Why Managing Potency and Degradation Are Crucial in ADC Cleaning Validation
At INTERPHEX 2026, Paul Lopolito of STERIS highlighted the unique cleaning‑validation challenges posed by antibody‑drug conjugates (ADCs). He explained that ADCs merge highly potent small‑molecule payloads with large‑molecule biologics, creating divergent degradation profiles that demand product‑specific, risk‑based cleaning strategies. Lopolito noted that many ADC processes use solvents incompatible with single‑use equipment, requiring reusable hardware and rigorous cross‑contamination controls in multi‑product facilities. He urged the industry to align small‑ and large‑molecule validation approaches to ensure safe, reliable manufacturing.
Merck's Welireg Combo Fails in First-Line Kidney Cancer
Merck reported that adding Welireg (lenvatinib) to Keytruda (pembrolizumab) did not improve outcomes for treatment‑naïve patients with advanced renal cell carcinoma. In the phase‑3 CLEAR trial, the combination failed to meet its primary progression‑free survival endpoint, showing a median of...
Merck’s Fast-Ascending Kidney Cancer Drug Hits a Setback
Merck announced that Welireg, combined with Keytruda and Lenvima, failed to meet primary endpoints in a Phase 3 first‑line clear‑cell renal cell carcinoma trial, missing both progression‑free and overall survival benefits. The setback curtails Merck’s plan to use Welireg to offset...
What Does It Take to Scale Cell and Gene Therapies From Discovery to Commercialization
MaxCyte CEO Maher Masoud says scaling cell and gene therapies requires developers to partner with manufacturers that can move seamlessly from R&D to commercial production. Integrated, best‑in‑class platforms eliminate the need for repeated process re‑optimization, enabling consistent, automated manufacturing. Advances...
FDA Public Meeting on Increasing Access to Nonprescription Drugs - 04/23/2026
The FDA announced a public meeting on April 23, 2026 to discuss expanding access to nonprescription, or over‑the‑counter (OTC), drugs. The agency is soliciting comments through May 8, 2026, with an earlier deadline of Feb 2, 2026 to shape the agenda. Topics include identifying conditions that...
Acorys System Gains FDA Clearance for Real-Time 4D Cardiac Mapping
Corify Care’s Acorys system received FDA clearance, offering clinicians a real‑time, four‑chamber view of cardiac electrical activity without the need for CT or MRI scans. The platform merges 3D anatomical modeling with live electrical signals, creating what the company calls...
FDA Accepts BLA for Gazyva/Gazyvaro for Systemic Lupus Erythematosus
Roche has received FDA acceptance of its supplemental Biologics License Application for obinutuzumab (Gazyva/Gazyvaro) as a treatment for systemic lupus erythematosus, with a regulatory decision expected by December 2026. The approval request is backed by the Phase III ALLEGORY trial, which...
Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval - 05/09/2024
On May 9, 2024, the FDA’s Office of Generic Drugs hosted a webinar on the redesigned pre‑submission meetings under GDUFA III. The session outlined new scope, procedural updates, and illustrated a hypothetical case to help sponsors prepare effective meeting requests. Speakers...
AI Can Streamline Drug Approval, Boost Biotech Valuations
That is an interesting idea. This doesn't seem catered to investors per se, but with two partners in the summer of 25, we explored building an “AI-powered AlphaSense for biopharma” ultimately concluding it was too much work to do as...
Complex Generics News
The FDA’s Center for Drug Evaluation and Research is intensifying its focus on complex generic drugs, which feature intricate active ingredients, formulations, or delivery systems. Recent milestones include the July 2023 approval of the first generic Vivitrol injectable and the March 2026...
Genflow and Acuitas Forge Fully Funded LNP Collaboration to Accelerate SIRT6 Gene Therapies
Genflow Biosciences announced a strategic, fully funded collaboration with Acuitas Therapeutics to apply Acuitas' lipid‑nanoparticle (LNP) delivery platform to Genflow's SIRT6 mRNA payload. The non‑dilutive agreement lets Genflow generate preclinical data without cash outlay, signaling strong external validation of its...
From Dorm to $275M: Early Ovarian Cancer Detection Breakthrough
This is my friend Surbhi Sarna. She came to Draper University in 2012. She had painful ovarian cysts as a teenager, but doctors didn’t have tools that could detect cancer without harming the ovaries. She studied molecular biology at UC Berkeley. Then came...
