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Myrio cracks binder challenge — higher affinity and specificity achieved
Myrio Therapeutics announced it has developed binders in which both affinity and specificity can be increased simultaneously — a capability the company says rivals have not achieved. The advance...
Phrontline raises $60M to fund bispecific ADC pipeline — Series pre-A+ round closed
Phrontline Biopharma Suzhou closed a $60 million pre-A+ financing round led by Lapam Investment to advance its bispecific antibody-drug conjugate (ADC) programs built on dual-linker payload and...
Otsuka’s anti-APRIL antibody clears FDA: first-in-class IgAN approval
The FDA granted accelerated approval to Otsuka’s sibeprenlimab (Voyxact) for adults with primary immunoglobulin A nephropathy (IgAN), based on positive interim results from the phase III Visionary...
Novartis wins FDA nod for Itvisma – gene therapy now cleared for older SMA patients
Novartis received FDA approval for Itvisma (onasemnogene abeparvovec) to treat spinal muscular atrophy (SMA) patients aged two years and older with biallelic SMN1 mutations. The intrathecal,...
Bayer’s asundexian nails Phase III goal: stroke prevention win for FXIa inhibitors
Bayer reported that asundexian met the primary endpoint in a Phase III trial, reducing ischemic stroke recurrence when added to standard antiplatelet therapy in a large secondary‑prevention...
Novo’s Alzheimer gambit fails: oral semaglutide misses against cognitive decline
Novo Nordisk disclosed negative topline results from two Phase III trials testing oral semaglutide in Alzheimer’s disease; the drug did not slow clinical progression versus placebo. The company...
Abbott bets $23B on diagnostics: Exact Sciences deal remakes lab testing landscape
Abbott Laboratories agreed to acquire Exact Sciences for $23 billion, a transformative move that expands Abbott into cancer diagnostics and substantially increases its addressable diagnostics...
Standards and partnerships to unclog cell & gene bottlenecks: USP guidance and Bracco–Limula tie-up
USP launched new standards aimed at viral vectors and plasmid DNA to improve quality and consistency for cell and gene therapy manufacturing. The guidance covers best practices for raw materials...
FDA moves to reclassify companion diagnostics: 510(k) pathway proposed
The FDA proposed reclassifying certain companion diagnostic assays—specifically nucleic acid‑based tests used with oncology therapeutics—from Class III down to Class II, subject to 510(k)...
Washington doubles down on AI and science funding: commission pushes reform, White House unveils 'Genesis Mission'
A federal commission recommended a retooling of the US research enterprise—streamlining grant processes and embedding AI and data integration across federal science funding—to preserve national...
Capital tide: Cormorant eyes $400M fund while Phrontline closes $60M for bispecific ADCs
Cormorant Asset Management filed to raise a new $400 million healthcare fund, underscoring renewed venture appetite for later‑stage biotech and life sciences investments. The Boston investor began...
Gene editing and in vivo therapies: clinical ambitions meet cross‑license pacts
Researchers highlighted the potential of targeted in vivo gene‑editing interventions to address life‑threatening congenital and early‑onset diseases—presentations at ASGCT emphasized preclinical...
Novo Nordisk’s Alzheimer’s gamble fails — phase III semaglutide misses endpoints
Novo Nordisk announced that two large phase III trials of oral semaglutide in early Alzheimer’s disease failed to slow clinical decline. The company tested the oral GLP‑1 agonist against placebo...
Bayer’s oral FXIa inhibitor hits phase III stroke goal — therapy shows efficacy without added bleeding
Bayer reported a positive phase III result for its oral factor XIa inhibitor asundexian in secondary prevention of ischemic stroke, meeting the trial’s primary endpoint. The Oceanic Stroke study,...
Novartis wins FDA nod for Itvisma — gene therapy extended to older SMA patients
The U.S. Food and Drug Administration approved Novartis’ Itvisma (onasemnogene abeparvovec) for patients aged two years and older with spinal muscular atrophy (SMA) caused by biallelic SMN1...
Abbott to buy Exact Sciences — $23 billion deal reshapes diagnostics landscape
Abbott Laboratories agreed to acquire Exact Sciences for about $23 billion, a transaction that will expand Abbott’s diagnostics footprint into cancer screening and molecular testing. The deal,...
Otsuka’s anti‑APRIL antibody cleared by FDA for IgA nephropathy
Otsuka Pharmaceutical won FDA accelerated approval for sibeprenlimab (Voyxact), an anti‑APRIL monoclonal antibody, to treat IgA nephropathy (IgAN), a chronic autoimmune kidney disease. The...
AstraZeneca commits $2 billion to Maryland biologics expansion — onshoring rare‑disease manufacturing
AstraZeneca announced a $2 billion U.S. manufacturing investment to expand its Frederick biologics plant and build a new clinical facility in Gaithersburg, Maryland. The company said the projects,...
FDA delays Ascendis’ achondroplasia review by three months over PMR protocol
The U.S. Food and Drug Administration extended the review clock for Ascendis Pharma’s once‑weekly therapy for achondroplasia, citing questions around the design of the treatment’s post‑marketing...
Kelun’s TROP2 ADC plus Keytruda shows first‑line lung benefit in phase III China trial
Kelun‑Biotech reported that its TROP2‑targeting antibody‑drug conjugate (sacituzumab tirumotecan, sac‑TMT) combined with Merck’s Keytruda improved progression‑free survival versus Keytruda alone...