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
Case Study: Executing a Complex Bioequivalence Study for Semaglutide Injection
Explore our meticulous approach to the bioequivalence study for Semaglutide injection, overcoming key challenges and ensuring successful execution. This case study highlights how Lambda played a pivotal role in driving the study’s success by offering a comprehensive range of services. Read More.
Endpoint Selection in Oncology Trials: Key Insights for Clinical and Regulatory Success
In our latest blog, we examine critical considerations for selecting oncology trial endpoints, their relevance across various study phases, and how thoughtful endpoint strategy can enhance study design and regulatory alignment. Read More.
Approvals
EMA approves Moleculin’s application for Phase IIb/III AML trial
13 May 2025
The European Medicines Agency (EMA) has approved Moleculin Biotech’s clinical trial application (CTA) for a pivotal, multi-centre Phase IIb/III trial of Annamycin plus cytarabine (Ara-C) for adults with acute myeloid leukaemia (AML). Read More
CHMP Recommends Mirdametinib for EU Approval in Adult/Pediatric NF1-PN
23 May 2025
The European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended mirdametinib (Gomekli) for approval as a treatment for symptomatic, inoperable plexiform neurofibromas in pediatric and adult patients with neurofibromatosis type 1 (NF1-PN), according to a press release from the developer, SpringWorks Therapeutics. Read More
CHMP Recommends EU Approval of Obe-Cel for Relapsed/Refractory B-ALL
23 May 2025
Zanubrutinib has demonstrated significant efficacy and a favorable safety profile in frontline CLL treatment, with promising progression-free survival rates. Triplet regimens, such as zanubrutinib with obinutuzumab and venetoclax, show deep remissions but raise concerns about increased toxicity. Read More
Regulatory
FDA and NIH Announce Innovative Joint Nutrition Regulatory Science Program
The joint initiative aims to research and tackle root causes of diet-related chronic diseases with evidence-based science. Read more.
FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities
he FDA started performing unannounced inspections in India and China and is now expanding unannounced inspections to other foreign entities. Read more.
FDA Announces Completion of First AI-Assisted Scientific Review Pilot and Aggressive Agency-Wide AI Rollout Timeline
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,
