Index
Lambda Insights
Global List of 1,500+ Validated Bioanalytical Assays
Explore our comprehensive list of over 1,500 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.
Summation of Similar Product Ions for Improved LC-MS-MS Quantitation: Advancing Peptide Analysis
This case study explores advanced techniques for peptide analysis, focusing on quantifying Desmopressin in plasma using LC-MS/MS. It highlights innovative strategies to achieve ultra-low limits of quantification, enhancing assay sensitivity and reproducibility for complex biological matrices. Read more.
Advancing Prostate Cancer Clinical Trials: Key Insights
Prostate cancer is a major global health issue, ranking as the second most common cancer in men and the fourth most common cancer overall. With its increasing incidence and significant impact on public health, prostate cancer clinical trials play a pivotal role in advancing treatment options and improving patient outcomes. This blog explores the latest insights on prostate cancer clinical trials, prevalence, treatment options, emerging therapies in clinical trials, and Lambda’s expertise in conducting prostate cancer clinical trials. Read more.
Industry News
Chugai, SoftBank, and SB Intuitions Partner to Advance Clinical Development with Generative AI
31 Jan 2025
Chugai Pharmaceutical Co., Ltd., SoftBank Corp., and its subsidiary SB Intuitions Corp. announced the signing of a Memorandum of Understanding. This joint research initiative will focus on leveraging generative AI to enhance clinical development processes and accelerate new drug development, aiming to improve productivity and efficiency in the pharmaceutical industry. Read more.
Versant invests again in obesity, this time backing Helicore Biopharma
28 Jan 2025
Versant Ventures has made its fourth investment in an obesity startup in eight months, co-leading a $65 million Series A round in Helicore Biopharma, a developer of an antibody drug that blocks a gut hormone tied to hunger and blood sugar levels. Versant’s investment in Helicore follows the firm’s involvement in rounds for Antag Therapeutics, Pep2Tango Therapeutics and SixPeaks Bio. Like Antag, Helicore is studying drugs that inhibit that hormone, called GIP. Read more.
European supergroup launches to tackle diversity in clinical trials
16 Jan 2025
The new pan-European group of 73 regulators, companies and trial sites is backed by €66.8m in funding with a six-year goal. Dubbed Research in Europe and Diversity Inclusion (READI), the new consortium, backed by a consortium of 73 continental healthcare entities, is led by the Servicio Madrileño de Salud (SERMAS) based out of the Spanish University Hospital of La Paz. It also has the backing of industry players ranging from biopharmaceutical giants such as Novo Nordisk, AbbVie and Roche, through to healthcare regulatory bodies such as the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) or Denmark’s Midtjyllands EU Kontor Forening (CDEU). It also comprises hospital sites and clinical research organisations (CROs) across the continent. Read more.
GenSight Biologics Announces Publication of 5-Year Outcomes for Patients Treated Unilaterally with LUMEVOQ® Gene Therapy
15 Jan 2025
Five years after the one-time injection, patients with Leber Hereditary Optic Neuropathy (LHON) due to the MT-ND4 gene variant demonstrated sustained bilateral improvement in visual acuity and favorable safety profile. The RESTORE study provides the first long-term benefit-risk assessment of gene therapy in LHON from a Phase III study. Read more.
JP Morgan 2025: NVIDIA partners with IQVIA, Illumina and Mayo Clinic
13 Jan 2025
The tech company has partnered with clinical research services company IQVIA, genomics specialist Illumina, and Mayo Clinic. Along with a collaboration with research organisation Arc Institute, the collaborations were announced during the JP Morgan Healthcare Conference on 13 January. Read more.
J&J to buy psychiatric drug developer Intra-Cellular Therapies for $14.6B
13 Jan 2025
Johnson & Johnson on Monday said it has agreed to acquire Intra-Cellular Therapies, a developer of drugs for diseases of the brain, for $132 per share, or about $14.6 billion. The announcement of the deal, which if completed would be the largest acquisition of a biotechnology company since early 2023. Read more.
LEO Pharma and Gilead Will Develop STAT6 Program for AD and Other Inflammatory Diseases
13 Jan 2025
LEO Pharma and Gilead Sciences partner to develop oral STAT6 therapies for chronic inflammatory diseases, including atopic dermatitis, asthma, and COPD. The collaboration aims to offer an oral alternative to injectable biologics, broadening patient appeal and treatment options. Gilead will lead manufacturing, while LEO Pharma focuses on topical formulations and co-commercialization outside the U.S. The agreement includes up to $1.7 billion in payments to LEO Pharma, emphasizing STAT6’s potential in treating inflammatory conditions. Read more.
