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

World Cancer Day: Patient-Centric Trials in Advancing Cancer Research: A Journey of Progress & Hope

04 Feb 2025
On #WorldCancerDay, we highlight the vital role of cancer clinical trials in providing patients early access to innovative treatments and generating critical insights that advance medical progress. At Lambda Therapeutic Research and Novum Pharmaceutical Research Services, we’re honored to partner with global biotech and pharmaceutical companies to support these life-changing studies, working together for a future with better outcomes for cancer patients. Read more

Industry News

Bambusa Therapeutics doses first volunteers in Phase I bispecific AD trial

28 Feb 2025
BullFrog AI Holdings has announced a partnership agreement with Eleison Pharmaceuticals to apply its artificial intelligence (AI) solutions to Eleison’s pivotal Phase III trial of pancreatic cancer treatment, glufosfamide. Leveraging its Data Networks AI solution, supported by the bfLEAP platform, BullFrog AI will ‘analyse’ clinical data from Eleison’s ongoing Phase III trial and prior studies involving the therapy. Read more.

Biogen inks royalty deal to gain funding for lupus drug R&D

12 Feb 2025
Biogen is set to receive as much as $250 million in funding to develop a late-stage experimental lupus medication called litifilimab after signing a deal with Royalty Pharma. Read more.

UK government announces £82.6 million for research into AI medical treatments

11 Feb 2025
The UK government is pledging £82.6m ($102.2m) in research funding to back artificial intelligence (AI) companies developing technologies to accelerate drug development. The government is investing £37.9m in three British research projects under the Research Ventures Catalyst (RVC) programme. This funding is complemented by an additional £44.7m in co-investment from various sources, bringing the total backing to £82.6m. Read more.

Alumis and ACELYRIN to Merge Creating a Late-Stage Clinical Biopharma Company Dedicated to Innovating, Developing & Commercializing Transformative Therapies for Immune-mediated Diseases

06 Feb 2025
Alumis and Acelyrin are merging, the biotechnology companies, in an all-stock deal that leaves the combined company with a bigger cash balance and three drugs in clinical testing. The merged entity will continue to develop Alumis’ two so-called TYK2 inhibitors, one of which is being developed for plaque psoriasis and lupus while the other is targeting neuroinflammatory conditions like multiple sclerosis. Acelyrin’s top prospect, a thyroid eye disease drug called lonigutamab, is part of the deal, too, but the program will be re-evaluated to “confirm its differentiation in a capital efficient manner,” the companies said. Read more.

Novartis to buy Boston-based clinical-stage biopharma company, Anthos Therapeutics for up to $3.1 billion

11 Feb 2025
Novartis announced that it has entered into an agreement to acquire Anthos Therapeutics, Inc., a Boston-based, privately held, clinical-stage biopharmaceutical company with abelacimab, a late-stage medicine in development for the prevention of stroke and systemic embolism in patients with atrial fibrillation. The transaction, which is subject to customary closing conditions, is fully in line with Novartis’ growth strategy and therapeutic area focus, leveraging the company’s strength and expertise in the cardiovascular area. Read more.

Bristol Myers, bracing for key patent losses, deepens cost-cutting plan

06 Feb 2025
Bristol Myers Squibb is expanding its plan to cut costs, announcing alongside quarterly earnings on Thursday that it will slash an additional $2 billion in annual expenses by the end of 2027 through “operational efficiencies across multiple areas of the business. Read more.

Joinn Biologics Acquires Lonza’s Guangzhou Facility to Expand Asia-Pacific Presence

05 Feb 2025
San Francisco-based CDMO Joinn Biologics has completed the acquisition of Lonza’s 183,000 sq. ft (17,000 m2) manufacturing plant in Guangzhou, as the company looks to increase its foothold in China’s Greater Bay Area and enhance its service offerings across the Asia-Pacific region. Read more.

Rentschler Biopharma Realigns Strategy to Focus on Biologics

05 Feb 2025
Leading global biopharmaceutical CDMO, Rentschler Biopharma SE, has announced its intention to withdraw from the cell and gene therapy sector, ceasing operations at its Stevenage, UK site. Instead, it will concentrate on biologics in response to, it says, evolving market conditions and client needs, so that it can focus on sustainable growth and innovation. Read more.

Is North America’s Hold on the Biologics CDMO Market at Risk?

05 Feb 2025
Historically, North America has dominated this market, primarily because of its robust infrastructure, strong regulatory frameworks, and the presence of industry-leading pharmaceutical companies. Yet, as global competition intensifies from Asia-Pacific and Europe, could the dynamics of the biologics CDMO market be shifting? Read more.