Xenon’s Azetukalner Clears Phase III Hurdle in Focal Epilepsy, Eyes FDA Filing
Xenon Pharmaceuticals reported on 19 April at the American Academy of Neurology that its KV7 potassium‑channel opener azetukalner met primary endpoints in the Phase III X‑TOLE2 trial for focal onset seizures. The study enrolled 380 adults, with 374 completing safety and...
Architecting Life: Authoring the Future of Species with Dr. Adrian Woolfson
Dr. Adrian Woolfson argues that DNA must be treated as a programmable engineering material, enabling the design of living systems from houses to organs. By decoding DNA's generative grammar, humanity could author genomes and potentially rewrite its own code, ushering...
'It's Just the Beginning' For Pancreatic Cancer's Long-Awaited Breakthrough
Revolution Medicines’ KRAS‑G12D inhibitor daraxonrasib has entered late‑stage trials as a potential first‑in‑class therapy for pancreatic cancer, a disease that still carries a five‑year survival rate below 12%. Early data show tumor shrinkage in roughly a third of heavily pre‑treated...
SMMT Spikes as Akeso OS Data Lands Plenary
Summit Thera. $SMMT Well… that answers that. SMMT shares initially popped (as much as ~15%) on today’s release of ASCO abstract titles with the unexpected news that the much-anticipated OS data from Akeso’s HARMONi-6 will be released in a Plenary slot...
Carvykti Shows Promise Before Multiple Myeloma; Two Megarounds; AstraZeneca Wins Twice
Researchers at Dana‑Farber Cancer Institute reported that all 20 high‑risk smoldering multiple myeloma patients treated with Carvykti, Janssen's BCMA‑directed CAR‑T therapy, achieved disease clearance. The single‑infusion regimen produced complete responses without immediate relapse, and patients remained progression‑free at a median...
BioAge Says Early Data Suggest ‘Best-in-Class’ Potential for Inflammation Drug
BioAge Labs released Phase 1 data for the 60‑mg dose of its NLRP3 inhibitor BGE‑102, confirming tolerability and inflammation‑lowering activity similar to the earlier 120‑mg readout. The oral pill crosses the blood‑brain barrier, opening possibilities for cardiovascular, obesity, eye and central‑nervous‑system...
Early Myocarditis Onset After Immunotherapy May Predict Treatment-Related Fatality
A new analysis of WHO VigiBase data presented at the AACR 2026 meeting shows that immune checkpoint inhibitor (ICI)‑induced myocarditis occurring within the first month of therapy dramatically increases the risk of death. Patients who develop myocarditis early are 59%...
Intralesional Nivolumab May Be Effective Against Precancerous Oral Lesions, Phase I Trial Results Indicate
A Phase I trial presented at AACR 2026 showed that injecting low‑dose nivolumab directly into precancerous oral lesions produced an 85% clinical response rate, with lesions shrinking an average of 60% and 41% achieving histologic downgrading. Patients received 10 mg or 20 mg...
One-Step Method Reveals Structures of RNA-Protein Complexes in Living Cells
Researchers at Baylor College of Medicine introduced a one‑step biochemical technique called multi‑site DMS‑MaP (msDMS‑MaP) that maps RNA three‑dimensional structures and protein‑binding sites directly in living cells. The method simplifies RNA structure probing, uses inexpensive reagents, and integrates with high‑throughput...
Unexpected Cancer Mutations in Brain's Immune Cells May Help Fuel Alzheimer's Disease
Researchers at Boston Children’s Hospital sequenced 149 cancer‑driving genes in 190 Alzheimer’s brains and found microglia accumulating mutations in five oncogenic genes. The same mutations were present in the patients’ blood cells, implying that mutated immune cells cross a weakened...
Agenus Names BAP Pharma as Exclusive Global Partner for BOT+BAL Access Programs
Agenus appointed BAP Pharma as its exclusive global partner to manage early‑access programs for the botensilimab‑balstilimab (BOT+BAL) immunotherapy combo. The collaboration will handle France’s government‑reimbursed Autorisation d’Accès Compassionnel (AAC) pathway and paid named‑patient programs in several other markets. Agenus has...
Charles River Highlights Effectiveness of VCGs in Toxicology
Charles River Laboratories published a retrospective analysis of 20 nonclinical toxicology studies that replaced traditional concurrent control groups with virtual control groups (VCGs). The review found 100% concordance in No Observed Adverse Effect Level (NOAEL) determinations and demonstrated up to...
