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AstraZeneca pledges $2 billion to Maryland – Biomanufacturing onshored, jobs promised
AstraZeneca announced a $2 billion investment to expand its biologics manufacturing footprint in Maryland, including a major expansion in Frederick and a new clinical-supply facility in...
Gilead buys TREX1 cancer program – $14M up front, $400M in biobucks
Gilead Sciences struck a deal to acquire a preclinical TREX1-targeting oncology program from Sprint Bioscience, paying $14 million upfront with potential milestone payments up to $400 million,...
NervGen posts durable gains in spinal cord injury – Expanded CONNECT data released
NervGen Pharma released expanded CONNECT SCI study data showing durable functional improvements in chronic spinal cord injury patients treated with NVG-291. The company reported gains that...
Lawmakers press FDA on new priority voucher scheme – Transparency, corruption flagged
Two congressional figures, Rep. Frank Pallone Jr. and Sen. Bernie Sanders, sent a letter to FDA Commissioner Marty Makary raising 'deep concerns' about the agency’s new Commissioner’s National...
FDA probes Takeda’s Adzynma after pediatric death – Neutralizing antibodies under review
The U.S. Food and Drug Administration is investigating reports that patients treated with Takeda’s Adzynma developed neutralizing antibodies, and that a pediatric patient’s death 'appears to be...
Pharmacogenetics consolidation: Tempus buys OneOme assets; Ovation and PrecisionLife to build GLP‑1 PGx test
Tempus has acquired the pharmacogenetics (PGx) assets of troubled OneOme, adding RightMed PGx capabilities and commercial partnerships to its diagnostics portfolio, GenomeWeb reported. Tempus said...
AstraZeneca doubles US biologics footprint: $2 billion Maryland build-out
AstraZeneca announced a $2 billion investment to expand biologics manufacturing in Maryland, enlarging its Frederick biologics plant and building a new clinical production site in Gaithersburg....
FDA clears Novartis’ Itvisma: gene therapy widened to older SMA patients
Novartis secured FDA approval for an expanded formulation of its one‑time gene therapy Itvisma aimed at older patients with spinal muscular atrophy (SMA). The approval extends the eligible patient...
Bayer’s FXIa drug snags Phase 3 stroke win – class revived
Bayer reported that its oral factor XIa inhibitor asundexian met the primary endpoint in a Phase 3 trial, reducing recurrent ischemic stroke without increasing major bleeding. The Oceanic Stroke...
Novo’s GLP‑1 Alzheimer hope fails... major Phase 3 misses
Novo Nordisk reported negative top‑line results from two large Phase 3 trials of oral semaglutide in early Alzheimer’s disease: the drug failed to slow cognitive and functional decline versus...
Abbott jumps into cancer testing: $23 billion Exact Sciences buy
Abbott Laboratories agreed to acquire Exact Sciences for $23 billion, a move that immediately expands Abbott’s diagnostics footprint into oncology screening, therapy selection and minimal residual...
NervGen posts durable gains in chronic spinal cord injury – expanded CONNECT data
NervGen released expanded CONNECT SCI data showing durable functional improvements and quality‑of‑life gains in individuals with chronic spinal cord injury treated with NVG‑291. The company...
Biogen bets on oral macrocycles: $50M deal with Versant spinout Dayra
Biogen struck an early‑stage collaboration with Versant‑backed Dayra Therapeutics, paying $50 million upfront to discover oral macrocyclic peptides for immune and inflammatory targets. Dayra...
Plasmidsaurus undercuts RNA‑seq norms: fast, cheap transcriptomes
Plasmidsaurus launched a low‑cost, shallow‑depth transcriptome service marketed at $50 per academic sample with a two‑to‑three‑day turnaround, aiming to displace qPCR and traditional RNA‑seq for...
Tempus scoops up OneOme pharmacogenetics assets: PGx consolidation continues
Tempus confirmed the acquisition of pharmacogenetics assets from the recently defunct OneOme, including the RightMed PGx business and its customer partnerships. OneOme’s abrupt shutdown left...
Africa CDC launches AGARI: continent‑wide pathogen genomics hub
The Africa Centres for Disease Control and Prevention launched AGARI (Africa Genome Archiving for Response and Insight), a continent‑wide genomic data platform developed with the African Society...
Abbott doubles down on cancer testing: Exact Sciences buy for $23B
Abbott announced a definitive agreement to acquire Exact Sciences in a transaction valued at about $23 billion, combining Abbott’s diagnostics infrastructure with Exact Sciences’ screening and...
Bayer’s FXIa inhibitor cuts stroke risk: Phase 3 win revives drug class
Bayer reported top-line Phase 3 results showing oral factor XIa inhibitor asundexian reduced the risk of recurrent ischemic stroke without increasing major bleeding in the Oceanic Stroke study of...
Novo’s GLP‑1 Alzheimer gamble fails: two Phase 3 trials negative
Novo Nordisk disclosed negative top-line results from two large Phase 3 trials testing oral semaglutide in early symptomatic Alzheimer’s disease; investigators found no slowing of cognitive or...
FDA oversight frays: staffing exodus and leadership tensions surface
Industry sources and reporting indicate the FDA is experiencing a loss of experienced reviewers that executives and patient advocates say is degrading regulatory predictability and slowing drug...