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Regulatory shift: FDA tightens approach to early-stage China data
The FDA signaled tighter scrutiny of early-stage clinical data submitted from China, acknowledging concerns while stopping short of a full ban on China-based data. The move reflects heightened...
FDA approvals: first radioligand generic enters market
The FDA approved the first “radioligand equivalent” generic to Novartis’ Lutathera, setting up direct regulatory and commercial rivalry in theranostics. Curium received approval for a radioligand...
GSK expands China oncology bets via Chimagen acquisition
GSK agreed to acquire global rights to a preclinical trispecific T-cell engager from Chimagen Biosciences in a deal worth up to $750 million, extending its China-focused licensing strategy in...
Sling Therapeutics advances oral Tepezza rival for thyroid eye disease
Sling Therapeutics closed a $123 million Series C funding round to advance its oral thyroid eye disease candidate, targeting a late-stage readout through Phase 3. The company is positioning the...
Novartis ends ALS program after Phase 2 failure
Novartis stopped work on an ALS candidate, ending development of VHB937/lifonebart after a Phase 2 flop. The decision adds to ongoing R&D strain for the Swiss pharma group as it continues pruning...
A new in vivo human-neuron model boosts neuropsychiatric research
Stanford researchers reported in Nature that they engineered mice whose brains contain extensive human neuronal cells, creating what they call “xenocortical mice.” By genetically modifying mice to...
RegCell raises non-dilutive + Series A to take immune tolerance platform into clinic
RegCell secured $66 million to advance its regulatory T-cell immune tolerance platform, combining a fully subscribed $44 million Series A with a $22 million non-dilutive grant from Japan’s AMED....
Chronic pain mechanism: exosomes drive persistent neuronal dysfunction after shingles
Researchers at the University of Colorado Anschutz reported in Annals of Neurology that circulating exosomes may help explain lingering pain after shingles (post-herpetic neuralgia). In lab...
Slinging the pipeline in AI-driven drug discovery: Novo teams with Anthropic
Novo Nordisk and Anthropic announced a collaboration to test Anthropic’s Claude Science across drug development R&D workflows, aiming to accelerate discovery and development. The companies say...
Regulatory acceleration
The FDA has opened applications for an Expedited Investigational New Drug (IND) Pilot designed to shorten the time from drug identification to first-in-human studies by removing regulatory...
FDA approvals and major regulatory milestones
The FDA approved Scholar Rock’s Isembyld (apitegromab-mstn), a myostatin inhibitor for spinal muscular atrophy (SMA) in adults and children 2 years and older who are receiving SMN2-targeted...
Oncology therapeutics: pipeline wins and setbacks
In multiple oncology updates, GSK logged major progress in blood cancer and lung cancer while an earlier amyotrophic lateral sclerosis attempt was scrapped. On the blood cancer front, GSK agreed...
T cell engager dealmaking and platform execution
Novartis moved to strengthen CNS delivery by paying Sironax $125 million to take up an option on a blood-brain barrier crossing platform. The transaction gives Novartis control of technology aimed...
Trial readouts across CNS and neurodegeneration
Skyhawk Therapeutics reported that its RNA-splicing Huntington’s disease program, SKY-0515, improved symptoms in extension results from a Phase 1/2 study, supporting movement toward pivotal...
Biotech funding and early clinical acceleration
Sling Therapeutics closed a $123 million Series C to fund a Phase 3 trial of its oral Tepezza rival in thyroid eye disease. The funding is aimed at advancing the company’s resurrected Astellas...
FDA and biotech operations: safety and manufacturing signals
Centric Compounding initiated a nationwide recall of three injectable drug lots over contamination concerns tied to an active pharmaceutical ingredient (API). The recall targets specific lots of...
Drug pricing, contracts, and policy pressure
Sen. Elizabeth Warren demanded access to Trump-era drug-pricing contracts, accusing RFK Jr. of hiding details. The call centers on transparency around contract terms and the underlying basis for...
Cancer imaging and diagnostics for neuro-oncology
Telix’s Pixclara approval reinforces the expanding role of targeted PET tracers in neuro-oncology. With Pixclara, the FDA approved the first FET-PET imaging agent for glioma and the first...
Oncology breakthroughs: ADC survival signals in relapsed SCLC
Two B7-H3-directed antibody-drug conjugates delivered overall survival primary-endpoint wins in China-based phase III trials for relapsed small-cell lung cancer, reinforcing the clinical momentum...
FDA expedited IND pathway
The FDA has finalized the design of its Expedited Investigational New Drug (IND) Pilot and began accepting applications from sponsors paired with qualified research institutions to accelerate...