Press Releases

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.

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.

WCG Appoints Anthony Doyle as Chief Financial Officer to Support Continued Growth and Operational Scale

WCG announced the appointment of Anthony Doyle as chief financial officer, effective June 15, 2026. Anthony brings more than two decades of financial leadership experience across healthcare, clinical research, and both public and private equity-backed organizations.

FibroFind appoints new CEO to lead firm through next phase of growth

Paradigm Clinical Research Appoints Greg Licholai, MD, Chief Medical Officer at Syneos Health, to Board of Directors

Greg Licholai, MD, Chief Medical Officer at Syneos Health, joins Board of Directors of Paradigm Clinical Research, a clinical research site organization

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.

Genesis AEC Highlights PharmaWater Pro® Modeling Capability for Early Stage Pharmaceutical Water System Design

Platform helps manufacturers evaluate sustainability, utilities, and lifecycle costs before committing to major infrastructure

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.

Sygnature Discovery collaborates with DaltonTx to advance AI-enabled drug discovery capabilities

Yunu Launches De-ID & Export to Simplify Site-to-Sponsor Trial Data Sharing

Yunu has launched a new De-ID & Export feature that streamlines how clinical research sites share imaging data with trial sponsors. The capability enables sites to securely export images, results, and supporting files while automatically applying study-specific de-identification requirements. By reducing the manual effort typically involved in preparing and transferring trial data, the tool aims to improve operational efficiency, reduce site burden, and accelerate data sharing across clinical studies.

Aragen to manufacture Renaissance Pharma’s FDA Fast Track mAb as part of ongoing strategic collaboration

Aragen has successfully completed the technology transfer and manufactured the first commercial-scale GMP batches of Renaissance Pharma’s Daretabart in just nine months. The humanized monoclonal antibody, which targets high-risk neuroblastoma, recently received FDA Fast Track Designation. Utilizing Aragen’s dual-hub model, production transitioned from early-phase development in Morgan Hill, California, to a new $40 million commercial biologics facility in Bengaluru, India. This strategic collaboration significantly increased the drug's titer, accelerating clinical production toward a future Biologics License Application submission.

ClearNote Health Secures $52 Million in Series D Financing and Strengthens Leadership Team to Accelerate Growth in Early Cancer Detection

ClearNote Health today announced a $52M Series D financing alongside the appointment of Kevin Keegan as President and COO.

CellCarta and Sonic Healthcare Establish Strategic Partnership to Commercialize Companion Diagnostics Through Lab Network

CellCarta has announced a Strategic Partnership with Sonic to launch the first commercial laboratory relationship in CellCarta’s Lab Network strategy.

Veeva Announces Falcon, an Agentic Platform and Standard Agents to Deliver Agentic Labor in Drug Development

Baptist Health South Florida and The START Center for Cancer Research Announce Strategic Partnership to Expand Patient Access to Early-Phase Cancer Trials

New START site to be established in collaboration with Baptist Health Herbert Wertheim Cancer Institute will bring novel oncology therapies closer to patients across South Florida.

Syncell Launches High-Precision Proteomics Discovery Service Powered by Microscoop® Mint Platform

Syncell announced the commercial launch of Syncell Discovery Services, a new sample-to-discovery offering that gives biopharma, translational, and academic researchers direct access to insights generated by the company’s unbiased nanoscopic Microscoop Mint platform.

‘Biopharma innovators must widen CDMO networks to accelerate development’ says Shilpa Biologicals CEO ahead of BIO San Diego

Ahead of BIO San Diego, Shilpa Biologicals urges biotech innovators to engage CDMO partners earlier and look beyond large-scale providers. Over-relying on a narrow network of large CDMOs increases the risk of scope creep, severe clinical trial delays, and budget overruns of up to 40%. Conversely, incorporating smaller CDMOs can lower costs and accelerate timelines from discovery to clinic by several months.

Quotient Sciences Advances AI-Designed Drug Product into Clinical Development