Valo Health and Novo Nordisk expand collaboration to discover and develop novel treatments for cardiometabolic diseases
8 Jan 2025
Novo Nordisk A/S and Valo Health, Inc. announced they have entered into an expanded agreement to discover and develop novel treatments for obesity, type 2 diabetes, and cardiovascular disease based on Valo’s extensive human dataset and computation powered by artificial intelligence (AI). Novo Nordisk has almost doubled the scale of an R&D alliance with Valo Health – a specialist in applying artificial intelligence to drug discovery – adding up to nine programmes to the original 11 covered in their original agreement. Read more.
7 research leaders awarded prestigious NIHR award
6 Jan 2025
The Australian Government’s Department of Health and Aged Care has announced the ‘2024 Clinical Trial Enabling Infrastructure’ grant opportunity, offering A$35.7m ($22.1m) for ‘innovation’ projects and medical research. The main objective of the initiative is to establish and extend critical research infrastructure, including equipment, facilities, services, and systems to conduct medical research. Read more.
Australian Government announces grant to boost clinical trials
6 Jan 2025
The Australian Government’s Department of Health and Aged Care has announced the ‘2024 Clinical Trial Enabling Infrastructure’ grant opportunity, offering A$35.7m ($22.1m) for ‘innovation’ projects and medical research. The main objective of the initiative is to establish and extend critical research infrastructure, including equipment, facilities, services, and systems to conduct medical research. Read more.
Atavistik Bio partners with Pfizer to accelerate discovery of Precision Allosteric Therapeutics
2 Jan 2025
Atavistik Bio, a biotechnology company committed to discovering the next generation of precision allosteric therapeutics inspired by the body’s natural regulators, announced that it has entered into a research collaboration with Pfizer to accelerate the discovery of novel precision allosteric therapeutics to address significant unmet medical needs. Under the terms of the collaboration, Atavistik Bio will leverage its proprietary AMPS™ platform to identify novel allosteric binders against two undisclosed, targets selected by Pfizer. At the completion of the research period, Pfizer will have the option to license the programs. Read more.
Regeneron acquires UK biotech, adding Oxular’s eye disease delivery tech to portfolio
2 Jan 2025
Regeneron Pharmaceuticals has acquired UK-based firm Oxular, enhancing its pipeline with the firm’s specialized ocular delivery tech, eyeing novel drug delivery. Read more.
Clinical Trial Updates
ImmunityBio and BeiGene partner on Phase III trial of NSCLC treatment combo
29 Jan 2025
ImmunityBio, Inc. announced it has entered into a collaboration and supply agreement with BeiGene, Ltd. (to be changed to BeOne Medicines, Ltd.), a global oncology company, to conduct a confirmatory randomized Phase 3 clinical trial (ResQ201A-NSCLC), combining BeiGene’s tislelizumab, a PD-1 checkpoint inhibitor (CPI), and ImmunityBio’s ANKTIVA (nogapendekin alfa inbakicept-pmln). The Phase 3 ResQ201A-NSCLC study (NCT06745908) aims to confirm the efficacy and safety of combination ANKTIVA plus CPI therapy previously demonstrated in the trial QUILT 3.055 and provide evidence of the potential for these two immunotherapeutic agents to improve overall survival in patients with advanced or metastatic NSCLC who have acquired resistance to immune CPI therapy. Read more.
Kashiv Biosciences Announces Successful Phase 1 Results for Abatacept Biosimilar Candidate, KSHB002
28 Jan 2025
US-based biopharmaceutical company Kashiv Biosciences has reported that a Phase I trial of its 125mg/mL pre-filled syringe injection, KSHB002, has achieved its primary endpoints. In the trial, the abatacept biosimilar candidate KSHB002 showed pharmacokinetic equivalence to the reference product, Orencia. The randomised, open-label study enrolled 300 healthy adult male and female subjects and was divided into three parallel arms. Read more.
Roche reports positive topline outcomes from DMD treatment trial
27 Jan 2025
Roche has reported positive topline outcomes from the second year of the multinational Phase III EMBARK trial of Elevidys (delandistrogene moxeparvovec) as a gene therapy for treating Duchenne muscular dystrophy (DMD). Roche entered into a worldwide partnership with Sarepta Therapeutics in 2019 to commercialise the gene therapy outside of the US. Read more.
FDA approves Zydus’ Phase IIb trial of Usnoflast for ALS treatment
20 Jan 2025
The US Food and Drug Administration (FDA) has granted approval for Zydus Lifesciences to proceed with a randomised Phase IIb trial of its oral NLRP3 inflammasome inhibitor, Usnoflast, for amyotrophic lateral sclerosis (ALS) treatment. The multi-centre, placebo-controlled, double-blind trial will assess the therapy’s safety, pharmacodynamics, efficacy, and pharmacokinetics in adult ALS patients. Read more.
