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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...
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...