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Regulatory path for rectal cancer immunotherapy
GSK is moving toward an FDA filing after Jemperli (dostarlimab) met its primary goal in a pivotal Phase 2 study in stage 2/3 dMMR/MSI-H locally advanced rectal cancer, with GSK describing a...
Immune-mediated alopecia drug differentiates from JAK inhibitors
Q32 Bio’s bempikibart is starting to separate from JAK inhibitors in alopecia areata after additional Phase 2 results, with the company saying part B of the SIGNAL-AA trial showed reduced disease...
FDA moves on drug factory registration rules
The FDA has proposed a rule to simplify how drug factories are registered, targeting the establishment-registration process for manufacturers supplying the U.S. market. The agency said the update...
Gene therapy funding for neurogenic bladder reaches Series C
Cyllene Therapeutics secured a $37 million Series C to advance EG110A through late-stage clinical development for severe neurogenic bladder. The financing signals continued investor appetite for...
AI drug metabolism competition spotlights PXR risk prediction
ASTAT+ coverage of drug metabolism AI competition results underscores a key lesson for pharmaceutical AI: predicting drug-body interactions tied to clearance sensors may not improve simply by...
Cancer biology: SPOP structural dynamics tie to mutation mechanisms
A study at St. Jude Children’s Research Hospital reported that SPOP adopts a finely tuned equilibrium between an active filamentous state and an inactive “double-donut” assembly, with...
AD biomarker scaling via large plasma proteomics effort
Alzheimer’s-focused researchers are using the Alamar platform to profile 21,000 plasma samples as part of a consortium effort aimed at improving detection of Alzheimer’s and related neurological...
Venture capital: Mindrank jumps into oral GLP-1 Phase III with $52M funding
China’s Mindrank raised $52 million in a Series B to advance MDR-001, its AI-discovered oral GLP-1 receptor agonist, which is in Phase III development for obesity in China. The company tied the...
Health policy: Germany passes drug discount reform despite pharma pushback
German lawmakers voted through a healthcare reform package designed to cut statutory health insurance costs next year, including higher mandatory rebates on branded medicines. Despite resistance...
Product approvals and deployment: wearable neuromodulation device gets FDA de novo for VA PTSD
Neurovalens received FDA de novo approval for Modius Spero, a wearable neuromodulation device for at-home treatment of PTSD in U.S. veterans, with the Department of Veterans Affairs listed as the...
GSK rectal cancer immunotherapy regulatory path
GSK said its PD-1 antibody Jemperli met the main goal in the pivotal Phase 2 AZUR-1 study in stage 2/3 dMMR/MSI-H locally advanced rectal cancer, setting up an FDA filing. The company reported a...
FDA guidance for psychedelics and regulatory momentum
The FDA finalized clinical guidance for psychedelic drug developers and scheduled a public hearing on future therapeutic use, adding regulatory momentum to the psychedelic pipeline. The agency’s...
FDA changes drug facility registrations for distributed manufacturing
The FDA proposed a rule to streamline drug establishment registration for facilities making products for the U.S. market, with an emphasis on distributed biopharma manufacturing and strengthening...
Q32 alopecia areata Phase 2 readouts and competitive positioning vs JAK inhibitors
Q32 Bio reported additional Phase 2 data for bempikibart (bempi), helping the company strengthen its pitch for an alopecia areata treatment that targets IL-7 and TSLP signaling without JAK...
Agenus pivots colorectal trial strategy
Agenus abandoned a Phase 3 colorectal study just three months after launch, redirecting resources toward a new focus on colon cancer. The company said it would scrap the Battman trial, which was...
Cyllene advances late-stage gene therapy for neurogenic bladder
Cyllene Therapeutics secured a $37 million Series C round to push EG110A through late-stage clinical development in severe neurogenic bladder conditions. The company’s funding plan targets...
Neurovalens wins FDA de novo approval for PTSD wearable for veterans
Neurovalens said the FDA granted de novo approval for Modius Spero, a wearable neuromodulation device, for U.S. veterans with PTSD. The treatment is designed for at-home use with 30-minute daily...
Mindrank raises Series B to advance oral GLP-1 program
Mindrank AI completed a $52 million Series B round to advance MDR-001, its AI-discovered oral GLP-1 receptor agonist in Phase III trials for obesity in China. The company said funding will support...
Q32 competition and broader investor read-through on alopecia efficacy
Additional market coverage around Q32’s alopecia results emphasized the company’s competitive framing versus JAK inhibitors and the strength of investor reaction to new efficacy signals. Reports...
FDA enablement decision narrows scope of patent infringement liability
The U.S. Court of Appeals for the Federal Circuit again addressed enablement for prescription drug claims, overturning a jury verdict that AstraZeneca should pay Wyeth, a Pfizer unit, $107.5...