DEBRA Research and LEO Pharma enter strategic partnership to advance treatments for rare skin diseases

05 Feb 2025
DEBRA Research GmbH, and LEO Pharma, announced a non-exclusive strategic partnership. This collaboration aims to enhance scouting capabilities and provide additional capacity to accelerate the development of life-changing therapies for EB (epidermolysis bullosa). Read more

Clinical Trial Updates

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.

Astria commences Phase III hereditary angioedema therapy trial

28 Feb 2025
Astria Therapeutics has commenced the randomised, placebo-controlled ALPHA-ORBIT Phase III trial of navenibart to treat individuals with hereditary angioedema (HAE). The global, double-blind trial is designed to assess the safety and efficacy of the therapy over six months. Read more.

IMUNON Announces New Immunogenicity Data from Phase 1 Clinical Trial of Its DNA Vaccine in Treatment of COVID-19

26 Feb 2025
Imunon a clinical-stage company focused on developing non-viral DNA-mediated immunotherapy and evaluating an adaptation of the platform’s potential as a next-generation vaccine, announced new safety and immunogenicity data from ongoing analyses of results from the Company’s first Phase 1 proof-of-concept clinical trial of IMNN-101, its investigational DNA plasmid vaccine based on the Company’s proprietary PlaCCine^® technology platform. Read more.

AstraZeneca’s oral SERD delays disease progression in breast cancer study

26 Feb 2025
Camizestrant demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) when paired with a CDK4/6 inhibitor in first-line patients with HR+/HER2- advanced breast cancer whose tumours have an emergent ESR1 mutation. Read more.

Regeneron gene therapy helps deaf children hear in small study

25 Feb 2025
Ten of 11 children born profoundly deaf experienced some degree of hearing improvement after receiving an experimental gene therapy developed by Regeneron Pharmaceuticals. Read more.

J&J’s fully subcutaneous Tremfya shows 27.6% clinical remission in UC

21 Feb 2025
Johnson and Johnson’s (J&J) fully subcutaneous Tremfya (guselkumab) has shown a second round of success in ulcerative colitis (UC), with 27.6% of patients achieving clinical remission in a Phase III trial. The randomised double-blind Phase III Astro trial (NCT05528510) study examined a subcutaneous injectable version of J&J’s blockbuster Tremfya for both induction and maintenance dosing in 418 adults with moderately to severely active UC, a form of inflammatory bowel disease (IBD) and an inadequate response to conventional therapies. Read more.

Boehringer and partners commence gene therapy trial for cystic fibrosis

21 Feb 2025
Boehringer Ingelheim, the UK Respiratory Gene Therapy Consortium (GTC), IP Group and Oxford BioMedica (OXB) have commenced the Phase I/II LENTICLAIR 1 trial of inhaled lentiviral vector-based gene therapy BI 3720931 targeting cystic fibrosis (CF). CF subjects who are ineligible for current cystic fibrosis transmembrane conductance regulator (CFTR) modulator treatments are mainly targeted in the trial. This first-in-human trial will assess the gene therapy’s tolerability, efficacy and safety in this particular patient group. Read more.

BMS’ Opdivo plus chemotherapy shows OS benefit in Phase III NSCLC study

20 Feb 2025
Bristol Myers Squibb (BMS) has reported outcomes from the Phase III CheckMate -816 trial, indicating an overall survival (OS) benefit when Opdivo (nivolumab) is used with platinum-doublet chemotherapy as a neoadjuvant treatment for resectable non-small cell lung cancer (NSCLC) patients. The open-label, randomised, multi-centre trial focused on NSCLC adults with tumours measuring at least 4cm, or those with node-positive disease. Read more.

Four regimens fail endpoints simultaneously in HEALEY ALS trial

18 Feb 2025
ALS candidates from Biohaven, Prilenia, Clene and UCB have all failed to halt disease progression versus placebo in the US-wide platform trial. Read more.

Recce Pharma exceeds expectations in antibiotic skin gel trial

17 Feb 2025
Phase II trial of Recce Pharmaceutical’s topical skin infection gel has ‘exceeded expectations’, with 93% of patients achieving the primary efficacy endpoint. The Australian company’s open-label trial of Recce 327, a topical treatment designed to treat acute bacterial skin and skin structure infections (ABSSSI) and diabetic foot infections (DFIs), reached the primary efficacy endpoint after 14 days using the synthetic anti-infective. In addition, 86% of patients treated with R327G had a successful clinical response after seven days. Read more.

New study offers hints of GLP-1 drugs’ potential in curbing alcohol cravings

12 Feb 2025
A small semaglutide trial suggests the medicine’s suppression of appetite may extend to alcohol, but larger trials are needed to establish a conclusive benefit. Scientists believe GLP-1 drugs like Novo Nordisk’s Ozempic help people with obesity lose weight in part because they can help quell food cravings. Intriguing evidence that these drugs may also help people with alcohol use disorder limit drinking has motivated some doctors to try prescribing GLP-1s for those individuals, too. Read more.

