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
Lambda-Novum at AAD Annual Meeting, DCAT Week, and BIO-Europe Spring 2025
Lambda & Novum participated in three premier industry events in March 2025.
- BIO-Europe Spring (March 17-19, 2025 | Milan, Italy).
- DCAT Week (March 17-20, 2025 | New York, USA)
- AAD Annual Meeting (March 7-11, 2025 | Florida, USA)
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 [email protected] to explore how our expertise can support your clinical research needs.
Industry News
AstraZeneca to expand cell therapy capabilities with $1bn EsoBiotec acquisition
18 March 2025
AstraZeneca (AZ) has announced that it will be expanding its cell therapy capabilities by acquiring EsoBiotec for up to $1bn. The deal will give AZ access to EsoBiotec’s Engineered NanoBody Lentiviral (ENaBL) platform, which the Anglo-Swedish drugmaker said “could offer many more patients access to transformative cell therapy treatments delivered in just minutes rather than the current process which takes weeks. Read more
BioCity and MSD to evaluate cancer treatment combination in Phase I/II trial
14 March 2025
BioCity Biopharmaceuticals and MSD have signed a clinical trial partnership agreement to assess BC3195 in conjunction with the latter’s Keytruda (pembrolizumab) in a global Phase I/II trial for individuals with locally advanced or metastatic solid tumours. Read more.
Bayer, Hurdle’s saliva-based epigenetic clock provides new window into ageing
13 March 2025
Bayer and Hurdle revealed new research on Thursday that validates InflammAge, a saliva-based DNA methylation (DNAm) biomarker developed to measure systemic chronic inflammation. The findings, published in Aging Cell, demonstrate how InflammAge can be used to measure and analyse biological mechanisms of ageing at the cellular level without blood or tissue samples. Read more.
Oncology Drugs Fast-Tracked by the FDA in February 2025
03 March 2025
In February, the U.S. Food and Drug Administration (FDA) granted fast track designations to key drugs for liver, colorectal, and ovarian cancers, among others. Read more.
Clinical Trial Updates
Novartis builds case for new SMA gene therapy
20 March 2025
Novartis has released detailed late-stage clinical data supporting its intrathecal drug, which contains the same active ingredient as Zolgensma, as a potential treatment for a broader range of spinal muscular atrophy (SMA) patients. The company believes these findings will play a key role in securing regulatory approval for the therapy, positioning it as a successor to its blockbuster gene therapy, Zolgensma. Read more.
Novel cancer therapy works for 73 per cent Indian patients in clinical trials: Why the Lancet report is significant
16 March 2025
The study looked at patients with leukaemia, which occurs in bone marrow, and lymphoma, which affects the lymphatic system. An indigenously developed gene therapy for specific blood cancers has shown a 73 per cent response rate among patients in India, according to results of clinical trials published in The Lancet Haematology journal. Read more.
SRC approves opening of TransCode’s fourth cohort in trial of TTX-MC138
14 March 2025
AUS Safety Review Committee (SRC) has granted unanimous approval for TransCode Therapeutics to open the fourth cohort in its Phase I trial of TTX-MC138 for treating several metastatic cancers. This decision follows the committee’s ‘favourable’ safety data review of cohort three.. Read more.
Vir enrols first subject in Phase III programme to assess CHD therapy
14 March 2025
Vir Biotechnology has enrolled the first subject in the Phase III ECLIPSE registrational programme of tobevibart and elebsiran in individuals with chronic hepatitis delta (CHD), an inflammatory liver condition. The programme is designed to assess the safety and efficacy of the combination in this patient population. Read more.
INOVIO’s Covid-19 dMAb maintains in-vivo detection in 100% participants
14 March 2025
INOVIO’s DNA-encoded monoclonal antibodies (dMAbs) have been able to maintain biologically relevant levels in 100% of Covid-19 in a Phase I proof-of-concept trial. Out of the 24 healthy volunteers recruited onto the open-label trial (NCT05293249) that made it to week 72, all still had biologically relevant levels of dMAb antibodies in their systems. Read more.
