SLAS Technology Volume 37 Highlights AI Drug Design and Field-Ready Diagnostics
Volume 37 of SLAS Technology features an AI drug discovery framework, a pipelining Bayesian optimization method, and a field-deployable virus detection platform.
News & Analysis
Curated news and analysis on clinical trials, drug approvals, and medical research.
C-peptide Seen as Key Biomarker for Type 1 Diabetes Drug Trials
C-peptide is described as a key biomarker for beta cell function in type 1 diabetes and a potential surrogate endpoint for drug approval. Current trial endpoints remain difficult for disease-modifying therapies.
ByteDance expands AI drug-discovery work through Anew Labs and US hiring
ByteDance is expanding its AI drug-discovery work through Anew Labs and US hiring for its Seed AI team. Anew Labs has presented AI-developed therapies and molecular modeling work at international conferences.
mRNA Medicine and Spatiotemporal Delivery Advance Cardiovascular Therapy
mRNA medicine and spatiotemporal drug delivery systems are expanding options for cardiovascular disease. The sources describe preclinical proof-of-concept, clinical trials and programmable cardiac repair platforms.
Pennsylvania Jury Finds J&J Liable in Talc Baby Powder Ovarian Cancer Case
A Pennsylvania jury ordered Johnson & Johnson to pay $250,000 to the family of Gayle Emerson in a talc baby powder ovarian cancer case. The verdict comes amid more than 90,000 talc lawsuits and ongoing fights over expert testimony.
Institutional investors adjust Moderna holdings as Vanguard raises stake
Vanguard increased its Moderna stake by 1.0% in the fourth quarter to 41.6 million shares worth $1.23 billion. Other institutional investors also adjusted positions, while 75.33% of the stock is held by institutions and hedge funds.
US court blocks CDC vaccine advisory panel appointments
A federal judge froze appointments to the CDC’s ACIP, halted its votes, and paused recent HHS vaccine policy changes. The ruling leaves several FDA-approved vaccines pending review.
Biotech companies disclose Nasdaq inducement grants for new employees
Dianthus, Taysha and aTyr disclosed inducement equity grants for newly hired employees under Nasdaq Listing Rule 5635(c)(4), detailing share awards, vesting schedules and exercise prices.
Laguna and Neurocrine advance schizophrenia diagnostic and treatment programs
Laguna won FDA Breakthrough Device Designation for a blood-based schizophrenia test, while Neurocrine dosed the first patient in a Phase 2 trial of NBI-1117570.
As insurers drop GLP-1 coverage, patients lose access despite reported benefits
Vermont insurers and employers are scaling back GLP-1 coverage as costs rise, leaving some patients without access. The drugs remain in high demand as studies point to benefits beyond weight loss.
Guardant Health CMO to Resign; Delfi and Singular Name New Leaders
Guardant Health said its chief medical officer will resign effective May 8, while Delfi Diagnostics appointed Charles Newton to its board and Singular Genomics named John Stark CEO.
Pfizer trial updates and FDA reviews add pipeline milestones
Pfizer reported new clinical and regulatory milestones across oncology, obesity and hemophilia, including BREAKWATER Phase 3 data and Priority Review for HYMPAVZI. The company also cited MagnetisMM-5 results and FDA priority review for PADCEV.
Fifth Circuit Reinstates In-Person Dispensing Requirement for Abortion Pill Mifepristone
The Fifth Circuit reinstated an in-person dispensing requirement for mifepristone, blocking telemedicine prescriptions. The ruling came after a federal judge paused Louisiana's lawsuit pending the FDA's safety review of the abortion medication.
FDA Rare Disease Hub, Draft Guidance, and Regulatory Updates for 2026
FDA released its 2026 Rare Disease Hub Strategic Agenda and a draft guidance on 3-year New Clinical Investigation Exclusivity. The agency also outlined new pathways including the plausible mechanism pathway and Rare Disease Evidence Principles to accelerate treatments for rare diseases.
FDA Launches Real-Time Clinical Trials, Seeks AI Pilot Input
FDA launched two proof-of-concept real-time clinical trials on April 28, 2026, and issued an RFI for an AI-focused pilot program to optimize early-phase trials. The agency aims to reduce gaps between trial phases and modernize drug development.
Daratumumab Shows Promise in NMOSD as FDA Accepts Iberdomide NDA for Multiple Myeloma
Phase 3 trial data show daratumumab reduced relapse risk by 74% in NMOSD. Separately, the FDA accepted an NDA for iberdomide plus daratumumab/dexamethasone in relapsed/refractory multiple myeloma, with a PDUFA date of August 17, 2026.
Protein Recycling and Genetic Mechanisms Offer New Paths to Reverse T-Cell Exhaustion
Two studies identify protein recycling dysfunction and transcription factors ZSCAN20/JDP2 as drivers of T-cell exhaustion, with E3 ligases and gene deactivation offering reversal pathways. A third study finds TCF1 insufficient to revert terminally exhausted T cells.
FDA Accepts NDA for Vepdegestrant, First PROTAC to Reach Regulatory Review in Breast Cancer
FDA has accepted the NDA for vepdegestrant (ARV-471), an oral PROTAC ER degrader from Arvinas and Pfizer, for ESR1-mutated ER+/HER2- advanced breast cancer. A PDUFA date of June 5, 2026 has been set. The submission is based on positive Phase 3 VERITAC-2 data.
FDA Grants Priority Review for Bictegravir/Lenacapavir HIV Single-Tablet Regimen
FDA grants Priority Review for Gilead's bictegravir/lenacapavir single-tablet HIV regimen. The NDA is supported by ARTISTRY-1 and ARTISTRY-2 trials showing noninferiority. A PDUFA target date of August 27, 2026 has been set.
European Biotechs Advance Next-Generation Immunotherapy Targets Beyond PD-1/PD-L1
European biotechs are exploring new immunotherapy targets beyond PD-1/PD-L1, including BTLA, TIGIT, and SLAMF6. Lund University researchers discovered a SLAMF6-mediated immune evasion mechanism. BioNTech and GenMab are advancing next-generation ICIs and bispecific antibodies through strategic partnerships.
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