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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...
NervGen’s NVG‑291 shows durable gains in chronic spinal cord injury — expanded CONNECT data
NervGen Pharma disclosed expanded CONNECT SCI data showing durable, clinically meaningful improvements in function, bladder control and spasticity with NVG‑291 in chronic spinal cord injury...
USP issues new viral‑vector standards to aid gene and cell therapy manufacturing
The U.S. Pharmacopeia (USP) launched new standards aimed at improving quality and consistency in viral‑vector production for cell and gene therapies, including guidance for plasmid DNA starting...
Otsuka wins FDA nod for anti-APRIL antibody—first-in-class for IgAN
The FDA granted accelerated approval to Otsuka’s sibeprenlimab (anti-APRIL) for immunoglobulin A nephropathy (IgAN), marking the first approval for a therapy that directly targets APRIL-mediated...
Novartis expands SMA gene therapy to older patients: Itvisma approved
The FDA approved Novartis’ Itvisma (onasemnogene abeparvovec) for spinal muscular atrophy (SMA) patients aged two years and older, extending access to gene replacement therapy beyond infants....
Novo’s GLP‑1 Alzheimer gamble fails—semaglutide misses Phase III endpoints
Novo Nordisk reported that two large Phase III trials of oral semaglutide in early Alzheimer’s disease failed to slow cognitive decline versus placebo. The company ran broad, placebo‑controlled...
Bayer’s asundexian meets Phase III stroke goal—FXIa class revived
Bayer announced positive top‑line Phase III results for its oral Factor XIa inhibitor asundexian, meeting the primary endpoint in a secondary stroke prevention study and demonstrating reduced...
Abbott to buy Exact Sciences for $23B—moves big into oncology diagnostics
Abbott struck a $23 billion acquisition of Exact Sciences to expand into cancer diagnostics at scale, adding stool‑based screening (Cologuard), molecular assays, tumor profiling and MRD...
NervGen’s NVG‑291 shows durable, multidimensional gains in chronic spinal cord injury
NervGen released expanded CONNECT SCI data showing durable functional improvements, enhanced patient‑reported outcomes and objective neurophysiologic signals after treatment with NVG‑291 in...
AstraZeneca to invest $2B in U.S. biologics manufacturing—rare disease capacity onshore
AstraZeneca announced a $2 billion U.S. investment to expand biologics manufacturing in Maryland, nearly doubling commercial capacity at its Frederick site and building a new clinical‑supply...
Gilead buys Sprint’s TREX1 oncology program—upfront plus $400M in milestones
Gilead agreed to acquire Sprint Bioscience’s preclinical TREX1 cancer program for an upfront payment reported at $14 million and potential milestone payments totaling up to $400 million. The deal...
Indian CRISPR startup CrisprBits raises $3M to scale diagnostics and gene‑editing platforms
Bengaluru‑based CrisprBits closed $3 million in pre‑Series A financing to commercialize its PathCrisp CRISPR diagnostic platform and accelerate development of a CRISPR‑driven strain engineering...
Standards and automation push to unclog cell and gene therapy manufacturing
Industry groups and private‑sector partners moved to address cell and gene therapy manufacturing bottlenecks through new standards and collaborative R&D. USP published draft standards for viral...
Otsuka FDA greenlight: anti‑APRIL therapy for IgA nephropathy
Otsuka Pharmaceutical secured U.S. regulatory approval for its anti‑APRIL antibody to treat IgA nephropathy (IgAN). The company announced accelerated approval after regulators cleared the therapy...
Novartis expands gene therapy reach: Itvisma approved for older SMA patients
Novartis received U.S. approval to extend its SMN1 gene‑replacement therapy to patients aged two and older under a new formulation called Itvisma. The approval follows a Phase 3 trial showing...
Bayer’s asundexian hits Phase III: FXIa inhibitor reduces recurrent ischemic stroke
Bayer reported a positive top‑line result from a Phase III stroke prevention study of its oral Factor XIa inhibitor asundexian. The Oceanic Stroke trial enrolled over 12,000 patients and met its...
Novo Nordisk’s Alzheimer’s gamble fails: semaglutide misses Phase III endpoints
Novo Nordisk disclosed that two large Phase III trials testing oral semaglutide in early Alzheimer’s disease failed to slow clinical progression versus placebo. The Evoke and Evoke+ studies...