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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...
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...