Polpharma Partners with Tuteur to Commercialize a Biosimilar Candidate Across LATAM for Autoimmune Diseases
Polpharma Biologics has signed a licensing deal with Tuteur to bring a biosimilar candidate for autoimmune diseases to Latin America, excluding Brazil. Polpharma will handle development and manufacturing, while Tuteur will manage commercialization, marketing and distribution across the licensed territories. The biosimilar is positioned as a potentially effective, well‑tolerated therapy, with a regulatory submission anticipated within the next three years. The agreement expands Polpharma’s footprint in the fast‑growing LATAM biologics market.
Liquid Biopsy Differentiation of Pancreatic Cancer From Non‐Cancerous Pancreatic Disease Using Dielectrophoresis‐Recovered Nanoparticles Carrying Cell‐Free DNA and Protein Biomarkers (Small...
Researchers led by Stuart D. Ibsen have unveiled a microfluidic chip that uses dielectrophoretic forces to pull extracellular‑vesicle nanoparticles out of undiluted plasma. The captured vesicles carry cell‑free DNA and protein biomarkers that together distinguish pancreatic cancer from non‑cancerous pancreatic...
Biogen Stock Slides After Trial Miss, But Analysts Stay Bullish
Biogen’s stock fell more than 10% after its Phase 2 CELIA trial of diranersen missed the primary endpoint. The study, however, demonstrated robust reductions in cerebrospinal‑fluid tau and PET‑measured pathology, with the 60‑mg dose showing the clearest slowing of clinical decline....
Merck Reports the P-III (TroFuse-005) Trial Data on Sacituzumab Tirumotecan for Advanced or Recurrent Endometrial Cancer
Merck disclosed Phase III TroFuse‑005 data for sacituzumab tirumotecan (sac‑TMT) in 776 patients with advanced or recurrent endometrial carcinoma or carcinosarcoma who had prior platinum‑based chemotherapy and PD‑1/PD‑L1 immunotherapy. The trial met its primary overall‑survival and progression‑free‑survival endpoints and also achieved...
TrivarX Engages Beyond Drug Development to Progress Stabl-Im Safety Trial
TrivarX announced a partnership with specialist CRO Beyond Drug Development to drive the Phase 1 safety trial of its Stabl‑Im oncology imaging platform. Beyond will handle protocol finalisation, regulatory documentation and site selection as TrivarX prepares to dose healthy volunteers in...
Elite Immune Cells Lead the Fight Against Multiple Myeloma
Researchers at Osaka University discovered that only a tiny fraction of CD8 T cells—about 2.3% of clones—undergo massive clonal expansion when exposed to the bispecific T‑cell engager elranatamab in a multiple myeloma model. Using single‑cell RNA sequencing, they tracked these elite...
The BioPharm Brief: Weight Loss, Oncology, Longevity
Merck has moved its antibody‑drug conjugate (ADC) targeting metastatic colorectal cancer into a Phase 3 trial, underscoring the growing confidence in precision oncology. Eli Lilly reported that its multi‑receptor obesity drug retatrutide achieved up to 28.3% weight loss in a pivotal Phase 3...
STAT+: Closely Watched Experimental Parkinson’s Drug Fails Key Clinical Trial
Biogen and Denali Therapeutics announced that their experimental Parkinson’s drug, a small‑molecule inhibitor of the LRRK2 protein, failed to slow disease progression in a randomized Phase 2 trial. The study enrolled 648 adults who received either the LRRK2 pill or...
![Perspective Therapeutics to Present Data From All Clinical Programs at the 2026 ASCO Annual Meeting, Including Findings From [212Pb]VMT01 in...](/cdn-cgi/image/width=1200,quality=75,format=auto,fit=cover/https://ml.globenewswire.com/media/e8b42463-3d31-441e-8c09-6b88826fe1c6/small/persp-jpg.jpg)
Perspective Therapeutics to Present Data From All Clinical Programs at the 2026 ASCO Annual Meeting, Including Findings From [212Pb]VMT01 in...
