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FDA approval spotlights a new multiple myeloma drug class
The FDA approved Bristol Myers Squibb’s iberdomide (Zenbexus), an oral multiple myeloma treatment intended for patients who have received at least one prior line of therapy. BMS is launching the...
Bankruptcy auction reshuffles rare-disease gene therapy assets
PTC Therapeutics won a competitive Sangamo bankruptcy auction for Sangamo’s Fabry gene therapy candidate ST-920 (isaralgagene civaparvovec). PTC’s bid brings $111 million upfront to Sangamo, plus...
FDA action pressure: enforcement and reimbursement reviews target new drug economics
A U.S. cost-effectiveness review criticized AstraZeneca’s newly approved hypertension drug Baxfendy on price relative to benefit. In a draft assessment, the Institute for Clinical and Economic...
Proteomics instrumentation delays force cost cuts and timeline resets
Quantum-Si said it is laying off about 20% of its workforce as it pushes the launch of its Proteus protein sequencing system to the second quarter of 2027. The company previously targeted early...
Sequencing and diagnostic financing: Illumina taps capital markets to fund operations
Illumina entered into a $1 billion credit facility with Bank of America and simultaneously signed an underwriting agreement for a separate $300 million notes offering, according to SEC filings....
Decentralized trial operations need trained mobile clinical workforce
Researchers argued that decentralized clinical trials may require formal training for mobile clinicians, including EMTs and community paramedics, to support safety monitoring and trial procedures...
AI in clinical monitoring and site operations delivers measurable financial lift
A Tufts Center for the Study of Drug Development analysis said an agentic AI clinical monitoring tool can generate material net financial gains in oncology programs, with modeled expected ROI up...
Surgical scene-understanding AI faces validation challenge in the operating room
A review highlighted a central hurdle for industry-built surgical AI systems: independent validation and trustworthiness. The piece focuses on algorithms that interpret surgical video in real...
Genome-directed precision for lung cancer: Freenome targets FDA review path
Freenome received FDA breakthrough device designation for its SimpleScreen lung cancer screening assay, positioning the blood-based, multiomic test for further clinical development. The...
Genomic newborn screening explores inherited risk for early cancers
A population-based analysis led by researchers at Dana-Farber Cancer Institute and Mass General Brigham for Children found genomic newborn screening could identify children at risk for early-onset...
FDA approvals & regulatory action
The FDA granted accelerated approval to Bristol Myers Squibb’s iberdomide (marketed as Zenbexus) for multiple myeloma patients whose disease has returned or stopped responding to treatment, the...
Regulatory policy – user fees
The FDA outlined changes for the next five-year prescription drug user fee program (PDUFA VIII), including new incentives for domestic manufacturers, faster review timelines for some application...
Bankruptcy M&A in gene therapy
PTC Therapeutics won a bankruptcy auction for Sangamo’s Fabry disease gene therapy program, with the deal structured around a $111 million upfront payment and additional contingent milestones tied...
Oncology trial readouts and phase transitions
Taiho Oncology and Cullinan Therapeutics reported a second Phase 3 win for zipalertinib, clearing the registrational trial’s front-line efficacy goal for EGFR exon 20 insertion–positive lung...
Company finance & fundraising
Silence Therapeutics priced an upsized public offering expected to raise about $175 million to support its short interfering RNA pipeline, including divesiran after a “best-case” outcome in a...
Venture funding for new biotechs
Khartis Therapeutics emerged from stealth with $95 million in total funding to pursue an oral treatment for thyroid eye disease (TED), aiming to compete with established infusion and biologic...
Digital health & AI in clinical operations
A new Tufts Center for the Study of Drug Development analysis concludes that an agentic AI clinical monitoring tool can deliver net financial gains up to $21 million per drug development program...
New diagnostics & biomarker tools
Freenome received FDA breakthrough device designation for its SimpleScreen lung cancer blood test, a multiomic assay combining machine-learning classification with DNA methylation and proteomics....
Clinical development in rare disease
Vaderis Therapeutics closed an oversubscribed Series B financing and simultaneously initiated a global Phase 3 trial, HEROIC, for engasertib (AKT inhibitor) in hereditary hemorrhagic...
Metabolic & cardiovascular drugs – health economics pushback
ICER said AstraZeneca’s newly approved hypertension drug Baxfendy does not meet its cost-effectiveness threshold at current list pricing, according to a draft report. ICER modeled Baxfendy at a...