Traws Pharma completes Phase I trials of H5N1 bird flu treatment drug
21 Jan 2025
Traws Pharma has completed the Phase I clinical trials of tivoxavir marboxil, a single-dose drug for treating or preventing H5N1 bird flu. The randomised, placebo-controlled, double-blind trial evaluated the pharmacodynamics (PD), tolerability, pharmacokinetics (PK), and safety of escalating doses in healthy and influenza-negative adult volunteers. The four dose levels of the therapy were reported to be well-tolerated by the subjects, and no treatment-related adverse events were observed. Read more.
Concept Medical enrols first patient in balloon angioplasty trial
17 Jan 2025
Florida healthtech firm Concept Medical has enrolled the first patient in its MAGICAL trial examining its sirolimus-coated balloon against traditional angioplasty for patients living with below-the-knee peripheral artery disease (PAD). The announcement comes after the company secured an Investigational Device Exemption (IDE) from the US Food and Drug Administration (FDA) for the MagicTouch PTA. The company is launching two other trials examining its drug-coated alternative to standard percutaneous transluminal angioplasty (PTA).Read more.
Novo Nordisk links high-dose Wegovy to increased weight loss in Phase III trial
17 Jan 2025
Novo Nordisk’s high dose Wegovy (semaglutide) has shown improved weight loss while remaining safe and tolerable. In the Phase IIIb STEP UP trial, 7.2mg Wegovy demonstrated statistically significant and superior weight loss abilities at week 72. In the trial, 1,407 obese adult subjects were randomised to receive once-weekly treatments, supplemented by lifestyle interventions. Read more.
Ocugen doses first patient in phase 1 trial of OCU200 for treatment of diabetic macular edema
17 Jan 2025
Ocugen announced the first patient in its OCU200 phase 1 clinical trial for diabetic macular edema (DME) has been dosed. OCU200 is a recombinant fusion protein targeting integrin receptors with anti-inflammatory and anti-VEGF properties, potentially transforming DME treatment. The phase 1 trial is a multicenter, open-label, dose-escalation study assessing OCU200’s safety via intravitreal injections in three dosage cohorts. Ocugen aims for OCU200 to be a first-line therapy for DME, diabetic retinopathy, and wet AMD, benefiting patients unresponsive to current treatments. Read more.
Palisade Bio begins MAD cohorts of Phase Ia/b ulcerative colitis therapy trial
16 Jan 2025
US-based biopharmaceutical company Palisade Bio has begun the multiple ascending dose (MAD) cohorts of its ongoing Phase Ia/b trial of PALI-2108 for treating ulcerative colitis (UC). These cohorts were launched following the completion of all five of the trial’s planned single ascending dose (SAD) cohorts. Initial data from the SAD cohorts, which assessed doses from 15mg to 450mg, suggest that the therapy is well-tolerated at all levels. Read more.
Iclepertin Fails to Improve Cognition in Schizophrenia Phase 3 Study
16 Jan 2025
Boehringer Ingelheim announced that iclepertin for schizophrenia in their phase 3 trial did not bring statistically significant effects on cognition or functioning. Therefore, the trial failed to meet its primary and secondary endpoints. Read more.
OS Therapies’ HER2 therapy prevents lung cancer recurrence in 33% patients
16 Jan 2025
OS Therapies’s HER2-immunotherapy met the primary endpoint in a Phase IIb trial in patients with recurrent, fully resected, lung metastatic (METS) osteosarcoma. The Phase IIb trial (NCT04974008) met its primary endpoint seeing 12-month event-free survival (EFS) in 33% of patients treated it when measured against previously published historical control groups who saw only 20%. An event in this case is defined as the recurrence of metastatic osteosarcoma. Read more.
German PEI approves enrolment in cohort 5 of Oncolytics’ pancreatic cancer trial
16 Jan 2025
The Paul-Ehrlich-Institute (PEI) in Germany has granted approval to continue subject enrolment in cohort 5 of Oncolytics Biotech’s GOBLET trial, assessing pelareorep plus modified FOLFIRINOX in patients with newly diagnosed pancreatic ductal adenocarcinoma (PDAC). This trial involves the combination with or without Genentech’s atezolizumab (Tecentriq). The approval follows a positive recommendation from the independent Data Safety Monitoring Board. Initial efficacy outcomes from cohort 5 are anticipated in the second half of this year. Read more.
Vistagen reports positive outcomes from Phase IIA cancer cachexia trial
15 Jan 2025
Vistagen has reported positive outcomes from the exploratory Phase IIA trial of an investigational pherine nasal spray, PH284, for the treatment of cancer cachexia. The ‘previously unreported’ double-blind, placebo-controlled Phase IIA study assessed the efficacy, safety, and tolerability of the nasal spray in 40 female subjects with cachexia due to terminal cancer. The nasal spray was administered four times a day before meals. The trial demonstrated a significant increase in the mean subjective feeling of hunger among subjects using PH284, compared to those receiving a placebo, without any serious adverse events. Read more.
