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Innovations in AI and Biotech Research Tools
The intersection of AI with biotech research advances therapeutic targeting and drug discovery. Nobel laureate David Baker's lab developed AI models to design binders for intrinsically disordered...
Biopharma Financing and Market Dynamics Slow Amid Patent Pressures
Venture funding for biotech startups declined sharply in Q2 2025, reflecting broader market contractions and fundraising difficulties. Despite this, late-stage financings and IPO activity...
Advances in Clinical Approvals and Therapeutics
June 2025 saw significant FDA activity including approvals for Gilead’s twice-yearly HIV preventive shot and Nuvation Bio’s ROS1 inhibitor for lung cancer, reflecting continued innovation in...
Biomanufacturing and Infrastructure Expansion in Boston and Beyond
GenesisM has commenced construction of a major 154,000 square-foot biomanufacturing facility in Bedford, Massachusetts, expanding capacity in the Boston area’s leading biopharma cluster. The...
Regulatory and Market Challenges Impact Oncologic and Diagnostic Firms
GSK faced an FDA advisory committee rejection over safety and dosage concerns for its multiple myeloma drug Blenrep, complicating its return to the U.S. market. Simultaneously, CareDx’s stock...
Artificial Intelligence Integrates Deeper Into Biopharma and Healthcare
Artificial intelligence is increasingly shaping biopharma innovation and clinical practice. From AI models diagnosing structural heart disease via ECG, to spatial transcriptomics projects...
Sarepta gene therapy deaths and FDA action
Sarepta Therapeutics faces major scrutiny following the deaths of three patients linked to its gene therapies for muscular dystrophies. Two teenage patients treated with Elevidys for Duchenne...
Sarepta CEO comments on gene therapy transparency and company strategy
Sarepta’s CEO Douglas Ingram addressed recent concerns around transparency, defending the company’s disclosure practices amid criticism over delayed public acknowledgement of patient deaths in...
FDA panel decisions on psychiatric and oncology therapies
The FDA’s advisory committees delivered notable decisions impacting drug approvals. The Psychopharmacologic Drugs Advisory Committee voted 10-1 against approving Otsuka’s Rexulti combined with...
Scipher Medicine expands from diagnostics to data-driven precision medicine
Scipher Medicine, known for its molecular diagnostics in rheumatoid arthritis, is pivoting toward broad precision medicine applications beyond oncology. Under CEO Reg Seeto, the company is...
FDA drug approvals and clinical trial updates in mid-2025
The FDA approved 22 new drugs in June 2025, tying for the highest monthly total this year and contributing to 107 approvals in the first half of 2025. Notable approvals include Gilead’s...
Corporate and industry financial updates in biopharma and med-tech
Biopharma financing activity showed nuanced trends with seed and Series A funding rising in first half 2025, though the total number of contributing companies decreased. In med-tech, companies...
AI and advanced technology applications in biotech research and diagnostics
Emerging technologies continue to reshape biotechnology R&D and diagnostics. Researchers at Oregon Health & Science University developed OmicsTweezer, an AI-powered machine learning tool...
Gene therapy trial developments and industry impact
Gene therapy programs face pivotal moments as safety concerns arise. Sarepta’s multiple deaths linked to its Duchenne and limb-girdle muscular dystrophy gene therapies have drawn FDA action and...
Biotech workforce and employment trends in 2025
The US life sciences workforce shows signs of slowing growth with a modest contraction in hiring during 2024 and early 2025. Despite this, companies continue investing in talent development and...
Regulatory and legal updates impacting life sciences
Regulatory environments continue to evolve, impacting clinical trial ecosystems and product labeling. The European pharmaceutical industry coalition urged swift implementation of the new EU Life...
Sarepta Faces FDA Shipment Halt Amid Duchenne Gene Therapy Deaths
Sarepta Therapeutics is confronting regulatory challenges after the FDA decided to request a halt on shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, following the deaths...
Sarepta Gene Therapy Safety Concerns Deepen with Third Patient Death
A third patient receiving Sarepta's gene therapy for limb-girdle muscular dystrophy died from acute liver failure, intensifying safety concerns around the company’s gene therapy portfolio. This...
Sarepta’s Strategic Overhaul: Workforce Cut and Pipeline Focus
Amid financial pressures and regulatory challenges linked to its gene therapy programs, Sarepta Therapeutics announced a strategic restructuring to reduce annual operating costs by approximately...
FDA Panel Rejects GSK’s Multi-Myeloma ADC Blenrep on Safety
The FDA’s Oncologic Drugs Advisory Committee voted against GSK’s application to reintroduce Blenrep, its antibody-drug conjugate for multiple myeloma, citing safety and clinical trial concerns....