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In‑vivo CAR‑T readout delayed as next‑gen CARs show safer, persistent responses in mice
Umoja Biopharma delayed its first clinical readout from an in‑vivo CAR‑T trial, citing program timing changes, while academic teams reported preclinical data for next‑generation CAR‑T constructs...
Lilly’s retatrutide posts record weight loss — tolerability questions surface
Eli Lilly’s next‑generation triple‑agonist, retatrutide, delivered unprecedented weight loss in late‑stage testing while prompting new tolerability scrutiny. Company and trial reports show...
AC Immune reports biomarker gains in Parkinson’s vaccine — regulators next
Swiss biotech AC Immune posted interim biomarker and safety data from its Phase II active immunotherapy program targeting alpha‑synuclein in early Parkinson’s disease. The company reported...
Rezolute’s pivotal miss collapses stock — program at inflection
Rezolute’s Phase III Sunrize trial of ersodetug for congenital hyperinsulinism failed to meet primary and key secondary endpoints, the company announced, triggering immediate market fallout. The...
Natera buys Foresight to bolster Signatera and enter hematology
Natera acquired Foresight Diagnostics for $275 million up front to integrate Foresight’s PhaseED‑seq phased‑variant enrichment technology into Natera’s Signatera circulating tumor DNA platform and...
Metagenomic editing inserts large DNA into gut microbes in vivo
A Nature Biotechnology report describes a metagenomic editing breakthrough that enables the integration of large DNA sequences into gut bacteria in vivo. The approach allows researchers to modify...
Novartis’ GanLum wins Phase III — high cure rates against falciparum malaria
Novartis and Medicines for Malaria Venture reported positive Phase III results for GanLum, a next‑generation antimalarial combining ganaplacide with lumefantrine. The KALUMA trial across 34 sites...
FDA clears first at‑home tDCS headset for depression — prescription rollout ahead
Regulators granted clearance for Flow Neuroscience’s wearable transcranial direct current stimulation (tDCS) headset as the first FDA‑cleared device intended for at‑home treatment of major...
FDA clears Waskyra — nonprofit wins first gene therapy approval
The FDA approved Waskyra, a gene therapy for Wiskott‑Aldrich syndrome, marking the first time a non‑profit applicant secured authorization for a genetic medicine. Regulators cited the program’s...
ARPA‑H backs AI toxicity project — Inductive Bio leads human‑centric safety models
Inductive Bio won an up‑to‑$21 million ARPA‑H award to develop next‑generation AI models for drug toxicity prediction, partnering with Amgen, Baylor, Cincinnati Children’s, and Torch Bio. The...
Scaling single‑cell atlases and sequencing firms double down on multiomics
Parse Biosciences and Tahoe Therapeutics announced a collaboration to generate a 300‑million‑cell perturbation atlas—expanding on Tahoe’s prior Tahoe‑100M dataset—to train AI models for predicting...
Lilly’s triple agonist sets new bar — 28.7% mean weight loss
Eli Lilly reported Phase 3 results showing its triple‑agonist retatrutide produced a mean 28.7% body‑weight reduction at 68 weeks in the trial population. The data, from the program’s high‑dose...
Next‑gen malaria drug passes Phase 3: Novartis’ GanLum cures 97.4%
Novartis and the Medicines for Malaria Venture (MMV) announced positive Phase 3 KALUMA results for GanLum, a ganaplacide–lumefantrine combination that cured 97.4% of participants with...
Teva recalls >500,000 prazosin bottles after nitrosamine impurity found
Teva Pharmaceuticals voluntarily recalled more than half a million bottles of prazosin hydrochloride after testing detected N‑nitroso prazosin impurity C above acceptable intake limits. The FDA...
AC Immune posts promising Parkinson’s biomarker signals — regulator engagement planned
AC Immune reported interim biomarker data from a mid‑stage Parkinson’s study suggesting the company’s immunotherapy may slow disease progression, and said it will seek regulatory feedback to...
Rezolute stock collapses after Phase 3 flop — ersodetug misses primary endpoints
Rezolute disclosed that its Phase 3 trial of ersodetug in congenital hyperinsulinism failed to meet the primary efficacy endpoint, triggering a catastrophic market reaction and an immediate...
Apple Tree Partners files Chapter 11 amid funding fight to keep portfolio afloat
Venture firm Apple Tree Partners filed for Chapter 11 to implement a restructuring plan intended to ensure continued funding for its biotech portfolio amid a months‑long dispute with primary...
Parse and Tahoe to build 300M‑cell perturbation atlas to train biology AI
Parse Biosciences and Tahoe Therapeutics announced a collaboration to generate a 300‑million‑cell single‑cell perturbation atlas using Parse’s GigaLab services and Tahoe’s Mosaic perturbation...
Inductive Bio lands ARPA‑H award to build next‑gen AI toxicity models with Amgen
Inductive Bio received an award worth up to $21 million from ARPA‑H to lead DATAMAP, a consortium that will develop AI models predicting drug toxicity using data from human organoids, ex vivo...
Moderna taps Nanexa’s PharmaShell to pursue long‑acting injectables — deal could hit $500M
Moderna signed a collaboration and option deal with Swedish formulation firm Nanexa to test PharmaShell coatings for sustained‑release injectable therapies, paying $3 million upfront and keeping...