Phase 2b study of rezpegaldesleukin for atopic dermatitis reaches target enrollment
15 Jan 2025
Nektar Therapeutics has completed target enrollment for its phase 2b study of rezpegaldesleukin for the treatment of patients with moderate to severe atopic dermatitis. Rezpegaldesleukin is a first-in-class interleukin-2 receptor agonist that proliferates and activates regulatory T cells. The study reached its target enrollment of 396 patients. Read more.
First participants randomized in AskBio Phase II gene therapy trial for Parkinson’s disease
14 Jan 2025
AskBio, a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, announced that the first participants have been randomized in its Phase II clinical trial in patients with Parkinson’s disease (PD). Enrollment ongoing in the United States for REGENERATE-PD clinical trial of AB-1005 (also known as AAV2-GDNF) glial cell line-derived neurotrophic factor (GDNF) investigational gene therapy for the treatment of moderate-stage Parkinson’s disease. Phase Ib 36-month data demonstrated a favorable safety profile and continued positive trends in assessed clinical measures of AB-1005 with no associated serious adverse events Read more.
Arcturus Therapeutics launches Phase I Avian Influenza trials in US
10 Jan 2025
Arcturus Therapeutics has initiated a Phase 1 clinical trial for ARCT-2304 (LUNAR-H5N1), a self-amplifying mRNA vaccine candidate designed to prevent pandemic influenza caused by the H5N1 virus. The randomized, placebo-controlled trial (NCT06602531) is fully funded by BARDA and involves approximately 200 healthy adults across two age groups (18–59 and 60–80 years). Launched in December 2024, the study aims to evaluate the safety and immune responses of three dose levels and two vaccination schedules, using hemagglutination inhibition (HAI), microneutralization (MN), and neuraminidase ELLA assays. Read more.
IO Biotech enrols all subjects in Phase II trial of cancer combination therapy
10 Jan 2025
Danish biotechnology company IO Biotech has finished enrolling subjects in a Phase II trial of its lead therapeutic cancer vaccine candidate, IO102-IO103, in conjunction with MSD’s KEYTRUDA (pembrolizumab). The multicentre IOB-032/PN-E40 basket trial has enrolled 93 subjects with resectable melanoma or squamous cell carcinoma of the head and neck (SCCHN) across Europe, Australia and the US. Its aim is to assess the safety, biomarker data and anti-tumour activity of the combination therapy. Read more.
Elinzanetant meets all primary and secondary endpoints in Phase III study OASIS 4 for treatment of moderate to severe vasomotor symptoms caused by breast cancer treatments
9 Jan 2025
In OASIS 4, a Phase III study conducted outside of the US, the investigational compound elinzanetant met all primary endpoints demonstrating a statistically significant reduction in frequency of moderate to severe vasomotor symptoms (VMS) caused by adjuvant endocrine therapy compared to placebo in women with or at high risk of developing hormone receptor positive breast cancer. The study also met all secondary endpoints with a reduction in severity of VMS at weeks 4 and 12, a reduction in frequency of VMS at week 1 as well as improvements in sleep disturbances and menopause related quality of life / The safety profile over 52 weeks is generally consistent with previously published data in postmenopausal women with VMS. Read more.
Tenpoint Therapeutics preps for ’26 market launch after phase 3 win for combo eye drop
9 Jan 2025
In a phase 3 trial, Tenpoint Therapeutics’ eye drop—a combination of carbachol and brimonidine—improved vision for patients with presbyopia for up to eight hours. The eye drop is designed to correct presbyopia, or age-related farsightedness. The late-stage trial enrolled 629 participants with both emmetropic phakic or pseudophakic presbyopia and included three arms: patients who received one daily drop of Brimochol PF per eye, those who received carbachol (sold as Miostat for glaucoma) or those who received a control solution. Read more.
Compugen Announces First Patient Dosed in Phase 1 Clinical Trial to Evaluate COM503 as Monotherapy and in Combination with Zimberelimab in Advanced Solid Tumors
8 Jan 2025
Compugen Ltd., a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, announced that the first patient was dosed in a Phase 1 clinical trial with COM503, a potential first-in-class antibody against IL-18 binding protein licensed by Compugen to Gilead. Compugen is responsible for running the Phase 1 trial (Phase 1 dose escalation and dose expansion trial to assess the safety and tolerability of COM503 as monotherapy and in combination for patients with advanced solid tumors.). Read more.
Suven doses first subjects in trial of SUVN-I6107 for cognitive disorders
8 Jan 2025
India-based Suven Life Sciences has announced the dosing of the first subjects in its Phase I clinical trial of SUVN-I6107 to treat cognitive disorders. SUVN-I6107 is a muscarinic M1 positive allosteric modulator intended for treating cognitive disorders. Read more.
