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.

Lambda Insights

A Highly Precise, Accurate, and Robust LC-MS/MS Method for the Quantification of Semaglutide in Human Plasma

Quantifying large peptide molecules like Semaglutide in complex biological matrices presents a significant challenge in bioanalysis. Read our latest blog, which explores the development and validation of a highly precise, accurate, and robust LC-MS/MS method for quantifying semaglutide in human plasma. Read more

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 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 BD@lambda-cro.com to explore how our expertise can support your clinical research needs.

Clinical Trial Updates

Eli Lilly’s lepodisiran cuts lipoprotein(a) by 93.9% in Phase II trial

31 March 2025
Eli Lilly has reported promising Phase II results for lepodisiran, its experimental therapy aimed at reducing lipoprotein(a) [Lp(a)], a genetically inherited risk factor for heart disease. The study demonstrated that the therapy significantly reduced Lp(a) by an average of 93.9%, with the highest tested dose of 400mg for 60 to 180 days, meeting the primary endpoint. The findings were presented as part of the American College of Cardiology 2025 Scientific Sessions in Chicago, US. Read more.

MITIGATE Trial Shows Uplizna Significantly Lowers Flare Risk, Glucocorticoid Dependence in IgG4-Related Disease

28 March 2025
Findings from the Phase III MITIGATE trial (NCT04540497) show the efficacy of Uplizna (inebilizumab) in lowering the risk of flares and reducing glucocorticoid dependence with higher rates of treatment- and glucocorticoid-free remission in patients with immunoglobulin G4-related disease (IgG4-RD). Uplizna is a humanized, afucosylated IgG1 kappa monoclonal antibody that was designed to target CD19 to induce rapid, deep, and durable B-cell depletion. Read more.

Lipocine’s Phase III trial of LPCN 1154 to begin for postpartum depression

27 March 2025
Lipocine has announced the commencement of a randomised Phase III clinical trial of LPCN 1154, an oral formulation of brexanolone, being developed for treating postpartum depression (PPD). The trial’s initiation follows comparative exposure between LPCN 1154 and the reference drug from a pharmacokinetic bridge trial. Read more.

J&J Releases New Data from Phase III MARIPOSA Trial of Rybrevant-Lazcluze Combination in Non-Small Cell Lung Cancer

26 March 2025
Johnson & Johnson has shared new, positive data from the Phase III MARIPOSA clinical trial of Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations. Compared head-to-head with osimertinib, the Rybrevant-Lazcluze combination demonstrated a significantly extended rate of overall survival (OS). Read more.

Ractigen’s RAG-01 shows potential in treating non-muscle invasive bladder cancer

26 March 2025
RAG-01 demonstrated preliminary anti-tumor activity in BCG-unresponsive NMIBC, with complete responses in some patients and a 66.7% disease-free survival rate in papillary tumors. The therapy upregulates the p21 tumor suppressor gene, showing minimal systemic exposure and dose-dependent urine concentration. The phase 1 study reported no dose-limiting toxicities, serious adverse events, or deaths, with most treatment-related adverse events being grade 1. The trial’s dose escalation phase is ongoing, with plans for a dose expansion phase to further explore RAG-01’s capabilities in NMIBC. Read more.

Solriamfetol Significantly Reduces ADHD Symptoms in Axsome’s Phase 3 Trial

25 March 2025
Solriamfetol significantly reduced ADHD symptoms in adults, achieving a 45% mean reduction compared to placebo in the FOCUS Phase 3 trial. Improvements in ADHD symptoms with solriamfetol were observed as early as week 1, with a favorable safety and tolerability profile. The trial met key secondary endpoints, significantly reducing overall ADHD severity compared to placebo. Axsome Therapeutics plans to initiate a trial for solriamfetol in pediatric ADHD patients this year. Read more.

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.

Immunovant’s Batoclimab Excels in Clinical Trials for Myasthenia Gravis and Chronic Inflammatory Demyelinating Polyneuropathy

19 March 2025
Immunovant has shared positive results of its batoclimab in a Phase III clinical trial in myasthenia gravis (MG) and a Phase IIb trial in chronic inflammatory demyelinating polyneuropathy (CIDP). In the Phase III MG study, batoclimab demonstrated a meaningful change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) in AChR+ population at week 12, with a 5.6 point improvement in the higher dose arm and a 4.7 point improvement in the lower dose arm, meeting the primary endpoint. Read more.

Arvinas and Pfizer Announce Positive Topline Results from Phase 3 VERITAC-2 Clinical Trial

16 March 2025
Arvinas have recently announced their new positive topline results from the Phase 3 VERITAC-2 clinical trial evaluating vepdegestrant monotherapy versus fulvestrant in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer whose disease progressed following prior treatment with cyclin-dependent kinase 4/6 inhibitors and endocrine therapy. These are the first pivotal data for vepdegestrant, a potential first-in-class investigational oral Proteolysis Targeting Chimera ER degrader. Read more.