AbViro launches NIH-funded dengue challenge trial

11 Feb 2025
US federally funded Phase II challenge trial investigating AbViro’s sole pipeline candidate, AV1, will see 84 patients infected with dengue virus. The US National Institutes of Health (NIH) has launched a Phase IIa, randomised, double-blind, placebo-controlled trial (NCT05048875) that will expose volunteers to a weakened strain of the virus that the US Centers for Disease Control (CDC) estimates infects approximately 400 million people every year. If successful, AV1 could go on to become the first treatment for dengue fever to be approved by the US Food and Drug Administration (FDA). The therapy is described as an investigational human monoclonal antibody therapeutic taken orally. Read more.

Eli Lilly reports positive data from trial of Omvoh for Crohn’s disease

10 Feb 2025
Eli Lilly and Company announced results from the VIVID-2 open-label extension study, which showed the majority of patients with moderately to severely active Crohn’s disease receiving two years of continuous treatment with Omvoh^® (mirikizumab-mrkz) achieved long-term clinical and endoscopic outcomes, including those (43.8%) with previous biologic failure. Data from this study will be presented at the Crohn’s and Colitis Congress (CCC), being held from February 6-8, 2025  in San Francisco. Read more.

Novo Nordisk’s haemophilia A drug stops bleeds in 74% of children

07 Feb 2025
Novo Nordisk’s haemophilia A therapy Mim8 stopped bleeding completely in 74.3% of children in a Phase III trial. The FRONTIER3 trial (NCT05306418) achieved its co-primary endpoints, demonstrating a statistically significant and superior reduction of treated bleeding episodes with both once-weekly and once-monthly Mim8 versus no prophylaxis treatment and prior coagulation factor prophylaxis treatment in 70 children aged one to 11 years. The drug has also been evaluated in adults and adolescents. Following the positive data, Novo Nordisk expects to make its Mim8 regulatory submission in 2025. Read more.

Replicate’s rabies vaccine rivals Bavarian Nordic’s RavAlert at Phase I

07 Feb 2025
A Phase I trial of Replicate Bioscience’s self-replicating RNA-based vaccine for rabies has elicited an immune response against a disease that the World Health Organization (WHO) describes as virtually 100% fatal. Results from the randomised, open-label clinical trial (NCT06048770) found a single dose of RBI-4000 prompted an immune response with a WHO-established immune threshold of protection against rabies across all dose levels tested. Read more.

Genentech eyes lupus market for Gazyva with positive Phase III data readout

07 Feb 2025
Roche’s subsidiary Genentech has shared positive Phase III data with the US Food and Drug Administration (FDA) as the company targets the billion-dollar lupus market for its CD20-targeting drug Gazyva (obinutuzumab). While the market for systemic lupus erythematosus (SLE) and lupus nephritis therapies remains dominated by generic drugs, the FDA has approved only a few targeted biologics, including GSK’s Benlysta (belimumab) and AstraZeneca’s Saphnelo (anifrolumab), specifically for SLE in over 50 years. Read more.

Maze Therapeutics Doses First Patient in Phase 2 Trial Evaluating MZE829 as a Potential Treatment for APOL1 Kidney Disease

07 Feb 2025
Maze Therapeutics, Inc. recently announced the first patient has been dosed in the company’s Phase 2 clinical trial, the HORIZON Study, of MZE829 in patients with APOL1 kidney disease (AKD). MZE829 is an oral, small molecule APOL1 inhibitor that Maze is advancing as a potential treatment for people living with AKD, a subset of chronic kidney disease estimated to affect over one million patients in the US alone. Read more.

Tonix Announces Positive Topline Phase 1 Data for TNX-1500

06 Feb 2025
Tonix Pharmaceuticals Announces Positive Topline Results from Phase 1 Trial for TNX-1500, a Next Generation anti-CD40L mAb Candidate for Prevention of Kidney Transplant Rejection and Treatment of Autoimmune Diseases. Read more.

Medtronic spinal cord stimulation (SCS) device restores function in SMA trial

05 Feb 2025
The University of Pittsburgh School of Medicine study (NCT05430113) examined the use of Medtronic’s Vectris SureScan device in three SMA patients with all of them able to increase their six-minute walk test (6MWT) score, a measure of estimating muscle fatigue, by at least 20 metres after three months. Read more.

International trial aims to prevent Alzheimer’s in high-risk young adults

04 Feb 2025
The Washington University trial comes as part of a larger platform study, which hopes to understand whether the disease can be prevented. Washington University School of Medicine has announced the first participants enrolled as part of its Alzheimer’s disease DIAN-TU-002 primary prevention trial (NCT06647498). The trial aims to enrol 240 participants from families with mutations in one of the three key genes and a family history of Alzheimer’s that puts them at risk of developing it at some point in their 30s. Some participants will be as young as 18. Read more.

