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Protego nets $130M — advances AL amyloidosis program
Protego Biopharma closed an oversubscribed $130 million Series B to accelerate PROT‑001, its oral candidate for AL (light‑chain) amyloidosis, into pivotal testing. The financing, led by several...
Janux shares tumble 50% after new prostate cancer data cut
Janux Therapeutics’ stock plunged after the company released a fresh cut of early‑stage data for JANX007, its masked T‑cell engager in metastatic castration‑resistant prostate cancer. The updated...
FDA draft: eliminate some monkey studies for monoclonal antibodies
The U.S. Food and Drug Administration issued draft guidance proposing conditions under which biopharma developers could reduce or waive nonclinical primate testing for certain monoclonal...
Generate moves AI‑engineered TSLP antibody into Phase III trials
Generate:Biomedicines advanced its lead AI‑discovered TSLP (thymic stromal lymphopoietin) antibody into Phase III studies, marking a notable late‑stage milestone for an AI‑designed therapeutic....
Novartis’ intrathecal SMA therapy cleared — Sarepta faces DMD setback
The FDA approved Novartis’ intrathecal version of its SMA gene therapy, expanding access pathways for spinal muscular atrophy patients by enabling direct spinal delivery. The approval follows data...
WHO guidance: combine GLP‑1 drugs with intensive behavioral therapy
The World Health Organization published guidance recommending that GLP‑1 receptor agonist medications for obesity be used alongside intensive behavioral therapy and as part of a broader obesity...
Top FDA drug regulator Pazdur files to retire — agency leadership in flux
Richard Pazdur has filed paperwork to retire as director of the FDA’s Center for Drug Evaluation and Research (CDER), signaling a sudden leadership disruption at the agency. Pazdur took the post...
FDA drafts plan to cut primate testing for antibody drugs — new safety pathways
The U.S. Food and Drug Administration released draft recommendations that in some cases allow biopharma companies to reduce or eliminate testing monoclonal antibodies in nonhuman primates before...
Regeneron bets $150M on Tessera’s gene‑writing program — rare disease push
Regeneron Pharmaceuticals agreed to a multi‑hundred‑million dollar collaboration to develop Tessera Therapeutics’ in vivo gene‑writing candidate TSRA‑196 for alpha‑1 antitrypsin deficiency (AATD)....
Belite’s oral tinlarebant hits Phase III endpoint — FDA filing in view
Belite Bio reported positive top‑line results from its Phase III DRAGON study: oral tinlarebant slowed the growth rate of retinal lesions in adolescents with Stargardt disease type 1, meeting the...
Protego secures $130M to push first‑in‑class AL amyloidosis drug toward pivotal
Protego Biopharma closed a $130 million Series B round to advance PROT‑001, an orally available small molecule candidate for AL (light‑chain) amyloidosis, into a potential pivotal study. The...
CDMO tie‑ups accelerate LBP and biologics scale‑up — Rentschler, Coriolis and Recipharm moves
Rentschler Biopharma and Coriolis Pharma announced a collaboration to offer integrated services from early formulation through commercial biologics manufacturing, combining formulation expertise...
CAR‑based immunotherapies advance — CAR‑NK enters clinic while CAR‑T pushes into CNS
Research and reviews this week spotlight rapid progress in engineered cell therapies: CAR‑NK approaches are moving from innovation to clinical testing, and novel strategies are extending CAR‑T...
AI and protein design attract capital — Profluent funding and Lilly’s TuneLab reveal strategy
Profluent closed a $106 million Series B to scale its AI‑driven protein design platform into therapeutics, agriculture and biomanufacturing applications, with new investors including Altimeter...
Vaccine policy shake‑up looms — FDA memo and scientists clash ahead of ACIP vote
Internal FDA guidance and leaked memos have ignited a policy fight over U.S. vaccine approval standards and schedules. CBER leadership outlined proposals that would require randomized trial...
Imvax reports survival signal in glioblastoma Phase 2b — FDA meeting planned
Imvax released Phase 2b data showing a survival benefit for its glioblastoma cell‑therapy program despite missing the trial’s primary endpoint. The company reported a median overall survival...
FDA drug czar exits: Pazdur files for retirement
Richard Pazdur, director of the FDA’s Center for Drug Evaluation and Research (CDER), has filed paperwork to retire at month’s end, creating immediate uncertainty at the agency’s drug-review helm....
FDA narrows primate testing for antibodies: new draft guidance
The FDA unveiled draft guidance enabling biopharma developers to reduce or eliminate nonhuman primate testing for certain monoclonal antibodies (mAbs), signaling a policy shift in preclinical...
Regeneron bets $150M on Tessera gene writing—rare disease target
Regeneron and Tessera Therapeutics signed a global collaboration to develop TSRA-196, an in vivo gene-writing candidate for alpha-1 antitrypsin deficiency (AATD), with Regeneron committing $150...
Belite’s tinlarebant wins Phase III—first Stargardt success
Belite Bio reported positive top-line results from its Phase III DRAGON study: oral tinlarebant met the primary endpoint by slowing progression of retinal lesions in Stargardt disease type 1. The...