression among patients receiving the higher dose. The development marks a major shift in the FDA’s stance following recent leadership changes and is being viewed as a positive signal for the broader cell and gene therapy sector. Following the announcement, UniQure shares surged nearly 80%, reflecting renewed investor confidence in the program and its regulatory pathway.

TrialAssure and Cancer Research UK Collaborate to Advance AI-Supported Regulatory Document Authoring

Cancer Research UK’s Centre for Drug Development is using TrialAssure LINK AI to support medical writing in CRUK-sponsored studies

Spot Biosystems Launches with $40 Million Funding and Breakthrough Non-Viral Gene Therapy for DMD

Spot Biosystems has emerged from stealth with $40 million in funding and a breakthrough non-viral gene therapy platform for Duchenne muscular dystrophy (DMD). The company demonstrated the world's first successful delivery of full-length dystrophin to human skeletal muscle using engineered extracellular vesicles (EVs). Early clinical data showed dystrophin increases of over 1,000% and 2,000% in two pediatric DMD patients, along with improved muscle function. The technology aims to overcome the limitations of traditional viral gene therapies by enabling repeat dosing and larger genetic payload delivery.

Biogen Expands Immunology Pipeline with $1 Billion RayThera Acquisition to Advance Next-Generation Therapies

Biogen has agreed to acquire RayThera in a deal worth up to $1 billion, significantly expanding its immunology pipeline and strengthening its presence in immune-mediated disease research. The acquisition brings multiple anti-inflammatory drug candidates to Biogen, including a lead therapy expected to enter Phase 1 clinical trials in Q3 2026. Once the transaction closes, Biogen will oversee the development, manufacturing, and global commercialization of these assets. The deal reflects Biogen’s long-term strategy to accelerate innovation and advance new treatment options in immunology.

Paradigm Clinical Research Opens Psychedelic Research Suite in Redding, California

Paradigm Clinical Research has opened a new psychedelic research suite at its Redding, California site, adding a purpose-built space to support psychiatric clinical trials investigating psychedelic-assisted therapies. The facility will support studies in major depressive disorder, treatment-resistant depression, PTSD, substance use disorders, and anorexia nervosa, overseen by board-certified psychiatric staff. The Redding location is notable for its access angle: Shasta County has a veteran population nearly double the state average, and recent regional health assessments have flagged behavioral health and substance use treatment as priority gaps. The company frames the expansion as part of a broader push to bring specialized psychiatric trial access to rural and underserved areas rather than concentrating it in major metro centers.

J‑Pharma Co., Ltd. and Uniphar Announce Advancement of Nanvuranlat into Phase 3 Clinical Development Following FDA Alignment and Initial Patient Enrollment

J Pharma Co., Ltd., a clinical-stage biotechnology company focused on novel therapies targeting amino acid transporters, and Uniphar, a leading international healthcare services company, today jointly announced progress in the development of JPH203 (nanvuranlat), a novel LAT1 inhibitor for the treatment of second-line biliary tract cancer. Following alignment with the U.S. Food and Drug Administration (FDA), the program has advanced into Phase 3 clinical development and initial patients are now enrolled in the global study.

MIB Agents' Community of Families Has Awarded $2.9M in Grants to Research Pediatric Bone Cancer