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Roche wins clearance for 15-minute point-of-care Bordetella PCR test
Roche secured FDA 510(k) clearance, a CLIA waiver and CE marking for a Cobas Liat point-of-care PCR test that identifies Bordetella pertussis, parapertussis and holmesii in 15 minutes. The company...
IND clearances open clinics for two CNS and rare-disease programs
The FDA granted IND clearance to Latus Bio for LTS-101, a gene therapy candidate for the CNS manifestations of late-infantile neuronal ceroid lipofuscinosis type 2 (CLN2), and also awarded orphan...
Regeneron backs Tessera: $150m pact to write AATD genes
Regeneron and Tessera signed a collaboration that delivers $150 million up front to Tessera to co-develop TSRA-196, a gene-writing therapy targeting alpha-1 antitrypsin deficiency (AATD). The deal...
Protego closes $130m: Pivotal push for oral AL amyloidosis stabilizer
Protego Biopharma closed an oversubscribed $130 million Series B to advance PROT-001, an oral small-molecule kinetic stabilizer aimed at amyloid light-chain (AL) amyloidosis, into a pivotal trial...
Pharvaris scores Phase 3 win – deucrictibant eases HAE attacks faster
Pharvaris reported topline Phase 3 data showing its on-demand drug deucrictibant significantly reduced symptom duration versus placebo for hereditary angioedema (HAE) attacks. The result meets the...
Capricor’s cell therapy: Phase 3 shows muscle and heart gains in Duchenne
Capricor Therapeutics reported that its cell therapy deramiocel met the dual efficacy goals of a placebo-controlled Phase 3 trial in Duchenne muscular dystrophy (DMD), showing statistically...
Belite cuts lesion growth in Stargardt – Phase 3 hit
Belite Bio announced positive top-line results from its 104-patient Phase 3 Dragon study: oral tinlarebant met the primary endpoint by significantly slowing the growth rate of retinal lesions in...
Janux down... market overreacts to prostate T‑cell engager data
Janux Therapeutics saw a steep stock decline after releasing an updated cut of early clinical data for its masked T‑cell engager JANX007 in metastatic castration-resistant prostate cancer. The...
FDA pares monkey tests: draft guidance cuts nonclinical monkey use for some mAbs
The FDA issued draft recommendations allowing biopharma companies to reduce or omit nonhuman primate testing for certain monoclonal antibodies during development. The guidance offers pathways to...
Prasad memo rattles markets: vaccine policy debate dents developers’ stocks
A leaked FDA internal memo from CBER leadership triggered a market reaction as vaccine developers’ shares dipped after investors digested proposals that could tighten evidence requirements for...
Top FDA drug regulator Pazdur to retire — sudden exit adds agency uncertainty
Richard (Rick) Pazdur, the director of the FDA’s Center for Drug Evaluation and Research (CDER), filed paperwork to retire at month-end, marking another abrupt leadership change at the agency....
Profluent raises $106m to scale AI‑driven protein design
Profluent closed a $106 million Series B to expand its AI-driven protein design platform across therapeutics, agriculture and biomanufacturing applications. The round was co-led by Altimeter...
CDER chief Pazdur set to depart — agency leadership shaken
Richard Pazdur has filed paperwork to retire as director of the FDA’s Center for Drug Evaluation and Research (CDER) after only weeks in the role. Multiple reports indicate Pazdur notified CDER...
FDA drafts guidance to curb primate testing for some antibodies
The FDA released draft recommendations aimed at reducing or eliminating the use of nonhuman primates for certain monoclonal antibody safety testing. The agency’s plan outlines circumstances where...
Regeneron plunks down $150M on Tessera gene writing — one-and-done bets
Regeneron and Tessera Therapeutics struck a deal worth $150 million to co-develop TSRA-196, Tessera’s near-clinic in vivo gene-writing candidate for alpha-1 antitrypsin deficiency (AATD)....
Belite’s oral Stargardt drug meets Phase 3 goal — path to first approval
Belite Bio reported positive top-line results from the Phase 3 DRAGON trial: tinlarebant reduced the growth rate of retinal lesions in Stargardt disease type 1 by a clinically meaningful margin...
Protego secures $130M to push first-in-class AL amyloidosis program
Protego Biopharma closed an oversubscribed $130 million Series B to advance PROT-001, its oral candidate for AL (light-chain) amyloidosis, toward a pivotal study. The financing was led by...
Janux shares tumble after prostate T‑cell engager data update
Janux Therapeutics’ stock plunged after the company released a new early-stage data cut showing a lower-than-expected response rate for JANX007, its masked T-cell engager in metastatic...
SMA gene therapy cleared as DMD drug faces new limits — regulatory seesaw
Novartis received FDA approval to expand delivery of its SMA gene therapy (Itvisma) via an intrathecal route, widening patient eligibility and affirming gene-replacement approaches for...
U.K.-U.S. trade deal lifts NICE threshold — U.K. to pay more for medicines
The U.K. and U.S. reached a trade agreement that locks in zero tariffs on pharmaceutical exports to the U.S. for three years in exchange for pricing concessions by the U.K. government. The deal...