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Blacksmith lands QIDP and Fast Track for novel LpxC antibiotic
Blacksmith Medicines received FDA Qualified Infectious Disease Product (QIDP) and Fast Track designations for FG‑2101, an LpxC inhibitor targeting Gram‑negative pathogens. The regulatory...
Regeneron to pursue FDA OK for hearing gene therapy – Children regain implant‑free hearing
Regeneron reported that nine of 12 children in a trial of its gene therapy for congenital deafness achieved hearing levels that could remove the need for cochlear implants, and the company said it...
Intranasal adenovirus‑subunit vaccine boosts Omicron immunity – New delivery strategy advances
Researchers unveiled an intranasal vaccine combining an adenovirus vector and a trimeric subunit protein that enhanced neutralizing immunity against the Omicron variant. Preclinical data described...
Lab‑grown embryo model produces blood stem cells – Hematoids mimic early human development
Scientists at the University of Cambridge and collaborators reported creation of three‑dimensional embryo‑like structures—'hematoids'—from human stem cells that recapitulate early developmental...
Trogenix raises $95M – AAV‑driven 'Trojan horse' platform targets aggressive solid tumors
Trogenix closed a $95 million Series A to advance an AAV‑based platform (Odysseus) that uses synthetic super enhancers to activate therapeutic payloads selectively in cancer cells. The company...
Novo Nordisk Raises MASH Stake: Up-to-$5.2B Akero Buy and Indiana Plant OAI
Novo Nordisk moved to acquire Akero Therapeutics for up to $5.2 billion to add efruxifermin, a Phase III FGF21 analogue that showed fibrosis regression signals in a long Phase IIb SYMMETRY cohort....
Bristol Myers Squibb Pays $1.5B for Orbital—Into in vivo CAR-T
Bristol Myers Squibb agreed to acquire Orbital Therapeutics for $1.5 billion to obtain an in vivo cell‑therapy platform intended to make CAR‑T–style approaches accessible for autoimmune disease....
Moderna Teases Melanoma Signals — IDO Move Underpinned by Early Data
Moderna previewed early clinical data for its cancer antigen mRNA program (mRNA‑4359) in melanoma patients ahead of ESMO and disclosed that those results informed internal decisions to prioritize...
Excellergy Debuts with $70M—Aims to Reset Allergy Therapeutics
Excellergy launched with a $70 million Series A led by Samsara Biocapital to advance a new class of allergy drugs called effector cell response inhibitors (ECRIs). The company says ECRIs work...
Regeneron Seeks Approval After NEJM Hearing Gains in Children
Regeneron disclosed NEJM‑published data showing that nine of 12 children treated with its gene therapy for a congenital form of deafness achieved hearing levels where cochlear implants were no...
Lab‑grown Embryo Models Produce Blood Stem Cells: Hematoids Advance
Researchers at the University of Cambridge reported creation of three‑dimensional embryo‑like structures—termed hematoids—that recapitulate early human developmental events including the emergence...
Bead‑based CRISPR Diagnostic Increases Sensitivity and Multiplexing
Researchers introduced a bead‑based enhancement to CRISPR diagnostics that significantly raises sensitivity and supports multiplexed detection, addressing key limitations of many CRISPR‑based...
Takeda Signs Second Deal for AI‑Designed Proteins — Protein Engineering Heats Up
Takeda expanded its multi‑year collaboration with AI protein design specialist Nabla Bio by signing a second research agreement to discover AI‑designed proteins. The deal extends a partnership...
U.S. Regulatory Squeeze: FDA Approvals Dip as Shutdown Strains Agency Capacity
Industry data show the FDA is on pace to approve its fewest new drugs and biologics since 2022, driven by lower application throughput and a tighter review calendar. Multiple companies await...
Trogenix Raises $95M to Advance Trojan‑Horse Platform for Aggressive Tumors
Edinburgh‑based Trogenix closed a $95 million Series A to advance its Odysseus platform, which deploys synthetic super enhancers via AAV vectors to activate therapeutic payloads selectively in...
Novo Nordisk raises MASH bet — Up to $5.2bn Akero deal
Novo Nordisk agreed to acquire Akero Therapeutics for up to $5.2 billion to secure efruxifermin (EFX), an FGF21 analogue now in Phase III for metabolic dysfunction‑associated steatohepatitis...
Bristol Myers buys Orbital — $1.5bn play for in vivo cell therapy
Bristol Myers Squibb acquired Orbital Therapeutics in a reported $1.5 billion transaction to gain an in vivo cell‑therapy platform aimed at autoimmune disease. The deal brings BMS a program that...
FDA under strain — Approval pace slows as shutdown bites regulator
The FDA is on pace for its lowest tally of new drug and biologic approvals since 2022 while a US federal funding impasse has constrained the agency’s operations. Companies and applicants face...
Regeneron to seek FDA OK after gene therapy restores hearing in children
Regeneron published trial results showing a gene therapy substantially improved hearing in children born with a specific genetic form of deafness and plans to file for regulatory approval....
Cambridge hematoids: lab‑grown embryo models generate human blood stem cells
Scientists at the University of Cambridge created three‑dimensional embryo‑like structures that recapitulate early human development and produce blood stem cells, according to new Cell Reports...