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Mutant p53 Reactivation Shows Clinical Activity – Rezatapopt in NEJM
PMV Pharmaceuticals published Phase I first‑in‑human data for rezatapopt in the New England Journal of Medicine showing objective responses in heavily pretreated patients with TP53 Y220C‑mutated...
CAR‑T Reboot: NR2F6 Deletion and Ultra‑Sensitive Cells Target Solids
Two independent research advances unveiled strategies to overcome barriers to CAR‑T efficacy in solid tumors. One study reports that deletion of the nuclear receptor NR2F6 — an intrinsic...
GSK Expands Pulmonary and RNA Plays: 35Pharma Buy and Frontier siRNA Deal
GSK is consolidating respiratory and RNA capabilities through two transactions. The company agreed to acquire 35Pharma for $950 million in cash, adding HS235 — a clinical‑stage activin‑signaling...
Asahi Kasei Buys Aicuris for $920M to Bulk Up Antiviral R&D
Asahi Kasei agreed to acquire Aicuris Anti‑infective Cures AG for €780 million (about $920 million) to expand its infectious‑disease portfolio. The acquisition brings marketed letermovir...
FDA Proposes 'Plausible Mechanism' and Ultra‑Rare Frameworks — Faster Paths
The FDA released draft guidance frameworks aimed at accelerating development of personalized and ultrarare therapies. The 'plausible mechanism' concept would let developers advance individualized...
FDA Under Fire: Senators and Advocates Challenge Rare‑Disease Rejections
A high‑profile Senate hearing and related public testimony put the FDA’s rare‑disease review record under scrutiny. Clinicians, patient advocates and company leaders testified that inconsistent...
BreezeBio Shifts to Internal Pipeline After $60M Raise
BreezeBio (formerly Genedit) closed a $60 million financing to pivot its Nanogalaxy delivery platform into an internal therapeutic pipeline. The company said it will fund lead programs toward...
Lex Diagnostics Starts Commercialization of 10‑Minute POC qPCR
Lex Diagnostics began commercial rollout of Velo, a point‑of‑care qPCR platform that secured FDA 510(k) clearance and a CLIA waiver for a flu/COVID cartridge. Velo performs true sample‑to‑answer,...
p53 pocket drug rezatapopt yields responses in Y220C tumors — NEJM
Researchers published Phase I first-in-human data for rezatapopt in the New England Journal of Medicine showing objective responses in heavily pretreated patients whose tumors harbor the TP53...
FDA voucher speeds Boehringer label expansion for HER2 lung cancer
The FDA used a National Priority Voucher to accelerate review and approve Boehringer Ingelheim’s oral drug Hernexeos as a first‑line treatment for HER2‑positive non‑small cell lung cancer. The...
Novo Nordisk inks up-to-$2.1B deal to get Vivtex oral biologics tech
Novo Nordisk agreed to license Vivtex’s gastrointestinal screening and formulation platform in a deal potentially worth up to $2.1 billion plus tiered royalties to pursue oral peptide and protein...
Astellas to co‑develop Vir’s masked T‑cell engager for prostate cancer — $1.7B
Astellas Pharma and Vir Biotechnology struck a co‑development and co‑commercialization agreement focused on VIR‑5500, a masked T‑cell engager (TCE) targeting PSMA for prostate cancer. The deal...
GSK pays $950M for 35Pharma and its PAH candidate HS235
GSK agreed to acquire 35Pharma for $950 million in cash, gaining HS235 — a protein‑based activin receptor signalling inhibitor positioned for pulmonary hypertension indications. HS235 completed...
Senate hearing and patient outcry spotlight FDA rare‑disease review tensions
A Senate Aging Committee hearing and patient‑advocate protests this week put FDA rare‑disease review practices under scrutiny, as witnesses and patient groups described inconsistent regulatory...
Ultra‑sensitive CAR‑T designs and novel cell therapies push into solid tumors...
Two reports describe technology advances aimed at overcoming key barriers to CAR‑T efficacy in solid tumors. Researchers unveiled ultra‑sensitive CAR T cells engineered to detect low‑density...
Tumor‑informed ctDNA predicts recurrence and survival in anal cancer — Nature Commun.
A tumor‑informed circulating tumor DNA (ctDNA) assay published in Nature Communications demonstrated strong prognostic power for patients with anal squamous cell carcinoma. The study showed that a...
Sequencing arms race: Roche reveals $150 genome for Axelios; Ultima launches UG200
Two hardware vendors revealed commercial sequencing advances at AGBT. Roche disclosed the Axelios 1 platform with a list price for consumables that equates to a $150 human genome at 30X in its...
City Therapeutics pursues cityRNA delivery; BreezeBio raises $60M for mRNA diabetes
Two delivery‑focused RNA plays signaled momentum in RNA therapeutics beyond the liver. City Therapeutics, led by RNAi veteran John Maraganore, is developing cleavage‑inducing tiny guide RNAs...
Novo inks potential $2.1B pact with Vivtex: oral biologics push
Novo Nordisk announced a research-and-license agreement with Vivtex to develop orally delivered peptide and protein therapeutics targeting obesity, diabetes and related metabolic conditions....
GSK to buy 35Pharma for $950M: HS235 joins pipeline
GSK agreed to acquire 35Pharma for $950 million in cash, obtaining HS235, a protein‑based activin‑signalling inhibitor being positioned for pulmonary hypertension (PH). GSK stated the deal will...