Star Therapeutics Receives FDA Rare Pediatric Disease and Breakthrough Therapy Designations for VGA039 in Von Willebrand Disease Prophylaxis
Star Therapeutics announced that the FDA has granted both rare pediatric disease and Breakthrough Therapy designations to its lead candidate VGA039, a monoclonal antibody aimed at preventing bleeding in von Willebrand disease (VWD). The designations support the ongoing Phase 3 VIVID‑6 study,...
Simulations Plus Announces Collaboration with Lonza and U.S. FDA to Advance Predictive Frameworks for Complex Oral Drug Products
Simulations Plus announced a funded collaboration with CDMO Lonza and the U.S. FDA to create a mechanistic, predictive framework for amorphous solid dispersion (ASD) oral drugs. The partnership will combine Lonza's advanced in‑vitro dissolution testing with Simulations Plus' GastroPlus and...
HIV's Earliest Immune Battle Leaves Blood Traces that Forecast Powerful Antibodies Years Later
Researchers analyzed cell‑free RNA and DNA from blood samples of 14 South African women tracked from pre‑infection through early HIV infection. They discovered that individuals who later produced broadly neutralizing antibodies (bNAbs) exhibited distinct early immune activation patterns and unique...
Tortugas Takes Neuro Deep Dive with $106M to Develop Eisai, Hansoh Programs
Tortugas, a Massachusetts‑based biotech, launched with $106 million in seed and Series A funding, securing clinical assets from Japan’s Eisai and China’s Hansoh Pharmaceutical. The capital will support two mid‑stage, oral small‑molecule trials targeting CNS disorders such as schizophrenia, tinnitus, and focal...
NIMBLE Trial Shows Efficacy of Cemdisiran in gMG: Tuan Vu, MD
The phase 3 NIMBLE trial evaluated cemdisiran, an RNA‑interference therapy, in patients with generalized myasthenia gravis (gMG). Over 26 weeks, cemdisiran monotherapy and its combination with pozelimab both achieved statistically significant improvements on the MG‑ADL scale versus placebo, and met the key...
Boehringer Targets AI-Driven Advances in Disease Research
Boehringer Ingelheim announced a £150 million (US$203 million) AI and machine‑learning accelerator in King’s Cross, London, expanding its global computational R&D network. The new hub, part of the UK Knowledge Quarter, will focus on disease biology, target identification and predictive modeling to...
Red Wolf Controversy Deepens After Colossal’s Clone Claim
The red wolf has long been a contentious species. The debate over its preservation got even messier last year, when Colossal said it had cloned the animal.
Daraxonrasib Beats Chemo in Pre‑treated Metastatic Pancreatic Cancer
#ASCO26 LBA5 - Wolpin - Daraxonrasib RAS(ON) multi-selective inhibitor vs chemo in prior Tx metastatic pancreatic adenocarcinoma (mPDAC) - Ph3 RASolute 302 [May 31, 2026] https://t.co/oWEeVo2oyq #NCT06625320 #pancsm #caxtx #PrecisionMedicine https://t.co/adz922fg5z
BioAge Reports Positive Phase 1 Data for BGE-102
BioAge Labs announced Phase 1 results for BGE‑102, an oral, brain‑penetrant NLRP3 inhibitor, showing up to 86% reductions in high‑sensitivity C‑reactive protein (hsCRP) in obese participants. A 60 mg once‑daily regimen over 21 days achieved biomarker improvements comparable to the previously tested...