Amgen’s Uplizna Deepens Response Against Myasthenia Gravis at 1 Year
13 March 2025
Amgen’s anti-CD19 antibody Uplizna maintains and improves treatment response in patients with generalized myasthenia gravis through 52 weeks of follow-up, according to a Phase III readout. Results from the company’s double-blind, placebo-controlled Mint study (NCT04524273) showed 72.3% of acetylcholine receptor autoantibody-positive (AChR+) gMG patients dosed with Uplizna saw a more than three-point improvement on the Myasthenia Gravis Activities of Daily Living (MG-DAL) scale. This is compared to just 45.2% in the placebo group. The MG-DAL uses points to quantify the impact of muscle fatigue in various areas of the body. Read more.
Bambusa Therapeutics doses first volunteers in Phase I bispecific AD trial
28 Feb 2025
Bambusa Therapeutics has announced the dosing of its first healthy volunteers as part of a Phase I trial on its half-life extended bispecific antibody therapy for atopic dermatitis (AD). Read more.
Approvals
Novartis receives third FDA approval for oral Fabhalta (iptacopan) as First C3 Glomerulopathy Therapy
21 March 2025
Oral iptacopan (Fabhalta) has received approval from the US Food and Drug Administration (FDA) for the treatment of adults with C3 glomerulopathy (C3G), to reduce proteinuria. Announced by Novartis on March 20, 2025, the approval marks the first approval for the ultra-rare kidney disease and is based on data from the phase 3 APPEAR-C3G trial. Read More
FDA Approves Celltrion’s Denosumab Biosimilars for Bone Loss Indications
03 March 2025
Celltrion announced that the U.S. Food and Drug Administration (FDA) has approved STOBOCLO® (CT-P41, denosumab-bmwo) and OSENVELT® (CT-P41, denosumab-bmwo), biosimilars referencing PROLIA® (denosumab) and XGEVA® (denosumab) respectively for all indications of reference products. Read More
Moderna receives MHRA marketing authorization for RSV vaccine
01 March 2025
Moderna (MRNA) announced that the Medicines and Healthcare products Regulatory Agency in the UK has granted marketing authorization for mRESVIA, indicated for active immunization for the prevention of lower respiratory tract disease caused by respiratory syncytial virus in adults 60 years of age and older. The approval is based on data from the Phase 3 clinical trial ConquerRSV, a randomized, placebo-controlled, observer-blind, case-driven clinical study conducted in approximately 37,000 adults aged 60 years or older in 22 countries. No serious safety concerns were identified in the Phase 3 trial. Read More
Regulatory
New clinical trial map launched in the European Union
03 March 2025
A new clinical trial map is now accessible from the public website of the Clinical Trials Information System
(CTIS). The map is designed to provide patients and healthcare professionals with easy access to comprehensive, real-time information about clinical trials conducted in their area, increasing access to clinical research in the European Union (EU). Read More
Interesting Articles/Insights
5 CAR T Cell Therapies With Autoimmune Readouts in 2025
Having established success in cancer, biopharma is now looking to leverage CAR T therapies against a new target, autoimmune disorders, with several early- to mid-stage readouts expected this year. Here, explore five of the most advanced players in this space and how they’re harnessing—and innovating on—CAR T technology to address autoimmune diseases. Read More
Can CDMOs Redefine Sustainability in Pharmaceutical Manufacturing?
CDMOs play a pivotal role in the pharmaceutical supply chain, providing outsourced development and manufacturing solutions to drug developers. Their unique position allows them to drive significant sustainability gains through economies of scale, operational efficiency, and shared infrastructure. Read More
Blocking PD-1 and VEGF: The bispecific cancer drugs that could best Keytruda
Striking study results last year indicated a new type of medicine may improve on Merck’s immunotherapy, spurring a wave of research practically overnight. 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,