MIRASOL: Elahere extends survival in hard-to-treat ovarian cancer

17 March 2025
Treatment with AbbVie’s Elahere (mirvetuximab soravtansine) reduced the risk of death by 32% in women with difficult-to-treat epithelial ovarian cancer over standard chemotherapy. That’s according to final data from the confirmatory Phase 3 MIRASOL (NCT04209855) trial, which supported the therapy’s full approval in the U.S. and the E.U. last year. 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.

Gilead’s once-yearly lenacapavir formulations show sustained efficacy for HIV PrEP in Phase 1 study

11 March 2025
New pharmacokinetic data, reveal long-lasting plasma concentrations, surpassing twice-yearly subcutaneous formulation for HIV prevention. Phase 1 Data Indicate Potential for Use of Once-Yearly Lenacapavir for HIV Prevention, with Plans to Launch a Phase 3 Trial in 2H 2025 Read more.

Baricitinib shows promise for adolescent alopecia areata in phase 3 trial

8 March 2025
Baricitinib, an oral Janus kinase (JAK) inhibitor, demonstrated significant hair regrowth in adolescents with severe alopecia areata (AA), according to 36-week results from a phase 3 trial presented at the 2025 American Academy of Dermatology (AAD) Conference. The study, known as BRAVE-AA-PEDS, was sponsored by Eli Lilly and Company and involved 257 adolescents aged 12 to under 18 years. Read more.

Imfinzi Plus Chemo May Improve Event-Free Survival in Gastric, GEJ Cancers

7 March 2025
Positive high-level results from the MATTERHORN Phase III trial showed perioperative treatment with AstraZeneca’s Imfinzi (durvalumab) in combination with standard-of-care FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival (EFS). Read more.

Amgen and AstraZeneca report results from Phase III trial of Tezspire for CRSwNP

3 March 2025
Amgen and AstraZeneca have reported complete outcomes from the registrational Phase III WAYPOINT trial of Tezspire (tezepelumab-ekko) for treating chronic rhinosinusitis with nasal polyps (CRSwNP). The trial showed that treatment with the therapy decreased the severity of nasal polyps and congestion at week 52, as well as the need for surgery and the use of systemic corticosteroid. Read more.

Approvals

FDA Approves Expanded Label of Novartis’ Prostate Cancer Treatment, Pluvicto

30 March 2025
The FDA has approved Novartis’ radioligand therapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been previously treated with an androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay chemotherapy. Read More

FDA approves first-of-its-kind RNA drug for hemophilia

28 March 2025
The Sanofi drug, known as fitusiran and now Qfitlia, was approved by FDA for a broad group of people with the rare bleeding disorder. The FDA cleared fitusiran for market based on two late-stage clinical trials that, together, showed it kept bleeding events in check for the two most common forms of hemophilia. It was also effective whether or not participants had “inhibitors,” a type of antibody that attacks the “replacement” blood-clotting protein many hemophilia patients require. Read More

FDA approves first-of-its-kind antibiotic from GSK

26 March 2025
Developed by British drugmaker GSK in collaboration with the US government’s Biomedical Advanced Research and Development Authority, gepotidacin is a first-in-class triazaacenaphtylene antibiotic that uses a distinct mechanism of action to inhibit bacterial replication. The FDA approved it for women and children 12 years and older with uUTIs caused by susceptible organisms, including Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis. Read More

FDA grants priority review to application for tolebrutinib for MS

26 March 2025
The U.S. Food and Drug Administration (FDA) has granted priority review to an application from Sanofi seeking the approval of its BTK inhibitor tolebrutinib to treat multiple sclerosis (MS). Read More

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 grants fast track designation to nipocalimab for Sjögren’s disease

18 March 2025
Nipocalimab, an experimental antibody-based therapy being developed by Johnson & Johnson, was granted fast track status by the U.S. Food and Drug Administration (FDA) for adults with moderate to severe Sjögren’s disease. 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

FDA Draft Guidance

• Data Standards Catalog (published 24-Mar-2025)
• Study Data Technical Conformance Guide – Technical Specifications Document (published 27-Mar-2025)

EMA establishes regular procedure for scientific advice on certain high-risk medical devices

24 March 2025
EMA, in close collaboration with the European Commission, has established a standard procedure for manufacturers of certain high-risk medical devices to request scientific advice on their intended clinical development strategy and proposals for clinical investigation. Manufacturers of class III devices and class IIb active devices intended to administer or remove medicines can now submit their request for advice via a portal and consult the medical device expert panels at different stages of the clinical development. Read More

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

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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.

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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,