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Xeltis Reports Positive Preliminary Clinical Data for Artificial Vascular Grafts
Xeltis BV announced encouraging preliminary safety and patency data from ongoing clinical trials of Xabg, its bioengineered coronary artery bypass conduit. The implant uses supramolecular...
GenesisM Breaks Ground on Multi-Tenant Biomanufacturing Facility in Boston
GenesisM, a joint venture between Bain Capital Real Estate and Botanic Properties, commenced construction of a 154,000-square-foot biomanufacturing facility in Bedford, Massachusetts, reinforcing...
Advancements in AI-Driven Targeting of Intrinsically Disordered Proteins
Researchers led by Nobel Laureate David Baker have developed novel AI-based methods to design protein binders targeting intrinsically disordered regions (IDRs), traditionally considered...
Medical University of Vienna Secures €2.5M Grant for Multiomic Biomarker Research
The Medical University of Vienna’s Organizational Unit Core Facilities received €2.5 million from the Austrian Research Promotion Agency to advance multiomics biomarker discovery and validation....
Genes2Me Prepares US Rollout of High-Multiplex PCR Diagnostic System
Indian molecular diagnostics company Genes2Me is gearing up for US market entry with its OnePCR sample-to-answer system, following CE marking of direct-from-blood assays for antimicrobial...
Sarepta gene therapy crisis intensifies: FDA moves to halt Duchenne treatment
Sarepta Therapeutics faces mounting challenges as the FDA prepares to request a halt to shipments of its gene therapy Elevidys for Duchenne muscular dystrophy. This decision follows the deaths of...
Scipher Medicine pivots to data-driven precision medicine beyond diagnostics
After a leadership change, Scipher Medicine has expanded its focus from diagnostics to data-driven precision medicine development, leveraging the world's largest clinical transcriptomic dataset...
FDA advisory panels deal setbacks to psychiatric and hematology drugs
Recent FDA advisory committee meetings have resulted in negative outcomes for multiple drug candidates. Otsuka Pharmaceutical's combination therapy for PTSD, Rexulti with Zoloft, failed to secure...
Xeltis posts encouraging clinical data on synthetic coronary artery conduit
Xeltis BV reported positive preliminary data from two ongoing clinical trials in Europe and South America evaluating its Xabg coronary artery bypass conduit. The device uses a novel polymer...
Advances in AI-driven protein binder design unlock drug targets in disordered regions
Researchers led by Nobel Laureate David Baker have developed novel AI methods to design protein binders targeting intrinsically disordered regions (IDRs) of proteins, which traditionally represent...
Biopharma financing surges with seed and Series A funds rising in 2025 H1
The first half of 2025 saw a notable increase in seed and Series A funding rounds within the biopharma sector, totaling $4.7 billion, although fewer companies accounted for a larger share of the...
Next-gen infectious disease testing with nanopore sequencing expands globally
Singapore-based Credence Genomics is advancing its nanopore sequencing-based microbial testing technologies targeting bacterial, fungal, and viral pathogens. Its assays, including Bactfast and...
FDA updates and approvals accelerate with notable June surge and novel agents
June 2025 marked a high point in FDA drug approvals with 22 new drugs authorized, tying March for the top monthly volume and contributing to 107 drugs approved in the first half of the year. Key...
Boston area biomanufacturing facility groundbreak marks infrastructure expansion
GenesisM, a joint venture of Bain Capital Real Estate and Botanic Properties, has broken ground on a 154,000-square-foot, Class A biomanufacturing facility in Bedford, Massachusetts, extending...
FDA panel calls for removal of menopause hormone therapy warnings
A Food and Drug Administration panel led by Commissioner Martin Makary recommended removing black box warnings from menopausal hormone therapy (MHT) labeling. The panel emphasized MHT benefits for...
Sarepta gene therapy deaths escalate: FDA steps in
Sarepta Therapeutics faces mounting scrutiny following the confirmation of a third patient death linked to its gene therapies. The latest fatality involved a 51-year-old man treated for...
Scipher Medicine pivots to precision medicine with extensive data partnerships
Scipher Medicine, under new leadership, is transitioning from a diagnostics-only focus toward leveraging its vast non-oncology transcriptomic data for precision medicine development. The firm...
FDA advisory panels reject key drug filings for PTSD and oncology
FDA advisory committees have issued negative votes on notable drug candidates. Otsuka’s combination treatment of Rexulti and Zoloft for PTSD failed to demonstrate convincing efficacy in phase 3...
Bristol Myers’ Reblozyl misses Phase III endpoints in myelofibrosis anemia
Bristol Myers Squibb reported that Reblozyl (luspatercept) failed to meet the primary endpoint in a Phase III INDEPENDENCE trial for treating anemia in myelofibrosis patients, specifically failing...
Xeltis reports positive early clinical results for coronary bypass conduit
Xeltis announced encouraging preliminary safety and patency data from clinical trials evaluating Xabg, its bioengineered coronary artery bypass conduit, in patients with multi-vessel...