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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...
CMS finalizes negotiated prices: Ozempic, Wegovy among IRA second‑round cuts
The Centers for Medicare & Medicaid Services published final negotiated prices under the Inflation Reduction Act for the second round of medications, including GLP‑1 weight‑loss drugs Ozempic and...
Indian CRISPR startup raises $3M: CrisprBits to scale diagnostics and gene‑editing platforms
Bengaluru‑based CrisprBits closed a $3 million pre‑Series A round led by Spectrum Impact to commercialize its PathCrisp CRISPR diagnostics and advance a CRISPR strain‑engineering platform for...
Otsuka’s anti‑APRIL win: FDA clears first‑in‑class IgAN therapy
The U.S. Food and Drug Administration granted accelerated approval to Otsuka’s anti‑APRIL antibody for IgA nephropathy (IgAN). The agency’s decision opens the first approval in an emerging...
Itvisma label expanded: Novartis lands gene‑therapy approval for older SMA patients
The FDA cleared Novartis’ Itvisma (onasemnogene abeparvovec) for spinal muscular atrophy (SMA) patients aged two and older, extending availability of a gene‑replacement option previously limited...
Novo’s Alzheimer gamble fails: semaglutide misses two phase III trials
Novo Nordisk reported that two large phase III trials testing oral semaglutide failed to slow progression of early Alzheimer’s disease. The Evoke and Evoke+ studies enrolled thousands of patients...
Bayer revives FXIa bets: asundexian hits phase III stroke goal
Bayer reported that its oral Factor XIa inhibitor asundexian met the primary endpoint in a pivotal phase III stroke prevention trial, reducing recurrent ischemic stroke without a reported increase...
Abbott buys Exact Sciences for $23B: diagnostics push reshapes Dx market
Abbott agreed to acquire Exact Sciences for roughly $23 billion, a strategic move to position Abbott in cancer screening, treatment selection and recurrence monitoring. The deal brings Cologuard,...
Gilead snaps up TREX1 program: $14M upfront, $400M in biobucks potential
Gilead purchased a preclinical oncology program targeting TREX1 from Sprint Bioscience, paying an upfront that industry reports place in the low‑double‑digit millions and agreeing to up to $400...
CDC shake‑up: controversial hire and website edits raise scrutiny
The U.S. Department of Health and Human Services appointed Dr. Ralph Abraham—who as Louisiana surgeon general ordered staff to stop promoting mass vaccination—as principal deputy director at the...
Standards and automation: USP and industry push to tame CGT manufacturing
The United States Pharmacopeia (USP) released new standards for viral vectors and plasmid DNA to address quality variability in cell and gene therapy manufacturing; USP collaborated with NIST and...
Proteome‑wide AI: popEVE prioritizes rare‑disease variants for clinics
Researchers from Harvard Medical School and the Center for Genomic Regulation unveiled popEVE, a proteome‑wide deep generative model that combines evolutionary data with human population variation...
NervGen posts durable SCI gains: NVG‑291 shows functional and neurophys signals
NervGen reported expanded CONNECT SCI results showing durable functional improvements in chronic spinal cord injury patients treated with NVG‑291; improvements continued through week 16 and...
Novo’s semaglutide misses endpoints — Alzheimer’s hopes dim
Novo Nordisk reported top-line results from two Phase III trials showing oral semaglutide failed to slow clinical progression in patients with early Alzheimer’s disease. The studies enrolled...
Bayer’s oral FXIa drug cuts stroke risk — market cheers
Bayer announced that asundexian, its oral factor XIa (FXIa) inhibitor, met the primary endpoint in a large Phase III secondary prevention trial, reducing recurrent ischemic stroke without...
FDA clears Novartis’ intrathecal gene therapy — Itvisma expands SMA reach
The U.S. Food and Drug Administration approved Novartis’ Itvisma (onasemnogene abeparvovec-brve) for patients aged 2 years and older with spinal muscular atrophy (SMA) caused by biallelic SMN1...
FDA opens probe into Takeda’s Adzynma after neutralizing-antibody reports
The U.S. FDA has launched an investigation into Takeda’s Adzynma (apadamtase alfa) following postmarketing reports of neutralizing antibodies to ADAMTS13, including a pediatric death that the...
AstraZeneca to invest $2 billion in U.S. biologics capacity — jobs, onshoring push
AstraZeneca committed $2 billion to expand biologics manufacturing in Maryland, nearly doubling capacity at its Frederick site and building a new clinical-manufacturing facility in Gaithersburg....
Gilead buys TREX1 oncology program — sprinting for preclinical advantage
Gilead Sciences struck a deal to acquire a preclinical TREX1-targeted oncology program from Sprint Bioscience, committing an initial payment with up to ~$400 million in development and commercial...