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- The global cosmetovigilance market, valued at $13.47 billion in 2025, is projected to reach $22.04 billion by 2035 with a CAGR of 5.15%, according to SNS Insider. - Pre-marketing services dominated with 56.38% of 2025 revenue, while post-marketing services are expected to grow fastest at a 5.80% CAGR through 2035. - Europe held the largest market share at 34.87% in 2025, while Asia-Pacific is forecast to grow at the highest rate of 6.91% CAGR through 2035. - A two-day cosmetovigilance masterclass scheduled for December 2026 will provide 12 CPD hours covering causality assessments, PIF architecture, signal detection, and regulatory compliance.
- The FDA's AI use-cases surged 148% between 2024 and 2025, driven by former commissioner Marty Makary's centralized approach and the rollout of the agency-wide Elsa large language model tool. - Recent departures of Makary, chief AI officer Jeremy Walsh, and acting CIO Sridhar Mantha have created uncertainty around leadership and governance of FDA-wide AI efforts. - Former FDA AI policy official Tala Fakhouri warns the agency may revert to a fragmented, department-specific AI approach, though sponsor-facing AI policies remain unchanged. - Experts call for greater transparency on how the FDA uses AI internally and streamlined rulemaking for AI validation in clinical trials.
- Parexel announced the launch of the Parexel Biotech Incubator at its Raleigh global headquarters to connect early-stage therapeutics companies with clinical and regulatory expertise. - The incubator launches alongside an inaugural partnership with Durham-based seed-stage venture capital firm Cape Fear BioCapital, linking investment to development guidance. - Participating companies gain access to development planning, regulatory strategy, and clinical trial design support at a stage when development decisions carry the most weight. - The initiative builds on Parexel's broader commitment to fostering early-stage innovation and deepens its roots in North Carolina's life sciences ecosystem, which ranks seventh nationally in employment.
- Parexel presents two virtual research posters at ASCO 2026, including real-world pulmonary safety analysis of trastuzumab deruxtecan in HER2-positive metastatic breast cancer patients. - The company's oncology experience spans over 560 clinical studies involving more than 104,000 patients across 26,000 sites in 50+ countries over the past five years. - Parexel Biotech has delivered data supporting six FDA and three EMA new solid-tumor oncology drug approvals during this period. - The company launches "From Insights to Life" patient-focused campaign to reinforce its commitment to patient-centered clinical development.
- HEPHAISTOS-Pharma has appointed Stephan Braun, former Chief Medical Officer of ImCheck Therapeutics, as its new Chief Medical Officer to lead clinical development strategy. - The appointment comes as the company prepares to advance its lead candidate HEPHA440, a third-generation TLR4 agonist small molecule, into first-in-human studies. - HEPHA440 is designed to activate the innate immune system by targeting myeloid cells within the tumor microenvironment and has demonstrated compelling anti-tumor activity in preclinical cancer models. - The drug candidate is scheduled to enter clinical trials in 2027, with Braun leading the preparation of clinical trial design and translational development strategy.
- Parexel announced the acquisition of Vitrana, an AI-enabled pharmacovigilance technology platform provider, with undisclosed financial terms. - The acquisition expands Parexel's technology capabilities by providing an integrated platform that uses automation and artificial intelligence to support end-to-end patient safety processes. - The system-agnostic platform integrates with any safety database and is expected to improve accuracy, cycle times, and operational efficiency for customers. - Customers will benefit from a single partner model for both pharmacovigilance technology and services, offering better pricing flexibility and streamlined vendor management.
- Real-world evidence (RWE) has transitioned from optional to mandatory for pharmaceutical manufacturers, requiring continuous data collection throughout a drug's entire market lifecycle for safety monitoring and regulatory compliance. - Regulatory agencies including FDA's Center for Real-World Evidence Innovation and EMA's DARWIN EU project are building comprehensive infrastructures to facilitate RWE integration, with Europe's network collecting data from approximately 130 million patients. - Beyond safety surveillance, RWE is driving patient-centric innovation by enabling adaptive regulatory pathways and helping developers choose optimal directions for novel therapies, particularly complex treatments like cell therapies in oncology.
- Parexel has announced two strategic AI partnerships with Weave Bio and Paradigm Health to revolutionize clinical trial operations and regulatory submission processes. - The partnership with Weave Bio has already demonstrated 50% faster completion times for Investigational New Drug applications using their AutoIND platform. - Collaboration with Paradigm Health aims to address the $2.23 billion average cost of bringing new therapies to market through AI-driven trial optimization. - These partnerships position Parexel to offer sponsors compressed timelines, lower operational costs, and improved patient access to clinical trials.
- Harbour BioMed has appointed Yajie Li as Chief Medical Officer to lead clinical development and regulatory strategy for the company's immunology and oncology programs. - Li brings over a decade of pharmaceutical experience from multinational corporations including Merck and Johnson & Johnson, plus nine years at China's National Medical Products Administration. - The appointment strengthens Harbour BioMed's capabilities as it advances its pipeline using proprietary antibody technologies including Harbour Mice, HBICE, and HBICA platforms. - Li will evaluate early-stage assets based on unmet medical needs and scientific differentiation while reporting directly to CEO Dr. Jingsong Wang.
- Panthera Biopartners, the UK's largest Site Management Organisation, has signed two clinical trial contracts worth over £10 million each with international pharmaceutical companies. - The company has demonstrated exceptional performance in 2024, becoming the top global recruiter in four studies and achieving first patient enrollment in nine studies across the UK and globally. - Despite declining NHS-registered trial enrollments, independent SMOs like Panthera are experiencing rapid growth, highlighting the UK's continued strength as a prime destination for clinical research.