Insilico announces positive results from Phase I trials of AI-designed ISM5411
7 Jan 2025
Insilico Medicine, a clinical-stage generative artificial intelligence (AI)-driven drug discovery and development company, announceD positive results from two Phase I studies in Australia and China of ISM5411, a novel gut-restricted and PHD specific Inhibitor designed and optimized with the support of Insilico’s Chemistry42 commercially-available generative reinforcement learning platform, for Inflammatory Bowel Disease (IBD). Read more.
Neumora Therapeutics’ depression drug fails to meet main goal of late-stage study
2 Jan 2025
The study, first of the three late-stage trials, was testing the drug, navacaprant, in patients with major depressive disorder (MDD). In a highly anticipated readout for the kappa opioid receptor class in major depressive disorder, Neumora’s navacaprant failed to meet the primary and key secondary endpoint in the first of three identical Phase III studies. Read more.
Verastem Oncology announces FDA acceptance and priority review of NDA for Avutometinib in combination with Defactinib for the treatment of recurrent KRAS mutant low-grade serous ovarian cancer
30 December, 2024
Verastem Oncology, a biopharmaceutical company announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) under the accelerated approval pathway for avutometinib, an oral RAF/MEK clamp, in combination with defactinib, an oral FAK inhibitor, for the treatment of adult patients with recurrent low-grade serous ovarian cancer (LGSOC), who received at least one prior systemic therapy and have a KRAS mutation. The NDA, which was completed in October 2024, has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) action date of June 30, 2025. In addition, the FDA has stated that it is not currently planning to hold an advisory committee meeting to discuss the application. Read more.
Axsome Therapeutics announces successful completion and results of Phase 3 clinical program of AXS-05 in Alzheimer’s Disease agitation
30 December, 2024
Axsome Therapeutics, a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, announced the successful completion of its Phase 3 clinical program evaluating AXS-05 (dextromethorphan-bupropion), a novel, oral, investigational NMDA receptor antagonist, sigma-1 agonist, and aminoketone CYP2D6 inhibitor, in Alzheimer’s disease agitation, and results of the ACCORD-2, ADVANCE-2, and long-term safety trials in this indication. Read more.
CARsgen announces positive Topline results from China GC/GEJ pivotal phase II clinical trial of Claudin18.2 CAR-T (Satri-cel)
30 December, 2024
China-based CARsgen Therapeutics’ claudin 18.2-targeting autologous CAR-T therapy satricabtagene autoleucel (satri-cel) has shown efficacy in gastric cancer, in a rare win for this type of cell therapy in a solid tumour. It has shared pivotal results from the latter portion of a phase 1/2 study evaluating the therapy for patients with gastric or gastroesophageal junction cancers that haven’t responded to at least two prior lines of treatment. Read more.
Approvals
Vertex’s non-opioid pain drug gets FDA approval in milestone for company and research
30 Jan 2025
Vertex Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved JOURNAVX™ (suzetrigine), an oral, non-opioid, highly selective NaV1.8 pain signal inhibitor for the treatment of adults with moderate-to-severe acute pain. JOURNAVX is an effective, well-tolerated medicine without evidence of addictive potential indicated for use across all types of moderate-to-severe acute pain. Read More
FDA approves Novo Nordisk’s Ozempic to treat chronic kidney disease in those with diabetes, expanding its use
29 Jan 2025
The FDA has approved Novo Nordisk’s diabetes drug Ozempic to help reduce the risk of worsening kidney disease, kidney failure, and heart-related death in adults with type 2 diabetes and chronic kidney disease (CKD). With this approval, Ozempic becomes the most broadly indicated drug in its class, now covering diabetes control, heart disease risk reduction, and kidney protection. Read More
FDA clears monthly dosing of Alzheimer’s drug Leqembi
27 Jan 2025
The Food and Drug Administration has approved monthly maintenance dosing of Eisai and Biogen’s Alzheimer’s disease drug Leqembi. After taking Leqembi every two weeks for 18 months, patients can now transition to a monthly dose that the companies say is supported by modeling of data from Phase 2 and Phase 3 testing. Leqembi works by removing toxic aggregates of a protein from the brain. Read More
FDA grants ODD status to Zai Lab’s lung cancer treatment
23 Jan 2025
The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Zai Lab’s delta-like ligand 3 (DLL3) antibody-drug conjugate (ADC), ZL-1310, for small cell lung cancer (SCLC). The designation provides the therapy with incentives such as fee waivers and tax credits to support its development, along with the possibility of seven years of market exclusivity upon approval. Read More
AstraZeneca, Daiichi’s Enhertu successor gets first FDA OK in breast cancer
21 Jan 2025
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by a Food and Drug Administration (FDA)-approved test, that has progressed on one or more endocrine therapies in the metastatic setting. Read More
China gives nod to Innovent’s limertinib NDA for lung cancer
17 Jan 2025
China’s National Medical Products Administration has given the green light to Innovent Biologics, Inc.’s and Jiangsu Aosaikang Pharmaceutical Co. Ltd.’s NDA for third-generation EGFR tyrosine kinase inhibitor limertinib, for treating adults with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer. Read More
