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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...
AI breakthroughs unlock drug discovery targeting intrinsically disordered proteins
Researchers led by Nobel Laureate David Baker have harnessed artificial intelligence to design protein binders for intrinsically disordered regions (IDRs), previously considered undruggable...
Quantum computing poised to tackle biopharma complexities
Emerging analyses highlight the potential of quantum computing to address complex challenges in biopharma, including molecular modeling and drug discovery processes difficult for classical...
Funding landscape: Seed and Series A investments rise amid concentrated capital
Data from the first half of 2025 indicate an increase in seed and Series A financing rounds within biotech, with $4.7 billion raised. However, the funding landscape is marked by concentration,...
Medical University of Vienna secures €2.5M grant for multiomic biomarker initiative
The Organizational Unit Core Facilities at the Medical University of Vienna received €2.5 million from the Austrian Research Promotion Agency to enhance multiomics-based biomarker discovery and...
GenesisM breaks ground on multi-tenant biomanufacturing hub in Greater Boston
GenesisM, a joint venture between Bain Capital Real Estate and Botanic Properties, has initiated construction on a 154,000-square-foot Class A biomanufacturing facility in Bedford, Massachusetts....
Sarepta Gene Therapy Safety Crisis: Third Death Confirmed
Sarepta Therapeutics is facing escalating safety concerns as a third patient has died after receiving one of its gene therapies. The latest fatality involved a 51-year-old participant in a...
Scipher Medicine Shifts to Data-Driven Precision Medicine Development
Scipher Medicine is evolving its strategy to expand beyond rheumatoid arthritis diagnostics toward broader personalized medicine using clinicogenomic datasets. Under new leadership, Scipher now...
FDA Adcomm Rejects Otsuka’s PTSD Drug Combo: Calls for More Evidence
The FDA Psychopharmacologic Drugs Advisory Committee voted 10-1 against the approval of Otsuka Pharmaceutical's combination therapy of Rexulti and Zoloft for PTSD treatment. Committee members...