Get the Daily Brief
Latest Biotech News
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...
GSK Pays $950M for 35Pharma — Adds PAH Candidate HS‑235
GlaxoSmithKline agreed to acquire 35Pharma for $950 million in cash to obtain HS‑235, a protein‑based candidate aimed at pulmonary arterial hypertension (PAH) and related pulmonary hypertensive...
Novo, Vivtex Tie Up: Big Bet on Oral Biologics
Novo Nordisk struck a multi‑hundred‑million to multi‑billion dollar collaboration with Vivtex to accelerate oral delivery of peptide and protein therapeutics, committing up to roughly $2.1 billion...
Novo Cuts Prices, Posts Competitive Triple‑G Data — Market Repositions
Novo Nordisk announced a plan to cut U.S. list prices for its GLP‑1 drugs by up to 50% starting in 2027 while simultaneously releasing midstage data showing its triple‑agonist delivered roughly...
Beam Advances Liver Base Editing for PKU; Pfizer Secures License Rights
Beam Therapeutics launched BEAM‑304, a liver‑targeted base editing program designed to correct prevalent PAH gene mutations that cause phenylketonuria (PKU), and plans IND filings in 2026. The...
Safety Signal: MacroGenics Trial Halted After Patient Death
Regulators ordered a pause in patient enrollment in MacroGenics’ Phase 2 oncology trial after a patient death and multiple life‑threatening adverse events were reported. The FDA placed a partial...
Massive MPRA Study Links 220K Variants to Cellular Function
Researchers at The Jackson Laboratory, the Broad Institute and Yale mapped the regulatory activity of more than 220,000 single‑nucleotide variants across five human cell types using a massively...
Proteomimetic Polymers Target 'Undruggable' Oncogenes for Degradation
A Northwestern University team described heterobifunctional proteomimetic polymers (HYDRACs) that bind disordered oncogenic proteins like MYC and KRAS and recruit cellular degradation machinery,...
Ultra‑Fast POC qPCR and Automation Partnerships Scale Molecular Testing
Lex Diagnostics began commercial rollout of the Velo point‑of‑care molecular PCR system after FDA 510(k) clearance and a CLIA waiver for its flu/COVID assay; the cartridge‑based platform delivers...
Vir, Astellas Link on Masked T‑Cell Engager – Up to $1.7B Deal
Astellas Pharma and Vir Biotechnology struck a global co‑development and co‑commercialization pact around Vir’s PRO‑XTEN masked T‑cell engager program, centered on the prostate cancer candidate...
Novo Invests $2.1B in Vivtex—Push for Oral Biologics
Novo Nordisk agreed to a collaboration with Vivtex to develop oral peptide and protein formulations, in a deal that could reach up to $2.1 billion in upfront, R&D and milestone payments plus...
GSK Buys 35Pharma — $950M for HS‑235 in Pulmonary Hypertension
GSK agreed to acquire 35Pharma for $950 million in cash to obtain HS‑235, a protein‑based candidate targeting the activin receptor signaling pathway for pulmonary hypertension (PH). The...
FDA Freezes MacroGenics Trial After Severe Toxicity
The U.S. Food and Drug Administration ordered a freeze on enrollment in MacroGenics’ Phase 2 trial following a patient death and multiple life‑threatening adverse events. The agency’s action...