FDA approves sotorasib with panitumumab for KRAS G12C-mutated colorectal cancer
17 Jan 2025
The FDA has approved the combination of sotorasib with panitumumab for the treatment of KRAS G12C-mutated metastatic colorectal cancer (mCRC) in adult patients who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. Read More
FDA Clears Ariceum Therapeutics’ 225Ac-Satoreotide Phase I/II Clinical Study in Patients with Small Cell Lung Cancer or Merkel Cell Carcinoma
16 Jan 2025
Ariceum Therapeutics, a biotech company specializing in radiopharmaceuticals for challenging cancers, announced FDA clearance of its IND application for a Phase I/II trial, SANTANA-225, evaluating its radiolabeled peptide 225Ac-SSO110 in patients with small cell lung cancer (SCLC) or Merkel cell carcinoma (MCC). Read More
FDA approves Lilly’s Omvoh® (mirikizumab-mrkz) for Crohn’s disease, expanding its use to the second major type of inflammatory bowel disease
15 Jan 2025
Eli Lilly and Company announced that the US Food and Drug Administration (FDA) has approved Omvoh (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn’s disease in adults. Omvoh is now approved in the US for two types of inflammatory bowel disease (IBD), following its October 2023 approval as a first-in-class treatment for moderately to severely active ulcerative colitis (UC) in adults. Read More
Annovis Granted U.S. Patent for Treatment and Prevention of Acute Brain or Nerve Injuries Securing Global Protection
11 Jan 2025
Annovis Bio announced it was granted the U.S. patent covering methods for the treatment and prevention of acute brain or nerve injuries using buntanetap. This newly issued patent is based on buntanetap’s ability to reduce neurotoxicity and mitigate neurodegenerative processes, which can be applicable to such conditions as stroke, ischemia, traumatic brain injury, micro infarcts, and other forms of acute injuries. The patent has already been granted in the EU, Japan, and worldwide. With this latest approval in the U.S., the company now holds global protection for the use of buntanetap in treating acute neurodegenerative disorders. Read More
US FDA grants priority review status to Johnson & Johnson’s Nipocalimab BLA to treat generalized myasthenia gravis
11 Jan 2025
Johnson & Johnson announced the Nipocalimab Biologics License Application (BLA) received Priority Review designation from the US Food and Drug Administration (FDA) for the treatment of antibody positive (anti-AChR, anti-MuSK, anti-LRP4) patients with generalized myasthenia gravis (gMG), as supported by findings from the phase 3 Vivacity-MG3 study. The FDA grants Priority Review to applications for medicines that, if approved, would offer significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. Read More
Astellas gets China’s NMPA approval for Vyloy in gastric cancer treatment
7 Jan 2025
China has the highest number of cases and deaths from gastric cancer of any country worldwide. Zolbetuximab is the first and only therapy approved in China to target claudin 18.2, a biomarker expressed by 35% of Chinese patients with advanced gastric and gastroesophageal junction (GEJ) cancer. Treatment with the claudin 18.2-targeted monoclonal antibody shown to significantly extend both progression-free survival and overall survival in the Phase 3 GLOW and SPOTLIGHT trials. Read More
CDSCO approved Wockhardt’s new generation oral antibiotic Miqnaf (Nafithromycin)
3 Jan 2025
The Indian drug regulator, Central Drugs Standard Control Organization (CDSCO) has approved Miqnaf (nafithromycin) as a new treatment for community-acquired bacterial pneumonia (CABP) in Adults. Miqnaf is an ultra-short course, once-a-day, 3-day treatment for CABP including those caused by multi-drug resistant (MDR) pathogens. The approval follows a favourable recommendation for the manufacture and marketing of Nafithromycin from the Subject Expert Committee (SEC) of CDSCO. Read More
Regulatory
ICH Releases Final Version of E6(R3) Good Clinical Practice Guideline
21 Jan 2025
On January 6, 2025, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) issued its final version of the “Guideline for Good Clinical Practice E6(R3)” to update its 2016 E6(R2) GCP guideline. On January 27, 2025, the European Medicines Agency (EMA) announced an effective date of July 23, 2025 for E6(R3) – Principles and Annex 1. E6(R3) is still pending adoption by other ICH member nations and regions. Read More
MHRA shares guidance on incoming changes to medtech post-market surveillance
17 Jan 2025
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on the interpretation and implementation of incoming changes to the post-market surveillance (PMS) rules for medical devices. Read More
FDA looks to clarify confirmatory trial mandate for accelerated approvals
7 Jan 2025
The FDA has increased its oversight of accelerated drug approvals, emphasizing the need for confirmatory trials to be “underway” at the time of conditional approval. However, mixed messaging on the definition of “underway” created uncertainty among drugmakers. To address this, the FDA released a draft guidance document, titled “Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway,“ aiming to clarify the agency’s interpretation of the term. Read More
FDA proposes framework to advance credibility of AI models used for Drug and Biological product submissions
6 Jan 2025