Perspective Therapeutics will unveil Phase 1/2a updates for its three alpha‑particle radiopharmaceuticals at the 2026 ASCO Annual Meeting. VMT‑α‑NET for SSTR2‑positive neuroendocrine tumors shows a 72% progression‑free rate with deepening responses. VMT01 in heavily pre‑treated melanoma reports two confirmed responses (29%)...
Zentalis Pharmaceuticals to Present Phase 1b MUIR Trial Data Showing Encouraging Clinical Activity and Manageable Safety Profile of Azenosertib Plus...
Zentalis Pharmaceuticals will present Phase 1b MUIR trial results showing that the WEE1 inhibitor azenosertib combined with paclitaxel yields a 39% overall response rate and a median progression‑free survival of 7.3 months in heavily pre‑treated platinum‑resistant ovarian cancer (PROC) patients. The data,...
#ASCO26: Key Head and Neck Cancer Readouts From J&J, Corbus, Summit, Akero and Bicara
At ASCO 2026, Johnson & Johnson, Corbus, Summit, Akero and Bicara unveiled pivotal data on next‑generation therapies for head and neck squamous cell carcinoma. J&J’s pembrolizumab‑plus‑chemotherapy regimen reduced the risk of death by roughly 20% in first‑line patients. Corbus reported...
#ASCO26: New Data Released for VEGF Bispecifics From BioNTech-BMS, Pfizer-3SBio
At ASCO 2026, BioNTech‑BMS and Pfizer‑3SBio unveiled new Phase 1/2 data on their VEGF‑targeting bispecific antibodies. BioNTech‑BMS reported a 45% overall response rate in heavily pre‑treated solid‑tumor patients, while Pfizer‑3SBio’s candidate achieved disease control in 78% of a similar cohort....
STAT+: Merck-Kelun Lung Cancer Drug Cut Risk of Tumor Progression by 65%, ASCO Abstract Shows
Merck and China‑based Kelun‑Biotech announced that their antibody‑drug conjugate sacituzumab tirumotecan (sac‑TMT) reduced the risk of tumor progression by 65% in a Phase 3 trial of untreated advanced non‑small cell lung cancer (NSCLC). The study, conducted in China, also showed an...
Cytokine‑Armored CAR T Cells Overcome Antigen Heterogeneity in Glioma Model
UCLA researchers have engineered cytokine‑armored CAR‑T cells that secrete IL‑12 and a decoy‑resistant form of IL‑18 (DR‑18) to treat glioblastoma in mouse models. The IL‑12/DR‑18 combination enabled CAR‑T cells to eradicate tumors even when cancer cells lacked the targeted IL‑13Rα2...
New Eye Drop Formulation Shows Promise for Dry Eye Disease
Researchers at Baylor College of Medicine and Okayama University have created a water‑soluble rexinoid eye‑drop, NEt‑3IB, that boosts resident macrophage function and mitigates dry‑eye pathology in mouse models. The formulation significantly lowered ocular inflammation, preserved corneal barrier integrity and goblet...
Vitamin B12 Analog Targets Deadly Brain Cancer Cells
Researchers at Nitric Oxide Services and Cleveland Clinic have demonstrated that nitrosylcobalamin, a nitric‑oxide‑releasing vitamin B12 analog, can penetrate the blood‑brain barrier and preferentially accumulate in glioblastoma tissue in rat models. Pharmacokinetic data show sustained tumor nitrate levels for at...
Site-Centered Startup: Approaching Predictability in an Imperfect System
Study start‑up continues to be hampered by complex protocols, lengthy negotiations, and fragmented communication. ICON’s executive vice president Brian Mallon argues that a site‑centered model—integrating early feasibility with real‑world capacity, sustained momentum, and automation—can transform activation from an imperfect science...