RedHill Biopharma launches trial of combination therapy for prostate cancer

04 Feb 2025
RedHill Biopharma has announced the initiation of a phase 2 trial to explore the combination of opaganib (ABC294640) plus darolutamide (Nubeqa) in patients with metastatic castration-resistant prostate cancer (mCRPC). Read more

Approvals

Medtronic earns U.S. FDA approval for the world’s first Adaptive deep brain stimulation system for people with Parkinson’s

24 Feb 2025
Medtronic’s aDBS and EI technologies have received FDA approval, enhancing personalized care for Parkinson’s disease patients. aDBS adjusts stimulation in real-time based on patient-specific brain activity, while EI optimizes initial DBS programming. The ADAPT-PD trial demonstrated significant improvements in programming speed and precision, supporting the FDA’s decision. aDBS offers a dynamic approach to DBS, potentially improving therapeutic outcomes and reducing side effects compared to traditional methods. Read More

Mirum drug for rare genetic disease gains FDA approval

24 Feb 2025
The drug, which Mirum will sell as Ctexli, treats adults with cerebrotendinous xanthomatosis, a metabolic disease that results in low levels of a needed bile acid. Read More

FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes

15 Feb 2025
Today, the U.S. Food and Drug Administration approved Merilog (insulin-aspart-szjj) as biosimilar to Novolog (insulin aspart) for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus. Read More

GSK’s 5-in-1 meningococcal shot wins FDA approval

15 Feb 2025
Penmenvy, which protects against five common types of disease-causing bacteria, is cleared for use in people aged 10 through 25 years old. Penmenvy combines components of GSK’s existing shots Bexsero and Menveo. By simplifying immunization, it could help boost vaccination rates, which have remained low due to a complex vaccine schedule. Read More

AbbVie, Pfizer gain FDA OK for novel antibiotic

10 Feb 2025
The Food and Drug Administration approved a new combination antibiotic developed by AbbVie and Pfizer for tough-to-treat bacterial infections.The drug, named Emblaveo, is cleared for use alongside the antibiotic metronidazole in adults who have either limited or no other available options to treat their complicated intra-abdominal infections. The drug is indicated for use even if those infections are caused by so-called gram-negative bacteria, like E. coli or Klebsiella pneumoniae. Read More

Valneva’s chikungunya vaccine wins UK approval

06 Feb 2025
Valneva’s chikungunya vaccine Ixchiq has been greenlit by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), allowing the single-dose vaccine to be made available for adults. France-based Valneva has also submitted label extension applications in the US, EU, and Canada, to expand the use of Ixchiq to patients aged 12 to 17, and now plans to do the same in the UK. Read More

Alys Pharmaceuticals receives regulatory approvals for alopaecia areata drug trial

05 Feb 2025
US-based immuno-dermatology company Alys Pharmaceuticals has received clearance from the US Food and Drug Administration (FDA) and Health Canada for a Phase IIa trial of ALY-101 for alopaecia areata (AA). Read More

Regulatory

FDA issues labeling changes for all testosterone products following conclusion of blood pressure monitoring studies and TRAVERSE trial

28 Feb 2025
FDA informed sponsors of testosterone products about new labeling changes following the agency’s review of the findings from the Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) clinical trial and the results from required post-market ambulatory blood pressure (ABPM) studies. Read More

New EU trial regulations could expedite approvals and address shortages

27 Feb 2025
New EU Clinical Trial Regulations simplify international trials while offering the means to counter drug shortages for trials in Europe. Read More

CDSCO brings clinical trial site addition and change of PI applications for biological products to online mode

27 Feb 2025
The Central Drugs Standard Control Organisation (CDSCO) notified that manufacturers of biological products such as vaccines and rDNA based drugs can now submit applications for the addition of clinical trial sites and changes in principal investigators (PIs) online through the Sugam Portal. Read More

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

11 Feb 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

MHRA asks for views on proposed guidance to support the safe regulation of new personalised cancer therapies  

03 Feb 2025
The Medicines and Healthcare products Regulatory Agency (MHRA) has today launched a consultation on regulatory guidance for individualised mRNA cancer immunotherapies (colloquially referred to as cancer vaccines). This is an important step in bringing these promising therapies closer to clinical practice. The draft MHRA guidance aims to clarify and streamline pathways for bringing these therapies through to patients, without compromising on robust safety principles. Read More

Interesting Articles/Insights

Decoding the M&A landscape

Consolidation has emerged as a major trend as the pharma industry seeks new avenues of growth and looks to expand its existing capabilities. A look at the factors spurring M&A activity in the sector. 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,