The U.S. Food and Drug Administration issued draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product’s safety, effectiveness or quality. This is the first guidance the agency has issued on the use of AI for the development of drug and biological products. Read More
FDA issues Draft Guidance on including tissue biopsies in clinical trials
6 Jan 2025
This draft guidance focuses on considerations for when a tissue biopsy, which involves taking tissue from a trial participant, is included in a clinical trial protocol. All biopsy procedures have a certain amount of risk, but biopsies can be necessary for obtaining information important to the trial, such as to determine clinical trial participant eligibility, to ensure enrolled trial participants have the intended target medical condition the trial is evaluating, or to evaluate primary or key secondary endpoints. Read More
CDSCO establishes sub-zonal office in Bhubaneswar, boosting Odisha’s pharmaceutical sector
3 Jan 2025
In a significant move to enhance drug regulation and monitoring in Odisha, the Central Drugs Standard Control Organisation (CDSCO) has announced the establishment of a Sub-Zonal Office in Bhubaneswar. This development is a crucial step towards strengthening drug control infrastructure, ensuring quality medicines, and fostering pharmaceutical industrialization in the region. Read More
CDSCO brings clinical trial site addition and change of PI applications to online mode
26 Dec 2024
The Central Drugs Standard Control Organisation (CDSCO) has sought the industry to start submitting the applications for clinical trial site addition and change of principal investigator through online mode, as part of streamlining the regulatory submission procedure. The applicants should submit their applications for these purposes through the Sugam portal along with the checklist of documents and the approval of the ethics committee. Read More
Interesting Articles/Insights
The Rising Specialization of CDMOs
With the increasing demand for advanced therapies, CDMOs are playing a crucial role in supporting biopharma companies by providing specialized expertise and scalable capabilities for drug development and commercialization. As 2025 approaches, a closer look at emerging drug modalities reveals key opportunities and challenges that CDMOs must navigate to stay competitive and drive innovation in the industry. Read More
The expanding world of RNA therapies
Over the past several years, a number of biotech companies have made strides in constructing small molecule drugs to target RNA. Now genetic messenger molecules power the coronavirus vaccines developed by BioNTech and Moderna, training the body’s immune system to detect and defend against disease and infection. Included in this trendline: (i) Exsilio pitches a ‘leap’ forward for genetic medicine, (ii) RNAi’s future the focus of new startup led by John Maraganore, (iii) Judo Bio debuts a plan to take RNA drugs to the kidney. Read More
The expanding world of RNA therapies
Over the past several years, a number of biotech companies have made strides in constructing small molecule drugs to target RNA. Now genetic messenger molecules power the coronavirus vaccines developed by BioNTech and Moderna, training the body’s immune system to detect and defend against disease and infection. Included in this trendline: (i) Exsilio pitches a ‘leap’ forward for genetic medicine, (ii) RNAi’s future the focus of new startup led by John Maraganore, (iii) Judo Bio debuts a plan to take RNA drugs to the kidney. Read More
The biggest challenges clinical trials will face in 2025
The Clinical Trials Arena spoke to industry experts about what the sector can expect in 2025. It has been a turbulent time for the pharmaceutical industry – especially in regard to the clinical trial sector. From reduced investment, to a lack of public trust in the industry, it has been difficult, especially for small and medium-sized biotechs, to get efficient clinical trials off the ground. On top of these challenges, the industry has also seen a change in demand, with the types of therapies in the pipeline, such as cell and gene therapies, requiring a shift away from the gold standard randomised controlled trial (RCT) model. As a result, companies have had to learn how to effectively run adaptive trial designs, while tackling small patient numbers and providing sufficient data to regulatory authorities. Other challenges, including shifts with new government administrations, and new regulatory guidance and legislations are also likely to cause further upheaval in 2025. Read More
‘The bar has risen’: China’s biotech gains push US companies to adapt
Pharma dealmaking for drugs invented in China is putting pressure on U.S. biotechs to compete harder, according to investors and executives interviewed by BioPharma Dive at the J.P. Morgan Healthcare Conference. Read More
EMA in 2024 recommended highest number of drug approvals in 15 years
In 2024, EMA recommended 114 medicines for marketing authorisation. Of these, 46 had a new active substance which had never been authorised in the European Union (EU) before. Among these are a number of medicines that stand out due to their contribution to address public health needs or the innovation they represent. The Agency recommended the first medicine to treat early Alzheimer’s disease, the first needle-free and smaller form of adrenaline to treat allergic reactions, the first treatment for tumours associated with von Hippel-Lindau disease, and two new antibiotic medicines for the treatment of certain severe infections. EMA also recommended several new vaccines, including one to protect against Chikungunya disease and a new mRNA vaccine against lower respiratory tract disease caused by respiratory syncytial virus (RSV), and extended the use of an mpox vaccine to protect adolescents from 12 to 17 years of age. Read More