LLY Clears Major Obesity Trial: Get Exposure in THNR
Eli Lilly’s latest obesity drug trial delivered an average weight loss of just under 30%, surpassing comparable GLP‑1 products from rivals such as Novo Nordisk. The strong results sparked a more than 3% rise in LLY’s stock over the past five days,...
Wacker Expands Service Offerings with Launch of Contract Research for Nucleic Acid-Based Therapies
Wacker Chemie has launched a contract research service (CRS) at its Munich biotech center, offering R&D‑grade plasmid DNA, RNA and lipid nanoparticle (LNP) production for preclinical studies. The offering adds construct design, lipid library screening, functional assays and analytical support,...
Massive Bio and BeeKeeperAI Deploy Federated Confidential Computing to Expand Oncology Trial Access Across Atlanta’s Underserved Communities
Massive Bio announced an expansion of oncology trial access in Atlanta’s underserved communities by deploying its AI‑powered patient pre‑screening on BeeKeeperAI’s EscrowAI platform. The collaboration uses federated confidential computing to run matching algorithms inside healthcare providers’ secure environments, keeping PHI...
Canada and India Now Have Generic Wegovy. Here’s Why the U.S. Doesn’t.
Novo Nordisk’s GLP‑1 drugs Ozempic and Wegovy have entered the Canadian market as generics, and multiple Indian manufacturers have already launched lower‑priced versions. In India, generic prices are up to 80% below the brand‑name rates, and upcoming launches in Brazil,...
Applied Biopharm Consulting Partners with South East Technological University to Advance Viral Vector Research
Applied Biopharm Consulting has teamed with South East Technological University’s Pharmaceutical and Molecular Biotechnology Research Centre under Ireland’s Enterprise Ireland Innovation Voucher scheme to experimentally validate its AI‑driven viral vector engineering platform. The partnership will conduct cell‑based studies that generate...
Financings for May 21, 2026
BioWorld reported three major developments on May 21, 2026. Researchers unveiled a “detargeted” gene‑therapy platform that enhances enzyme activity and reduces off‑target effects for Pompe disease. The World Health Organization declared the Ebola outbreak in the Democratic Republic of Congo a public‑health...
Drug Application Process for Nonprescription Drugs
The FDA offers two routes—New Drug Application (NDA) and Abbreviated New Drug Application (ANDA)—to bring nonprescription drugs to market. Sponsors must secure approval before sales, and they can file directly for OTC status or transition a prescription product. Critical to...
BioMarin Notches Win in Study that Could Expand Use of Top-Selling Medicine
BioMarin announced positive Phase 3 data showing its blockbuster drug Voxzogo accelerates growth in children with hypochondroplasia, a milder form of dwarfism. The trial reported significant gains in standing height and arm span after one year versus placebo. Analysts estimate the...
The Multiple Myeloma Revolution Happening Right Now: Swarup Kumar, MD
Swarup Kumar, MD highlights that bispecific antibodies are driving multiple myeloma cure rates up to 30‑40%, a stark rise from the historic sub‑10% figure. He notes that real‑world outcomes, while promising, still trail slightly behind trial data, underscoring the need...
Fixing Medication Adherence In Clinical Trials: How Technology Stops Data Corruption
Medication adherence in clinical trials is notoriously difficult to measure, with self‑reports often exceeding 90% while biomarker data reveal far lower rates. Traditional methods such as dosing diaries and pill counts are vulnerable to patient error and intentional manipulation, compromising...
Avaí Bio, Austrianova Advance Α-Klotho Cell Therapy Manufacturing Step
Avaí Bio and Austrianova have finished a GMP‑compliant master cell bank (MCB) of genetically engineered cells that overexpress the anti‑aging protein α‑Klotho. The bank will now undergo independent viral and adventitious‑agent testing before a working cell bank is created for...
How Eli Lilly's Next-Gen Obesity Drug Is 'Raising The Bar' In Weight Loss
Eli Lilly’s next‑generation obesity drug retatrutide delivered dramatic weight loss in the Phase 2 Triumph‑1 trial, with participants shedding an average 28.3% of body weight (about 70 lb) after 80 weeks and up to 30.3% (≈85 lb) in a 104‑week extension. Nearly half of...
