Press Releases

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

Revecore Launches ReClaim(TM), an AI-Native Platform Built for the Complexity Modern Hospitals Face

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.

Bio-Gate: Update on the HIPrevision clinical trial for HyProtect™-coated hip revision implants

Bio-Gate AG (ISIN DE000BGAG981), a leading provider of innovative healthcare technologies, provides an update on the current status of the clinical development of the HyProtect™ coating for orthopedic implants: Following the completion of the pilot phase, the comprehensive main clinical trial has now commenced. The project – conducted in collaboration with a project partner and initially announced in December 2024 – is on track to reach the next milestone toward CE approval of HyProtect™-coated revision implants.

Ambience Healthcare Introduces Nursing Suite to Extend System of Intelligence Across Inpatient Nursing

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.

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

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.

Proscia Launches Fifth Generation of Concentriq, Bringing the Latest Advancements in AI to Pathologists and Scientists

Built on a new AI-native architecture, Concentriq delivers clinically and scientifically grounded intelligence to decisions throughout drug discovery, development, and case review

Novo Nordisk Brings Weight-Loss Treatment to a New Era as Wegovy® Pill Becomes UK's First Daily GLP-1 Obesity Tablet

Novo Nordisk's Wegovy® pill has become the first daily GLP-1 weight-loss tablet approved in the UK, offering adults with obesity and overweight a convenient alternative to weekly injections. The approval was based on the Phase 3 OASIS 4 trial, where patients achieved up to 16.6% average weight loss over 64 weeks. As obesity affects around 15 million people in the UK, the launch of this oral semaglutide treatment is expected to expand access to effective obesity care and strengthen the growing role of GLP-1 drugs in long-term weight management.

Roche Secures Historic FDA Approval for First PTEN Companion Diagnostic in Prostate Cancer

Roche has received FDA approval for the VENTANA PTEN (SP218) RxDx Assay, the first companion diagnostic test designed to identify PTEN protein loss in patients with prostate adenocarcinoma. The breakthrough test helps clinicians determine which patients may benefit from AstraZeneca’s targeted therapy TRUQAP (capivasertib), advancing personalized cancer treatment. Supported by results from the CAPItello-281 clinical trial, the approval marks a significant step in precision oncology, offering new hope for patients with aggressive PTEN-deficient metastatic prostate cancer while reinforcing Roche’s leadership in companion diagnostics and personalized healthcare solutions.

WID®-easy referenced in the German S3 Guideline on Endometrial Cancer

The WID®-easy test has now been included in the updated German S3 Guideline on Endometrial Cancer (Version 4.0, May 2026, AWMF 032-034OL). It is referenced in the explanatory background text supporting the recommendations, on pages 67 and 68. Key points at a glance: • The guideline cites four peer-reviewed validation studies and describes a reduction of invasive workup from 19 to 2 D&C procedures per cancer detected, compared with transvaginal ultrasound alone. • On the basis of the cited studies, the guideline attributes to the WID®-easy Test a sensitivity of > 95 % and a negative predictive value, NPV, of ≥ 99.7 %. • The guideline states that the WID®-easy Test "has the potential to improve the diagnostic workup of women with peri- and postmenopausal bleeding by reducing the rate of invasive procedures." The full guideline (in German) is available here: https://www.leitlinienprogramm-onkologie.de/fileadmin/user_upload/Downloads/Leitlinien/Endometriumkarzinom/Version_4/LL_Endometriumkarzinom_Langversion__4.0.pdf Please note that the guideline itself is only available in German. The summary above reflects the relevant statements from pages 67–68.

New from MRC Holland: NGS-based Assay for Confident, High-Resolution CNV Detection in the DMD gene

MRC Holland is announcing the launch of our latest assay: NXtec™ D008 DMD. This NGS-based solution delivers highly reliable detection of CNVs associated with Duchenne and Becker muscular dystrophies. NXtec D008 DMD is a high-throughput assay providing comprehensive coverage of DMD with two probes per each of its 79 exons, and 50 additional probes distributed across the X chromosome to aid with result interpretation. It enables the detection of single-exon to whole-gene CNVs in DMD, as well as larger X-chromosome CNVs and aneuploidies in a single reaction.

Moderna and Oxford Secure $60 Million CEPI Funding to Advance Ebola Bundibugyo Vaccine Development During Congo Outbreak

CEPI has committed $60 million to accelerate Ebola Bundibugyo vaccine development with Moderna and the University of Oxford amid an ongoing outbreak in the Democratic Republic of Congo. The funding will support preclinical and early clinical development, along with manufacturing readiness for potential large-scale trials. Health agencies report 282 confirmed cases and 42 deaths, highlighting urgent containment needs. The initiative strengthens global vaccine R&D efforts focused on faster outbreak response and infectious disease preparedness.

Alithea Genomics and Revvity Announce Distribution Agreement to Expand Access to MERCURIUSTM DRUG-seq Solutions

Alithea Genomics has announced a new agreement with Revvity Inc. to broaden access to MERCURIUS™ DRUG-seq and MERCURIUS™ Total DRUG-seq solutions through Revvity’s global commercial network.

Roche and Nurix Place a Multi-Billion-Dollar Bet on the Future of BTK Degradation

Nurix Therapeutics and Roche have announced a global collaboration to develop and commercialize bexobrutideg, an investigational BTK degrader designed to treat blood cancers, autoimmune disorders, and neurological diseases. Under the agreement, Nurix will receive a $700 million upfront payment and could earn up to $2.3 billion in additional milestone payments. Bexobrutideg is designed to eliminate the BTK protein rather than simply block its activity, potentially offering advantages over existing BTK inhibitors, including effectiveness against treatment-resistant disease. The partnership will support ongoing late-stage studies in chronic lymphocytic leukemia (CLL) while expanding development into multiple sclerosis (MS) and chronic spontaneous urticaria (CSU), aiming to unlock the therapy’s full potential across multiple disease areas.

Baxfendy’s FDA Approval Puts AstraZeneca on Track for a $5 Billion Cardiometabolic Opportunity

AstraZeneca has received FDA approval for Baxfendy, a first-in-class treatment for hypertension, marking a significant milestone in its cardiometabolic growth strategy. The company believes the drug could address a major unmet need among millions of patients with uncontrolled blood pressure and has the potential to generate up to $5 billion in peak annual revenue. AstraZeneca is also evaluating Baxfendy for chronic kidney disease, heart failure, and other related conditions. The approval strengthens the company's position in cardiovascular and metabolic care while supporting its long-term growth ambitions.

Moderna and Merck Report Five-Year Melanoma Data Showing Durable Benefit of Personalized Cancer Vaccine With KEYTRUDA

Moderna and Merck shared 5-year results from the KEYNOTE-942 study showing that their personalized mRNA cancer vaccine, intismeran autogene, combined with KEYTRUDA, significantly improves outcomes for high-risk melanoma patients. The treatment reduced the risk of cancer recurrence or death by 49% and distant metastasis or death by 59% compared to KEYTRUDA alone. It also showed encouraging overall survival trends and stronger immune responses driven by tumor-targeted T-cells. The therapy remained safe over long-term follow-up with mostly mild side effects, highlighting the potential of personalized cancer vaccines in future oncology care.

NextGen Pathology Selects Proscia to Establish AI Foundation for Business Growth

National group positions itself as key partner for biopharmaceutical research, strengthening its role in precision medicine