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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...
Abbott buys Exact Sciences: $23 billion bet to double diagnostics footprint
Abbott Laboratories agreed to acquire cancer diagnostics company Exact Sciences for $23 billion, a deal that would significantly expand Abbott’s presence in oncology testing. Company executives...
FDA probe opened after reports tie Takeda’s Adzynma to fatality
The U.S. Food and Drug Administration launched an investigation into Takeda’s recombinant ADAMTS13 replacement therapy Adzynma after post‑marketing reports described neutralizing antibodies and...
Standards and automation: USP, Bracco and Limula target cell and gene manufacturing bottlenecks
Industry bodies and private partners moved to tackle cell and gene manufacturing constraints with new standards and collaborative R&D. USP released standards aimed at viral vectors (starting with...
Gilead scoops Sprint’s TREX1 program: $14M now, $400M in milestones
Gilead Sciences struck deals to acquire Sprint Bioscience’s preclinical TREX1‑targeted oncology program, paying upfront consideration to access the early‑stage asset and securing milestone‑based...