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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....
Advances in Precision Medicine: Scipher Medicine Expands Beyond Diagnostics
Scipher Medicine, known for its molecular assay supporting rheumatoid arthritis treatment decisions, announced a strategic expansion into data-driven precision medicine and drug discovery across...
Quantum Computing Poised to Transform Biopharma Research
Biopharmaceutical companies are beginning to explore quantum computing for solving complex research problems that are intractable with classical methods. This nascent technology holds promise for...
Strong Seed and Series A Biotech Funding Persist in First Half 2025
Despite a challenging capital environment, early-stage biotech venture financing showed resilience in the first half of 2025. Seed and Series A rounds increased compared to the previous year,...
Major Life Sciences IPO Activity and Capital Raise Trends in 2025
The biotechnology, pharmaceutical and medical device sectors are witnessing significant activity on public and private capital markets. Hong Kong is an active venue, with 36 life science...
MedTech Sector Growth Boosts Johnson & Johnson’s Q2 Performance
Johnson & Johnson posted a strong second quarter, with med-tech divisions notably outperforming expectations. The company recorded a 6.9% increase in overall sales, led by a 22.3% surge in...
Sarepta’s Duchenne Gene Therapy Halt and Safety Concerns Deepen
Sarepta Therapeutics faces intensified scrutiny after the FDA requested the halt of its Duchenne muscular dystrophy gene therapy, Elevidys, following two patient deaths from acute liver failure....
Scipher Medicine Expands Precision Medicine via Clinicogenomic Datasets
Scipher Medicine is broadening its precision medicine efforts beyond diagnostics. After leadership changes, the company is leveraging its extensive collection of non-oncology transcriptomic data...
FDA Rejects GSK’s Blenrep Reapproval Citing Safety and Trial Issues
GSK’s antibody-drug conjugate Blenrep faced setbacks as the FDA’s Oncologic Drugs Advisory Committee voted against its relapsed multiple myeloma label expansion. Concerns raised include...