Clinical Research Updates provides key insights into the latest developments, trends, and breakthroughs shaping the clinical research landscape. Stay informed with concise summaries of regulatory updates, industry collaborations, and advancements in trial methodologies, ensuring you never miss critical updates in the evolving world of clinical development.
Index
Lambda Insights
Global List of 1,600+ Validated Bioanalytical Assays
Explore our comprehensive list of over 1,600 validated bioanalytical assays by Lambda and Novum, conducted across a wide range of biological matrices. The Assay list features – Large Molecules / Therapeutic Proteins / Biosimilars, Immunogenicity Assessment, Small Molecules, New Chemical Entities, In-Vitro Studies, PD Markers, Evaluation of the Effectiveness of Healthcare Hygiene Products. Read more
Lambda-Novum at BIO US, and CPHI China 2025
Lambda & Novum participated in two premier industry events in June 2025.
- BIO International Convention 2025 (June 16-19, 2025 | Boston, USA).
- CPHI China (June 24-26, 2025 | Shanghai, China)
We appreciate the insightful discussions and collaborations at these events. They provided an excellent platform to connect with industry leaders and showcase our comprehensive clinical research solutions for the innovator, biotech, and generic pharmaceutical sectors.
If we missed the opportunity to connect, we’d love to continue the conversation. Reach out at BD@lambda-cro.com to explore how our expertise can support your clinical research needs.
Lambda Showcases Expertise in AI-Driven Pharmacovigilance at Drug Safety Symposium 2025
Dr. Ashish Akar, Vice President – Clinical Trials & Pharmacovigilance Operations at Lambda Therapeutic Research, recently spoke at the 4th Edition Drug Safety Symposium 2025 – India Chapter, held on 25–26 June at Holiday Inn Mumbai International Airport.
His session, titled “Smarter Pharmacovigilance: AI and ML for Scalable Safety Solutions,” focused on the application of artificial intelligence and machine learning to improve the scalability, efficiency, and compliance of safety operations.
The symposium brought together industry leaders and subject matter experts to discuss emerging trends in drug safety and the growing impact of technology in strengthening pharmacovigilance frameworks.
Approvals
HIV prevention drug – Lenacapavir hailed as a ‘breakthrough’ gets FDA approval
18 June 2025
Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Yeztugo® (lenacapavir)—the company’s injectable HIV-1 capsid inhibitor—as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg, making it the first and only twice-yearly option available in the United States for people who need or want PrEP. Data show that ≥99.9% of participants who received Yeztugo in the Phase 3 PURPOSE 1 and PURPOSE 2 trials remained HIV negative. Read More
Regulatory
FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs
The FDA’s animal testing requirement for Monoclonal Antibodies and Other Drugs, will be reduced, refined, or potentially replaced using a range of approaches. Read more.
Advances in EMA plans to streamline biosimilar assessment
The EMA’s new proposed approach will potentially reduce the amount of clinical data required for the development and approval of biosimilar medicines. Read more.
FDA eliminates REMS for approved CAR-T therapies
The US Food and Drug Administration (FDA) has announced that six approved autologous chimeric antigen receptor T-cell (CAR-T) immunotherapies will no longer be required to comply with risk evaluation and mitigation strategies (REMS) reporting requirements. This decision is based on a better understanding of these products since their initial approval in 2017. Read More.
Note: This newsletter includes links to published news articles and press releases, which may retain the original titles and summaries. The views and opinions expressed in these articles are those of the original author(s) and do not necessarily reflect the perspective of Lambda Therapeutic Research Ltd.
About Lambda Therapeutic Research
Lambda Therapeutic Research is a global full-service Clinical Research Organization (CRO) with roots in Ahmedabad, India, and a presence across Mehsana (India), Las Vegas (USA), Toronto (Canada), Pittsburgh (USA), London (UK), Barcelona (Spain) and Warsaw (Poland).
We specialize in supporting the pharmaceutical, biotech, and generic drug industries with end-to-end clinical research services. Over the years, we have grown through both innovation and strategic expansion. A significant milestone in this journey was the 2019 acquisition of Novum Pharmaceutical Research Services, a well-established CRO with a 50-year legacy. Today, in North America, we operate under the Novum brand, further strengthening our global footprint in clinical research.
Prioritizing secure IT infrastructure and automation, Lambda ensures timely project delivery, adhering to global regulatory standards. Our outstanding regulatory track record is underscored by over 60 successful international inspections and audits conducted by esteemed authorities, including the USFDA, EMEA, MHRA, EU member states, and other global bodies over the past five years.
Lambda has been recognized for its expertise and commitment to quality, earning several prestigious industry awards. We were honored as the ‘Best Indian CRO’ by Frost & Sullivan (USA) and recognized as a ‘Great Indian Workplace’ by UBS Transformance. More recently, we received the ‘Regulatory Excellence‘ Award at the CPhI Awards 2023 and were awarded the ‘Industry Partner of the Year‘ Award at the Global Generics & Biosimilar Awards 2023. Industry Outlook has also highlighted Lambda among the ‘Top 10 CROs‘ in 2022 and ‘Top 10 Contract Research Organizations‘ in 2023. These accolades reflect our strong focus on regulatory compliance, industry leadership, and meaningful collaborations in the biotech,