Unlocking peak operational performance in clinical development with artificial intelligence
Artificial intelligence (AI) and generative AI are transforming clinical development by reducing costs, accelerating processes, and improving success rates across 12 critical use cases. This article by Mckinsey highlights three prominent examples adopted by leading biopharma companies, demonstrating substantial gains in trial efficiency and organizational productivity through AI-driven innovations. Read More
Operational excellence in biopharma research and early development
Leading biopharma companies are addressing the challenges of lengthy timelines and rising costs in drug development by streamlining research and early development processes. Despite technological advancements, the journey from candidate nomination to market launch averages a decade, with investigational new drug (IND) costs rising 20–30% in recent years. Growing data complexity, novel molecular mechanisms, and niche indications further complicate the landscape. To counter these issues, companies are leveraging automation, digitization, and leaner processes, achieving up to 40% reductions in cycle times for first-in-human (FIH) trials. This article by Mckinsey highlights 12 strategic actions biopharma organizations are adopting to enhance speed, cost-efficiency, and capacity in R&D, as part of a broader effort to improve sustained performance. Read More
10 clinical trials to watch in the first half of 2025
The article highlights ten crucial clinical trials anticipated to yield significant results in the first half of 2025. Eli Lilly’s Surpass-CVOT will test whether tirzepatide can improve heart health, while Novartis’ Lp(a) Horizon explores lowering Lp(a) protein to reduce cardiovascular risks. Arvinas’ Veritac-2 will assess vepdegestrant for breast cancer, a potential breakthrough in protein degradation therapies. Vera Therapeutics’ Origin 3 focuses on atacicept for IgA nephropathy, targeting cytokines linked to kidney damage. Novo Nordisk’s Evoke evaluates semaglutide for Alzheimer’s, potentially broadening the use of incretin drugs. Beam Therapeutics tests its gene-editing therapies for sickle cell disease and alpha-1 antitrypsin deficiency. Compass Pathways’ psilocybin trial aims to treat-resistant depression. Vertex and Moderna’s NCT05668741 targets cystic fibrosis patients unresponsive to existing therapies via mRNA technology. Eli Lilly’s Emerald-2 will test an oral treatment for ulcerative colitis, challenging injectable options. Finally, Verve Therapeutics’ Heart-2 trial will assess next-generation base editing for lowering cholesterol. These trials, spanning diabetes, cancer, gene editing, and neurological diseases, are poised to influence therapeutic innovation and redefine treatment paradigms across several medical fields. Read More
FDA: Novel Drug Approvals for 2024: Small companies loom large with several key FDA nods
The 2024 approvals highlight significant progress in areas such as oncology, cardiology, and rare diseases. In 2024, the Center for Drug Evaluation and Research (CDER) of the US Food and Drug Administration (FDA) approved a total of 50 new molecular entities (NMEs), including 32 new chemical entities (NCEs) and 18 biological entities (NBEs). Read More
5 Key Advances in Mammalian Orthoreovirus Clinical Trials
After years of research, MRV clinical trials have made significant progress, yielding promising results in various types of cancer. Explore the five breakthroughs that highlight the advancements in MRV clinical trials. 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.
Lambda Therapeutic Research
Lambda Therapeutic Research stands at the forefront of the global Clinical Research Organization (CRO) landscape, headquartered in Ahmedabad, India, and extending its impact across Mehsana (India), Warsaw (Poland), London (UK), Barcelona (Spain), Toronto (Canada), Pittsburgh (USA), and Las Vegas (USA).
Our unwavering mission revolves around providing comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries. Lambda has consistently raised the bar in the Clinical Research sector, achieving milestones through both organic growth and strategic acquisitions. In 2019, we strategically bolstered our North American presence by acquiring Novum Pharmaceutical Research Services, a distinguished 50-year-old CRO. Operating under the unified brand of Novum Pharmaceutical Research Services in North America, Lambda reinforces its position as a key player in the global CRO market.
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’s dedication to excellence has garnered widespread recognition, with accolades such as the distinction of ‘Best Indian CRO’ by Frost & Sullivan (USA) and the prestigious title of ‘Great Indian Workplace’ by UBS Transformance. In the latest achievements, Lambda Therapeutic Research proudly received the ‘Regulatory Excellence’ Award at the CPhI Awards 2023 and the ‘Industry Partner of the Year’ Award at the Global Generics & Biosimilar Awards 2023. These honors reflect our ongoing commitment to regulatory compliance, industry leadership, and impactful collaborations within the pharmaceutical and clinical research sectors.