Ivonescimab Plus Chemo Rivals Tislelizumab in First‑line sqNSCLC
#ASCO26 LBA4 - Zhiwei - Ivonescimab + chemo vs tislelizumab + chemo 1L sq NSCLC - Ph3 HARMONi-6 [May 31, 2026] Zhiwei et al. https://t.co/oWEeVo2oyq #NCT05840016 #lcsm #ImmunoOnc https://t.co/NP2qr2gPuY
Adjuvant Selpercatinib Shows Promise
#ASCO26 LBA3 - Goldman - EFS w/ adjuvant sepercatinib in stage IB-IIIA RET fusion-positive NSCLC: Ph3 LIRETTO-432 trial https://t.co/oWEeVo2oyq #NCT04819100 #lcsm #PrecisionMedicine https://t.co/HWIS9mg57w
Senolytics Fail to Reset Senescence DNA Methylation Marks
DNA Methylation Signatures of Cellular Senescence Are Not Reversed by Senolytic Treatment https://t.co/uemETuWkqI H/T @NataliaMitin
Phase 3 Trial Shows Abemaciclib Benefits Advanced Liposarcoma
#ASCO26 LBA2 - Dickson -SARC041: Ph3 DBRCT abemaciclib vs placebo in Pts w/ adv dedifferentiated liposarcoma [May 31, 2026] https://t.co/oWEeVo2oyq #NCT04967521 #scmsm https://t.co/uD6A9JmBCn
Genomic Profiling Boosts Survival for Advanced Sarcoma Patients
Using Tumor Genomic Profiling to Guide Treatment Selection Extends Survival in Advanced Sarcoma [May 10, 2019] @ASCO Daily News #scmsm #PrecisionMedicine https://t.co/8625ixTvQu
Perioperative
#ASCO26 LBA1 - Taplin - Perioperative APA + ADT - prostate CA [May 31, 2026] https://t.co/oWEeVo2oyq #NCT03767244 #pcsm https://t.co/8o91ntAwL9
Two Decades of Evolving ASCO Clinical Trial Trends
Trends and characteristics of clinical trials presented in ASCO plenary sessions (2011–2025) [] Overheu #ASCO26 Abstract # 11024, Poster Bd # 7 https://t.co/JYI0LY7FbU #ClinicalTrials #ctsm @ASCO
Autonomous Labs: America’s Edge in Manual Work
Robots are how the US wins in manual work long term. Including at the lab bench ! Need autonomous labs
Scientists Save Billions; CRISPR Cures Sickle Cell
You live in luxury. Without scientists, 6 billion of us would not be alive & the rest would live in hell. Remember that Great choices @brkthroughprize 🏆 Congrats to my colleague @Harvard, Stu Orkin, who won the prize for helping cure...
WGS Uncovers Clinically Relevant Findings Missed in MDS
Whole genome sequencing [WGS] to identify novel, clinically relevant findings missed by standard of care for Pts w/ myelodysplastic syndrome [MDS] - @AlexBataller etal @garciamanero @UTMDAnderson @TempusAI #ASCO26 abst 6570 Pst 363 https://t.co/t7aNW89eRL #MDSsm #leusm #cagenome
First Trial Shows Best‑in‑Class NLRP3 Inhibitor Promise
Excited to complete our first clinical trial for BGE-102. Clinical data supporting best-in-class potential, built on new chemistry and a novel binding site targeting NLRP3 - a central driver of of chronic inflammation in aging. On to Phase 2!
AQUARIUS Registry Uncovers Biomarkers in Blood Cancers
AQUARIUS: A longitudinal multi-center molecular biomarker discovery registry for Pts w/ hematologic malignancies - @mtmdphd et al. @TempusAI & IFLI - Instit Follicular Lymphoma Innovation #ASCO26 abstr TPS7105, Poster 599a https://t.co/70G0v1P968 #NCT07154823 #lymsm #cagenome
ASCO26 Unveils Pancreatic
#ASCO26 abstract titles were released today: $RVMD RASolute Ph3 study in pancreatic cancer will be presented during the plenary session. Also, Akeso $SMMT ivonescimab HARMONi-6 trial in lung cancer. China-only data.
BioAge's Inflammation Drug Shows Best‑in‑class Promise
BioAge says early data suggest ‘best-in-class’ potential for inflammation drug https://t.co/D2owlYxCRa by Kristin Jensen $BIOA $LLY $NMRA
Nabla Bio Secures Seed Funding Directly at Conference
Some companies raise a seed round. Nabla Bio had one built at a conference. https://t.co/1xmbmuqA8p
MRNA Brand Stigmatized by COVID Vaccine Backlash, Says Bhattacharya
That is literally a lie, as Bhattacharya wrote an op-ed trying to explain their move. He essentially was arguing that the "brand" of mRNA is tainted by public backlash to the COVID vaccine. https://t.co/5KXQJtCCxM https://t.co/HDQRvQK0ki
Promising Mufemilast Results Unveiled at DDW
Strong mufemilast data being presented at DDW this week for anyone still following the $PALI story. https://t.co/Oi4WI6R0iW