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FDA backtracks: Immedica’s Loargys accelerated to patients after earlier rejection
The FDA granted accelerated approval to Immedica Pharma’s Loargys (pegzilarginase) for arginase 1 deficiency (ARG1‑D), reversing a 2023 refusal-to-file and clearing an enzyme replacement therapy...
FDA outlines personalized path for ultra‑rare therapies: Plausible mechanism draft guidance
The FDA released a draft framework to expedite therapies for ultra‑rare diseases, focusing on individualized, mechanism‑targeting treatments including genome editing and RNA modalities. The...
Novo picks Vivtex for oral biologics push — potential $2.1B collaboration
Novo Nordisk struck a collaboration with Vivtex to co‑develop oral formulations of peptide and protein therapeutics, a deal valued at up to $2.1 billion including milestones and royalties. The...
Beam expands gene editing and secures strategic license deals — PKU program advances
Beam Therapeutics launched BEAM‑304, a liver‑targeted base‑editing program aimed at correcting common PAH mutations that cause phenylketonuria (PKU), and expects an IND filing in 2026. The company...
Novo cuts GLP‑1 list prices amid competitive pressure and new data
Novo Nordisk announced steep list‑price reductions for its GLP‑1 medicines, lowering monthly list prices to $675 effective 2027 as the company responds to pricing pressure and competitive data...
PacBio and DNAstack launch federated HiFi platform for global rare‑disease genomics
Pacific Biosciences partnered with DNAstack to host a federated environment for sharing HiFi long‑read whole‑genome sequencing data across the HiFi Solves Global Consortium. The platform enables...
Slate Medicines raises $130M to advance anti‑PACAP migraine antibody
Slate Medicines closed a $130 million Series A to develop SLTE‑1009, a monoclonal antibody targeting PACAP for migraine prevention, positioning the company as an alternative to CGRP‑directed...
Ultima Genomics taps Hamilton to automate high‑throughput sequencing workflows
Ultima Genomics and Hamilton announced a collaboration to automate sample‑prep and amplification workflows on Hamilton’s Microlab STAR platform, aiming to scale next‑generation sequencing...
Novo Nordisk doubles down on oral biologics: $2.1B Vivtex pact
Novo Nordisk signed a collaboration with Vivtex to develop oral formulations of peptide and protein therapeutics for obesity, diabetes and related metabolic diseases. The agreement can total up to...
Astellas and Vir team on masked T‑cell engager: up to $1.7B
Astellas Pharma and Vir Biotechnology agreed to co‑develop and co‑commercialize VIR‑5500, a PRO‑XTEN masked CD3 T‑cell engager targeting PSMA, under a deal potentially worth more than $1.7 billion...
GSK pays $950M for 35Pharma – adds PAH candidate HS‑235
GSK agreed to acquire 35Pharma for $950 million in cash to obtain HS‑235, a protein‑based candidate aimed at pulmonary arterial hypertension (PAH). HS‑235 completed a Phase I study and is set to...
Scale breakthrough: 220,000 variants mapped to cell function
Researchers at The Jackson Laboratory, Broad Institute, and Yale executed a massively parallel reporter assay testing over 220,000 single‑nucleotide variants across five human cell types,...
FDA reverses course: approves Immedica’s Loargys for ARG1‑D
The U.S. Food and Drug Administration granted accelerated approval to Immedica Pharma’s Loargys (pegzilarginase) to treat arginase 1 deficiency (ARG1‑D) in patients two years and older. The...
Pfizer secures Beam liver editor; Beam advances PKU base‑editing program
Pfizer exercised its option to secure global rights to Beam Therapeutics’ liver‑targeted base‑editing candidate, after shifting away from in‑house gene therapy assets. The move gives Pfizer access...
ARPA‑H backs anti‑aging research: $144M program and $38M grant
The Advanced Research Projects Agency for Health (ARPA‑H) designated up to $144 million to study anti‑aging approaches across multiple teams, signaling federal investment in translational aging...
Pharma builds federated ADMET network; AI tools gain capital
Apheris launched the ADMET Network, a federated data initiative that permits pharmaceutical partners to train joint models for absorption, distribution, metabolism, excretion and toxicity...
Polymer proteomimetics degrade ‘undruggable’ MYC and KRAS
Northwestern University researchers reported heterobifunctional proteomimetic polymers (HYDRACs) that selectively bind and target intrinsically disordered oncogenic drivers MYC and KRAS for...
FDA halts MacroGenics enrollment after treatment‑related fatality
The FDA placed a partial clinical hold on MacroGenics’ Phase II study of lorigerlimab following a patient death and several life‑threatening adverse events, prompting the sponsor to stop new...
Astellas, Vir Strike Big: Masked T‑Cell Engager Deal
Astellas Pharma and Vir Biotechnology agreed to co-develop and co-commercialize Vir’s PRO‑XTEN masked T‑cell engager targeting PSMA, in a collaboration that could deliver over $1.3 billion to Vir...
FDA Reverses Course: Immedica’s ARG1‑D Drug Clears Accelerated Approval
The FDA granted accelerated approval to Immedica Pharma’s pegzilarginase (Loargys) for treating arginase 1 deficiency (ARG1‑D) in patients aged two and older, reversing an earlier regulatory...