M11 Template: Clinical Electronic Structured Harmonised Protocol (CeSHarP)
The ICH has issued the M11 Template — Clinical Electronic Structured Harmonised Protocol (CeSHarP) – a draft guidance released in June 2025. The template standardizes the format, table of contents, and common headers for clinical trial protocols, while the accompanying Technical Specification defines...
Economic and Market Impact of the PRRS-Resistant Pig
In April 2025 the FDA cleared Pig Improvement Company’s gene‑edited PRRS‑resistant pig, a breakthrough against the disease that costs the global pork sector billions annually. Dr. Jayson Lusk of Oklahoma State University built an economic model to simulate adoption scenarios across...
Eli Lilly Reports P-III (TRIUMPH-1) Trial Data on Retatrutide for Weight Management
Eli Lilly’s phase‑III TRIUMPH‑1 trial showed its triple‑agonist retatrutide produced dramatic weight loss in adults with obesity and at least one weight‑related comorbidity. Across 80‑week endpoints, the 12 mg dose cut mean body weight by 28.3% and waist circumference by 24.1 cm, with...
Fixed-Duration AV Is a Compelling Option, With Important Caveats: Adam Kittai, MD
In a follow‑up interview, Dr. Adam Kittai of NYU Langone compares fixed‑duration acalabrutinib + venetoclax (AV) with continuous Bruton tyrosine kinase (BTK) inhibitor therapy for chronic lymphocytic leukemia (CLL). The AMPLIFY trial showed AV’s safety advantage—atrial fibrillation in 0.7% and major hemorrhage...
Infex Chases After Insmed with Bronchiectasis Trial Win
Infex Therapeutics announced that its anti‑PcrV antibody RESP‑X (INFEX702) successfully completed a Phase 2a trial in patients with non‑cystic fibrosis bronchiectasis (NCFB) colonised by Pseudomonas aeruginosa. The study demonstrated early efficacy signals, a favorable safety profile and a 28.8‑day half‑life supporting...
Bayer Gets Swift Review for Kerendia in Type 1 Diabetes
Bayer has applied to the FDA for a label extension of its mineralocorticoid receptor antagonist Kerendia to treat chronic kidney disease in type 1 diabetes patients. The agency granted priority review, promising a decision within six months. Phase 3 FINE‑ONE data showed...
ATS 2026: Long-Term Data Show Durable Benefit of Trikafta for Cystic Fibrosis
At the 2026 American Thoracic Society conference, a German single‑centre cohort of 106 adults with cystic fibrosis and at least one F508del allele reported four‑year outcomes on Trikafta (elexacaftor/tezacaftor/ivacaftor). Patients showed a 0.5 L (15.6%) rise in FEV1, a 28.9% drop...
Infex Reports Phase IIa Win for Anti-Pseudomonas Antibody
Infex Therapeutics announced positive Phase IIa results for RESP‑X, its first‑in‑class anti‑virulence monoclonal antibody targeting PcrV in Pseudomonas‑colonised non‑cystic fibrosis bronchiectasis. The randomized, double‑blind trial demonstrated safety, tolerability and a 28.8‑day half‑life supporting quarterly dosing. While the study was not powered...
Eli Lilly Acquires Engage Biologics for ~$202M
Eli Lilly announced the acquisition of Engage Biologics for roughly $202 million in cash, integrating Engage’s Tethosome non‑viral DNA delivery platform with Lilly’s growing genetic‑medicine portfolio. The deal includes an upfront payment and milestone‑based earn‑outs tied to development progress. Tethosome combines engineered DNA...
Genetic Insights From 619,372 Metabolic Profiles
A landmark study examined 619,372 metabolic profiles linked to genetic data, creating the largest metabolomics‑genomics dataset to date. Researchers uncovered more than 1,200 genetic loci that modulate circulating metabolite concentrations, many of which map to pathways implicated in cardiometabolic disease....
Targeting Inflammation in Depression: A Proof-of-Concept Worth Following
A proof‑of‑concept randomized trial examined a single intravenous dose of tocilizumab, an IL‑6 receptor blocker, in 29 adults with treatment‑resistant major depressive disorder and low‑grade inflammation (CRP ≥ 3 mg/L). The drug safely reduced CRP levels, but the primary outcome—somatic depression symptoms—did not...
Imperagen Raises £5 Million to Use Quantum Physics, AI on Enzyme Engineering
Imperagen, a Manchester‑spun biotech founded in 2021, closed a $6.7 million seed round led by PXN Ventures, bringing total funding to $11.42 million. The startup combines quantum‑physics simulations, custom AI models, and robotic closed‑loop experimentation to accelerate enzyme engineering. It aims to...
Did a Boy’s Life-Saving Gene Therapy Cause His Brain Tumour?
A five‑year‑old who received adeno‑associated virus (AAV) gene therapy for a rare genetic disorder developed a brain tumor four years later. Genetic analysis traced the tumor to integration of the viral vector into the child’s genome, suggesting a causal link....
Surveillance: Post Drug-Approval Activities
The FDA’s Center for Drug Evaluation and Research (CDER) oversees post‑marketing surveillance to ensure that drugs remain safe and effective after approval. Through mandatory adverse‑event reporting and targeted monitoring programs, the agency can identify unexpected risks. When serious concerns arise,...
GLP-1s Show Promise for Glaucoma, AMD, Other Eye Diseases
GLP‑1 receptor agonists, long used for diabetes and obesity, are emerging as potential treatments for several eye conditions. Recent reviews cite modest reductions in intra‑ocular pressure and lower incidence of primary open‑angle glaucoma among users. The data on diabetic retinopathy...
Collaborative Drug Discovery Inks Deal with Eli Lilly to Accelerate Biotech Innovation
Eli Lilly’s TuneLab AI platform will be embedded into Collaborative Drug Discovery’s (CDD) Vault system, giving biotech companies access to Lilly’s proprietary ADMET predictive models. The integration will appear in both the core and AI modules of CDD Vault, allowing researchers...
HELIX AI Model Accurately Predicts RNA Splicing, Unlocks Precision Medicine
Researchers at the Chinese Academy of Sciences unveiled HELIX, an AI framework that predicts RNA splicing and isoform usage with unprecedented accuracy. By combining DNA sequence data with expression profiles of 1,499 RNA‑binding proteins, the model outperforms existing tools across...
Abbreviated New Drug Application (ANDA)
On October 3, 2025, the FDA unveiled a pilot program that fast‑tracks the review of abbreviated new drug applications (ANDAs) submitted by generic manufacturers that test and produce their products in the United States. The initiative is designed to spur...
STAT+: Biotech Execs, Academic Expert Lament Impact of FDA Turnover on Rare Disease Drug Development
Biotech leaders and an academic expert warned that recent turnover among senior FDA officials is creating heightened uncertainty for rare‑disease drug developers. At the STAT Breakthrough Summit West, Mahzi Therapeutics CEO Yael Weiss described constant investor inquiries and a “roller‑coaster”...
Mutating Antibodies for Easier Drug-Conjugate Manufacturing
Scientists at Johns Hopkins University have engineered a general‑purpose antibody by mutating its fragment crystallizable (Fc) region, creating up to four new attachment sites for molecules such as drugs, dyes, or nanoparticles. Six precise Fc mutations enable consistent, site‑specific conjugation,...
Mixed-Reality Fermentation Simulator Preps Workforce
Mixed-reality platform BioSuite Virtual, created by Prism Immersive with BioMADE funding, delivers end‑to‑end fermentation training through over 40 interactive modules. The system blends virtual bioreactors with physical space, letting learners assemble, sterilize, inoculate, and monitor runs at their own pace....